Rull, The Millennium Cohort Study, NHRC.2000.0007-AM107-EP-A
INSTITUTIONAL REVIEW BOARD
MODIFICATION REVIEW
Date of Review:
August 14, 2024
Protocol Number: NHRC.2000.0007
Protocol Title:
Prospective Studies of U.S. Military Forces: The Millennium Cohort
Study
Principal Investigator:
Rudolph Rull, PhD
Project ID/WBS:
Deployment Health Research, 60002/100001869677_007A
The principal investigator submitted a modification request for a protocol that was
previously classified as minimal risk. With funding from the Defense Health Agency
administered Military Operational Medicine Research Program (JPC-5) and Department of
Veterans Affairs (VA) Research Development Testing and Evaluation funds, the primary
objective of this project is to evaluate the impact of military service, including deployments and
other occupational exposures, on long-term mental, physical, and behavioral health. The goal is
to provide evidence-based knowledge products to inform and improve interventions, guidelines,
and policy of key stakeholders including DOD and VA leaders. The objective of this research is
to examine any trends in the health of U.S. service members and their families over time.
Toward that end, the health of a cohort of regular active-duty, National Guard, and Reserve
military personnel will be followed for 67 years via surveys administered at three-year intervals.
Participants are requested to complete questionnaires every 3 to 5 years. Participants are allowed
to complete the questionnaire by paper-and-pencil or online. Individuals are tracked while
serving, as they integrate into civilian life and beyond. Participant follow-up is planned through
at least 2068. Survey information collected includes mental, physical, and behavioral health
metrics as well as military and post-service experiences. These data are linked to enterprise
databases, including military, healthcare utilization, and mortality records.
The modification requests to:
(1) Add two new participant contacts (to be included in Appendix G):
a. A completion email for those that complete the web survey
b. A thank-you card for responders that choose to receive the gift hat
(2) Revise Section 13.2 of the protocol to include:
a. Update the date of the last Office of General Counsel approval
b. Add a challenge coin thank-you gift option for participants that complete the
web survey
c. Indicate that instead of a gift card, the project will offer a gift code
d. Remove listed vendors that the study team was unable to establish contracts
e. Explain the process for providing participants with the gift code
A waiver of documentation of informed consent has been granted for this study under 32
CFR§219.116(f) in that the research involves no more than minimal risk, subjects’ rights and
Rull, The Millennium Cohort Study, NHRC.2000.0007-AM107-EP-A
welfare would not be adversely affected, and the only record linking the subject to the study
would be the signature on the consent form.
The Principal Investigator is informed that any research personnel engaged in human
subject research on this protocol with missing or expired required training certificates are not
authorized to work on this study until the NHRC HRPP Office receives their current training
certificates for file.
The NHRC IRB Chair reviewed this submission under the expedited review authority and
permitted under 32 CFR §219.110(b)(2). The 32 CFR §219.111 criteria for the approval of
research have been met. The NHRC Chair approves this protocol modification.
The research is expected to end on September 30, 2068.
In accordance with 32 CFR § 219.109(f), the Revised Common Rule, continuing review of
this protocol is no longer required. All other reporting requirements remain in effect. The NHRC
IRB Chair approves this research.
PHI NGO, MA
Chair, Institutional Review Board (IRB)
EIRB Modification Form (Version 34.1)
1.0
1.1
Study and PI Info
Principal Investigator:
Name:
Rudolph P Rull
Email:
[email protected]
PH #:
6195539267
1.2
Study Information:
Study Title:
Prospective Studies of U.S. Military Forces: The Millennium Cohort Study
Study Number:
The Millennium Cohort Study, NHRC.2000.0007
Expiration Date:
Protocol Abstract/Summary:
Summarize the proposed study in 500 words or less, to include the purpose, the subject
population, the study's design type, and procedures
In the late 1990s, the US Department of Defense (DoD) and Congress identified the need for coordinated
epidemiological research to determine how military occupational exposures, including deployment, affect longterm health. The Institute of Medicine more specifically defined the importance of a large, prospective study for
evaluating exposures and a broad spectrum of important health outcomes. The Millennium Cohort Study was
designed, in collaboration with all military services and the Department of Veterans Affairs (VA), to meet
these research challenges.
Launched in 2001, the Millennium Cohort Study began by recruiting a representative sample of US military
personnel, including both active duty and Reserve/ National Guard members. Currently, over 200,000
participants have been enrolled in the study. Participants are requested to complete questionnaires every 3 to 5
years. Individuals are tracked while serving, as they integrate into civilian life and beyond. Participant follow-up
is planned through at least 2068. Survey information collected includes mental, physical, and behavioral health
metrics as well as military and post-service experiences. These data are linked to enterprise databases, including
military, healthcare utilization, and mortality records. The fifth follow-up survey is currently underway (20192020).
The primary objective of this project is to evaluate the impact of military service, including deployments and
other occupational exposures, on long-term mental, physical, and behavioral health. The ultimate goal is to
provide evidence-based knowledge products to inform and improve interventions, guidelines, and policy of key
stakeholders including DoD and VA leaders.
As the largest and longest running cohort study in military history, the Millennium Cohort Study is uniquely
positioned to follow the course of mental, physical, and behavioral health of service members, including the
transition to civilian life. Veteran’s health and well-being have become growing priorities for our research
portfolio as 70% of our participants have left active military service.
1.3
Study Status:
Study is open to accrual:
No participants have been enrolled
No additional risks have been identified
Participants are currently receiving study intervention
Participants have been enrolled but none are currently receiving study intervention
Ongoing data/medical record review/biological specimen collection
Study is closed to accrual:
Some participants are still receiving study intervention
Study intervention is complete for all participants; research-related diagnostic tests or followup clinic visits are continuing
Study intervention is complete or there was no intervention and there is ongoing researchrelated follow-up contact with participants via questionnaires, phones calls, interviews or
mailings
Study intervention is complete or there was no intervention and follow-up is limited to review
of medical records or other records (no ongoing contact)
Study is in data analysis phase only
2.0
2.1
Modifications
Type of modification:
Personnel changes
Administrative changes
Minor Modification – a non-administrative change that does not affect the rights, safety, or
welfare of the subjects
Major Modification – a change that does affect the rights, safety, or welfare of the subjects
Convert to multi-site
2.2
This modification requires changes to (check all that apply):
Protocol (This must be selected if making changes to the PI or if making changes to personnel
without an EIRB account)
Consent documents or Waiver/Modification of Consent (revising or adding new documents)
HIPAA Authorization/Waiver
Recruitment/Advertising documents
Other study documents (revising or adding new documents)
2.3
Has any component of this modification already been implemented?
Yes
2.4
Does the modification impact study design in such a manner that requires scientific review?
Yes
2.5
No
No
Does this modification impact any Investigators’ Conflict of Interest Disclosure form?
Yes
No
If yes please explain:
2.6
This modification includes a change to enrollment targets:
Yes
2.7
No
* Please describe all changes that are being requested in this submission.
The Millennium Cohort Study is submitting for review and approval:
1. Two (2) additional participant contacts added to Appendix G.
2. Updates to section 13.2 of the protocol.
2.8
* Explain why these modifications are being made:
1. Two (2) new contacts have been added to Appendix G.
2. Section 13.2 of the protocol has been modified to
1. update the date of the last OGC approval
2. add the challenge coin as a thank you gift option for participants that complete the
web survey
3. show that instead of a gift card, the project will offer a gift code
4. remove vendors with whom we were not able to establish contracts
5. explain the way with which we will provide the participant with the gift code, if
selected.
2.9
This modification is being submitted as a result of an adverse event (AE) report, protocol violation or
incident report, unanticipated problem involving risks to subjects or others (UPIRTSO), or publication
of a new Investigator's Brochure (IB) or other safety data:
Yes
No
UPIRTSO Adverse event report
Protocol violation or incident report
New Investigator's Brochure
Other safety data
Was this event previously reported?
Yes
2.10
No
Have the risks to subjects changed (i.e. increased or decreased) by the modification?
Yes
No
If yes, describe how the modification will affect the risk/benefit ratio for the subjects:
3.0
3.1
Revisions to the Protocol
Make revisions to the protocol template form as necessary:
If making changes to the PI, or to personnel without an EIRB account, changes to the Personnel
Details (5.0) section are required.
Edit/
View
Version
1.46
Title
EIRB Protocol Template (Version 1.46) - Attached
3.2
Do you plan to notify currently or previously-enrolled subjects of these changes?
Yes – all subjects
Yes – currently-enrolled subjects only
No
If no, why not (e.g., Correcting typos or administrative changes that do not affect subjects’
decision to participate?)
This modification does not change the risks of the study, therefore, the participants will not be
notified.
If yes, describe the process for informing subjects (e.g., re-consent, letter sent to subjects, etc.)
4.0
Other Study Documents
4.1
Attach Other Study Documents (revised documents or new documents)
Version
Title
Category
1.0
Completion
Messages
Other
1.42
APPENDIX G
PARTICIPANT
CONTACTS
Other
Expiration
Date
Document
Outcome
Checked
Out
View
Document
248.33
KB
8.74 MB
5.0
Updated Conflict of Interest Disclosure
5.1
Are there any changes in any financial interests related to this study or in any conflicts of interest of
the PI or any other investigator?
Yes
No
EIRB Protocol Template (Version 1.46)
1.0
General Information
*Please enter the full title of your study:
Prospective Studies of U.S. Military Forces: The Millennium Cohort Study
*Please enter the Protocol Number you would like to use to reference the protocol:
The Millennium Cohort Study, NHRC.2000.0007
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
2.0
No
Add Site(s)
2.1 List sites associated with this study:
Primary
Department Name
Dept?
Navy - Naval Health Research Center (NHRC)
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
Rull, Rudolph P
Select if applicable
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
Castaneda, Sheila Faye, PhD
Co-Investigator
Stander, Valerie A, Ph.D.
Co-Investigator
B) Research Support Staff
Altarejos, Isabel Velasco, MPH
Team Member
BRAMER, BRITTANY ANN
Research Coordinator
Carinio, Sarah Rebecca
Team Member
Gumbs, Gia R
Team Member
Lovec-Jenkins, Denise Elaine
Research Coordinator
Seay, Julia S, PhD
Team Member
Sheppard, Beverly DESIREE
Research Coordinator
Tannenbaum, Karen, PhD
Team Member
Walstrom, Jennifer Lee
Research Coordinator
3.3 *Please add a Protocol Contact:
BRAMER, BRITTANY ANN
Castaneda, Sheila Faye, PhD
Lovec-Jenkins, Denise Elaine
Rull, Rudolph P
Sheppard, Beverly DESIREE
Walstrom, Jennifer Lee
The Protocol Contact(s) will receive all important system notifications along with the Principal
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
Add the name of the individual authorized to approve and sign off on this protocol from your Site
(e.g. the Site Chair).
4.0
4.1
Project Information
* What department(s) will be associated with this protocol?
Other
4.2
* Is the IRB of record for this study an IRB/HRPP that does NOT use EIRB? If Yes, complete the
application according to the IRB/HRPP Determination.
If your Projects or Protocols are under the oversight of another IRB that does use EIRB, stop this
submission and contact the core site and request an invitation as a performing site.
If your Project or Protocol is now being submitted for the first time to an IRB that does use EIRB,
continue with this application and answer the questions to be reviewed by the IRB.
Answering yes means the board of record is an IRB that does NOT use EIRB.
Yes
4.3
* Is this protocol research, expanded access, or humanitarian use device?
Yes
4.4
No
No
* What type of protocol is this?
Behavioral Research
Biomedical Research
Clinical trial (FDA regulated)
Educational Research
Expanded Access
Humanitarian Use Device (HUD)
Psychosocial Research
Oral History
Other
4.5
Are you conducting this project in pursuit of a personal degree?
Yes
4.7
* Is this human subjects research? (As defined by 32 CFR 219) Human subject means a living
individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and
uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable
biospecimens.
Yes
4.8
5.1
No
Personnel Details
Does the Principal Investigator have a Permanent Change of Station (PCS) Date or Estimated
Institutional Departure Date (EIDD)?
Yes
5.2
No
* Do you believe this human subjects research is exempt from IRB review?
Yes
5.0
No
No
List any Research Team members without EIRB access that are not previously entered in the protocol:
Name:
(Last, First, M.I.)
McMaster, Hope
Role on Protocol:
Phone Number:
619-767-4624
Email Address:
hope.m.mcmaster.
[email protected]
Associated
Institution:
NHRC
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Trone, Daniel
Role on Protocol:
Phone Number:
619-767-4567
Email Address:
daniel.w.trone.
[email protected]
Associated
Institution:
NHRC
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Carey, Felicia
Role on Protocol:
Phone Number:
619-767-4905
Email Address:
felicia.r.carey.
[email protected]
Associated
Institution:
NHRC
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Castaneda, Sheila
Role on Protocol:
Phone Number:
619-553-8025
Email Address:
sheila.f.castaneda.
[email protected]
Associated
Institution:
NHRC
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Belding, Jennifer
Role on Protocol:
Phone Number:
619-553-6889
Email Address:
jennifer.n.belding.
[email protected]
Associated
Institution:
NHRC
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Carnes, Nathan
Role on Protocol:
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Phone Number:
405-816-5079
Email Address:
nathan.c.carnes.
[email protected]
Associated
Institution:
NHRC
Stander, Valerie
Phone Number:
Email Address:
619-553-7174
valerie.a.stander.
[email protected]
Associated
Institution:
Role on Protocol:
Co-Principal
Investigator;
engaged in HSR
NHRC
Name:
(Last, First, M.I.)
Rull, Rudolph
Phone Number:
Role on Protocol:
619-553-9267
Principal
Investigator;
engaged in HSR
Email Address:
rudolph.p.rull2.
[email protected]
Role on Protocol:
NHRC
Associated
Institution:
Name:
(Last, First, M.I.)
Peretti, Jacqueline
Associated
Institution:
Phone Number:
209-373-9646
Email Address:
jacqueline.
[email protected]
Key Support; not
engaged in HSR
NHRC/UCSDSDSU Preventive
Medicine
Residency, Naval
Medical Center
San Diego
Name:
(Last, First, M.I.)
Allos, Khider
Phone Number:
Role on Protocol:
Associated
Institution:
(619) 553-6892
khider.e.allos.
[email protected]
Phone Number:
Email Address:
Associated
Institution:
Phone Number:
Email Address:
Associated
Institution:
IT Specialist/Data
Managment;
engaged in HSR
Name:
(Last, First, M.I.)
Email Address:
NHRC
Role on Protocol:
Name:
(Last, First, M.I.)
Role on Protocol:
5.3
Are any Contractors or Subcontractors involved in this study? If yes, please list them and describe their role.
Yes
Name:
No
(Last, First, M.I.)
Bauer, Lauren
Role on Protocol:
Phone Number:
619-767-4605
Email Address:
Associated
Institution:
lauren.m.bauer2.
[email protected]
NHRC; Leidos,
Inc., IAIR executed
Email Address:
Associated
Institution:
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Baccetti, Anna
Phone Number:
Role on Protocol:
530-263-9567
anna.l.baccetti.
[email protected]
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Speigle, Steven
Phone Number:
Role on Protocol:
619-553-8096
Email Address:
steven.j.speigle.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Dorrell, Michael
Phone Number:
Role on Protocol:
650-576-1171
Email Address:
michael.s.dorrell2.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Richardson,
Sabrina
Email Address:
Phone Number:
Associated
Institution:
619-553-7598
sabrina.m.
richardson5.
[email protected]
NHRC; Leidos,
Inc., IAIR executed
Tu, Xin
Phone Number:
Email Address:
Associated
Institution:
Role on Protocol:
(610) 724-6925
[email protected]
Role on Protocol:
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
NHRC; IES, IIA
executed
LeardMann,
Cynthia
Role on Protocol:
Phone Number:
619-553-8447
Email Address:
cynthia.a.
leardmann.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Rivera, Anna
Phone Number:
Role on Protocol:
619-567-9025
Email Address:
anna.c.rivera4.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Jacobson, Isabel
Phone Number:
Role on Protocol:
619-553-0684
Email Address:
isabel.g.jacobson.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Hall, Clint
Phone Number:
Role on Protocol:
619-767-4762
Email Address:
clinton.j.hall15.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Bukowinski, Anna
Phone Number:
Role on Protocol:
619-553-4690
Email Address:
anna.t.bukowinski.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Boparai, Satbir
Phone Number:
Role on Protocol:
619-553-7980
Email Address:
satbir.k.boparai.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Geronimo-Hara,
Toni
Email Address:
Phone Number:
Associated
Institution:
Role on Protocol:
619-553-7938
tonirose.t.
geronimo-hara.
[email protected]
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Kolaja, Claire
Phone Number:
Role on Protocol:
619-553-7859
Email Address:
claire.a.kolaja.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Email Address:
Esquivel, Alejandro
Phone Number:
Role on Protocol:
619-767-4489
alejandro.p.
esquivel.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Woodall, Kelly
Phone Number:
Role on Protocol:
(562) 355-7387
Email Address:
kelly.a.woodall.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Barkho, Wisam
Phone Number:
Role on Protocol:
619-553-9337
Email Address:
wisam.z.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Ray, Travis
Email Address:
Phone Number:
travis.n.ray2.
[email protected]
Role on Protocol:
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Email Address:
Moreno Ignacio,
David
Phone Number:
Role on Protocol:
619-553-6892
david.
morenoignacio.
Associated
Institution:
NHRC; Leidos,
[email protected]
Inc., IAIR executed
Email Address:
Associated
Institution:
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Zhu, Yunnuo
(Katie)
Role on Protocol:
Phone Number:
858-531-6133
yunnuo.zhu.
[email protected]
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Sharifian, Neika
Phone Number:
Role on Protocol:
919-271-7891
Email Address:
neika.sharifian.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Villalobos, Jr.,
Javier
Role on Protocol:
Phone Number:
559-974-1129
Email Address:
javier.villalobos12.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Roesch, Scott
Phone Number:
Role on Protocol:
Email Address:
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Romano, Celeste
Phone Number:
Role on Protocol:
619-553-9292
Email Address:
celeste.j.romano.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Harbertson, Judith
(Judy)
Phone Number:
Role on Protocol:
619-553-9095
Email Address:
Associated
Institution:
judith.harbertson.
[email protected]
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Email Address:
Jackson, Lauren
Phone Number:
Role on Protocol:
619-553-7317
lauren.e.
jackson27.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Jamil, Ammar
Phone Number:
Role on Protocol:
619-767-4719
Email Address:
marc5477@gmail.
com
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Altarejos, Isabel
Velasco
Role on Protocol:
Phone Number:
619-507-0337
Email Address:
isabel.v.altarejos.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Bramer, Brittany
Phone Number:
Role on Protocol:
619-226-5059
Email Address:
brittany.a.bramer.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Carinio, Sarah
Phone Number:
Role on Protocol:
619-767-4847
Email Address:
sarah.r.carinio.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Gumbs, Gia
Phone Number:
Role on Protocol:
619-813-8271
Key Support;
Email Address:
gia.r.gumbs.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
engaged in HSR
Name:
(Last, First, M.I.)
Lovec-Jenkins,
Denise
Role on Protocol:
Email Address:
Phone Number:
619-553-7433
denise.e.lovecjenkins.ctr@health.
mil
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Email Address:
Sheppard, Beverly
Phone Number:
Role on Protocol:
619-553-8750
beverly.d.
sheppard.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Tannenbaum,
Karen
Email Address:
Phone Number:
karen.tannenbaum.
[email protected]
Role on Protocol:
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Walstrom, Jennifer
Phone Number:
Role on Protocol:
619-553-9145
Email Address:
jennifer.l.walstrom.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Lewis, Crystal
Email Address:
Phone Number:
crystal.l.lewis43.
[email protected]
Role on Protocol:
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Richard, Erin
Role on Protocol:
Key Support;
engaged in HSR
Email Address:
Phone Number:
erin.l.richard.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Name:
(Last, First, M.I.)
Consigli, Rebecca
Phone Number:
Role on Protocol:
(661) 334-0837
Email Address:
rebecca.a.consigli.
[email protected]
Associated
Institution:
NHRC; Abbtech,
IIA executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Toma, Helen
Email Address:
Phone Number:
helen.toma.
[email protected]
Role on Protocol:
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Haile, Yohannes
Phone Number:
Role on Protocol:
(619) 767-4847
Email Address:
yohannes.g.haile.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Burce, Cleo, M
Phone Number:
Role on Protocol:
(619) 553-7569
Email Address:
cleomae.p.burce.
[email protected]
Associated
Institution:
NHRC; Leidos,
Inc., IAIR executed
Key Support;
engaged in HSR
Name:
(Last, First, M.I.)
Woods, Kerris, J
Phone Number:
Role on Protocol:
(619) 553-7522
Email Address:
kerris.j.woods.
[email protected]
Key Support;
engaged in HSR
5.4
Will you have a Research Monitor for this study?
Yes
No
N/A
6.0
Associated
Institution:
NHRC; Dan
Sources, Inc., IIA
executed
Data/Specimens
6.1
Does the study involve the use of existing data or specimens only (no interaction with human
subjects)?
Yes
7.0
7.1
No
Funding and Disclosures
Source of Funding:
Funding Source
Funding Type
Military Operational
Medicine Research
Program (MOMRP)
(JPC-5)
:
:
Research
Development
Testing and
Evaluation (RDT&E)
funds
:
Research
Development
Testing and
Evaluation (RDT&E)
funds
Amount
Defense Health Program
:
Other
Department of Veterans
Affairs
Total amount of funding:
7.2
Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
Yes
No
All personnel engaged in research must complete and attach a Conflict of Interest (COI) form.
8.0
8.1
Study Locations
Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
Yes
8.2
No
Study Facilities and Locations:
Institution
Site Name
Site Role
No records have been added
FWA or DoD Assurance
Assurance
Expiration
Number
Date
IRB
Is there an
Reviewing
agreement?
for Site
Other:
Other
Institution
Site
Site Role
FWA or DoD
Assurance
Number
FWA or DoD
Expiration
Date
Is there an
agreement?
IRB
Reviewing for
Site
No records have been added
8.3
Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local
research context has been considered
Yes
8.4
No
Is this an OCONUS (Outside
Yes
Continental United States) study?
No
Select the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to
study approval)
Yes
9.0
9.1
No
Study Details
Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
service members, longitudinal, mental health, physical health, behavioral health
9.2
Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include
descriptions of any preliminary studies and findings that led to the development of the
protocol. The background section should clearly support the choice of study variables and
explain the basis for the research questions and/or study hypotheses. This section establishes
the relevance of the study and explains the applicability of its findings
Background
In response to Iraq’s invasion of Kuwait (August 2, 1990) the United States began deploying
troops to the Arabian Gulf region five days later in Operation Desert Shield (Operation Desert
Storm, 1997). A total of 40 coalition countries deployed troops to the region, including the
United Kingdom, Canada, and France. On January 17, 1991, the air war against Iraq began
(Operation Desert Storm), which was followed by a 4-day ground war starting on February 24,
1991.
By the end of active hostilities on February 28, 1991, the United States had deployed
approximately 697,000 troops to the theater of operations, the British had deployed 53,000
troops, and the Canadians had deployed 4,500 military personnel. In contrast to previous
conflicts, a larger proportion of U.S. troops were from the reserves/National Guard (17%) and
were female (7%). Mortality and morbidity rates during the fighting were markedly lower than
expected. By May 1991, most U.S. military personnel had left the theater of operations.
Beginning soon after the Desert Storm fighting ended in 1991, numerous Gulf War veterans
complained of morbidity that they attributed to their deployment exposures. With the aid of a
number of expert external review panels, (1-5) the U.S. government created intensive health
registry examinations, (6,7) sponsored medical research, (8) and created large investigative
organizations with a focus of risk management.9 As of 1999, the U.S. government has invested
approximately one billion dollars (Riddle, LTC James R., OASD/HA, personal communication)
in examining the health of Gulf War veterans.
Expert External Review Panels
The federal government has commissioned numerous external review panels to examine the
health of Gulf War veterans or to monitor actions of the federal government in conducting such
examinations. The external review panels have included:
Defense Science Board(1,10)
Presidential Advisory Committee on Gulf War Veterans’ Illnesses (2,5,11)
Institute of Medicine(IOM) Committee on Measuring Health of Gulf War Veterans
(3,4,12-16)
General Accounting Office (17-29)
Presidential Special Oversight Board for Department of Defense Investigations of Gulf
War Chemical and Biological Incidents (30,31)
While it is beyond the scope of this introduction to review the findings of the external review
panels, it should be recognized that review panel findings have greatly influenced the directions
of clinical care, research, public relations, and veteran compensation.
Health Registry Evaluations
The Department of Veterans Affairs (DVA) established comprehensive clinical evaluations of
Gulf War veterans in 1992. The Department of Defense (DoD) followed this example in
establishing similar structured evaluations in 1994. The United Kingdom established similar
evaluations soon thereafter. In the United States more than 150,000 Gulf War veterans and
family members have registered in these programs. (6,32) In the United Kingdom more than
1,000 Gulf War veterans have been evaluated. (33)
Since registry participants are self-referred, registry health findings are really a series of
cases. While these case series are not generally valuable in determining exposure risk, they
have been valuable in demonstrating that few Gulf War veterans have unexplained symptoms
without a recognized medical condition or diagnoses.(7,32) They have also been helpful in
identifying the most frequent self-reported symptoms among Gulf War veterans and in
demonstrating that among symptomatic Gulf War veterans, many would meet diagnostic criteria
for multi-symptom conditions, such as chronic fatigue syndrome and posttraumatic stress
disorder (PTSD).(34)
Previous Gulf War Veteran Research
The investment in medical research concerning Gulf War veterans has resulted in numerous
important findings. Research reports and manuscripts are best chronicled in the DVA Annual
Report to Congress (8) and in a 4,462-citation Topical Bibliography of Published Works
Regarding the Health of Veterans of the Persian Gulf War. (35)
Much of Gulf War veteran research has involved epidemiological studies. Empirically, we
categorized these studies into five areas:
Studies of mortality-Several studies have examined deaths among Gulf War veterans,
(36-38) and with the exception of increased deaths due to accidents, (38) found little
evidence of unexplained deaths associated with service in the Gulf War.
Studies of hospitalizations–Numerous comparisons of post-1991 hospitalizations of Gulf
War veterans and those of other veterans of the same era have been published. (39-43)
Data from DoD, VA, and California hospitals do not support arguments that Gulf War
veterans are being hospitalized at a higher rate for Gulf War-related conditions.
Studies of symptoms-Controlled studies of Gulf War veterans unanimously document
that Gulf War veterans report more conditions and have evidence of more psychological
morbidity. (44-48) However, investigators have not been able to implicate specific Gulf
War exposures as causing these symptoms. While one team of scientists used factor
analysis to suggest unique aggregations of symptoms among Gulf War veterans, (49)
other investigators have found the same factor-analysis symptom aggregations among
non-deployed veterans. (50-52)
Studies of reproductive outcomes–While a number of news reports have suggested that
Gulf War veterans are experiencing unusual reproductive outcomes, published research
studies have not validated these reports. Thus far, researchers have not found increases
in the number of birth defects among the offspring of Gulf War veteran families. (53-56)
Etiologic exposures–A number of investigators have championed hypotheses concerning
the cause of increased symptom reporting among Gulf War veterans. While often not in
the mainstream of etiologic thinking, these hypotheses have influenced some
investigative research. (4,15,57,58) These hypotheses have implicated:
Mycoplasma fermentans (59-61)
Pyridostigmine bromide (62,63)
Multiple chemical sensitivity (64)
Depleted uranium (65)
Sand exposure (66)
Deployment vaccinations (67)
Chemical agent resistant coating (CARC)
Oil well fires (17)
Nerve agents (42)
In general, no one specific exposure or group of exposures has been implicated as the cause of
illnesses among Gulf War veterans.
Data Limitations
The lack of pre-deployment health data and deployment exposure data have been chief
limitations in examining Gulf War veteran morbidity questions. Numerous improvements have
or are being made to gain such data for future U.S. military deployments. These efforts include
capturing better service-entry health data, before and after deployment health data,
environmental and morbidity data during deployments; improving communications regarding
deployment risks; and focusing clinical and epidemiological research programs on deployed
populations. (13,68-71)
Risk Management
Following the Gulf War, veterans from the 123rd Army Reserve Unit in Indiana began to
complain of health problems they associated with their service in the Gulf. An investigation by
the Army Medical Corps was unrevealing. Soon afterward, stories of individual illnesses and
clusters of illnesses came to public attention. The media soon labeled these illnesses Gulf War
syndrome. The DVA (1992) and DoD (1994) responded to veterans’ concerns with initiation of
two comprehensive self-referral clinical evaluation programs. Early reports finding neither
common illnesses nor a specific cause for Gulf War syndrome, were attacked as incomplete by
veterans’ groups and the media. More vocal commentators pointed to a “conspiracy of silence”
and a large-scale coverup. In late 1996, the story acquired new urgency, with several reports
documenting the “probable” exposure of U.S. personnel to enemy chemical weapons destroyed
in the Khamisiyah area in March 1991 and highlighting the lapses of Pentagon authorities in
publicizing that information. In 1996, the Special Assistant to the Deputy Secretary of Defense
for Gulf War Illnesses (OSAGWI) was appointed to investigate the possible chemical and
biological events and environmental exposures during Operations Desert Shield and Desert
Storm that might have caused veterans’ illnesses. Over the ensuing months, news reports
appeared almost daily focusing on “hidden” exposures, new and often not biologically plausible
hypotheses about disease causation, and strident criticisms of government efforts to address the
problems of Gulf War illnesses. (72) Since then, OSAGWI, comprising over 100 risk
management and medical staff, has done much to investigate and inform veterans of exposures
and health risks concerning their Gulf War service. OSAGWI has published a number of case
narratives and environmental exposure reports, which have been disseminated via the Internet:
(see http://www.gulflink.osd.mil/)
Recommendations for the Longitudinal Study of Deployed Forces
The 1999 IOM Measuring Health Report (12) surmised that numerous investigations and
research efforts have been undertaken because of concern about the impact of the Gulf War on
the health of U.S. troops who served in that conflict. Some of these efforts addressed the federal
government’s preparedness to meet its obligations and responsibilities to protect U.S. military
service members, veterans, and their families. Others attempted to determine what health
effects might be attributed to service in the Gulf War. Still others have identified possible causes
for the myriad reports of health problems among Gulf War veterans.
IOM also recognized that the continuing focus on the health problems of Gulf War veterans is
attributable in no small part to the efforts of individual veterans and the organizations that
represent them. They have tirelessly pressured policy officials and the Congress that more
needs to be done to help those Gulf War veterans who are experiencing health problems. In its
report on measuring health, the IOM committee recommended implementation of a research
portfolio centered on a prospective cohort study of deployed forces. The IOM committee
maintained that establishing a prospective cohort study of deployed forces would lead to a
greater understanding of the longer-term health effects of military service, including service in
deployments such as the Gulf War.
IOM also noted that a schism has developed, with ill veterans and their representatives on one
side and the federal agencies charged with addressing veterans’ health problems on the
other. IOM recommended that coordinated and concerted efforts must be made to bridge this
gap. The IOM committee believes that if DoD and DVA initiate the recommendations in this
report, the actions will greatly facilitate that unification process.
One of the current difficulties inherent in researching deployment health concerns is the lack of
a system for monitoring the longitudinal health of active, reserve, and National Guard forces, as
well as the health of veterans and their families. The VA and DoD have developed health
registries for active-duty service members and for veterans involved in specific events and
deployments. While these registries serve useful purposes, they reflect the health of a selfselected sample of veterans, and thus they are not representative of the active-duty and veteran
population in general. Of fundamental importance is the development of a longitudinal
monitoring system that is representative of active-duty, National Guard, reserve troops, and
veterans; that measures health at specific time points; and that measures changes in health over
time.
The 1999 IOM report presents a research portfolio and prospective cohort study that could, with
appropriate extension, provide a model for a long-term tracking system of the health of veterans
of military deployments. The portfolio encompasses three principal categories of research:
population studies, health-services research, and clinical and biomedical investigations. An
essential feature of the research portfolio is facilitating linkages across individual studies
through the collection of a core set of key data elements (describing health, individual, and
cultural characteristics) in order to provide for comparisons across all research.
Additionally, future efforts to measure the health of those individuals deployed to military
conflicts and peacekeeping missions should include, to the extent possible, information obtained
before, during, and after deployment. The National Academy of Sciences is currently
conducting an evaluation of strategies to protect the health of deployed U.S. forces, and a
component of this study examines improvements in keeping medical records and documenting
exposures, treatment, tracking of individuals through the medical evacuation system, and health
/administrative outcomes. Data obtained before, during, and after deployment through the kinds
of systems reviewed in this forthcoming Academy report will be important components of future
deployment-related health research.
Section 743 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999
authorized the Secretary of Defense to establish a center devoted to “…longitudinal study to
evaluate data on the health conditions of members of the Armed Forces upon their return from
deployment…” On September 30, 1999, Dr. Sue Bailey, Assistant Secretary of Defense, Health
Affairs, under delegated authority from the Secretary of Defense directed the Services to
establish a Research and Clinical Center for Deployment Health. The research component of
the Center has been designated as a responsibility of the Naval Health Research Center (NHRC),
San Diego, California.
Planning, funding, and implementing the deployed forces study recommended in the IOM report
is the next logical course. No other national studies provide follow-up of active military forces
that explicitly address exposures specific to operational deployments.
Future Efforts
Federal Gulf War veteran research is coordinated by the Research Working Group of the
Military and Veterans Health Coordinating Board. This body also guides new research activity.
(8,73)
In 1998, considering all the completed and existing research regarding Gulf War veterans, the
Research Working Group established four priorities for future research:
Research on treatments for Gulf War veterans’ illnesses
Longitudinal follow-up of Gulf War veterans’ illnesses
Research on improved disease prevention, especially in the area of stress-related
symptoms
Research to improve environmental and occupational hazard identification and risk
assessment
Various new studies have been commissioned in accordance with these priority areas.
In response to health questions following the Gulf War and the increasing demands of a series of
hazardous deployments, the military health system has undergone a fundamental reorientation.
A new strategy has been developed and is being implemented to protect U.S. forces against all
foreseeable physical and psychological threats. This "Force Health Protection" strategy
balances our key responsibilities to (1) promote and sustain health and wellness throughout each
person's military service; (2) prevent acute and chronic casualties; (3) rapidly stabilize, treat, and
evacuate casualties; and (4) perform medical surveillance, longitudinal health studies, and
ensure adequate medical records documentation and clinical follow-up for deployed forces. The
Force Health Protection strategy has played a key role in further reductions in illness and injury
rates since the Gulf War.
In the report to the Committee on National Security, House of Representatives and the Armed
Services Committee, U.S. Senate on Effectiveness of Medical Research Initiatives Regarding
Gulf War Illnesses, the DoD identified the need for a coordinated capability to apply
epidemiological research to determine whether deployment-related exposures are associated
with postdeployment health outcomes. The proposed Millennium Cohort Study, a prospective
study of U.S. military forces, responds to this need and to recent recommendations from IOM to
systematically collect population-based demographic and health data on service personnel
throughout their military careers and after leaving military service.
IOM, in making the recommendations that initiated this study, recognized that the study will be
challenging and that it will require a sustained commitment of resources by Congress, DVA, and
DoD, and of time and cooperation by study participants. Nevertheless, IOM felt that these
commitments are important and worthwhile if the nation is to adequately understand and
respond to the health needs of not only Gulf War veterans, but veterans of future conflicts in
which U.S. military forces are committed.
IOM recognized that if a prospective study had been ongoing at the time of the Gulf War, many
of the problems researchers have faced in attempting to resolve Gulf War veterans’ health issues
several years removed from the end of that conflict, could have been eliminated. The IOM,
DoD, and DVA agreed that such efforts would contribute greatly to our understanding of the
impact of military conflict on the health of the men and women who served in those
conflicts. This study design will permit estimation of the distribution within the population of a
broad variety of health-related measurements, including psychological measurements. The
study design will also capitalize on existing and planned DoD and VA infrastructure and
resources to track and measure the health of military forces and veterans.
The proposed Millennium Cohort Study is an essential component of DoD’s Force Health
Protection strategy. The lack of ongoing prospective longitudinal health studies was recognized
as a critical shortfall in our ability to answer questions concerning illness among Gulf War
veterans. The planning, funding, and development of the infrastructure to accomplish
population-based prospective studies to examine the impact of military service, including
deployments, on the physical and mental health of veterans has been ongoing for several years.
Million Veteran Program (MVP)
The Million Veteran Program (MVP) is a national, voluntary research program conducted by the
Department of Veterans Affairs (VA) Office of Research and Development (ORD). A data use
agreement between NHRC/MCS and VA/MVP has been established to cover the activities listed
here, specifically the bi-directional sharing of contact information to determine appropriate
MCS participants to contact. No research data will be sent to the MVP until these agreements
are in effect.
This effort will initially be restricted to Millennium Cohort Study (MCS) participants who have
separated from active duty service, but is planned to also include active duty MCS participants
once appropriate high-level DoD and VA agreements are in place. Additional restrictions will
apply depending on the study panel. For Panel 1 and 2 participants, only those participants who
meet the following criteria will be contacted:
Have a good postal address.
Answered YES to question #114 in the 2014 MCS follow-up survey: “A great deal has
been learned from this study and as a result we may be asked to consider other research
possibilities. If other related research studies become available, may we contact you to let
you know about them?"
Have not already enrolled or refused to enroll in MVP.
For Panel 3 and 4 participants, only those participants who meet the following criteria will be
contacted:
Have a good postal address.
Have not answered NO to question #114 on the 2014 MCS follow-up survey.
Have not already enrolled or refused to enroll in MVP.
In order to determine those MCS participants who have already enrolled in MVP or refused to
join MVP, MVP study staff will send to MCS encrypted social security numbers (SSNs) of
those MCS participants. These data will be sent via the DoD Secure Access File Exchange
(SAFE) site. Upon receipt of these data, MCS staff will remove these participants with matching
SSNs from the list of MCS participants who have met the other eligibility criteria.
The remaining eligible participants will be sent one postal contact with information about
enrolling in MVP along with the option to opt out from receiving any information. This letter
includes information about the Precision Medicine Initiative (PMI). Those participants who do
not wish to receive information and enrollment materials from MVP will be asked to tear off the
bottom portion of the letter and return it to the Millennium Cohort Study in a provided postage
paid envelope within 30 days of receipt of the letter. After 60 days of the expected receipt of the
letter, MCS study staff will generate a list of eligible participants who did not return the postcard
along with their respective current contact addresses. This list will be encrypted and sent to
MVP staff via the DoD SAFE site. The MVP will then send these individuals an invitation to
enroll in the MVP study.
The above-mentioned high-level DoD and VA agreement (NMR-9558-Memorandum of
Agreement Between Department of Defense, Naval Health Research Center and Department of
Veterans Affairs, Office of Research and Development for Data Sharing- Millennium Cohort
Study with Million Veteran Program) has been established. A copy of the established
Agreement is located in Appendix J of this protocol.
Per this Agreement, the MCS will provide the MVP study with five data elements for all living
Millennium Cohort participants: MVP study specific Study Identification Numbers (Dummy
SIDs), last name, DOB, SSN, and postal address. Additionally, MCS will contact eligible active
duty and Veteran MCS participants with information about enrolling in MVP. Only those MCS
participants who meet the following criteria will be contacted:
MVP criteria
Never enrolled in MVP
Did not decline participation in the MVP
Was not previously invited to join MVP
MCS Criteria
Must have completed the MCS 2019-21 follow-up survey
Did not refuse future contact or withdraw from the MCS
Did not opt out from future contact during the previous 2017 MVP co-enrollment effort
Have not answered NO to question #114 on the 2014 MCS follow-up survey.
Not deceased
Good quality mailing address with no returned mail
Currently or previously on active duty service
If no longer in active service, discharged or released under conditions other than
dishonorable
In order to determine those MCS participants who have already enrolled in MVP, refused to join
MVP, or who were previously invited to join MVP, MCS staff will send to MVP a list of
encrypted social security numbers (SSNs) and dates of birth (DOB) that are linked to Dummy
SIDs for all follow-up MCS participants. These data will be sent via the DoD Secure Access
File Exchange (SAFE) site.
Upon receipt of these data, MVP staff will remove these participants with matching SSNs and/or
DOB from the list of MCS participants and then return the filtered file to the MCS. MCS staff
will then apply the MCS eligibility criteria from the above list. Additionally, from this list, MVP
staff will flag approximately 20,000 MCS participants that were eligible to receive an invitation
from the MVP during the previous effort, but were not contacted. The MCS will provide
updated contact information for these participants during the final data transfer.
The remaining eligible participants will be sent one postal contact with information about
enrolling in MVP along with the option to opt out from receiving any information. This letter
includes information about the PMI. Those participants who do not wish to receive information
and enrollment materials from MVP will be asked to tear off the bottom portion of the letter and
return it to the Millennium Cohort Study in a provided postage paid envelope within 30 days of
receipt of the letter. After 60 days of the expected receipt of the letter, MCS study staff will
generate a list of eligible participants who did not return the bottom portion of the letter along
with their respective current contact addresses and corresponding Dummy SID. MCS will also
include the updated mailing address, if one exists, and Dummy SID for the 20,000 MCS
participants mentioned above. This list will be encrypted and sent to MVP staff via the DoD
SAFE site. The MVP will then send these individuals an invitation to enroll in the MVP study.
Background: Family Study Component
Due to logistical reasons, the Family component of the Millennium Cohort study was separated
as a standalone sub-study. Dr. Valerie Stander assumed the role of Principal Investigator for the
Family component and formally submitted to the IRB the initial sub-study for review and
approval by the IRB in March 2015. All regulatory approvals/requirements related to the
Millennium Cohort Family study up to and through the 2014-2015 survey cycle remain under
the Millennium Cohort regulatory approvals (OMB Control Number 0720 – 0029 RCS: DD-HA
(AR) 2016 and SORN N06500-1). Any future regulatory approvals needed for the Millennium
Cohort Family study will be submitted under the standalone sub-study.
Background: Millennium Cohort Study Feedback Survey
Due to the ongoing decline in survey response not just to this study but all DoD studies, the
Millennium Cohort Study (MCS) has designed a participant feedback survey that will help us
gather crucial information about participant recruitment and study retention.
This feedback survey was developed to assess participant feedback on study marketing and
branding methods, the effectiveness of the MCS survey design, identify any areas for
improvement, provide participants with an opportunity to express their opinions about the study,
and assess participant satisfaction and motivation to participate. These data will inform future
participant communication and engagement efforts. Additionally, insights gained from this
feedback survey can be used to inform future studies and improve the design, implementation,
and participant experience. Finally, surveying participants about their experiences with the study
can build trust and demonstrate the commitment of our researchers to transparency and
participant-centered practices.
The MCS Feedback survey is low-burden way to obtain participant feedback on study methods
and materials that are typically obtained via focus group methods. Given the large sample size in
the MCS and the remote nature of the study (e.g., all participant contacts are via the web or via
postal mail), focus groups are not feasible. The MCS Feedback survey is estimated to take 8
minutes to complete.
The MCS Feedback Survey has been developed by MCS staff and reviewed and approved by
the Office of Management and Budget (OMB Control # 0703-0064).
9.3
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
The objectives the Millennium Cohort Study are to determine how the health of U.S. military veterans’ changes
over time.
A.
Primary Objective:
To compare the adjusted incidence of chronic disease between cohorts.
B.
Secondary Objectives:
To compare the adjusted change in health between cohorts by Short Form-36 Questions/Veterans (SF
36V) scores. (74)
To compare the change in health between cohorts by Patient Health Questionnaire (PHQ) score
diagnostics. (75)
To serve as the foundation for a portfolio of future studies of the impact of military service, including
anthrax vaccination, on the health of members of the armed forces.
9.4
Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled,
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug
research
Self-reported health information (e.g., mental, physical, and behavioral health metrics as well as military and
post-service experiences) is collected from study participants through periodic surveys through the year 2068.
These data are linked to enterprise databases, including military, healthcare utilization, and mortality records to
create a total picture of health.
9.5
Target Population:
Describe the population to whom the study findings will be generalized
This prospective cohort study will follow regular active duty, National Guard, and reserve military personnel.
For each new panel, a probability-based sample of service members is randomly drawn from the electronic
rosters of active duty and reserve personnel at Defense Manpower Data Center (DMDC), Seaside, California.
Individuals are tracked while serving, as they integrate into civilian life and beyond. Participant follow-up is
planned through at least 2068. Given the longitudinal design and sampling frame of the study, findings from this
research will be generalizable to service members as well as veterans.
9.6
Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
This study is supported by the highest officials in the DoD healthcare system. It will serve as a foundation for
many future health policy decisions and as the framework for numerous follow-on studies. The information is
not known to be collected in this format across DoD at this time.
10.0
10.1
Study Procedures, Data Management, and Privacy
Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
PROPOSED DATES OF RESEARCH: 01OCT2000 to 30SEP2068
PROJECT TITLE and ID#: The Millennium Cohort Study, 60002
WORK BREAKDOWN STRUCTURE (WBS) (or JON, if a legacy project): 100001869677_007A
This prospective cohort study will follow regular active duty, National Guard, and reserve
military personnel through, at least, the year 2068.
The cohorts will be followed via serial postal surveys with on-line completion options. The
sample will be drawn randomly from the electronic rosters of active-duty and reserve personnel
at Defense Manpower Data Center (DMDC), California. The cohort will be selected as a
probability sample, stratified for deployment vs. nondeployment, active duty vs. reserve, and
male vs. female. Subjects will be contacted in five phases.
1.
2.
3.
4.
First Phase: 2001 Cohort (Millennium Cohort). Panel 1 members included regular active
duty, National Guard, and Reserve U.S. military personnel. A probability-based sample
of 256,400 active duty and reserve military personnel was randomly drawn from the
electronic service member rosters at the Defense Manpower Data Center (DMDC),
Seaside, California, as of October 1, 2000. Veterans who served in Southwest Asia,
Bosnia, and Kosovo (after 1997) made up 18% of the military population at this time but
were over-sampled such that 30% of the population was invited to participate. Females
comprised 15% of the military population at this time but were over-sampled such that
24% of females were invited. The expected cohort response of 100,000 will represent
approximately a 3.7% sample of the 2.7 million persons in uniform at that time.
Second Phase: 2004 Cohort. Panel 2 members included regular active duty, National
Guard, and Reserve U.S. military personnel with 1 - 2 years of service. A probabilitybased sample of 150,000 service members was randomly drawn from the electronic
rosters of active duty and reserve personnel as of October 1, 2003 at Defense Manpower
Data Center (DMDC), Seaside, California. To achieve a higher proportion of Marines,
the population was comprised of 20% Marines and 80% other service branches (Army,
Navy, Air Force, and Coast Guard). Females were also over-sampled; the 80% nonMarine group was comprised of 70% males and 30% females with random distributions
of all other variables.
Third Phase: 2007 Cohort. Panel 3 members included regular active duty, National
Guard, and Reserve U.S. military personnel with 1-3 years of service. A probabilitybased sample of 250,000 service members was randomly drawn from the electronic
rosters of active duty and reserve personnel as of October 1, 2007. To achieve a higher
proportion of Marines, the population was comprised of 20% Marines and 80% other
service branches (Army, Navy, Air Force, and Coast Guard). Females were also oversampled; the 80% non-Marine group was comprised of 70% males and 30% females with
random distributions of all other variables.
Fourth Phase: 2011 Cohort. Panel 4 members included regular active duty, National
Guard, and Reserve U.S. military personnel with 2-5 (24-60 months) years of service. A
4.
5.
probability-based sample of 250,000 service members was randomly drawn from the
electronic rosters of active duty and reserve personnel as of October 1, 2010 at Defense
Manpower Data Center (DMDC), Seaside, California. To achieve a higher proportion of
married participants, the population was comprised of 80% male and 20% female service
members. For each gender, the sample was comprised of 50% married and 50% not
married with random distributions of all other variables.
Fifth Phase: 2020 Cohort. Panel 5 members will include regular active duty, National
Guard, and Reserve U.S. military personnel with 1-5 years (12-60 months) of service. A
probability-based sample of 600,000 service members was randomly drawn from the
electronic rosters of active duty and reserve personnel as of June 1, 2020 at Defense
Manpower Data Center (DMDC), Seaside, California. To achieve a higher proportion of
married participants, the population was comprised of 80% male and 20% female service
members. For each gender, the sample was comprised of 35% married and 65% not
married with random distributions of all other variables.
In an effort to ensure the highest response rate possible, the study team will be contacting
an initial 500,000 potential participants selected from the 600,000 DMDC sample while
the remaining 100,000 are maintained as reserve pool. These initial 500,000 participants
selected will include all service members whose DMDC records indicate they are
married followed by a random sampling of the remaining service members. After 2 email
contacts, all participants that have had an email contact bounce back, indicating that the
email address on file is not usable, will have their email address marked as “do not use”.
The team will not attempt to contact potential participants at this email address
again. Additionally, all potential participants will be sent one postal mailing to the
address received from DMDC. All participants that have their postal item returned to us
due to the post office indicating it is a “bad address” will not be contacted at this postal
address again.
These cohorts will be followed with repeat surveys at approximately 3-year intervals through, at
least, the year 2068.
A subject is presumed to have received a questionnaire if the postal service does not return it as
undeliverable. Some subjects presumed to have received the survey instrument will return the
questionnaire uncompleted. Under these circumstances, we will continue to send
correspondence to them until one of the following occurs: (a) we receive a completed survey
from them; (b) they explicitly decline to participate; or (c) they do not respond after all mailed
questionnaires have reached them successfully.
Those who did not sign the consent form on the baseline survey will be excluded from
enrollment into the study.
Informed consent documents are updated just prior to periods of recruitment and
enrollment. Therefore, the Millennium Cohort Study consent form will be updated every three
to six years.
Supplemental Medical and Administrative Data
NHRC manages or has access to numerous established military data sets. Information from
these data sources can be used to supplement the survey instruments and enhance the ability to
track study outcomes. Data linkage for the Millennium and Family Cohort will be linked to
Department of Defense personnel and medical records obtained from the following sources:
DMDC (Data Manpower Data Center) and Defense Health Administration. For mortality data,
we submit requests to Armed Forces Medical Examiner System (AFMES), Armed Forces
Health Surveillance Branch (AFHSB), JPC (Joint Pathology Center), NDI (National Death
Index), Defense Suicide Prevention Office (DSPO), DMDC and VA (US Department of
Veterans Affairs). In addition, if the spouse is an active duty member and retires or separates
from military service and utilizes Department of Veterans Affairs for medical services, we will
link to VA medical and personnel data as well as the DoD Joint Theater Trauma Registry and
the Navy/Marine Corps Trauma Registry.
These data will complement subjective measures with objective measures of exposures and
health outcomes. Access to additional datasets for linkage with survey data will be established
using data use agreements.
Millennium Cohort Study Feedback Survey
Before the launch of the 2023-2024 survey cycle (pre-launch) and again near the end of the
same survey cycle (post-launch), the Millennium Cohort Study will conduct the participant
feedback survey among Panel 1-5 responders and non-responders. The survey will be bi-modal
and was designed to assess a variety of factors including those that have motivated and/or
discouraged Millennium Cohort participants to stay connected with the study. This survey will
be sent to already enrolled and consented participants and falls under the scope of the original
consent; therefore, we will not be re-consenting any participants for this project.
1.
2.
10.2
The pre-launch feedback survey will collect data from study participants for
approximately 6 weeks. During the pre-launch feedback survey cycle all Panel 1-4 (Panel
5 will be excluded from the pre-launch survey cycle due to their limited involvement
with the study at this time point) responders and non-responders will be contacted and
asked to provide feedback. Initial contact method will be determined based on a
participant’s individual response to the 2019-2021 survey cycle (paper responder, web
responder, non-responder). 8,500 paper responders and 8,500 non-responders will
receive a postal letter invitation, paper survey, and pre-paid return envelope, while all
other remaining participants will receive an email invitation with a link to the web
version of the survey. Each participant will then be contacted for a maximum of two
additional times until they provide a response, or the survey cycle closes. If the
participant completes a survey, they will also receive a thank you email.
The post-launch feedback survey will be conducted among Panel 1-5 responders and nonresponders to the 2023-2024 survey cycle. The methods for this data collection will be
submitted for review and approval at a future date.
Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the
data will be operationally measured.
Questionnaire Development
A questionnaire was developed specifically for this study and modeled after the DVA National Health Survey of
Persian Gulf War Era Veterans that provides the framework to ask participants about current and historical
medical conditions, health complaints and symptoms, military and personal experiences, and approaches to selfmedication and self-care. The questionnaire is available to participants via physical copy sent through the postal
service and on the Internet at www.millenniumcohort.org.
Survey measures
After providing informed consent and completing a baseline survey, participants are invited to complete followup surveys every 3 to 5 years through 2068. Study measures assessed over time utilize from validated measures
or publicly available epidemiological survey sources. Although constructs assessed have largely remained
consistent over time, certain measures have changed in response to developments in research priorities, military
policy, stakeholder input, or scientific advances. A summary of the survey measures is described below and
listed in Table 1.
Sociodemographic factors. Financial problems, marital status, occupation (military and civilian), and
educational attainment have been consistently assessed over time. The survey has expanded to assess
employment (e.g., unemployed, part-time, full-time), household income, homelessness, household composition,
relationship quality, sexual orientation, and gender identity.
Military service characteristics. Service-related factors that have been consistently assessed over time include
Military service characteristics. Service-related factors that have been consistently assessed over time include
combat experiences, environmental exposures, deployments (e.g., locations and dates), military satisfaction, and
reasons for separating from the military. Assessment of unit cohesion was recently added.
Stressful life events. Varying stressful events stemming from the Social Readjustment Rating Scale have been
assessed over time. More recently, detailed assessments of sexual harassment and assault and additional life
stressors, such as adverse childhood experiences, discrimination, bullying, harassment, and hazing experienced
have been included.
Psychosocial factors. Posttraumatic stress disorder (PTSD) has been measured using the PTSD Checklist (PCL),
originally with the PCL Civilian Version (PCL-C) and more recently with the PCL for DSM-5 (PCL-5). In
addition, major depressive disorder has been measured using the Patient Health Questionnaire (PHQ)-9 or PHQ8, with other anxiety syndrome, panic syndrome, and disordered eating measured using additional corresponding
modules in the PHQ. Social support has been consistently measured using an item from the PHQ and a 6-item
version of the Multidimensional Scale of Perceived Social Support (MSPSS) was added more recently. More
recent psychosocial factors include anger measured by the Dimensions of Anger Reactions-5 (DAR-5), positive
outlook measured by a modified “current standing” short form of the Posttraumatic Growth Inventory (PTGI),
and self-mastery measured by the Perlin Mastery Scale.
Health-related behaviors. Tobacco use has been included since the Study’s beginning (e.g., lifetime cigarette
use, quit attempts, use of other tobacco products), with vaping and e-cigarette use recently added. Alcohol use (e.
g., heavy weekly drinking, binge drinking, problem drinking, and potential alcohol dependence) has been
assessed throughout the duration of the study. In addition, varying sleep measures have been included over time,
including sleep duration and insomnia symptoms measured by the PHQ anxiety screen and the PCL-C, clinical
insomnia measured by the Insomnia Severity Index (ISI), and sleep medication use from the Pittsburg Sleep
Quality Index (PSQI). In addition, fast-food consumption, dietary supplement use, caffeine intake, physical
activity and sedentary time, have been included.
Physical health, illness, and injury. Body mass index calculated from self-reported height and weight, physical
health symptoms (e.g., pain, somatic symptoms), reproductive health, and quality of life/functional health
assessed by the Short Form 36-item Health Survey for Veterans (SF36-V) or Veterans RAND 12 Item Health
Survey have been assessed over time. In addition, traumatic brain injury, motor vehicle injury, hospital days and
lost workdays due to illness or injury have been assessed over time.
Medical conditions and health care utilization. Self-reported medical diagnoses (e.g., asthma, diabetes, heart
disease, cancer, sleep apnea, chronic bronchitis, emphysema, PTSD, infertility), complementary and alternative
medicine use, medication use, disability, and vaccinations (e.g., anthrax and smallpox) have been assessed over
time. More recently, access to healthcare (e.g., health insurance coverage), and health and mental health care
utilization have been assessed.
Table 1.
Survey measures
Financial problems
Marital status
Occupation (e.g., military and civilian)*
Sociode Educational attainment
mograph Employment and household income
ic factors Homelessness
Household composition and relationship quality
Sexual orientation
Gender identity
Combat experiences
Environmental exposures*
Military
Deployments (e.g., locations and dates)*
service
Military satisfaction
factors
Military separation*
Morale and unit cohesion
Stressful life events
Sexual harassment and assault
Adverse childhood experiences
Stressful
Discrimination, bullying, harassment, and hazing
life
Intimate Partner Violence (IPV)
events
Stress around transition out of service
Substance use (veteran/separated only)
Posttraumatic stress disorder*
Depression*
Panic/anxiety*
Disordered eating
Psychoso
Social support
cial
Anger
factors
Posttraumatic growth, self-mastery
Suicide risk
Firearm ownership/storage
Community support
Healthrelated
behavior
s
Tobacco and alcohol use
Sleep (e.g., duration, medications, disorders)
Fast food, dietary supplements, caffeine intake
Physical activity and sedentary behavior
Body Mass Index (BMI)
Physical health symptoms (e.g., pain, somatic symptoms)
Physical Reproductive health*
health, Pregnancy
illness, Quality of life /functional health
Hospital days and lost work days*
and
Traumatic brain injury*
injury
Motor vehicle injury
Respiratory health*
Medical
conditio
ns and
health
care
utilizatio
n
Medical diagnoses*
Medications (e.g., pain)*
Disability
Complementary and alternative medicine
Vaccination (i.e., anthrax and smallpox; COVID)*
Access (e.g., health insurance) and health and mental health care utilization*
*Objective measures, in addition to self-reported measures, have been available for this variable throughout the
Study period.
Table 2.
MILLENNIUM COHORT SURVEY INSTRUMENTS
Instrument:
Assesses:
Short Form 36-item
Health Survey for
Veterans (SF-36V) or
Veterans RAND 12
Item Health Survey
Physical, mental, and
functional health
Patient Health
Questionnaire (PHQ)
Depression, anxiety,
panic syndrome, bingeeating, bulimia
nervosa, and alcohol
abuse
Posttraumatic Stress
Disorder (PTSD)
Checklist-Civilian
Version (PCL-C (20012019/PCL-5 (2019+)
Post-traumatic stress
disorder
CAGE questionnaire
Alcohol problems
Insomnia Severity
Index (ISI)
Sleep
Pittsburgh Sleep
Quality*
Quality and patterns of
sleep
National Survey of
Families & Household*
Marital satisfaction
Modified Adverse
Childhood Experiences
(ACE)*
Childhood trauma
Short Dimension of
Anger Reaction
Anger disposition
National Health and
Nutrition Examination
Survey (NHANES)*
Physical activity level
Posttraumatic Growth
Inventory (PTGI) *
Posttraumatic growth
(positive outlook)
Deployment Risk and
Resilience Inventory*
Military and unit
support
Social Readjustment
Rating Scale*
Stressful life events
Multidimensional
Scale of Perceived
Social Support
Special support
Perlin Mastery Scale
Self mastery
*full inventory not used
Assessment of Psychiatric Conditions
Since 2001, the Millennium Cohort Program has used the 17-item PCL-C (slightly modified version) to assess
PTSD symptoms and probable PTSD, which is based on the DSM-IV criteria. In 2013, The definition of
posttraumatic stress disorder (PTSD) changed markedly between the Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition (DSM-IV) and DSM-5, creating challenges for studies spanning this transition.
To evaluate the ability to compare and assess PTSD, based on DSM-IV and DSM-5 criteria, using PTSD
Checklists (PCLs), during the 2019-2020 data collection cycle the Millennium Cohort Study implemented an
IRB-approved experiment in a small group of follow-up web responders.
The findings of this experiment indicated that PTSD can be successfully assessed and compared over time with
either PCL instrument in veteran and military populations.104
Assessment of Physical Conditions
Those military personnel who deploy and sustain an injury and are in both the Millennium Cohort Study and
Joint Theater Trauma Registry (JTTR) will be looked at over the long term in order to better understand the
effects of combats injuries on psychological and functional health outcomes. The JTTR provides data in detail
about wounds received and the medical care provided from combat support hospitals, aboard ships and aircraft,
and throughout the course of their treatment.
Morbidity Tracking
Self-reported morbidity data may be validated by a variety of methods. While receiving care in DoD medical
treatment facilities, veteran healthcare data, including diagnoses, may be obtained from the Standard
Ambulatory Data Record (SADR) and Standard Inpatient Data Record (SIDR) inpatient and outpatient billing
data. Similarly, various DVA databases will be examined for DVA healthcare utilization. These electronic
records archive diagnoses in the ICD-9 format.
Bias and External Validity
Analysis of response bias requires accessing existing information on healthcare utilization among both
participants and non-participants. Existing data sources include, but are not limited to, demographic files from
the Defense Manpower Data Center, and healthcare utilization data from the Tricare, Executive Information and
Decision Support Program, Management Analysis and Reporting Tool (M2).
Supplemental Medical and Administrative Data
NHRC manages or has access to numerous established military data sets. Information from these data sources
can be used to supplement the survey instruments and enhance the ability to track study outcomes. Data linkage
for the Millennium and Family Cohort will be linked to Department of Defense personnel and medical records
obtained from the following sources: DMDC (Data Manpower Data Center) and Defense Health Administration.
For mortality data, we submit requests to Armed Forces Medical Examiner System (AFMES), Armed Forces
Health Surveillance Branch (AFHSB), JPC (Joint Pathology Center), NDI (National Death Index), Defense
Suicide Prevention Office (DSPO), DMDC and VA (US Department of Veterans Affairs). In addition, if the
spouse is an active duty member and retires or separates from military service and utilizes Department of
Veterans Affairs for medical services, we will link to VA medical and personnel data as well as the DoD Joint
Theater Trauma Registry and the Navy/Marine Corps Trauma Registry.
These data will complement subjective measures with objective measures of exposures and health outcomes.
Appropriate agreements/approvals will be in place prior to any data sharing for any linkages. Additionally, the
following sources are available:
Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) - CHAMPUS contains one
record for each claim voucher for care by a civilian provider. Care is rendered to dependents of the military, and
retirees and their dependents who are not Medicare eligible. These files contain historical data from December
1979.
Defense Enrollment Eligibility Reporting (DEERS) - DEERS is the central source for personnel information
from the DoD personnel community. This database is used to determine medical benefits eligibility, insurance,
immunizations, and patient information. This data set is thought to be 93% accurate for the addresses of military
personnel, and the accuracy continues to improve.
Defense Outplacement Referral System (DORS) - DORS is a national resume and referral network
established to help separating DoD personnel transition into civilian life. DORS provides private and public
sector employers with immediate access to resumes from transitioning service members and federal civilian
employees.
DoD Birth Defects Registry - Beginning in January 1999, a DoD Birth Defect Registry was established at
NHRC. The registry uses a hybrid system of intensive active surveillance among the largest military population
in the United States (Naval Medical Center San Diego) and passive surveillance via electronic hospitalization
databases for the rest of the DoD dependents.
Health Enrollment Assessment Review (HEAR) - HEAR was created to assist providers and managers in
identifying individuals and groups of individuals in their panel who require proactive interventions. Soon to be
routinely administered to all active-duty personnel, HEAR identifies patients whose clinical preventive services
are not current or have never been performed. Additionally, HEAR describes a patient’s risk factors, his or her
chronic medical conditions, and whether the enrollee falls into the high resource utilization category.
Master Crosswalk File - This file provides "crosswalks" between military occupational codes of the four
military services and the Coast Guard and their civilian counterparts as defined by the standard occupational
classification codes, occupational employment statistics codes, census codes, Office of Personnel Management
codes, and classification of instructional programs codes.
Military Operation Rosters - As DoD deploys large groups of military personnel for sustained time periods,
participants are recorded by the various services and compiled in databases at DMDC. Such military operation
databases are now available for the Gulf War, Bosnia, and Kosovo. The latter two operations continue to
document new participants.
Recruit Assessment Program (RAP) - This electronic database represents a collection of baseline
demographic, medical, psychological, occupational, and risk factor data from U.S. Marine Corps recruits at
Marine Corps Recruit Depot in San Diego, CA at the time of their entry into military service.
Pre- and Post-Deployment Health Assessments (DD2795 and DD2796) - Health assessments prior to and
following deployments are forwarded to the Army Medical Surveillance Activity (AMSA) where they are
scanned and entered into the Defense Medical Surveillance System (DMSS). Information regarding health
status, health perceptions, mental health screening and potential environmental exposures are captured by these
health assessments as well as relevant medical referrals and dispositions before and after deployment.
Department of Defense Trauma Registry (DoDTR) U.S. Army Institute of Surgical Research - The
DoDTR captures details about wounds received and the medical care provided from combat support hospitals,
aboard ships and aircraft, and throughout the course of their treatment, as well as the results.
Theatre Medical Data Store (TMDS) - TMDS provides healthcare encounter data, lab data, procedure data,
and pharmacy data delivered at any military treatment facility, including the first echelons of care at deployed
locations,
Army Center for Substance Abuse Programs' (ACSAP) Drug and Alcohol Management Information
System (DAMIS) - The ACSAP and DAMIS will allow us to capture individual data on drug test positivity
among participants who screened positive during their service time.
Global Assessment Tool (GAT) - The GAT is a confidential self-assessment tool that includes information on
Soldiers well-being, resilience, and their overall health. GAT data is stored in the PDE, a virtual secure platform
designed for integrating data, linking commands for analysis, and conducting studies/projects. This repository is
an ever-evolving cloud-based, virtual technology that provides strong protections of human subjects via encoded
and de-identified data.
Family Advocacy Program (FAP) - The Family Advocacy program provides various treatment and support
services for perpetrators and victims of spouse and child abuse and neglect, and makes referrals for additional
care where needed. Within the DON, the Family Advocacy Program services are provided as part of the Fleet
and Family Counseling Support Centers.
Beneficiary Identification and Records Locator System (BIRLS) - BIRLS provides the social security
number and the state in which death occurred for all veterans whose survivors apply for a death benefit. This
database is updated quarterly and contains 8.32 million records that are in SAS file format.
National Student Clearinghouse - The NSC is a non-profit organization that collects data on student
enrollment, degree earned, and other credential completion from most institutions of higher education in the
country. The NSC has the most extensive database of enrollments and credentials available. Over 3,600 colleges
and universities, enrolling 98 percent of all students in public and private institutions, provide data to the
clearinghouse. NSC provides educational history information that confirms an individual’s degrees, academic
credentials, and enrollment status.
VA National Enrollment Database - This database consists of veterans eligible for VA care.
VA National Patient Care Database (NPCD) - NPCD combines several VA databases, including Patient
Treatment File (PTF) and Outpatient Clinic File (OPC).
VA Outpatient Clinic File - OPC provides information regarding principal diagnosis and location of all VAprovided episodes of outpatient care. The database contains over 20 million records per year with weekly
updates.
VA Patient Treatment File - PTF contains up to 10 discharge diagnoses and 5 procedure codes for all VAprovided hospital care. PTF is updated weekly.
Veterans Information Systems Technology Architecture (VISTA) - This is a comprehensive clinical and
administrative database that contains laboratory, radiology, and pharmacy data. Access to VISTA is usually
made through individual DVA medical centers.
Virtual Pooled Registry Cancer Linkage System (VPR-CLS) provides a single location to facilitate access to
and use of high-quality cancer surveillance data for minimal risk linkage studies.
Individual Longitudinal Exposure Record (ILER) is an individual, electronic record for each service member
and future Veteran designed in collaboration between VA and the Department of Defense (DoD) to link service
member and veteran data to known exposures.
Millennium Cohort Feedback Survey
The Millennium Cohort Study (MSC) feedback survey was developed specifically for this study by MCS staff
and is designed to assess a variety of factors including those that have motivated and/or discouraged MCS
participants to stay connected with the study. This survey will help us gather crucial information about
participant recruitment and study retention, such as reasons for non-response, correlates of non-response,
motivations to participate, acceptability of study communication methods, and recommendations for
improvement. This data will be utilized in the design of the future surveys and survey operations to maximize
retention and increase participation from previous non-responders. The survey will be available to participants
via physical copy sent through the postal service and on the Internet at www.millenniumcohort.org.
Participant tracking
In the Millennium Cohort Study, henceforth ‘the study’, maintaining contact with our research participants is
crucial for obtaining accurate and complete data over the study’s period of performance. Loss to follow-up can
introduce bias and compromise the validity and reliability of study findings. Despite diligent efforts, some
participants have become lost to follow-up due to invalid or outdated contact information that makes it
challenging to collect essential survey information and maintain the integrity of the study. For this reason, the
study will utilize external resources such as LexisNexis and TransUnion, comprehensive databases of public
records, and other government resources as a solution for obtaining current email and postal addresses for study
participants.
To ensure that the study is obtaining contact information for the correct individual, the study will provide
LexisNexis or TransUnion, henceforth the ‘vendor’, with the name, SSN, DOB, and last known address of all
study participants for whom email, and postal mailing address are needed by the study. The name, SSN, DOB,
and last known address will be provided to the vendor via DoD SAFE.
The vendor will provide the study with the current and historical email and postal addresses for all study
participants. The email and post addresses must be linked to the individual participant via name, SSN, DOB, and
last known address. Then every 6 months the vendor will conduct a new inquiry where they will only report to
the study any new email or postal addresses.
The website states in the FAQ's "We will connect your survey data with other databases, medical records,
surveys, or biological specimens collected or maintained by the Department of Defense, Department of Veterans
Affairs, federal or state agencies, or nongovernmental organizations such as the National Student Clearinghouse.
We may also utilize commercial sources such as LexisNexis, TransUnion, and other government resources to
obtain up-to-date contact information."
Given the size of the cohort and the highly mobile nature of this population, it is crucial that participants can
swiftly and easily update their contact details (including name, address, and email) with the study staff to ensure
uninterrupted receipt of study communications.
On the contact information update page, participants are prompted to provide their Subject ID along with the
specific details they wish to update. Additionally, participants are asked to provide their birth year as verification
of their identity.
Once the participant completes the form and submits it, the website application forwards the request to a mail
(SMTP) server for processing. The email is promptly placed in a queue, and an attempt to send it to the study
team at [email protected] is made almost immediately.
Upon successful transmission, the email is removed from the queue, and the server logs the message as sent. If,
for any reason, the email fails to send, it remains in the queue for 5 minutes before a retry is initiated. The
system will continue attempting to send the email for up to 1 hour before generating a failed send message. To
safeguard participant Personally Identifiable Information (PII), the logs are deleted daily at 0100 PST.
If a participant does not provide their birth year on the form, upon receipt, study staff will contact the participant
to verify their identity. Only upon successful verification will the participant’s contact information be updated in
the database.
Additionally, participants may be asked to provide an email address upon completing their survey. All
participants who complete the online survey will be given the option to select a gift code from various vendors.
Following vendor selection, participants will be given the choice to receive a copy of the code, which will be
displayed on the subsequent page. If they opt to receive the code copy, they will be prompted to enter their email
address.
Once the participant enters their email address and submits the form, the website application forwards the
request to a mail (SMTP) server for processing, following the same process as detailed above to ensure
successful transmission and logging while prioritizing data security and privacy.
10.3
At any point in the study, will you request, use, or access health information in any form, including
verbal, hard copy and electronic?
Yes
10.4
No
Review the definitions below and respond to the following two questions. If you are not sure of the
answers, email [email protected] for assistance. The Military Health System (MHS) is
defined as all DoD health plans and DoD health care providers that are organized under the
management authority of, or in the case of covered individual providers, assigned to or employed by,
the Defense Health Agency (DHA), the Army, the Navy, or the Air Force MHS workforce members
are employees, volunteers, trainees, and other persons whose conduct, in the performance of work
for the MHS, is under the direct control of the MHS, whether or not they are paid by the MHS. MHS
business associates are persons or entities that provide a service to the MHS and require protected
health information (PHI) to provide the service.
Are you an MHS workforce member?
Yes, I am an MHS workforce member
No, I am not an MHS workforce member
10.5
Have you consulted with an MHS data expert to determine the data elements required for your study?
Consulting with a data expert often saves time later in the compliance process because the data
expert can advise on the data available in the numerous MHS information systems, the quality of
that data and the methods for encrypting and collapsing data. To schedule a consult with an
MHS data expert, send an email to: ([email protected])
Yes, then complete the questions below according to the data consult
No, then complete the questions below according to the best of your knowledge
10.6
Indicate how you will request data from the MHS. Select all that apply.
Talking with MHS health care providers or MHS health plans about specific research
participants
Obtaining MHS hard copy records specific to research participants
Obtaining data from an MHS information system(s)
10.7
If you are obtaining data from an MHS information system(s), indicate whether you plan to receive a
data extract or whether you plan to access an MHS information system directly to create a data set.
A data extract is when the MHS or a contractor provides the data set directly to the
researcher. When receiving a data set through data extract, the researcher may indicate
whether the data elements should be provided as is, encrypted or collapsed. In contrast to a
data extract, access to an information system means that the researcher may directly access an
MHS information system and create a data set for the research study
Data Extract
Access
10.8
Do you intend to request de-identified data from the MHS in your research study?
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the
researcher does not have actual knowledge that the remaining data can be used alone or in
combination with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally
accepted statistical and scientific principles and methods for rendering information not
individually identifiable, determines that the data is not individually identifiable
Yes
10.9
No
Indicate the MHS information system(s) from which you will seek to obtain data
If you do not know which system(s) contains the data elements you need, refer to the Guide for
DoD Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA.
[email protected].
Below is a list of commonly used MHS systems. If the system from which you seek to obtain
data is not listed below, list the name of the system in the “Other MHS Systems” category below
PHI Systems:
MHS Information System
Requesting Data
:
MDR
:
Yes
:
PDTS
:
Yes
:
AHLTA
:
Yes
:
CHCS
:
Yes
:
PDHRA
:
Yes
:
PHDA
:
Yes
:
TMDS
:
Yes
PII-Only Systems:
MHS Information System
Requesting Data
DMDC
:
Yes
MHS Genesis
:
Yes
De-Identified Data & Other Systems:
Information System
Requesting Data
Other MHS System May include PII and/or
PHI
List other system here:
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
ESSENCE
Other MHS System May include PII and/or
PHI
List other system here:
AFMES
Other MHS System May include PII and/or
PHI
List other system here:
Ancillary
Other MHS System May include PII and/or
PHI
List other system here:
CAPER
Other MHS System May include PII and/or
PHI
List other system here:
CDR
Other MHS System May include PII and/or
PHI
List other system here:
DoDSER
Other MHS System May include PII and/or
PHI
List other system here:
HCSRN
Other MHS System May include PII and/or
PHI
List other system here:
HCSRI
Other MHS System May include PII and/or
PHI
List other system here:
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
:
Yes
NMOP
Other MHS System May include PII and/or
PHI
List other system here:
MOR
Other MHS System May include PII and/or
PHI
List other system here:
POTS
Other MHS System May include PII and/or
PHI
List other system here:
SIDR
Other MHS System May include PII and/or
PHI
List other system here:
SADR
Other MHS System May include PII and/or
PHI
List other system here:
TEDN
Other MHS System May include PII and/or
PHI
List other system here:
TENDI
Other MHS System May include PII and/or
PHI
List other system here:
Death
10.10
Do you intend to merge or otherwise associate the requested data with data from any sources
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data
No, will not merge data
10.11
Indicate the data elements about research participants or relatives, employers, or household
members of the research participants that you will request from MHS hard copies or from MHS
information systems.
If you will merge data, also indicate non-MHS data elements about research participants or
relatives, employers, or household members of the research participants that you will have access
to in any form or medium.
Direct and
Indirect
Identifiable Data
Elements
1. Names
2. Postal
address with
only town,
city, state,
and zip code
3. Postal
address with
all geographic
subdivisions
smaller than
state,
including
street
address, city,
county,
precinct, zip
code and their
equivalent
geocodes,
except for the
initial three
digits of a zip
code if,
according to
the current
publicly
available data
from the
Bureau of
Census: 1)
the
geographic
unit formed by
combining all
zip codes with
the same
three initial
digits contains
more than
20,000
people; and 2)
the initial
three digits of
a zip code
from all such
geographic
units
containing
20,000 or
fewer people
DHA Hard
Copies
DHA Data
Elements
to be
Accessed
DHA Data
Elements
Verbal
Non-DHA
Extracted
Downloaded
Hard
DHA Digital DHA Digital
Copies or
Data
Data
Digital
is changed to
000
4. Dates
including all
elements
(except year)
directly
related to an
individual,
including
birthdate,
admission
date,
discharge
date, and date
of death
5. Ages over
89 and all
elements of
dates
(including
year)
indicative of
such age,
unless you will
only request a
single
category of
“age 90 or
older”
6. Telephone
Numbers
7. Fax
Numbers
8. Email
Addresses
9. Social
Security
Numbers
10. Medical
Record
Numbers
(MRN)
(including
record ID)
11. Health
Plan
Beneficiary
Numbers
(including
DEERS ID,
Electronic
Data
Interchange
Personal
Identifier
(EDIPI) or
Number
(EDIPN))
12. Account
Numbers
13. Certificate
/License
Numbers
14. Vehicle
identifiers and
serial
numbers,
including
license plate
numbers
15. Device
identifiers and
serial numbers
16. Web
Universal
Resource
Locators
(URLs)
17. Internet
Protocol (IP)
address
numbers
18. Biometric
identifiers,
including
finger and
voice prints
19. Full-face
photographic
images and
any
comparable
images
20. Any
other unique
identifying
number,
characteristic,
or code
(including nonmilitary
provider IDs)
21. Free Text
Fields
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot
be used.
Due to guidelines stated within DoDI 1000.30, Reduction of SSN Use within DoD, the reduction
or elimination of SSN usage must occur wherever possible. If SSNs are required to complete the
project, the PI must provide a justification and explanation as to why a substitution cannot be
used.
For example:
• If alternatives to SSN (e.g., EDIPNs or pseudo person IDs) are sufficient in other instances,
will those alternatives to SSN usage be sufficient to respond to Congressional inquiries and
/or Senior DoD stakeholders inquiries?
• Are alternatives to SSN used first?
• Are those alternatives to SSN insufficient to combine data from multiple data sources? Is
the issue that some individuals do not possess alternatives ID numbers and SSN is the only
way to identify them?
Continued use of the Social Security Number (SSN) is justified for this system in accordance with DODI
Instruction 1000.30 (8): Computer Matching. Continued capture and use of SSNs are necessary for computer
matching of electronic sponsor demographic and exposure data with deployment, occupational, vaccination, and
healthcare utilization data related to individual health status. The Millennium Cohort Study matches existing
records or specimens to those contained in other Department of Defense (DoD) electronic data sources (SSNs
would be destroyed prior to data analysis). The use of SSN as a unique identifier is needed for this database
where there is potential for duplicate registration and no other means of unique identification exists. Therefore,
the elimination of SSNs would prevent the ability to link sponsor demographic and exposure data from DoD
electronic data sources to measures of health outcomes.
A signed SSN Justification Memo for the current survey cycle can be found in Appendix K External Approvals.
a. Will you receive or obtain health information?
Note: If you indicate you are not receiving health information, the answer
must be consistent with the DHA data source. For a non-health
information data request, if you are a non-MHS employee or non-MHS
business associate, you may not access an information system that has
PHI or LDS. For both MHS and Non-MHS employees and MHS business
associates, you may NOT include data elements in the above table on:
1) lines 10 or 11, 2) line 21 if the free text field comes from a PHI or LDS
system, and 3) lines 12, 13, or 18 if the account numbers, certificate and
license numbers, biometric data, or any other data elements are health
information created or received by an MHS health care provider, health
plan, or business associate in relation to the physical or mental health or
condition of an individual or payment for health care.
Yes, I will receive or obtain health information
No, I will not receive or obtain health information
b. If no data elements were checked in the above table, is it possible that the requested DHA
data is or will be identifiable because of any unique data elements, triangulation, or small cell
size?
Data elements were checked in the above table, STOP HERE.
NOTE: A unique data element includes any unique features that alone are not identifiable but
that could be used to identify an individual within the context of other information, such as any
type of code (such as diagnosis or procedural), rank of general or admiral, gender, or race.
Triangulation means using different data elements that when combined can be used to identify
an individual, such as including the above lists of unique data elements in a data set.
Determining whether an individual is identifiable through triangulation requires consideration of
all data elements in combination. Within the military, the use of rank and/or diagnosis code,
procedural codes, or any other code that changes on a predictable basis, increases the possibility
of identification. Small cell size means that there is only a small number of eligible individuals
that satisfy the category description. Department of Defense Manual 6025.13, Medical Quality
Assurance and Clinical Quality Management in the Military Health System MHS, provides that the
threshold for de-identifying data within the MHS requires a cell size of three, but also states that
the de-identification standards must meet the DoD implementation of the HIPAA Privacy Rule.
Centers for Medicare and Medicaid also gives guidance on small cell size stating that no data cell
less than 11 may be published or displayed. However, the Office for Civil Rights’ OCR, which is
the official regulatory office for the HIPAA Privacy Rule, provides that OCR does not designate a
universal value for small cell size in accordance with the de-identification standard; instead, the
cell size should be set at a level that is appropriate to mitigate risk of identification by the
anticipated recipient of the data set. This means that a cell size of 3 or 11 may not meet the
HIPAA Privacy Rule requirements if the cell size level does not appropriately mitigate risk of
identification by the anticipated recipient of the data set.
Note: If dates are altered as a means of de-identifying the data, diagnosis and
procedural codes need to be rolled-up or collapsed. If dates are provided “as time
between events,” the roll-up is not necessary.
Yes, the DHA data will become identifiable
No, the DHA data will not become identifiable
10.12
Do you believe it is possible for the MHS data to become identifiable because of triangulation, a
small cell size, or any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that
when combined can be used to identify an individual. For example, triangulation would use rank
and race together to determine the identity of an individual with a particular health condition.
Small cell size means that there is only a small number of eligible individuals that satisfy the
category description. Guidance for acceptable cell size is available from the Centers for Medicare
and Medicaid Services. For example, the rank category of four star generals with a particular
diagnosis may be less than 30, so the rank category may need to be expanded to include lower
ranks.
A unique data element includes any unique features that are not explicitly enumerated in the
categories of data in rows 1 – 20 of the table above (in Section 10.10), but that could be used to
identify an individual. Unique data elements include characteristics that are not themselves
identifying, such as the rank of general or admiral, or a race or gender, but within the context of
other information could be identifiable.
Yes, I believe there is a reasonable possibility the MHS data will become identifiable
No, I believe there is no reasonable possibility the MHS data will become identifiable
10.13
Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will
be obtained or Waiver/alteration of HIPAA Authorization is being requested)?
Yes
No
N/A
If yes, please check which one.
HIPAA Authorization
HIPAA Waiver (Full or Partial)
Other (please provide copies when uploading Other Study Documents)
10.14
Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during
the study, data/specimen storage and length of time stored, shipment/transmission, and the
plan for storage and final disposition at the conclusion of the study. Describe any data
agreements in place for accessing data within and/or outside of your institution (e.g., Data
Sharing Agreement, Data Use Agreement, Business Agreements, etc.)
The Millennium Cohort Study has the following agreements in place:
CRADA
University of Southern California: In support of the NIH funding for the project entitled,
“Contextual Effects on Cardiometabolic Health: Evidence from a Natural Experiment” (NIH
grant 1 R01 HL141870-01A1)
Data Sharing Agreement
Defense Health Agency Data Sharing Agreement (DHA DSA)
VA/ORD/CSP: DUA is a bilateral agreement which allows NHRC to transfer data to VA and
the VA to transfer data to NHRC
Educational Partnership Agreement (EPA)
San Diego State University
HIPAA Waivers/DUA
Data Request - Uniformed Services University (USU)- Labor Outcome
Data Request - Uniformed Services University (USU)- Healthy Behaviors
Inter/Intra-Agency Agreement (IAA)
NIOSH—(NMR 9443) Used to obtain addresses for participants via IRS
VA—(NMR 4150) Supports VA Collaboration (Department of Veterans Affairs OPH (10P3)
and ORD (10P9))
VA—(NMR 9558) Supports VA Collaboration
Knowledge Transfer Agreement (KTA)
U.S. Army Public Health Center (APHC)
Preservation of the Force and Family (POTFF), United States Special Operations Command
(USSOCOM)
Humana Government Business, Inc. (Humana Military)
DoD Sexual Assault Prevention and Response Office (SAPRO)
Defense Suicide Prevention Office (DSPO)
U.S. Army Public Health Center (APHC)
Memorandum of Agreement (MOA)
VA and DoD—supports MVP collaboration (see below)
VA Million Veteran Program (MVP) (NMR 9958). We contact participants giving them the
option to opt out of being contacted by the MVP study team.
National Center for Health Statistics—National Death Index (NMR 4143)—Receive death
records
United States Army Center for Environmental Health Research (USACEHR) (NMR 9418)—
Supports the Millennium Cohort BioMarkers Study
Memorandum of Understanding (MOU)
Army Analytics Group (AAG)—(NMR 9971)—Use of AAG’s secured cloud-based system
(Person-Event Data Environment (PDE))—Millennium Cohort data uploaded into the cloud for
analysis.
Office of People Analytics (OPA)—objective is to share survey data from OPA and Millennium
Cohort Program
NHRC manages or has access to numerous established military data sets. Information from these data sources
can be used to supplement the survey instruments and enhance the ability to track study outcomes. Data from the
Millennium Cohort surveys will be linked to Department of Defense personnel and medical records obtained
from the following sources: DMDC (Data Manpower Data Center) and Defense Health Administration (DHA).
For mortality data, we submit requests to Armed Forces Medical Examiner System (AFMES), Armed Forces
Health Surveillance Branch (AFHSB), JPC (Joint Pathology Center), NDI (National Death Index), Defense
Suicide Prevention Office (DSPO), DMDC and VA (US Department of Veterans Affairs). We will link to VA
medical and personnel data as well as the DoD Joint Theater Trauma Registry (JTTR) and the Navy/Marine
Corps Trauma Registry (CTR). These data will complement subjective measures with objective measures of
exposures and health outcomes.
These databases are accessed electronically through secure computers located at the Naval Health Research
Center. Unique identifiers are used to link each participant with their electronic data; however, in some cases
name and SSN will be provided. All data upon receipt will be confidentially maintained on-site in our secure
computer database. No data regarding a child and his/her health will be linked from any source for the purposes
of this study. Appropriate agreements/approvals will be in place prior to any data sharing for any linkages.
Collected data will be maintained until all research questions under the study objectives are answered.
Is this a data repository?
Yes
10.15
No
Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents
(either by the Investigator or through an established repository) for FUTURE research, address.
How the specimens/data will be used, where and how data/specimens will be stored (including
shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures
that will fulfill subjects’ request as stated in the consent, whether subjects may withdraw their
data/specimens from storage, whether and how subjects may be recontacted for future research
and given the option to decline, whether there will be genetic testing on the specimens, who will
have access to the data/specimens, and the linkage, the length of time that data/specimens will
be stored and conditions under which data/specimens will be destroyed.
N/A
Is this a data repository?
Yes
11.0
11.1
No
Statistical/Data Analysis Plan
Data Analysis Plan and Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific
aims, and/or research hypotheses. Explain how missing data and outliers will be handled in the
analysis. The analysis plan should be consistent with the study objectives. Include any subgroup
analyses (e.g., gender or age group). Specify statistical methods and variables for each analysis.
Describe how confounding variables will be controlled in the data analysis.
Statistical Analysis
Statistical analyses of Millennium Cohort survey data and linked datasets, including military and medical
records, encompass a wide variety of approaches, depending on the scope and complexity of the research
question, the hypothesis to be tested, and available data. Descriptive statistics will be generated using t-tests,
analysis of variance (ANOVA), chi-square tests, and other approaches depending on the form of the data and the
scope of comparison. These statistics will also be used identify any outlying responses in collected data as part
of the data cleaning process. Estimations of effect and association (e.g., risk or hazard ratios, odds ratios) will be
generated using regression methods, including linear, Cox proportional hazards regression, logistic and loglinear regression, generalized estimating equations, and structural equation modeling. With the expansion of
available data resulting from additional enrollments, survey waves, and linkages with external datasets, we will
employ machine learning and ensemble methods for generating hypotheses.
The inclusion of potential confounding variables into statistical models for each analysis will be informed by
causal inference considerations, including the use of directed acyclic graphs (DAGs) and change-in-estimate
criteria. Covariates commonly included in statistical models are: age or birth year, gender, occupation, marital
status, race/ethnicity, educational attainment, deployment status, branch of service, income, length of military
service, and prior diagnosed health conditions. The use of stratified analyses and tests for effect measure
modification (i.e., statistical interaction) will be determined based on a priori considerations and observed
heterogeneity in results. Common sub-group analyses include those stratified by sex, service branch, component,
deployment status, veteran status, and military occupation.
Statistical programs that will be used in include SAS, Mplus, SPSS, and R.
Morbidity Tracking
Self-reported morbidity data may be validated by a variety of methods. While receiving care in DoD medical
treatment facilities, veteran healthcare data, including diagnoses, may be obtained from the Standard
Ambulatory Data Record (SADR) and Standard Inpatient Data Record (SIDR) inpatient and outpatient billing
data. Similarly, various DVA databases will be examined for DVA healthcare utilization. These electronic
records archive diagnoses in the ICD-9 format. Comparisons between survey endorsements of diagnosed
conditions with existing electronic medical records will be conducted when possible.
Bias and External Validity
The evaluation of response bias is a key component to assessing the validity of a prospective study. For
example, those who consent to participate in a long-term prospective study may be more motivated to do so if
they have more health concerns than those who do not. Alternatively, those with serious health problems may
not participate because they are too ill to do so. In either case, this may result in the participant population not
well representing the target population.
Service members decline to participate in one of two ways: they either ignore all invitations, or they submit a
response that clearly shows they decline the invitation for enrollment. All such cases are considered nonparticipants, and none of these receive further invitations or contact.
Analysis of response bias, however, requires accessing existing information on healthcare utilization among both
participants and non-participants. Existing data sources include, but are not limited to, demographic files from
the Defense Manpower Data Center, and healthcare utilization data from the Tricare, Executive Information and
Decision Support Program, Management Analysis and Reporting Tool (M2).
In assessing existing DoD data on non-participants, as well as participants, extreme care is taken to protect
personal identifying information. Such data are used for linking purposes only. After linking, only de-identified
demographic, administrative, and medical data for non-responders and decliners will be maintained to explore
potential differences between survey participants and non-participants.
Sampling Non-respondents
Computer-assisted telephone interview (CATI) techniques will be used to reach a 3% sample of
nonrespondents. CATI survey work will be performed via contract with survey consultants. A similar procedure
will be employed to obtain reliability estimates from respondents.
Missing Data/Attrition
Subject matter experts from the Institute for Measurement, Methodology, Analysis and Policy (IMMAP) at
Texas Tech University assisted in meeting the OMB requirement to provide an approach to handle missing data
and adjustments for selective attrition. A subcontract between NHRC/Henry Jackson Foundation and Texas
Tech was established for this project. Informed by this work, analyses include multiple imputation to address
missing data and attrition concerns.
Interpretation of Results
Study work will be guided by a Strategic Board. This Board will be composed of 5 distinguished external
researchers and 3 representatives from veterans service organizations. This group first met June 22-23, 2000, in
San Diego to finalize study design. The group will continue to review study design, progress, and data analyses
and serve to frequently advise investigators. We expect to conduct Committee meetings approximately once a
year.
All research work will be reviewed and approved by the NHRC’s Institutional Review Board (IRB).
Investigators will report study results to various policy groups including:
Research Working Group-In conjunction with other deployment health research, the Research Working
Group will receive annual progress updates and review study progress in light of other federally
sponsored veteran research. The Research Working Group update will be included in the annual report
to Congress.
U.S. Army Medical Research Acquisition Activity Annual Peer Review-This annual review is generally
conducted by the American Institute of Biological Sciences (AIBS). Several AIBS scientists are invited
to review deployment health research programs.
Both the Millennium Cohort Study and the Millennium Cohort Family Study, collectively the Millennium
Cohort Program (MCP) have a broad mandate to assess the impacts of past, current, and future military conflicts
and other types of operational stress on service members and their families. As a requirement of the research
sponsor, the MCP develops a plan annually defining research priorities in collaboration with the Millennium
Cohort Strategic Board and chair of the DHA Joint Program Committee-5. Priorities are evaluated based on
DoD written research requirements, stakeholder requests, and/or the identification of emergent research gaps
with of high relevance to the health and well-being of service members and their families. Specific projects to be
initiated under the MCP annual plan are further required to develop a detailed analysis plan to address the
research questions defined for that project. Analysis plans are approved by either the Millennium Cohort or
Family Study Science Review Committee . The members of each committee include both internal MCP research
investigators, as well as external military population health research subject matter experts representing DoD,
VA, and academic institutions.
11.2
Sample Size:
260257
11.3
Total number of subjects requested (including records and specimens):
1506400
11.4
Panel
Panel
Panel
Panel
Panel
11.5
If you are recruiting by study arm, please identify the arms of the study and how many subjects will
be enrolled in each arm
1
2
3
4
5
(2001):
(2004):
(2007):
(2011):
(2020):
77,047
31,110
43,439
50,052
58,609
enrolled
enrolled
enrolled
enrolled
enrolled
Please provide a justification for your sample size
We estimated the necessary study sample sizes by knowing the estimated incidence for our healthy young
population and using the following equation (94):
Formula 1: N={ZaÖP(1-P) (1/q1+1/q2) + ZbÖP1 (1-P1) (1/q1) +P2 (1-P2) (1/q2)}2
______________________________________________________
______________________
______________________
(P1-P2)2
Where P1 = rate of outcome of interest in exposed group
P2 = rate of these outcomes in nonexposed group
N = estimated minimum sample size required
Za = standardized normal deviate for a two-tailed probability of an a-error
Zb = standardized normal deviate for a two-tailed probability of a b-error
q1 = proportion of sample population in group 1
q2 = proportion of sample population in group 2
P = q1P1+ q2P2
The level of acceptable alpha error was set at < 0.05, and beta error at 0.20 (statistical power at >0.80). The
statistical power of this study depends on the incidence of the conditions of interest in the comparison groups.
Estimates of incidence of hospitalization in the active-duty military population for the chronic diseases were
calculated by scanning for the specific disease in fiscal year 1995 hospitalization data. These data were output
and match-merged by social security number to any hospitalization with that specific disease for fiscal years
1989 to 1994. If a match occurred, that record was dropped, resulting in only new diagnoses of the specific
disease. The minimum sample sizes required to detect a significant difference for the overall hospitalization
incidence and incidence of specific chronic diseases over a 3-year and over a 6-year period are calculated in
Tables 1 and 2 respectively. Included are various relative risks for power equal to 0.80 and 0.90.
Table 1. Sample Size Necessary at Different Levels of Statistical Power to Detect a Difference of Given
Magnitude in Incidence (as Reflected by Relative Risk) Over Three Years. Population Numbers Reflect Total of
Two Equal Cohort Sizes.
Relative
80%
Outcome (ICD-9 Codes)
Incidence Rate
Risk
Power
1.2
2,934
Any cause hospitalization
0.222
1.5
508
2.0
139
90%
Power
3,927
679
185
Hypertension (401-404)
0.0035
Diabetes (250)
0.0016
Stroke (436)
0.0001
Myocardial infarction (410)
0.0005
Renal failure (584)
0.0001
Asthma (743)
0.0004
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
245,449
44,602
13,367
538,049
97,802
29,327
8,623,049
1,567,802
470,327
1,723,849
313,402
94,007
8,623,049
1,567,802
470,327
2,155,049
391,802
117,527
328,650
59,720
17,897
720,436
130,953
39,267
11,546,086
2,099,253
629,757
2,308,198
419,637
125,873
11,546,086
2,099,253
629,757
2,885,566
524,613
157,365
In addition to hospitalization data from DoD facilities, we searched the medical literature to obtain reasonable
incidence rates of these medical conditions to confirm or refute our hospitalization-based estimates. We found,
as expected, for most conditions that data from population-based studies yielded higher incidence rates for
conditions that do not usually require hospitalization for diagnosis and treatment. This means that the sample
size calculations that we have presented are likely to represent conservative estimates, and that smaller effect
sizes (i.e., relative risks) will be detectable with 80% power than are shown in Tables 1 and 2. Hypertension
incidence in middle-aged men in the Atherosclerosis Risk in Communities Study was estimated at 0.172 over a
6-year follow-up period, for an annual incidence of 0.032.(95) A similar estimate of hypertension incidence
comes from an additional study of middle-aged normotensive subjects (mean age 44 years) followed over a 7year period (cumulative incidence 0.255, annual incidence 0.042). (96,97) These estimates are considerably
smaller than the cumulative incidence estimate of 0.0035 over 3 years (or approximately 0.0012 annually) used
in the sample size calculations. The same is true for asthma, with an annual incidence reported in the literature
of 0.001, compared with the 3-year cumulative incidence of 0.0004 (or 0.00013 annually) based on DoD
hospitalization data, and diabetes mellitus (0.0016 per 3 years based on hospitalization data or 0.0005 annually,
compared to an annual incidence of 0.0018 in the U.S. in the 25-44 year age category based on data from the
1990-92 National Health and Nutrition Examination Survey (http://diabetes-in-america.s-3.com/contents.htm
- Chapter 4).
Yearly incidence of stroke based on U.S. national data was 0.00017 for persons ages 24-34 year old and 0.00045
for 35-44 years. Both of these estimates exceed that of 0.0001 per 3 years based on hospitalization data used in
the power calculations. Sparse data exist on myocardial infarction incidence in younger subjects. In one British
study, this outcome occurred in 0.00029 men aged 49 years or younger, and 0.00004 women annually in this
same age range. (98) These estimates exceed the 0.0005 per 3-year incidence obtained from hospitalization data
(0.00017 annually) for men but do not exceed the incidence for younger women reported in the
literature. Yearly incidence for end stage renal disease incidence estimates that come from the U.S. Renal Data
System for subjects ages 25-44 years, where new cases occurred in 1999 at an incidence of 0.0001 (http://www.
usrds.org/1999_adr.htm - Chapter 2). This rate also exceeds the hospital-based rate of 0.0001 over 3 years.
Table 2. Sample Size Necessary at Different Levels of Statistical Power to Detect a Difference of Given
Magnitude in Incidence (as Reflected by Relative Risk) Over 6 Years. Population Numbers Reflect Total of
Two Equal Cohort Sizes.
Incidence
Rate
Relative
Risk
80%
Power
90%
Power
Any cause
0.444
1.2
1.5
2.0
991
155
33
1,326
206
43
Hypertension (401-404)
0.0070
1.2
1.5
2.0
122,249
22,202
6,647
163,688
29,727
8,899
Outcome (ICD-9 Codes)
Diabetes (250)
0.0032
1.2
1.5
2.0
268,549
48,802
14,627
359,581
65,343
19,584
Stroke (436)
0.0002
1.2
1.5
2.0
4,311,049
783,802
235,127
5,772,406
1,049,493
314,829
0.0011
1.2
1.5
2.0
783,049
142,347
42,691
1,048,486
190,599
57,161
0.0002
1.2
1.5
2.0
4,311,049
783,802
235,127
5,772,406
1,049,493
314,829
0.0009
1.2
1.5
2.0
957,271
174,024
52,194
1,281,766
233,013
69,885
Myocardial infarction (410)
Renal failure (584)
Asthma (743)
Another objective is to compare the age- and gender-adjusted change in health between cohorts by SF-36V
scores. The SF-36V has a Physical Component Summary Scale (PCS) and a Mental Component Summary
(MCS) Scale. SF-36V data from healthy military populations are not available. However, Ware et al. (99) have
reported that among adults with chronic disease, approximately 20% will have more than a 5.43-point increase
in the PCS scores one year from baseline. Changes in scores among a healthy population should be much
smaller. If we assume, as have previous DVA Gulf War study planners, that a 7-point change in PCS score is a
significant change and further assume that on average between 5% and 10% of subjects will report such a 7point increase (health decline) after 3 years, we can then use this 5-10% as the estimated incidence of a new
condition. Table 3 demonstrates the necessary total sample size (using equal groups) to detect a small effect size
difference of between 5-20%.
In a similar fashion, if we compare the difference in incidence of psychiatric diagnoses between cohorts by the
Patient Health Questionnaire and further estimate that the incidence of the 18 different mental health conditions
detected by the Patient Health Questionnaire ranges from 0.01 to 0.10 every 3 years, we can infer from Tables 13 that we should be able to detect small risk differences between cohorts.
Table 3. Sample Size Necessary to Detect Differences Between Cohorts at Different Levels of Statistical Power
With an Expected 5% or 10% Incidence Over 3 Years (2-Tailed)
Power
Expected
Incidence
Effect size to detect
.80
.85
.90
.95
5%
243,877
279,944
326,505
404,180
10%
62,350
71,566
83,464
103,311
15%
28,322
32,507
37,909
46,919
20%
16,274
18,677
21,779
26,954
5%
115,301
132,344
154,345
191,046
10%
29,422
33,766
39,374
48,728
15%
13,339
15,307
17,846
22,082
20%
7,650
8,777
10,232
12,658
.05
.10
From our previous studies, we can estimate that among the 2.7 million U.S. servicepersons serving on January 1,
2001, less than 20,000 (< 0.7%) will have served in the Gulf War, 185,703 (6.9%) will have served in Southwest
Asia (since August 1991), 86,263 (3.2%) will have served in the Bosnia conflict (since December 1995), and
18% will have served in more than one conflict. Approximately 15% of the force will be women. These data
will be used in planning the stratified, probability-based sampling.
In selecting the deployed and nondeployed groups for the Millennium Cohort Study, we will avoid selecting
servicepersons who have been deployed to the Gulf War, or who have been deployed to Southwest Asia, Bosnia,
or Kosovo prior to September 1997.
The study group sizes are:
Southwest Asia, Bosnia, Kosovo Veterans-30,000
Millennium Cohort-70,000
From our previous experience, we found good addresses for about 65% of Gulf War veterans potential subjects
and among those we reached approximately 65% agreed to participate in our postal surveys.
With this percentage in mind, we will send the initial preliminary postcard mailing to 256,400 subjects with the
goal of gaining the 100,000 respondents.
In summary, the large sample size and follow-up for up to 20 years should assure excellent power to detect small
effects on health outcomes occurring with a frequency similar to that of many important chronic diseases. Using
the cohort sizes of 50,000 will give us considerable power to detect small differences in risk for chronic
diseases, such as hypertension, diabetes, myocardial infarction, and asthma during the first 9 years of
observation. Less common disease risks will take longer.
A large sample size is fundamental to the successful detection of disease-exposure relationships in a timely
fashion such that preventive measures may be taken to reduce risk for future deployments. It is difficult to
predict which diseases will merit study for possible associations with future deployments. Some may be too rare
to study, but it seems prudent to have a significant sample size to evaluate most common chronic diseases.
12.0
12.1
Participant Information
Subject Population:
At the time of enrollment into the study, all participants will be a member of the US military serving on active
duty, Reserve Guard, or National Guard, have 1 to 5 years for service, and be over the age of 18.
Due to the longitudinal nature of the study and time frame in which data will be collected (until the year 2068),
the age ranges and special categories for this study can include all ages above 18 years old and many of the
special categories.
12.2
Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3
Gender:
Male
Female
Other
12.4
Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5
Inclusion Criteria:
Order
Number
Members of the regular active duty, National Guard, or Reserve U.S. military.
1
1-5 years of military service.
2
12.6
Exclusion Criteria:
Order
Number
1
13.0
13.1
Criteria
Criteria
For Panel 1 (2001) we will avoid selecting servicepersons who have been deployed
to the Gulf War, or who have been deployed to Southwest Asia, Bosnia, or Kosovo
prior to September 1997.
Recruitment and Consent
Please describe the recruitment process, including how subjects will be identified and selected for
the study.
The sample for each enrollment panel will be drawn randomly from the electronic rosters of
active-duty and reserve personnel at Defense Manpower Data Center (DMDC), California. The
cohort will be selected as a probability sample, stratified for deployment vs. nondeployment,
active duty vs. reserve, and male vs. female.
All selected subjects will receive an IRB approved invitation email and/or postal letter asking
them to participate in the study and complete a web-based questionnaire. Once a subject
completes their online questionnaire, the study team will send one final contact letting them
know that their submission was received and to thank them for their participation.
If a subject does not respond to the initial invitation, the study team will send reminder emails
and postal items, to include postcards and paper questionnaires, to the subject to encourage
participation for the duration of the survey cycle.
No further communication will be attempted with service members who do not respond after the
last reminder contact, who do not consent, or who withdraw their consent before the end of the
recruitment period. Service members will consent by signing an on-line or paper informed
consent statement and completing a questionnaire.
Thank You notes (an e-mail or post card depending on the cost and available budget) will be
sent to service members who complete their survey before the end of the enrollment period. The
same procedures will be followed for administering the follow-up questionnaires except that the
follow-up questionnaire invitation letter and reminders will be sent only subjects who completed
the baseline questionnaire.
Informed consent documents are updated just prior to periods of recruitment and
enrollment. Therefore, the Millennium Cohort Study consent form will be updated every three
to six years.
Marketing for Participant Recruitment and Retention
The Millennium Cohort Study team has collaborated with the NHRC PAO and other
organizations develop marketing materials to aid in the recruitment of new participants for the
baseline survey and to re-engage follow-up participants. All proposed marketing materials have
been/will be submitted for review and approval prior to distribution.
Recruiting Service Member Spouses for the Millennium Cohort Family Study
To facilitate the recruitment of service members’ spouses into the Millennium Cohort Family
Study, all responders who, upon completion of their 2020 Millennium Cohort Study baseline
survey, are flagged as married by DMDC and who have a marital status of either married or
separated on the baseline survey will be directed to a secure incentive fulfillment page operated
by Anderson Direct & Digital (AD&D). In addition to requesting their current mailing address
for incentive fulfillment, these participants will be asked to provide their spouse’s email address
with the following message: Because families serve too, the Millennium Cohort Program
includes a study designed for military spouses - The Millennium Cohort Family Study. Spouses
can complete a survey and receive a $10 gift card! Please provide an email so we can request
their participation.
Please see section 13.2 for more detailed information regarding the process of compensation for
participation.
Service member spouses will be invited to participate in the Millennium Cohort Family Study at
a later date. The Millennium Cohort Family Study will maintain the consent form, Privacy Act,
HIPAA Authorization, survey documents and participant contacts for their study under protocol
NHRC.2015.0019.
Recruiting Service Members for the Family Cohort Study Single Parent Module
Upon completion of their Millennium Cohort Study survey, all 2020 baseline survey responders
who fit the criteria below based on their self-reported data, will be invited to participate in the
Millennium Cohort Family Study single parent module. This module was designed to align with
the parenting and child sections of the Family Study surveys in order to broaden the definition
of military families.
Marital status:
Single, never married
Divorced
Widowed
Minor children (17 or younger):
Yes
On the final page of the Millennium Cohort Study survey, all 2020 baseline survey responders
that meet the single parent criteria mentioned above will see the following message:
Single Parents Matter – The Millennium Cohort Family Study
Because families serve too, the Millennium Cohort Program includes a study designed for single
parents in the military - The Millennium Cohort Family Study. Single parents will receive a
$10 gift card for answering an additional set of questions, which should take no longer than 1015 minutes to complete. You will be receiving an email shortly with additional details and
instructions.
During the data import, all participants that are deemed ‘single parents’ will be flagged to
receive an automated email from the Millennium Cohort Family Study inviting them to
complete the Single Parent Module of the Millennium Cohort Family Study Survey. The
invitation email has been submitted for review and approval.
The Millennium Cohort Family Study will maintain the consent form, Privacy Act, HIPAA
Authorization, survey documents and participant contacts for the single parent module under
protocol NHRC.2015.0019. No service member will receive an invitation email until the Family
Study has received IRB approval for the consent form, Privacy Act, HIPAA Authorization, and
single parent survey.
Dyad Invitation Experiment
The need to understand the impact of war on military families has never been greater than
during the past decade, with more than three million military spouses and children affected by
deployments to Operations Iraqi Freedom and Enduring Freedom. Understanding the impact of
the recent conflicts on families is a national priority, however, most studies have examined
spouses and children individually, rather than concurrently as families. The Department of
Defense (DoD) has authorized the largest study of military families in US military history (the
Millennium Cohort Family Study), which includes dyads of military service members and their
spouses. A dyad is a group of two people; in this case a military service member and their
spouse.
The Millennium Cohort Study of service members and the Millennium Cohort Family Study of
military spouses (Family Study) plans to conduct an experiment to determine the impact of the
timing of service member–spouse dyadic invitations sent to request participation in the Family
Study versus the Millennium Cohort Study, as well as the nature of specific incentives during
the course of the Family Study Panel 2 recruitment cycle. A group of 2,000 service member–
spouse dyads from the Family and Millennium Cohort Study sampling frames were held out
from the initial study invitations, and will be included in this experiment. The experiment will
be initiated within two months of the initial launch of the Family Panel 2 recruitment. Married
service member–spouse dyads will be assigned to 1 of 5 experimental groups. Each
experimental group will vary by combination of recruitment type and incentive type (see table
below).
INCENTIVE TYPE RECRUTIMENT TYPE
Single
Dyadic
Group1
Group3
Post
Group 2
Group 4
Pre/Post
Group 5
Bonus
Service members assigned to Single Recruitment will be invited to participate in the Millennium
Cohort Study 8 weeks prior to their spouses being invited to the Family Study. Couples assigned
to Dyadic Recruitment will be invited simultaneously. Couples assigned to a Post-Incentive
group will receive contacts explaining that they will receive a gift card for completion of the
survey. Couples assigned to a Pre/Post Incentive group will receive a postal invitation that
includes a magnetic picture frame, as well as messaging about the opportunity for a gift card
after completing the survey. Couples assigned to the Bonus Incentive group will receive
contacts explaining that they will receive a gift card for completing the survey, as well as a
Bonus $10 gift card for the Family Study participant if both members of the couple complete
their survey. When participants log into the study website survey portal, their survey experience
will be the same as participants not included in the experiment. Additional details about the
experiment are included in the Millennium Cohort Family protocol (NHRC.2015.0019) sections
10.1, 13.1, and 13.2.
Millennium Cohort Study Feedback Survey
The population for this project will be all currently enrolled participants in Panels1-5 of the
Millennium Cohort Study.
All eligible participants will receive an invitation email and/or postal letter asking them to
participate in the feedback survey by completing a paper or web-based survey. Once a
participant completes their survey, the study team will send one final contact letting them know
that their submission was received and to thank them for their participation.
If a subject does not respond to the initial invitation, the study team will send two (2) reminder
emails to the participant to encourage participation for the duration of the survey cycle.
Consent Addendum and HIPAA Authorization
Beginning in the 2019 survey cycle (2019-2021), the Millennium Cohort Study attempted to
engage existing study participants to review and sign an IRB approved consent addendum. The
addendum informed the participants that: (1) the length of the study has been extended past its
original 21 years to 67 years; (2) that other databases that the study links with has been
expanded to include medical records, surveys, or biological specimens collected or maintained
by the Department of Defense, Department of Veterans Affairs, federal or state agencies, or
nongovernmental organizations such as the National Student Clearinghouse; and (3) that the
study has obtained a Certificate of Confidentiality (CoC) from the National Institutes of Health
(NIH).
Additionally, during the 2019 survey cycle, the Defense Health Agency required the study to
engage existing study participants to review and sign an IRB approved DHA HIPAA
Authorization to allow the study to obtain requested participant Military Health System data.
Per IRB guidance, the study can and will continue to engage existing study participants to
review and sign the consent addendum and DHA HIPAA Authorization until such time that the
participant signs the forms, they contact the study team and refuse to sign the forms, or a waiver
of consent and/or HIPAA waiver is granted by the NHRC IRB and/or Privacy Officer.
Changes to the Informed Consent Addendum
After concluding the 2019-2021 survey cycle, the Study realized many participants didn't fully
grasp the Addendum's significance. Unaware of the consequences, many unknowingly missed
the opportunity for continued participation by neglecting to sign the Informed Consent
Addendum. Subsequent attempts to rectify this through postal mail and email revealed that
many may have seen the Addendum as simply informative, overlooking the essential need for
their signature.
To address misconceptions surrounding the Informed Consent Addendum, the Study sought and
obtained approval from the IRB Chair to modify the Addendum. The Study has been approved
to remove the signature requirement and instead clearly state that completion and return of the
survey itself signifies agreement to the updated terms. This updated Addendum will be provided
during the 2024-2025 to all participants who do not yet have one on file.
13.2
Compensation for Participation:
We plan to follow standard techniques (92,93) of gaining high participation percentages: pre-survey introductory
postcard mailing, cover letter with survey, postcard reminders, and three repeat survey mailings (Appendix
G). We will mail the subjects a preliminary postcard to alert them to the forthcoming survey. This will also
allow us to gather address information inexpensively for subjects who have changed addresses after our data
extraction. The questionnaire will next be sent by first-class U.S. mail, with a cover letter describing the study,
and a consent form. The investigators will employ a commercial address tracking company to locate subjects
with inaccurate addresses. One month after the initial mailing, a postcard reminder will be sent. Two months
after the first survey mailing, a second survey with a cover letter will be mailed, and this will again be followed
with another reminder postcard 1 month later. Four months after the second questionnaire mailing, a final
questionnaire with cover a letter will be mailed, and this mailing will again be followed with a third postcard
reminder. After three survey mailings, a tracking service and additional data updates will be used to find correct
addresses for undelivered mail.
An IRB-approved investigation into whether Millennium Cohort Study response rates were affected by
incentives offered prior to survey completion was conducted during the 2014-2016 survey cycle. For the 20142016 pre-incentive investigation, all participants with a current postal address were randomly assigned one of
five pre-incentives: a two-dollar bill, a five-dollar gift card, a magnet, entry into a drawing for an iPad, or no preincentive. Pre-incentives were mailed in September 2014 along with an invitation to participate in the 2014-2016
survey. Additionally, since some participants did not get a pre-incentive by design or because of outdated
contact information, the team sent challenge coins to all participants who completed the survey as another means
of increasing retention and to keep contact with participants.
The number of participants in each group was determined a priori based on incentive availability, cost, and
current literature. A total of 1,000 participants received entry into the iPad drawing. This number was chosen to
ensure that the odds of winning one of the two available iPads were no greater than 1 in 500 and equates to
approximately $2 per person. The group that did not receive an incentive included 5,000 participants. This
number was chosen because the literature and past experience suggested that this would be the least effective
method to increase survey response. Resource availability dictated that 10,040 participants receive a gift
card. The remaining participants were allocated evenly between the cash and magnet groups, each with a final
total of 78,203 participants. Literature indicated that cash would elicit the highest response rates, thus the study
team ensured that this was one of the largest groups. The magnet was a nominal gift of equal value ($2) and was
also predicted to have a high success rate in inducing response. After the pre-incentives were mailed, we
received 10,770 (6.2%) returned incentives due to outdated mailing addresses. These participants were removed
from the analyses since we were unable to contact them via postal mail and therefore could not assess the preincentive effect on their response.
Results from the 2014-2016 investigation determined that a $2 bill and a $5 gift card had higher response rates
among participants who received them, compared to those who received no pre-incentive (Table 1). Participants
given a $2 bill or $5 gift card had an approximately 27-28% higher odds of responding compared with those
who were not given a pre-incentive. There was no observed difference in the odds of responding to the survey
among participants who were entered into the iPad drawing or sent a magnet compared to those who did not
receive a pre-incentive.
Table 1. Survey response rate and odds of response by pre-incentive type
% response
Total
32.4†
Pre-Incentive Type
No pre-incentive
$2 bill
Gift card
Drawing/lottery
Magnet
30.4
35.0
35.5
29.4
29.5
Survey Response*
Odds Ratio (95% CI)
1.00 (ref)
1.27 (1.18, 1.35)
1.28 (1.18, 1.39)
0.97 (0.83, 1.15)
0.94 (0.88, 1.01)
*Logistic regression model adjusted for age, gender, race/ethnicity, marital status, education, service branch,
military service status, service component, accession group, and foreign address. After adjustment, incentive
type was statistically significantly associated with response (p-value < 0.001).
†Total includes all enrolled, living Millennium Cohort participants with a currently known postal mailing
address.
In addition to overall response rate, another area of specific interest was the effectiveness of pre-incentives in
getting previous non-responders to re-engage in the study. These results indicated that the pre-incentives
effective in the general study population (gift card and cash) were also the most effective among previous nonresponders (Table 2). A total of 8.6% of last cycle’s (2011-2013) non-responders who received a cash preincentive responded to the 2014 survey, and 8.3% responded after receiving the gift card, compared with 4.9%
who did not obtain a pre-incentive. Participants given a $2 bill or $5 gift card had an approximately 82% or 77%
greater odds of responding, respectively, compared with those who did not receive a pre-incentive.
Table 2. Survey response rate and odds of response by pre-incentive type among 2011 survey nonresponders
% response
Total
6.8†
Pre-Incentive
Letter
Cash
Gift card
Lottery
Magnet
4.9
8.6
8.3
3.8
5.1
Survey Response*
Odds Ratio (95% CI)
1.00 (ref)
1.82 (1.43, 2.33)
1.77 (1.34, 2.33)
0.77 (0.40, 1.48)
1.03 (0.80, 1.32)
*Logistic regression model adjusted for age, gender, race/ethnicity, marital status, education, service branch,
military service status, service component, accession group, and foreign address. After adjustment, incentive
type was statistically significantly associated with response (p-value < 0.001).
†Total includes enrolled, living Millennium Cohort participants with a currently known postal mailing address,
and did not complete a 2011 Millennium Cohort survey.
This investigation not only indicated that pre-incentives were effective in boosting survey response rates, but
also that certain types of pre-incentives were more successful than others, namely cash and gift cards. This
information will help to maximize study retention and reduce costs. Based on the findings from this IRBapproved investigation, the Millennium Cohort Study will invest in monetary incentives for the upcoming
survey cycle to enhance participant engagement and increase the survey response rate. All original ODCs for the
purchase of these incentives have been submitted as a part of this package.
During the latest OMB and RCS approval process the use of incentives by the Millennium Cohort Study was
reviewed and approved by the Office of the General Counsel for Navy Medicine on February 25, 2022. All
external approvals have submitted as part of this package in Appendix K.
Through an existing sub-contract with Anderson Direct & Digital (AD&D), the Millennium Cohort study will
offer each participant who completes the web survey their choice of a Millennium Cohort ball cap, a challenge
coin, or a $5 gift code to Starbucks or Amazon. On the final page of the web survey, the participant will have the
option to choose their gift by clicking a radio button. For those participants that choose a hat or coin, this radio
button will redirect the participant to the AD&D secure gift fulfillment page. Here, the participant will confirm
their gift selection and provide AD&D with their current mailing address for fulfillment.
On the last page of the Millennium Cohort survey below the radio button the following message will appear:
By clicking the button above, you understand that you are being re-directed to our gift card fulfillment partner,
Anderson Direct & Digital. Please be assured that the Millennium Cohort Study and Anderson Direct & Digital
treat your privacy very seriously. Your personal information will not be shared with any outside parties.
On the AD&D page the following message will appear:
The Millennium Cohort Study has partnered with Anderson Direct & Digital to offer you a selection of gifts as a
token of our appreciation. Please be assured that the Millennium Cohort Study and Anderson Direct & Digital
treat your privacy very seriously. Your personal information will not be shared with any outside parties.
For those participants that choose a gift code, upon their selection confirmation the Millennium Cohort web page
will page will display the gift code from the chosen vendor.
13.3
Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
Not applicable.
13.4
Consent Process: Revised Common Rule, Section 219.116: General requirements for informed
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and
(c) of this section only with respect to the storage, maintenance, and secondary research uses of
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
Yes
No
What type?
Waiver of documentation of informed consent
Waiver or alteration of informed consent
Please explain why your study is eligible for the requested waiver
The Millennium Cohort Study is eligible for the requested waiver of documentation of informed
consent because while initially planned for a 21-year duration, the Millennium Cohort study
received an extension in 2013, stretching its timeframe to 67 years and setting its new period of
performance to 2068. To reflect this change and accommodate additional data linkages and a
Certificate of Confidentiality, and in order to harmonize informed consent across the Study
panels, the Study developed an Informed Consent Addendum with guidance from the Naval
Health Research Center's Institutional Review Board Chair. This addendum informed
participants of the updated terms and required their wet or digital signature (paper or online) to
confirm their awareness. Distribution of the addendum began in the 2019-2021 survey cycle,
with attempts to collect signatures during two additional periods outside ongoing data collection.
After concluding the 2019-2021 survey cycle, the Study realized many participants didn't fully
grasp the Addendum's significance. Unaware of the consequences, many unknowingly missed
the opportunity for continued participation by neglecting to sign the Informed Consent
Addendum. Subsequent attempts to rectify this through postal mail and email revealed that
many may have seen the Addendum as simply informative, overlooking the essential need for
their signature.
To address misconceptions surrounding the Informed Consent Addendum, the Study sought and
obtained approval from the IRB Chair to modify the Addendum. The Study has been approved
to remove the signature requirement and instead clearly state that completion and return of the
survey itself signifies agreement to the updated terms. This updated Addendum will be provided
during the 2024-2025 to all participants who do not yet have one on file.
Please explain the consent process:
For all newly invited participants, an informed consent statement will be included in both the online and paper questionnaires. The informed consent statement will include a phone number and
e-mail address of the Millennium Cohort Study team and the NHRC IRB chair. Service
members can contact these individuals if they have questions.
The on-line survey will include an “I Agree” button that subjects will click to signify that they
have read the information and agree to participate. Once the button is selected, the subject will
be redirected to the research survey questionnaire. The paper questionnaire’s informed consent
will be the first page of the questionnaire after the cover page. Subjects will be required to sign
and print their names for the informed consent to be valid. Subject medical data will not be
obtained unless service members provide informed consent.
Changes and/or updates to the original Informed Consent will be provided to participants in an
Informed Consent Addendum. The online survey and paper survey's Addendum will
immediately follow the Privacy Act and Agency Disclosure Notice and will be located before
the first survey question. The Addendum will clearly state that completion and return of the
survey itself signifies agreement to the updated terms.
13.5
DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If
applicable, you may nominate an individual to serve as the ombudsman.
N/A
Propose ombudsman
13.6
Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from
the study
Participants may change their mind and revoke their permission for this project to collect or use their health
information at any time. Per the consent form, to revoke their permission, they must contact the study team at
the email or phone number provided in the consent form and on the study website. When they revoke their
permission, no new questionnaire or health information about them will be gathered after that date and they may
no longer be allowed to participate in the study. Per the consent form, information that has already been gathered
may still be used and there is no guarantee that it will be removed from the electronic database for this study.
They also have the right to review an electronic copy of their survey and medical information for as long as the
survey and health information are maintained by contacting the study team.
14.0
14.1
Risks and Benefits
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research
procedure or intervention as a result of participation in this study. Consider the risks of breach
of confidentiality, psychological, legal, social, and economic risks as well as physical risks. Do
not describe risks from standard care procedures; only describe risks from procedures done for
research purposes
This protocol uses demographic, occupational, and deployment data, as well as survey data and existing medical
data. Thus, the study poses no physical risk to the participants. The data of interest are, however, of a sensitive
nature, and strict procedures will be followed to minimize loss of confidentiality. Although personal identifiers
will be kept and utilized to ensure proper linkage of data, they will be protected such that no individual could be
identified in any report.
Records and computer files will be maintained securely in accordance with DoD regulations. The potential loss
of confidentiality for participants who complete the online survey is minimized because completed surveys are
transmitted to NHRC over Secure Sockets Layer (SSL) data transmission lines.
14.2
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate
risk of harms to subjects and study personnel
The following procedures are in place to ensure that confidential information will not be used or abused in ways
that might directly or indirectly harm the individuals involved:
Administrative
All study staff will receive training in confidentiality protection procedures.
Supervisors will monitor staff to ensure that they follow proper confidentiality procedures.
An annual review of confidentiality procedures will be conducted.
If study staff resign or otherwise leave the program, they will remain under obligation to protect the
confidentiality of all data collected as part of the study.
Procedural
The respective service survey approval managers will review the participant contacts and paper
questionnaire. Their approval will be required before initiating any mailings.
The participants will be informed of the process that will be used to link their answers with pre-existing
data. It is required that NHRC’s IRB permit the investigators to forgo use of the formal informed
consent documentation.
Study staff will transport survey records, which contain PII and PHI, other paper records, and computer
disks from one location to another securely per the approved transportation SOP (Appendix L). Study
staff will store study files in locked metal file cabinets at NHRC. Paper records that are no longer
needed will be shredded according to the dispositions instructions of the active SORN (Appendix K).
14.3
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and
records throughout the study and at its conclusion (e.g., destruction, long term storage, or
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure
servers, firewalls, and other appropriate methods). If data will be shared electronically with
other team members/collaborators outside the institution, describe the method of transmission
and safeguards to maintain confidentiality. Explain whether this study may collect information
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse
The following procedures are in place to ensure that confidential information will not be used or abused in ways
that might directly or indirectly harm the individuals involved:
Administrative safeguards
A Certificate of Confidentiality (CoC) issued by the National Institutes of Health (NIH) has been
obtained for this study. CoCs protect participants’ privacy such as name or other identifying information
from being disclosed in any civil, criminal, administrative, legislative or other proceedings, whether at
the federal, state or local level.
Physical safeguards
NHRC is located on a secure access-controlled site. Personnel access to NHRC is controlled by a DoDissued access card. Visitors must be escorted at all times.
Computer Security
To gain entry into the study database, staff will be required to enter their personal ID numbers and
password.
Study staff will download data through secure data transmission links meeting standard DoD
requirements. The data will be stored on existing NHRC information systems network. This system
meets current DoD data security requirements.
Study data are maintained within project specific data folders on network drives located on NHRC
servers. Access controls are in place to restrict, monitor, and protect data, thus ensuring data availability,
integrity, and confidentiality. All data will be carefully guarded and used only to meet the stated study
objectives.
The NHRC network firewall is in place to deter unauthorized access to these files.
Personal identifying information will be removed from the analytic database once the survey, medical
facility use, and demographic information are linked and stored separately. Only the data mangers, who
are familiar with the database, will link personal identifiers with the data for the initial match or any
subsequent matches, and the identifiers will again be stripped following the match.
The study database will reside within the NHRC network environment. There are no subcontractors who
would have access to or possession of this database at any time.
Information transmitted over the Internet will be done so using SSL-encrypted transmission lines.
Further, users will have to enter their unique study ID number and last four digits of their social security
number to send completed questionnaires.
Appendix M details the website security procedures.
The PHI/PII collected in the survey (if any) will be specified in the informed consent document and used with
authorization from the subject as stipulated in the informed consent document. The informed consent agreement
includes the following required information: a description of the information to be used; the name of the person
(s) requesting the use; the name of the person(s) who may use the requested PHI/PII, (i.e., the intended
recipients, a description of each purpose of the requested use, the length of time that the data will be maintained
tied to an expiration date or an expiration event, a statement regarding the individual’s right to revoke
authorization for use of PHI/PII and whom to contact in writing to revoke the authorization, a statement
regarding the individual’s right to inspect hard copies of any PHI/PII collected, and who to contact in writing to
inspect the contributed data). The study participants will also be asked to sign a DSA approved HIPAA
Authorization. Participant medical data will not be obtained from Military Health System (MHS) sources unless
participants provide a signed Authorization.
Our use of PHI/PII involves no more than minimal risk to the individuals since we will implement procedures to
control access to the information collected. Each individual invited to join the study will be assigned a subject
identification number (SID). Two databases will be created for study use. The first database (identified) will
contain participant data such as name, contact information (phone, address, and email), data of birth, and SID.
This database will be the source of names and addresses when individuals are contacted and will be used for
tracking purposes. The second analytic database (redacted) will store participant questionnaire responses and
relevant administrative data in conjunction with the SID and without identifiers. This procedure will separate
individual identifiers from participant survey data, while making it possible to pair names and contact
information with SIDs for update and tracking purposes. The principal investigator controls access to both the
analytic and identified databases, which are located onsite at NHRC on a secure DoD controlled network.
Records and computer files will be maintained securely in accordance with DoD regulations (NMRDCINST
5870.4). Access to PHI/PII will be restricted to onsite NHRC investigators who have signed the Investigator
Compliance Attestation. Identifiable data sets will be shared only with those co- investigators listed on the
protocol who have signed the Investigator Compliance Attestation. Identifiable data will not be re-used or redisclosed to any other entity. Data will be maintained securely at NHRC both within the physical environment
and IT environment, as per NAVHLTHRSCHCENINST 6500.1A. Hard copies of completed surveys will be
stored in locked file cabinets in buildings 337 and 347. Further, as mentioned above, all electronic data are
stored as password-protected files that are stripped of personal identifiers, such as names, and will retain only
study-specific subject identification numbers. Data are managed and analyzed using only these de-identified data
files, which will be destroyed after a minimum of six years following completion of the study, or as dictated by
any future required retention periods, whichever is longer. Findings will only be released as an aggregate; no
individuals will be identified. Hard copies of completed surveys will be securely destroyed per the disposition
instructions of the active SORN. Please see Appendix O for the active SORN.
Millennium Cohort study participant names and postal addresses will be provided to Anderson Direct & Digital
(Anderson) by a secure encrypted website so they can solicit participants by postal mail. Anderson will be
required by contract to keep the information confidential, not use the information beyond the purposes of the
investigation, and destroy the names and addresses upon the project’s completion.
Solicitation of participants by Anderson is performed on an individual basis by postal mail letter and post card
that ask them to complete a web-based survey; e-mail reminders are sent by NHRC study staff from servers
located at NHRC. Participants who chose to volunteer will access the server at LightEdge Solutions
(LightEdge), in San Diego Data Center using a unique username (SID) that will be provided in all
correspondence. On the survey login page, the participant’s SID and DoD ID Number or the last four of their
SSN are keyed in by the participant. The participant’s SID and digits 6-10 of their DoD ID Number or the last
four of their SSN are held in memory by the web server over an encrypted Secure Sockets Layer (SSL)
connection (Hypertex Transfer Protocol Secure [HTTPS]) using the Transport Layer Security (TLS) 1.2 protocol
and Advanced Encryption Standard (AES) Galois/Counter Mode (GCM) 128-bit block cipher. Digits 6-10 of the
keyed-in DoD ID Number or the last four of their SSN are then hashed by the server using the earlier described
method and compared against the stored hash value in the SID-hashed identifier log. At this point, the SSN or
DoD ID Number information which was held in memory is discarded (it is not stored) and the user is either
granted or denied access to the survey and assigned a session token.
Questionnaire responses stored at LightEdge are transferred to NHRC by encryption and participant’s IP
addresses are not included in the transfer. All transfers between other participating organizations (NHRC,
DMDC, VA) are accomplished using the DoD SAFE site. All transmittals of PII and questionnaire and medical
data are performed separately.
In summary, records and computer files will be maintained securely in accordance with DoD regulations and
contracts. PII and data will be transmitted separately and stored in separate file servers at NHRC. The potential
loss of confidentiality for participants who complete the online survey is minimized because no PII is collected
on the survey, digits 6-10 of their DoD ID Number or the last four of their SSN are hashed then matched and not
stored, and surveys are encrypted while they are transmitted. Sharing of data between DMDC, NHRC,
LightEdge, Anderson, and VA is accomplished using encrypted sites. Data storage is on government computers
with their inherent required security protocols.
14.4
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and
they cannot provide their own consent, the protocol must describe the intent to directly benefit
all subjects
While participation in this study may not directly benefit study subjects, their participation may help the
researchers and the military understand the impacts of military deployment, military occupations and general
military service on long-term service member health. Even if they have not or will not ever deploy, they are
encouraged to participate so the investigators can understand similarities and differences between service
members wo do and do not deploy.
14.5
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and
all research activities, etc.
This study involves surveying participants on-line and via paper questionnaire and collecting existing medical
data and does not involve any direct interaction with individuals or their biological specimens. All paper
questionnaires will be kept in locked files. When data are entered into computer files for analysis, the participant’
s answers will be identified only by a special study identification number (SID) known to participant and
research team members. This number is located on the barcode of the study envelope and survey for that
participant. Their social security number and any other personal identification information will be removed from
their questionnaire and data file upon return to the researchers. Even if someone outside the research team broke
into the files, it would be impossible for them to identify the participant’s data. To minimize the risk of anyone
breaking into the data files, those files will be maintained on DoD computers protected by all the measures
required by DoD computer security regulations. All members of the research team with access to data files will
be trained in DoD computer security procedures specifically designed to protect sensitive data. Reports of the
study findings will contain only group data, so that no individual study participant can be identified.
The PHI/PII collected in the survey (if any) will be specified in the informed consent document and used with
authorization from the subject as stipulated in the informed consent document. The informed consent agreement
includes the following required information: a description of the information to be used; the name of the person
(s) requesting the use; the name of the person(s) who may use the requested PHI/PII, (i.e., the intended
recipients, a description of each purpose of the requested use, the length of time that the data will be maintained
tied to an expiration date or an expiration event, a statement regarding the individual’s right to revoke
authorization for use of PHI/PII and whom to contact in writing to revoke the authorization, a statement
regarding the individual’s right to inspect hard copies of any PHI/PII collected, and who to contact in writing to
inspect the contributed data). The study participants will also be asked to sign a DSA approved HIPAA
Authorization. Participant medical data will not be obtained from Military Health System (MHS) sources unless
participants provide a signed Authorization.
Our use of PHI/PII involves no more than minimal risk to the individuals since we will implement procedures to
control access to the information collected. Each individual invited to join the study will be assigned a subject
identification number (SID). Two databases will be created for study use. The first database (identified) will
contain participant data such as name, contact information (phone, address, and email), data of birth, and SID.
This database will be the source of names and addresses when individuals are contacted and will be used for
tracking purposes. The second analytic database (redacted) will store participant questionnaire responses and
relevant administrative data in conjunction with the SID and without identifiers. This procedure will separate
individual identifiers from participant survey data, while making it possible to pair names and contact
information with SIDs for update and tracking purposes. The principal investigator controls access to both the
analytic and identified databases, which are located onsite at NHRC on a secure DoD controlled network.
Records and computer files will be maintained securely in accordance with DoD regulations (NMRDCINST
5870.4). Access to PHI/PII will be restricted to onsite NHRC investigators who have signed the Investigator
Compliance Attestation. Identifiable data sets will be shared only with those co- investigators listed on the
protocol who have signed the Investigator Compliance Attestation. Identifiable data will not be re-used or redisclosed to any other entity. Data will be maintained securely at NHRC both within the physical environment
and IT environment, as per NAVHLTHRSCHCENINST 6500.1A. Hard copies of completed surveys will be
stored in locked file cabinets in buildings 337 and 347. Further, as mentioned above, all electronic data are
stored as password-protected files that are stripped of personal identifiers, such as names, and will retain only
study-specific subject identification numbers. Data are managed and analyzed using only these de-identified data
files, which will be destroyed after a minimum of six years following completion of the study, or as dictated by
any future required retention periods, whichever is longer. Findings will only be released as an aggregate; no
individuals will be identified. Hard copies of completed surveys will be securely destroyed per the disposition
instructions of the active SORN. Please see Appendix O for the active SORN.
Millennium Cohort study participant names and postal addresses will be provided to Anderson Direct & Digital
(Anderson) by a secure encrypted website so they can solicit participants by postal mail. Anderson will be
required by contract to keep the information confidential, not use the information beyond the purposes of the
investigation, and destroy the names and addresses upon the project’s completion.
Solicitation of participants by Anderson is performed on an individual basis by postal mail letter and post card
that ask them to complete a web-based survey; e-mail reminders are sent by NHRC study staff from servers
located at NHRC. Participants who chose to volunteer will access the server at LightEdge Solutions
(LightEdge), in San Diego Data Center using a unique username (SID) that will be provided in all
correspondence. On the survey login page, the participant’s SID and DoD ID Number or the last four of their
SSN are keyed in by the participant. The participant’s SID and digits 6-10 of their DoD ID Number or the last
four of their SSN are held in memory by the web server over an encrypted Secure Sockets Layer (SSL)
connection (Hypertex Transfer Protocol Secure [HTTPS]) using the Transport Layer Security (TLS) 1.2 protocol
and Advanced Encryption Standard (AES) Galois/Counter Mode (GCM) 128-bit block cipher. Digits 6-10 of the
keyed-in DoD ID Number or the last four of their SSN are then hashed by the server using the earlier described
method and compared against the stored hash value in the SID-hashed identifier log. At this point, the SSN or
DoD ID Number information which was held in memory is discarded (it is not stored) and the user is either
granted or denied access to the survey and assigned a session token.
Questionnaire responses stored at LightEdge are transferred to NHRC by encryption and participant’s IP
addresses are not included in the transfer. All transfers between other participating organizations (NHRC,
DMDC, VA) are accomplished using the DoD SAFE site. All transmittals of PII and questionnaire and medical
data are performed separately.
In summary, records and computer files will be maintained securely in accordance with DoD regulations and
contracts. PII and data will be transmitted separately and stored in separate file servers at NHRC. The potential
loss of confidentiality for participants who complete the online survey is minimized because no PII is collected
on the survey, digits 6-10 of their DoD ID Number or the last four of their SSN are hashed then matched and not
stored, and surveys are encrypted while they are transmitted. Sharing of data between DMDC, NHRC,
LightEdge, Anderson, and VA is accomplished using encrypted sites. Data storage is on government computers
with their inherent required security protocols.
14.6
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from
screening to the end of the subject’s participation in the research. In cases where the subject
could possibly benefit medically or otherwise from the information, state whether or not the
results of screening, research participation, research tests, etc., will be shared with subjects or
their primary care provider. State whether the researcher is obligated or mandated to report
results to appropriate military or civilian authorities and explain the potential impact on the
subject
Not applicable.
15.0
15.1
Study Monitoring
Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring
Board (DSMB).
DSMP
DSMB
Both
Not Applicable
A DSMP should describe the plan to monitor the data to verify that the data are collected and
analyzed as specified in the protocol. Include who will conduct the monitoring, what will be
monitored, and the frequency of monitoring. It should also include the plan to ensure the safety
of subjects
Study data are maintained within project specific data folders on network drives located on NHRC servers.
Access controls are in place to restrict, monitor, and protect data, thus ensuring data availability, integrity, and
confidentiality.
Briefly, the NHRC Information Technology (IT) Department securely stores the servers within a restricted
access room in an access-controlled building located on the NHRC complex in a manner that meets or exceeds
DoD requirements. The IT Department creates incremental backups of the data nightly, which are stored locally
on site. Once weekly, backups are replicated to an off-site server located at a remote NHRC building for disaster
recovery. Access to project specific data folders is controlled by the DHRD Data Management Team. The study
team prepares a data access request outlining the planned analyses, the data sources, agreements in place to
access source data, and the PHI/PII involved. Personnel seeking access are limited to those with a need to know,
and data are limited to what is necessary to address the study objectives. The request is reviewed by the Study
PI, NHRC Privacy Officer, DHRD Head, Regulatory Affairs Manager, and members of the Data Management
team. If a positive endorsement is received from each reviewer, the Data Manager then grants access to the data
outlined on the request to the individuals listed on the request. Failure to receive an endorsement from each
reviewer means that the study team needs to revise the request until the concerns raised by reviewers are met.
Each time data are accessed, the date, time, and name of individual accessing are logged. Although access is
restricted, the Data Manager conducts weekly reviews of the logs to ensure only approved individuals have
accessed the data. Identifiable data must be maintained within project specific data folders. The PI verifies that
data are analyzed as specified in the study protocol, and the IRB and command conduct annual reviews to ensure
study progress continues in alignment with the protocol. The Privacy Office and NHRC IT independently
exercises the right to monitor other network drives and folders for PHI/PII. These reviews occur periodically and
are unannounced.
16.0
16.1
Reportable Events
Reportable Events: Consult with the research office at your institution to ensure requirements are
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address
how unexpected adverse events will be identified, who will report, how often adverse events and
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form
are needed and the scale that will be used to grade the severity of the adverse event.
Consult with the research office at your institution to ensure requirements are met
• Describe plans for reporting expected adverse events. Identify what the expected adverse
events will be for this study, describe the likelihood (frequency, severity, reversibility, shortterm management and any long-term implications of each expected event)
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address
how unexpected adverse events will be identified, who will report, how often adverse events and
unanticipated problems will be reviewed to determine if any changes to the research protocol or
consent form are needed and the scale that will be used to grade the severity of the adverse
event
The PI will report to the IRB any reportable events in a timely manner as outlined below:
Data Slip/Breach will be reported within 24 hours from the time the incident was identified
Protocol deviation/violations or other issues of noncompliance with the protocol will be
reported within 5 business days from the date of discovery.
17.0
17.1
Equipment/non-FDA Regulated Devices
Does the study involve the use of any unique non-medical devices/equipment?
Yes
18.0
18.1
No
FDA-Regulated Products
Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.5
Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
19.1
Research Registration Requirements
ClinicalTrials.gov Registration:
Registration is not required
Registration pending
Registration complete
19.2
Defense Technical Information Center Registration (Optional):
Registration is not required
Registration pending
Registration complete
20.0
20.1
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
References and Glossary
References:
Defense Science Board. Final Report: Defense Science Board Task Force on Persian Gulf War Health
Effects. Washington, DC: Office of the Under Secretary of Defense for Acquisition and Technology,
1994.
Presidential Advisory Committee on Gulf War Veterans' Illnesses. Final Report, December 1996.
Washington, DC: US Government Printing Office, 1996.
Institute of Medicine. Adequacy of the Comprehensive Clinical Evaluation Program: A Focused
Assessment. Washington, DC: National Academy Press, 1997.
Institute of Medicine (U.S.). Committee to Review the Health Consequences of Service During the Persian
Gulf War. Health consequences of service during the Persian Gulf War : recommendations for research
and information systems. Washington, D.C.: National Academy Press, 1996:xii, 193.
Presidential Advisory Committee on Gulf War Veterans' Illnesses. Special Report, November 1997.
Washington, DC: US Government Printing Office, 1997.
Kang HK, Dalager NA, Lee KY. Health Surveillance of Persian Gulf War Veterans: a Review of the
Department of Veterans Affairs Persian Gulf Registry and in-Patient Treatment Files. Washington, DC:
Environmental Epidemiology Service, Department of Veterans Affairs, 1995.
Gray GC, Hawksworth AW, Smith TC, Kang HK, Knoke JD, Gackstetter GD. Gulf War veterans' health
registries. Who is most likely to seek evaluation? Amer J Epidemiol 1998; 148:343-349.
Department of Veterans Affairs. Annual Report to Congress: Federally Sponsored Research on Persian
Gulf Veterans' Illnesses for 1998. Washington, DC: Department of Veterans Affairs, The Research
Working Group of the Persian Gulf Veterans Coordinating Board, 1999.
Office of the Special Assistant to the Deputy Secretary of Defense for Gulf War Illnessees. Annual Report,
November 1996 - November 1997. Washington, DC: Department of Defense, 1997.
Report of the Defense Science Board Task Force on Persian Gulf War Health Effects. Washington, DC:
Office of the Under Secretary of Defense for Acquisition and Technology, 1994.
Presidential Advisory Committee on Gulf War Veterans' Illnesses. Interim Report, February 1996.
Washington, DC: US Government Printing Office, 1996.
Committee on a National Center on War-Related Illnesses and Postdeployment Health Issues IoM.
National Center for Military Deployment Health Research. In: Hernandez L, Liverman C, Greenlick M,
eds. Washington, DC: National Academy Press, 1999.
Committee on Measuring the Health of Gulf War Veterans IoM. Gulf War Veterans: Measuring Health.
In: Hernandez L, Durch J, Blazer II D, Hoverman I, eds. Washington, DC: National Academy Press,
1999.
Institute of Medicine. Veterans at Risk: The Health Effects of Mustard Gas and Lewisite. In: Pechura C,
Rall D, eds. Washington, DC: National Academy Press, 1993.
Institute of Medicine. Health Consequences of Service During the Persian Gulf War: Initial Findings and
Recommendations for Immediate Action. Washington, DC: National Academy Press, 1995.
Institute of Medicine: Committee on the Evaluation of the Department of Defense Comprehensive Clinical
Evaluation Program. Adequacy of the Comprehensive Clinical Evaluation Program: Nerve Agents.
Washington, DC: National Academy Press, 1997.
United States General Accounting Office. Defense Health Care: Efforts to Address Health Effects of the
Kuwait Oil Well Fires. Washington, DC: United States General Accounting Office, 1992.
United States General Accounting Office. Operation Desert Storm: DoD Met Need for Chemical Suits and
Masks, But Longer Term Actions Are Needed. Washington, DC: United States General Accounting
Office, 1992.
United States General Accounting Office. Operation Desert Storm: Improvements Required in the Navy's
Wartime Medical Care Program. Washington, DC: United States General Accounting Office, 1993.
United States General Accounting Office. Operation Desert Storm: Potential for Reproductive Dysfuction
Is Not Being Adequately Monitored. Washington, DC: United States General Accounting Office, 1994.
United States General Accounting Office. Operation Desert Storm: Questions on Possible Exposure to
Reproductive Toxicants. : GAO; 1994. Washington, DC: US General Accounting Office, 1994.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
United States General Accounting Office. Operation Desert Storm: Health Concerns of Selected Indiana
Persian Gulf War Veterans. Washington, DC: United States General Accounting Office, 1995.
United States General Accounting Office. Foreign Assistance: Contributions to Child Survival Are
Significant, But Challenges Remain. Washington, DC: US General Accounting Office, 1996.
United States General Accounting Office. Defense Health Care: Medical Surveillance Improved Since
Gulf War, But Mixed Results in Bosnia. Washington, DC: United States General Accounting Office,
1997.
United States General Accounting Office. Gulf War Illnesses: Improved Monitoring of Clinical Progress
and Reexamination of Research Emphasis Are Needed. Washington, DC: United States General
Accounting Office, 1997.
United States General Accounting Office. Operation Desert Storm: Evaluation of the Air Campaign.
Washington, DC: United States General Accounting Office, 1997.
United States General Accounting Office. Gulf War Illness: Public and Private Efforts Relating to
Exposures of U.S. Personnel to Chemical Agents. Washington, DC: United States General Accounting
Office, 1997.
United States General Accounting Office. Gulf War Veterans: Incidence of Tumors Cannot Be Reliably
Determined from Available Data. Washington, DC: United States General Accounting Office, 1998.
United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on
Human Resources. The status of efforts to identify Persian Gulf War syndrome : recent GAO findings :
hearing before the Subcommittee on Human Resources of the Committee on Government Reform and
Oversight, House of Representatives, One Hundred Fifth Congress, first session, June 24, 1997.
Washington: U.S. G.P.O. : For sale by the U.S. G.P.O. Supt. of Docs. Congressional Sales Office, 1997:
iii, 97.
Presidential Special Oversight Board for Department of Defense Investigations of Gulf War Chemical and
Biological Incidents. Special Oversight Board Interim Report. Washington, DC: Presidential Special
Oversight Board for Department of Defense Investigations of Gulf War Chemical and Biological
Incidents, 1999.
Richter P. Clinton to form oversight panel on Gulf War illnesses. Los Angeles Times. Los Angeles, CA,
1997.
Joseph S, The Comprehensive Clinical Evaluation Program Evaluation Team. A comprehensive clinical
evaluation of 20,000 Persian Gulf War veterans. Mil Med 1997; 162:149-155.
Coker WJ, Bhatt BM, Blatchley NF, Graham JT. Clinical findings for the first 1000 Gulf war veterans in
the Ministry of Defence's medical assessment programme. Bmj 1999; 318:290-4.
Pollet C, Natelson BH, Lange G, et al. Medical evaluation of Persian Gulf veterans with fatigue and/or
chemical sensitivity. J Med 1998; 29:101-13.
Henry L, Gray G. Topical Bibliography of Published Works Regarding the Health of Veterans of the
Persian Gulf War. San Diego: Naval Health Research Center, 1999.
Helmkamp JC. Epidemiological characteristics of US fatalities during Desert Storm. Mil Med 1992; 157:
A7.
Writer JV, DeFraites RF, Brundage JF. Comparative mortality among US military personnel in the Persian
Gulf region and worldwide during Operations Desert Shield and Desert Storm. JAMA 1996; 275:118121.
Kang HK, Bullman T. Mortality among US veterans of the Persian Gulf War. N Engl J Med 1996; 335:
1498-1504.
Gray G, Coate B, Anderson C, et al. The postwar hospitalization experience of US veterans of the Persian
Gulf War. The New England Journal of Medicine 1996; 335:1505-1513.
Knoke JD, Gray GC. Hospitalizations for unexplained illnesses among US Persian Gulf War veterans.
Emerging Infectious Diseases 1998; 4:211-219.
Knoke JD, Gray GC, Garland FC. Testicular cancer and Persian Gulf War service. Epidemiology 1998; 9:
648-653.
Gray G, Smith T, Knoke J, Heller J. The postwar hospitalization experience of Gulf War veterans possibly
exposed to chemical munitions destruction at Khamisiyah, Iraq. Amer J Epidemiol 1999; 150:532-540.
Gray GC, Smith TC, Kang HK, Knoke JD. Are Gulf War veterans suffering war-related illnesses? Federal
and civilian hospitalizations examined, June 1991 to December 1994. Am J Epidemiol 2000; 151:63-71.
The Iowa Persian Gulf Study Group. Self-reported illness and health status among Persian Gulf War
veterans: a population-based study. JAMA 1997; 277:238-245.
Gray GC, Kaiser KS, Hawksworth AW, Hall FW, Barrett-Connor E. Increased postwar symptoms and
psychological morbidity among U.S. Navy Gulf War veterans. Am J Trop Med Hyg 1999; 60:758-66.
Fukuda K, Nisenbaum R, Stewart G, et al. Chronic multisymptom illness affecting Air Force veterans of
the Gulf War. JAMA 1998; 280:981-988.
Unwin C, Blatchley N, Coker W, et al. The health of United Kingdom servicemen who served in the
Persian Gulf War. Lancet 1999; 353:169-78.
Goss Gilroy Inc. Health study of Canadian forces personnel involved in the 1991 conflict in the Persian
Gulf Vol I. Ottawa, Ontario: Gos Gilroy Inc., 1998.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.
77.
78.
79.
Haley RW, Kurt TL, Hom J. Is there a Gulf War syndrome? Searching for syndromes by factor analysis of
symptoms. JAMA 1997; 277:215-222.
Ismail K, Everitt B, Blatchley N, et al. Is there a Gulf War syndrome? Lancet 1999; 353:179-82.
Nisenbaum R, Reyes M, Mawle AC, Reeves WC. Factor analysis of unexplained severe fatigue and
interrelated symptoms: overlap with criteria for chronic fatigue syndrome. Am J Epidemiol 1998; 148:727.
Knoke J, Smith T, Gray G, Kaiser K, Hawksworth A. Factor analysis of self-reported symptoms: Does it
identify a Gulf War syndrome? Amer J Epidemiol, in press. 2000.
Penman AD, Tarver RS, Currier MM. No evidence of increase in birth defects and health problems among
children born to Persian Gulf War veterans in Mississippi. Mil Med 1996; 161:1-6.
Cowan DN, DeFraites RF, Gray GC, Goldenbaum MB, Wishik SM. The risk of birth defects among
children of Persian Gulf War veterans. N Engl J Med 1997; 336:1650-1656.
Araneta M, Kamens D, Gastanaga V, et al. Reproductive and Perinatal Outcomes Among Conceptions and
Pregnancies during the Persian Gulf War., Conference on Federally Sponsored Gulf War Veterans'
Illnesses Research, June 17-19, Arlington, Virginia., 1998.
Araneta MR, Moore CA, Olney RS, et al. Goldenhar syndrome among infants born in military hospitals to
Gulf War veterans. Teratology 1997; 56:244-251.
Hyams KC, Wignall FS. Identification of Gulf War syndrome: methodological issues and medical
illnesses. JAMA 1997; 278:384.
Hyams KC, Roswell RH. Resolving the Gulf War syndrome question. Am J Epidemiol 1998; 148:339-42.
Nicolson GL, Nicolson NL. Mycoplasmal infections--diagnosis and treatment of Gulf War illness/CFIDS.
Int J Occup Med Immunol Tox 1996; 9:66-69.
Nicolson GL, Rosenberg-Nicolson NL. Doxycycline treatment and Desert Storm. JAMA 1995; 273:618619.
Nicolson GL, Nicolson NL. The eight myths of Operation "Desert Storm" and Gulf War syndrome. Med
Confl Surviv 1997; 13:140-146.
Golomb B. A review of the scientific literature as it pertains to Gulf War illnesses. Vol 2 Pyridostigmine
bromide. Washington, DC: National Defense Research Institute, Rand, 1999.
Kaiser K, Hawksworth A, Gray G. Pyridostigmine bromide intake during the Persian Gulf War not
associated with postwar handgrip strength,. Mil Med, in press 2000.
Bell IR, Warg-Damiani L, Baldwin CM, Walsh ME, Schwartz GEW. Self-reported chemical sensitivity
and wartime chemical exposures in Gulf War veterans with and without decreased global health ratings.
Mil Med 1998; 163:725-732.
Study cites danger from Gulf War depleted uranium. Associated Press, 1998.
Hafemeister R. Sand linked to Gulf War syndrome. Tampa (FL) Tribune. Tampa, 1999.
Foster S. Vaccine Role Cited in Gulf War Illness. Vol. 1999: World Net Daily, 1999.
Executive Order of the President. A National Obligation: Planning for Health preparedness for and
Readjustment of the Military, Veterans, and their Families After Future Deployments. Presidential
Review Directive 5. Washington, DC: Executive Order of the President,, 1998.
Brundage JF. Military preventive medicine and medical surveillance in the post-cold war era. Mil Med
1998; 163:272-7.
Rubertone MV BM. Deployment Medical Surveillance Data Analysis Plan. Washington, DC: Army
Medical Surveillance Activity, 1999.
Department of Defense Instruction No. 6490.3. Implementation and Application of Joint Medical
Surveillance for Deployments.: Department of Defense, 1997.
Rostker B. DoD not ignoring issue. USA Today. Arlington, VA, 1996:14A.
Department of Veterans Affairs. Annual Report to Congress: Federally Sponsored Research on Persian
Gulf Veterans' Illnesses for 1997. Washington, DC: Department of Veterans Affairs, The Research
Working Group of the Persian Gulf Veterans Coordinating Board, 1998.
McHorney CA, Ware JE, Jr., Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II.
Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care
1993; 31:247-63.
Spitzer RL, Williams JB, Kroenke K, et al. Utility of a new procedure for diagnosing mental disorders in
primary care. The PRIME-MD 1000 study (see comments). Jama 1994; 272:1749-56.
Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): L conceptual framework
and item selection. Med Care 1992; 30:473-483.
Smith T, Gray G, Knoke J. Is systemic lupus erythematosus, amyotrophic lateral sclerosis, or fibromyalgia
associated with Persian Gulf War service? An examination of Department of Defense hospitalization
data. Amer J Epidemiol, in press. 2000.
Ballou RW, Ohl CA. Viscerotropic Leishmaniasis in Returnees From Operation Desert Shield/Storm.
Chester, MD: Armed Forces Epidemiological Board, Parson's Island, 1992.
United States General Accounting Office. Agent Orange. Actions Needed to Improve Communications of
Air Force Ranch Hand Study Data and Results. Washington, DC: United States General Accounting
Office, 1999.
80.
The Women's Health Initiative Study Group. Design of the women's health initiative clinical trial and
observational study. Controlled Clin Trials 1998; 19:61-109.
81. Kazis LE, Ren XS, Lee A, et al. Health status in VA patients: results from the Veterans Health Study. Am
J Med Qual 1999; 14:28-38.
82. Kazis L, Miller D, Clark J, et al. Health-related quality of life in patients served by the Department of
Veterans Affairs. Arch Intern Med 1998; 158:626-632.
83. Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory
bowel disease. Gastroenterology 1989; 96:804-10.
84. Spertus JA, Winder JA, Dewhurst TA, et al. Development and evaluation of the Seattle Angina
Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995; 25:
333-41.
85. Bergner M, Bobbitt RA, Kressel S, Pollard WE, Gilson BS, Morris JR. The sickness impact profile:
conceptual formulation and methodology for the development of a health status measure. Int J Health
Serv 1976; 6:393-415.
86. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the
PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire.
Jama 1999; 282:1737-44.
87. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J
Trauma Stress 1995; 8:75-90.
88. Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD
Checklist (PCL). Behav Res Ther 1996; 34:669-73.
89. Dalager NA, Kang HK. Mortality among Army Chemical Corps Vietnam veterans. Am J Ind Med 1997;
31:719-26.
90. Kang H, Bullman T. Mortality among US veterans of the Persian Gulf War. N Engl J Med 1996; 355:14981504.
91. Kang H, Mahan C, Lee K, Magee C. Women Vietnam Veteran Reproductive Outcomes Health Study.
Washington, DC: Department of Veterans Affairs, 1998.
92. Dillman DA. Mail and telephone surveys : the total design method. New York: Wiley, 1978:xvi, 325.
93. Willett WC, Colditz GA. Approaches for conducting large cohort studies. Epidemiol Rev 1998; 20:91-9.
94. Hulley S, Cummings S. General Formula for Total Sample Size. Designing Clinical Research. An
Epidemiologic Approach. Baltimore. Baltimore: Williams and Wilkins, 1988:217.
95. Zheng ZJ, Folsom AR, Ma J, Arnett DK, McGovern PG, Eckfeldt JH. Plasma fatty acid composition and 6year incidence of hypertension in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC)
Study. American Journal of Epidemiology 1999; 150:492-500.
96. He F, Wang S, Liu L, Chen S, Zhang Z, Sun J. Clinical manifestations and diagnosis of acute pyrethroid
poisoning. Arch Toxicol 1989; 63:54-58.
97. He J, Klag MJ, Caballero B, Appel LJ, Charleston J, Whelton PK. Plasma insulin levels and incidence of
hypertension in African Americans and whites. Archives of Internal Medicine 1999; 159:498-503.
98. Volmink JA, Newton JN, Hicks NR, Sleight P, Fowler GH, Neil HA. Coronary event and case fatality
rates in an English population: results of the Oxford myocardial infarction incidence study. The Oxford
Myocardial Infarction Incidence Study Group. Heart 1998; 80:40-4.
99. Ware N, Kleinman A. Culture and somatic experience: the social course of illness in neurasthenia and
chronic fatigue syndrome. Psychosom Med 1992; 54:546-560.
100 Mueller, J. Research on-line: human participants ethics issues. Retrieved September 12, 2000 from the
World Wide Web: http://www.psych.ucalgary.ca/research/ethics/online.html
101. On-line payment systems. A congressional budget office study, Emerging electronic methods for making
retail payments. Retrieved September 13, 2000 from the World Wide Web: http://minneapolisfed.org
/banking/payments/cbo3.html
102. Azar, B. Online experiments: ethically fair or foul? Monitor on psychology 2000; 31: retrieved September
12, 2000 from the World Wide Web: http://www.apa.org/monitor/apr00/fairorfoul.html
103. Frankel, F, Siang, S. Ethical and legal aspects of human subjects research on the internet; a report of a
workshop June 10-11, 1999, Washington, DC. American Association for the Advancement of
Science. Retrieved September 12, 2000 from the World Wide Web: http://www.aaas.org/spp/dspp/sfrl
/projects/intres/main.htm
104. LeardMann CA, McMaster HS, Warner S, Esquivel AP, Porter B, Powell TM, Tu XM, Lee WW, Rull
RP, Hoge CW; Millennium Cohort Study Team. Comparison of Posttraumatic Stress Disorder Checklist
Instruments From Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition vs Fifth Edition
in a Large Cohort of US Military Service Members and Veterans. JAMA Netw Open. 2021 Apr 1;4(4):
e218072. doi: 10.1001/jamanetworkopen.2021.8072. PMID: 33904913; PMCID: PMC8080232.
20.2
Abbreviations and Acronyms:
Completion email for web survey completers
*** This is an automated message, please do not reply***
On behalf of the Millennium Cohort Study team, thank you for completing your Millennium Cohort survey!
Your participation in this important health study will benefit future generations of military service members.
Your Millennium Cohort Study survey was submitted on at