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pdfAttachment 5. LOI3-RT-01-N - IRB Protocol
OMB # 0925-0647
Expiration Date: 1/31/2015
Medical/Behavioral Protocol Summary Form
Directions for Protocol Submission
(do not include this page with your submission)
Behavioral Exempt Protocol Submissions:
If requesting Exempt Review for a Behavioral research study, submit one completed Medical/Behavioral Protocol Summary Form
(containing original signatures) the entire descriptive protocol and/or grant application and all instruments (survey tools), a HIPAA
Summary Form (if applicable), and two copies of other documentation as appropriate [e.g., informed consent, assent, information
sheet(s), HIPAA authorization, and advertisements] to the HIC office. There is no deadline for submission of Behavioral Exempt
protocols.
Medical Exempt Protocol Submissions-Do NOT use this form:
If requesting Exempt Review for a Medical research study, submit one completed Medical Exemption Form (containing original
signatures), the entire descriptive protocol and/or grant application and all instruments (survey tools), a HIPAA Summary Form (if
applicable), and one copy of any other documentation. There is no deadline for submission of Medical Exempt protocols
Medical/Behavioral Expedited Protocol Submissions:
If requesting Expedited Review for a Medical or Behavioral research study, submit one completed Medical/Behavioral Protocol
Summary Form (containing original signatures), the entire descriptive protocol and/or grant application and all instruments (survey
tools), a HIPAA Summary Form (if applicable), and two copies of other documentation as appropriate [e.g., informed consent, assent,
information sheet(s), HIPAA authorization(s), and advertisement(s)] to the HIC office. There is no deadline for submission of Expedited
Protocols.
Medical/Behavioral Full Board Protocol Submissions:
If requesting Full Board Review, see the HIC website for submission deadlines.
Submit one copy of the Protocol Submission Checklist, manually checking each box that reflects the item(s) being submitted with this
research project. Submit 20 submission packets as follows:
• 3 collated packets containing the HIC Protocol Summary Form (one copy containing original signatures), the entire descriptive
protocol/grant application, investigator’s (drug) brochure(s)/package insert(s), HIPAA Summary Form (if applicable) and copies of
all other documentation as appropriate [e.g., informed consent, assent, information sheet(s), HIPAA authorization(s), all
Instruments (survey tools), and any advertisements or flyers].
• 17 collated packets containing copies of the Protocol Summary Form, informed consent/assent/information sheet(s), nonstandardized instruments (survey tools-e.g., tools developed by the PI or questionnaires/surveys that deal with sensitive subjects
such as drug use or sexual practices) and any advertisements or flyers. Other documentation may be included if appropriate.
***
HIC Pre-Review Service (for Full Board research proposals):
For information regarding this optional service for pre-review of Full Board research proposals, please go to:
http://www.hic.wayne.edu/hicinfo/IRBPreReviewerAnnounce.doc
NOTE: HIC responses will be forwarded by mail, email or fax to the investigator approximately 7 to 10 working days following
review by the HIC/IRB. The HIC requests that you refrain from contacting the office regarding the status of a protocol
before the end of the 10 working days.
Public reporting burden for this collection of information is estimated to average 20 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD
20892-7974, ATTN: PRA (0925-0647*). Do not return the completed form to this address.
Page 1 of 21
Form Date: 04-08-09
Medical/Behavioral Protocol Summary Form
PI Name: William Lyman
Protocol Submission Checklist
Protocol Summary Form
Appendix A (International)
Appendix B (Internet)
Appendix C (Minors)
Appendix D (Mentally Disabled/Cognitively Impaired)
Appendix E (Prisoners)
Appendix F (Drugs/Devices)
Appendix G (Radiation)
Appendix H (Biological Specimens)
Letter of Support (State how many:
)
Coordinating Center Form
Debriefing script
Materials to be distributed to participants or others:
Pamphlets, brochures
Books
Educational/training materials
Other
Letter of Approval from a scientific review committee
Protocol Review Monitoring Committee (PRMC)
Clinical Investigation Committee (VAMC)
Departmental Review Board (Psychiatry)
DMC Research Review Authorization (all research at the DMC)
http://content.dmc.org/ResearchReviewProcess/
Advertisement/Notice/Flyer:
Advertisement(s) (state how many
Notice(s)/Flyer(s) (state how many
)
)
Consent/Assent/Information Sheet:
Consent(s) (state how many2)
HIPAA Authorization Form included in consent
Parental Permission/Research Informed Consent (state how many
Assent(s) (state how many
)
Information Sheet(s) (state how many
)
)
HIPAA Summary Form
Grant Application/Research Protocol
Investigator Brochure for a drug/device
Package Insert(s) (state how many
)
Page 2 of 21
Form Date: 04-08-09
Human Investigation Committee
101 East Alexandrine
Detroit, MI 48201
www.hic.wayne.edu
Medical/Behavioral Protocol Summary Form
Fax (313) 993-7122
Office (313) 577-1628
Medical/Behavioral Protocol Summary Form
All HIC Submission Forms must be the current form date and typed/computer generated
HIC Protocol Number
HIC Use ONLY
Section A: Principal Investigator (PI), Project Title & Endorsements
Phone:
William Lyman
1. Name of PI:
(313) 7452400
Date:
09/21/2010
Department:
Pediatrics
Fax:
(313) 7450282
Division:
Children's Research Center of MI
E-mail:
[email protected]
Campus Address:
Children's Hospital of Michigan
3901 Beaubien
Detroit, MI 48201
Pager:
313 247 3336
2. NOTE: PIs who are students or who are not WSU faculty or employees of WSU or an affiliated health care institution must
provide home mailing address and phone number in addition to the above information. (NOTE: If provided, all correspondence
from the HIC office will be sent to the home address.)
Home Address:
Home
(
)
Phone:
3. Name of Protocol
N/A
Coordinator:
Phone:
(
)
E-mail:
4. Form completed
William Lyman
Title:
Principal Investigator
(313) 7452400
E-mail:
[email protected]
by:
Phone:
5. Project Title:
RT-01-M GC/MS methods to determine environmental factors on fetus and newborn
Page 3 of 21
Form Date: 04-08-09
6. Endorsements and Financial Conflict of Interest Disclosure:
Medical/Behavioral Protocol Summary Form
Objectivity in research is a key component of any research project. One method for maintaining objectivity is to have
all individuals involved in research design, development, or data evaluation/analysis disclose any potential and/or real
financial conflict of interest. This includes all personnel listed in response to Questions #6 and #7.
Examples of relevant relationships for potential conflict of interest include but are not limited to:
(1)
(2)
(3)
(4)
receiving past, current, or expecting future income in the form of salary, stock or stock options/warranties, equity, dividends, royalties,
profit sharing, capital gain, forbearance or forgiveness of a loan, interest in real or personal property, or involvement in a legal
partnership with the sponsor
receiving past, current, or expecting future income in the form of consulting fees, honoraria, gifts, gifts to the University, or payments
resulting from seminars, lectures, or teaching engagements, or service on a non-federal advisory committee or review panel
serving in a corporate or for-profit leadership position, such as executive officer, board member, fundraising officer, agent, member of
a scientific advisory board, member of a scientific review committee, or member of a data safety monitoring committee, regardless of
compensation
inventor on a patent or copyright involving technology/processes/products licensed or expected to be licensed to the sponsor.
See HIC Policy and Procedures Institutional Review Board & Institutional and Individual Financial Conflict of Interest (COI)
7. All Investigators and other study personnel are required to take the WSU educational training program on the protection
of Human Participants @ www.citiprogram.org .
Page 4 of 21
Form Date: 04-08-09
Medical/Behavioral Protocol Summary Form
If any response below is “yes,” there must be a “Financial Conflict of Interest Detailed Disclosure Form” submitted
directly to the Financial Conflict of Interest Committee at the time of this protocol submission and then annually or when
changes occur; if this form is not submitted, the protocol cannot be approved. The form and more information are
available at: www.research.wayne.edu/coi. For additional information please contact the Conflict of Interest Coordinator,
5057 Woodward, Suite 6305, Detroit, MI 48202, Fax 313-577-2159, Phone 313-577-9064.
PRINCIPAL INVESTIGATOR:
For students or individuals without a WSU faculty appointment, a WSU faculty supervisor/sponsor or authorized signatory (e.g.; official
from DMC, KCI, etc.) is required.
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict of
interest with the sponsor of this project, including all secondary sources?
NO
YES
In signing the description of this research project, the PI agrees to accept primary responsibility for the scientific and ethical conduct of
the research, as approved by the HIC, and abide by the HIC’s policies and procedures. The project cannot begin until the investigator
has received documentation of HIC review and final approval.
Signature of Principal Investigator
Professor of Pediatrics
09/21/2010
Title
Date
FACULTY SUPERVISOR/SPONSOR:
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict of
interest with the sponsor of this project, including all secondary sources?
NO
Campus Address:
YES
Phone:
E-mail:
In signing the description of this research project, the faculty supervisor/sponsor certifies that he/she has reviewed the research plan
and has approved the scientific and ethical aspects of this research. The faculty supervisor/sponsor will supervise all compliance with
the HIC’s guidelines.
Signature of WSU Faculty Supervisor/Sponsor
Printed name
Title
Date
DEPARTMENT CHAIR/DEAN OR AUTHORIZED SIGNATORY:
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict of
interest with the sponsor of this project, including all secondary sources?
NO
YES
In signing the submission of this research project, the Department Chair, Dean, Institute/Center Director or other authorized signatory
certifies that (1) appropriate support will be provided for the research project including adequate facilities and staff, and (2) appropriate
scientific and ethical oversight has been and will be provided.
Bonita Stanton, MD Professor
09/21/2010
and Chair of
Pediatrics
Signature of WSU Dept Chair/Dean or authorized signatory (e.g.; official
Printed name
Title
Date
from DMC. KCI, etc.)
If PI is a student, or an individual without a WSU faculty appointment, the above signature must be that of the Chair/Dean at WSU or
authorized signatory (e.g.; official from DMC, KCI, etc.).
Page 5 of 21
Form Date: 04-08-09
Medical/Behavioral Protocol Summary Form
Briefly describe their role in the study and disclose any potential and/or real financial conflict of interest. If a response is
“Yes” see previous page for additional information about the “Financial Conflict of Interest Detailed Disclosure Form.”
Study personnel are persons engaged in the collection of data or have access to data through intervention or interaction with the
participant, including the consent process, or have access to the participant’s identifiable private information. This may include
collaborators, fellows, residents, research assistants, etc.
a.
Name
Division/Dept
Research Role
Michael Diamond
OB/GYN
Investigator
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
NO
YES
Signature:
b.
Alan Dombkowski
Pediatrics
Investigator
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
YES
NO
Signature:
c.
Dawn Bielawski
Pediatrics
Investigator
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
YES
NO
Signature:
d.
Ronald Thomas
Pediatrics
Biostatistician
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
YES
NO
Signature:
e.
TBD
Pediatrics
Study Coordinator
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
NO
YES
Signature:
f.
TBD
Pediatrics
Research Assistant
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
NO
YES
Signature:
Additional study personnel list @www.hic.wayne.edu/hicforms/AdditionalStudyPersonnelList.doc
Page 6 of 21
Form Date: 04-08-09
Medical/Behavioral Protocol Summary Form
8. Check the type of IRB committee
Medical
Behavioral
9. Is this request for Clinical and
No
Yes
10. Is this a Clinical Trial?
No
review.
Translational Science Award (CTSA
review)?
PI must have HIC Chairman
approval for CTSA review.
http://clinicaltrials.gov/ct2/info/about
Check
the applicable type of review
11.
being requested. Include the
category for exempt or expedited
review. (Check only one)
* Guidance on review
categories is available at
www.hic.wayne.edu/hicsub.html
NOTE: For Medical EXEMPT
Protocols, please use the Medical
Exemption Protocol Form.
Yes
If yes, NIH Registration number
Exempt Review * for Behavioral Research ONLY
(enter category #):
Expedited Review * for Behavioral or Medical Research
(enter category #):
Full Board Review for Behavioral or Medical Research
12. State age range of participants’ for
this proposed research
a. Adult Age Range:
18to 45
b. Child (<18 years) Age
Range:
0to 18
(NOTE: For research outside of Michigan, check local laws for legal definition of a
“child.”)
13. Status of Principal Investigator
(Check all that apply)
14. Type of Project
#
15
WSU Faculty
VAMC Staff
DMC Staff
KCI Staff
Research Proposal
Thesis/Dissertation
Resident/Fellow
Graduate
Undergraduate
Other (explain):
Master’s Project
Other (describe):
Section B: Narrative Summary
Provide a complete and concise description of the protocol in non-technical language (lay terms). The completed
summary should be 1-3 pages in length, with up to ¾ of a page allowed for the response to each question. If the
narrative summary exceeds the allowed page length, an additional page(s) can be added. Do not ‘paste’ text from
the full protocol or refer to protocol page numbers. Literature citations should not be included in this section.
The narrative summary below does not take the place of the full descriptive protocol and/or grant application.
Page 7 of 21
Form Date: 04-08-09
Medical/Behavioral Protocol Summary Form
a. Describe the
background and
rationale for the study:
The goal of this project is to determine if current technology can be used to
establish whether exposure of the human fetus to a class of chemicals called
phthalates, which are known to negatively affect the endocrine (hormone)
system alters male sex hormone gene expression in the newborn. The basis
for this research is founded on the evidence that, in animal models and in
vitro tests, phthalates, which are found ubiquitously in the environment, can
disrupt the endocrine system with specific effects in male neonates.
Because there is mounting evidence that the prevalence of undescended
testicles and abnormal penile openings are increasing in human males, this
research proposal may have significant public health importance. In
contrast to males, the question about the effect of phthalates on female
development is less clear. Although the prevalence of abnormal early
puberty in pre-teen girls is increasing, the potential relationship between
this occurrence and fetal or early childhood exposure to phthalates is still to
be determined. The potential impact of phthalates on human growth and
development also includes its effect on metabolism as there is mounting
evidence that these compounds contribute to the childhood obesity epidemic
that is afflicting the United States.
Phthalates have been detected in medicines, nutritional supplements,
emulsifying agents, adhesives, agricultural products, building materials,
personal-care products, detergents and packaging. More importantly,
phthalates are found in children's toys and alimentation products. Phthalate
exposure can be through direct or by indirect routes. Diet is believed to be
the most common source, with foods such as milk, butter, and meats being
major sources. However, absorption through the skin and via inhalational
of low-molecular-weight phthalates may occur because some phthalates are
volatile. A recent study reported that the use of infant lotion, infant powder,
and infant shampoo were associated with increased infant urine
concentrations of phthalate metabolites. Additionally, a 2005 study
reported that increased human phthalate exposure during pregnancy resulted
in decreased anogenital distance between the scrotum and anus among baby
boys. Phthalate metabolites were measured in urine samples collected from
pregnant women and their male babies. Boys born to mothers with the
highest concentrations of phthalates were 7 times more likely to have
shortened anogenital distances.
b. State the goals/aims/
hypothesis for the study:
The research project is designed to determine if a combination of gas
chromatography/mass spectrometry (GC/MS) and high-throughput
microarray gene technology can be used efficiently in the National
Children’s Study (NCS) to analyze the potential effect of phthalate on fetal
and newborn male gene expression.
Pregnant women who consent to this study and deliver their newborn boys
at Hutzel Hospital. We will determine which woman will deliver a boy by a
chart review in which there is a prenatal ultrasound that documents the sex
of the fetus.
Women who have had a previous baby with severe endocrine abnormalities.
After the women consent to the study, we will collect a sample of their
urine and that of the baby before it leaves the hospital. We will also collect
the foreskin after circumscion and photocopy the baby's handprint.
c.
List inclusion criteria:
d. List exclusion criteria:
e. Describe the methods/
procedures of the study:
Page 8 of 21
Form Date: 04-08-09
Medical/Behavioral Protocol Summary Form
#
Section C: Research Project Characteristics
16
Check the applicable type of submission
17
Funds for this project are being provided by or
requested from:
*Must answer question #18
18
Sponsor(s):
FOR WSU Must match FES Form
Initial Submission
Resubmission of expired study
If
applicable
provide HIC #
HIC requested
Resubmission
Private/Pharmaceutical*
WSU Institute*
Industry*
Drug/Device Provider*
Governmental agency*
Departmental (WSU/DMC/VAMC)
Foundation*
None
Non-Profit Organization*
Other (describe):
1. Prime: National Institute of Child Health and
N/A
Human Development
Subcontract from: Michigan State University)
2.
Contact Name:
Address:
Katherine Cook
301 Administration Building, MSU, E Lansing, MI
48824
517 355 5040, ext 237
HHS275200800007C
00002509
Phone:
Grant Number:
SPA Proposal Number from FES Form
(eight digit number)
If there are more than one funding source please list the Sponsor who is supplying the funds first
19
Status of Funds:
20
Check all applicable performance sites where
this research will be conducted. It is essential
that this information is accurate. All human
research conducted at DMC, KCI or VAMC sites
require authorization through their institutional
review process in addition to HIC approval.
Approved
Pending
Wayne State University: site
University Physician Group (UPG): site
Kresge Eye Institute Outpatient Care
Detroit Medical Center Hospital or Institute:
Children’s Hospital of Michigan
Detroit Receiving Hospital/University Health Center
Harper University Hospital
Huron Valley/Sinai Hospital
Hutzel Women’s Hospital
Kresge Eye Institute Operating Room
Michigan Orthopedic Specialty Surgery Hospital
Rehabilitation Institute of Michigan
Sinai-Grace Hospital
Barbara Ann Karmanos Cancer Institute
John D. Dingell Veterans Administration Medical Ctr.
Other:
Page 9 of 21
Form Date: 04-08-09
N/A
N/A
#
Section C: Research Project Characteristics
21
Provide the names of all other locations where
the WSU PI will perform this research (e.g., nonUPG outpatient clinic, unaffiliated hospital(s)
[e.g. other cancer centers, Henry Ford Hospital,
St. Johns, etc.] school, home, church,
community center, etc.).
Attach a letter of support and/or IRB
approval if the research is being
done (1) outside of the PI’s
department or WSU/DMC/Practice
Plans, and/or (2) at a location not
affiliated with WSU.
a. Are any of the facilities/locations listed
in the response to Q#21outside of the
United States?
Medical/Behavioral Protocol Summary Form
N/A
NO
Yes
If checked, complete Appendix A and
complete the optional CITI module for
International Research, if not already
complete.
NOTE: An approval letter must accompany research from facilities that require scientific review prior to submission to the HIC.
Scientific review committees are in place to review all research being conducted at or from researchers from (1) the Veterans
Administration Medical Center (Clinical Investigation Committee), (2) the Department of Psychiatry and Behavioral Neuroscience
(Departmental Review Board), (3) the Karmanos Cancer Institute (Protocol Review Committee) for review of all cancer-related
research, and (4) Detroit Medical Center (Research Review Authorization).
22 Is this a multicenter study or clinical trial (i.e.,
NO
Yes
N/A
more than one investigator at different sites,
drug company study, cooperative group, etc.)?
a. IF YES, Is WSU the Coordinating
Center for this study?
23
NO
Is the local PI conducting research outside of
NO (GO TO QUESTION
Michigan?
#24)
Yes
If yes, complete the Coordinating Center
Form, available on the HIC website, and
include with this application.
Yes
If yes:
24
Does the research include adults unable to
consent as participants?
NO
Yes
If yes, complete Appendix D
Does the research include children as
participants?
NO
FOR MEDICAL RESEARCH ONLY - Is this is a
treatment/intervention study?
NO
Yes
If yes, complete Appendix C and
complete the optional CITI module for
Research with Children/Minors if not
already complete.
Yes
N/A
Page 10 of 21
Form Date: 04-08-09
#
Medical/Behavioral Protocol Summary Form
Section C: Research Project Characteristics
a. If Yes, describe your plan to protect
and monitor the study data to ensure
safety of the participants (e.g., Data
Safety Monitoring Board, safety
committee, PI oversight, etc.)
See HIC Policy/Procedure: Data Safety
Monitoring Board
b. Provide the name of the board, if
applicable, and its contact
information
#
25
Section D: Data Collection
26
Prospective Data Collection Methods
(Check all that apply):
What is the approximate number of participants/
documents / specimens to be enrolled
/collected?
* If using medical records from the
DMC/practice plans or a database created
from medical records from the DMC/practice
plans, complete a HIPAA Summary Form.
FOR SOCIAL/BEHAVIORAL RESEARCH
ONLY- COMPLETE THE “HIPS” MODULE
FOR THE CITI TRAINING.
** Provide a copy of each data collection
instrument and/or interview script with this
submission.
*** Audiotapes and/or videotapes can be a
significant risk to the participant’s
confidentiality. Consequently, such
materials should be destroyed at the end of
the study unless specified in the consent
form and the participant has given explicit
permission for their retention.
N/A
At WSU/DMC
800
At non-WSU/DMC
(e.g., multicenter
sites)
Medical Records/Database*,**** Site:
Specimens**** Site: Hutzel Hospital
Non-Medical Documents/Records/Database
Observation of participants (i.e. their behavior)
Questionnaire/Survey**
Diaries**
Interview**
Psychological testing **
Educational testing/evaluations**
Focus groups**
Audio/video taping ***
Internet If checked, complete Appendix B and
complete the optional CITI module for Internet
Research if not already complete.
Imaging**** Site:
Other (describe):
****All human research conducted at DMC
sites requires DMC Research Review
Authorization including the use of medical
records, specimens, imaging, etc..
http://content.dmc.org/ResearchReviewPro
cess/
Page 11 of 21
Form Date: 04-08-09
N/A
#
27
Medical/Behavioral Protocol Summary Form
Section D: Data Collection
Archival data**, *** Site:
Specimen repository**, *** Site:
Database*,**, *** Site:
Retrospective data sources
(Check all that apply)
* If using medical records from the
VAMC/DMC/practice plans or a database
created from medical records from the
VAMC/DMC/practice plans, complete a
HIPAA Summary Form.
FOR SOCIAL/BEHAVIORAL RESEARCH
ONLY- COMPLETE THE “HIPS” MODULE
FOR THE CITI TRAINING.
N/A
Medical records/Database*, *** Site:
Non-Medical Documents/Records/Database***
Internet If checked, complete Appendix B and
complete the optional CITI module for Internet
Research if not already complete.
Imaging** Site:
Other (describe):
**All human research conducted at DMC
sites requires DMC Research Review
Authorization including the use of medical
records, specimens, imaging, etc..
http://content.dmc.org/ResearchReviewPro
cess/
*** Provide a copy of each data collection
instrument with this submission.
28
Pamphlets, brochures
Educational Materials (e.g., curriculum)
Training Materials
Other (describe): Consent form
Identify any material(s) to be distributed to
participants or others.
Provide a copy of each.
29
30
N/A
Over what period of time will each participant
spend doing research-related activities?
a. State total number of visits
1
b. State length of each visit
Less than 60 minutes
c.
One visit only
State the total expected duration (including
long-term follow-up) for each participant’s
involvement? (e.g., three 15 minute visits,
two 10 minute visits for a total of 65
minutes over 2 months)
Will deception or experimental manipulation be
used without the participant’s knowledge?
a. If Yes, explain why deception is necessary,
and
b. describe the debriefing plan and attach a
debriefing script.
N/A
No
Page 12 of 21
Yes
N/A
Form Date: 04-08-09
#
31
Section D: Data Collection
Will a “control” group (e.g., normal healthy
volunteer, participants with an absence of the
condition under study, participants who are
receiving standard of care, placebo or no
intervention, etc.) be used in the study?
Medical/Behavioral Protocol Summary Form
No
Yes
N/A
No
Yes
N/A
No
Yes
N/A
No
Yes
N/A
a. If yes, explain what is meant by “control”?
32
See the HIC Policy/Procedure:
“Vulnerable Participants: Normal
Volunteers”
Indicate if any of the below apply to this
research study : (Check all that apply)
a. Pregnant women are excluded
See the HIC Policy/Procedure: “Inclusion of
Pregnant Women in Research”
If Yes, provide scientific
justification
b. Research participants are selected
based on racial/ethnic criteria
See the HIC Policy/Procedure: “ Inclusion of
Women and Minorities in Research”
If Yes, provide justification
c. Research participants are selected based
on gender.
See the HIC Policy/Procedure: “Inclusion of
Women and Minorities in Research”
If Yes, provide justification
33
Indicate if the research involves participants
likely to be vulnerable to coercion or undue
influence. (Check ALL that apply)
See the HIC policies/procedures on
vulnerable participants
Complete the CITI module for the specific
Study requires pregnant women and male newborns
Pregnant Women, Fetus(es), Neonates (birth to 4
weeks)
* If checked for neonates, complete Appendix C and
complete the optional CITI module for Research
Involving Pregnant Women and Fetuses in Utero
and/or Research involving Children/Minors if not
already complete.
Page 13 of 21
Form Date: 04-08-09
N/A
#
Medical/Behavioral Protocol Summary Form
Section D: Data Collection
vulnerable group (www.citiprogram.org)
Children (under 18 years of age)
*If checked, please complete Appendix C and complete
the optional CITI module “Research involving
* Not required for chart reviews.
Children/Minors” if not already complete. If students
are involved complete the optional CITI modules
**Prisoners are defined as individuals (children
“Students in Research-SBR” and if applicable,
or adults) who are being held in a jail, prison, or
treatment facility or who have been convicted or “Research in Public Elementary & Secondary SchoolsSBR” if not already complete.
are awaiting arraignment, trial, or sentencing.
This includes those who are in hospitals,
alcohol and drug treatment facilities under court
order and children in detention facilities as an
alternative to prison.
Mentally disabled/cognitively impaired adults who are
unable to give consent
*If checked, please complete Appendix D
Prisoners
**If checked, please complete Appendix E and complete
the optional CITI module for Research with Prisoners if
not already complete.
Non-consenting participants, in emergency situations
Terminally ill
Other – explain
34
Provide specific justification for inclusion of any
vulnerable participants identified in the previous
question.
35
Are students and/or employees of
WSU/DMC/VAMC the target population to be
enrolled in this protocol?
Need to address both prgnant women and male
infants
No
Yes
N/ A
See the HIC policy/procedures: “Vulnerable
Participants: Students, Trainees and
Employees”
If students are involved complete the
optional CITI modules “Students in
Research-SBR” and if applicable,
“Research in Public Elementary &
Secondary Schools-SBR” if not already
complete.
a. If Yes, describe how the PI and/or
recruiters will avoid potential coercion of
students/employees
Page 14 of 21
N/A
Form Date: 04-08-09
#
36
Medical/Behavioral Protocol Summary Form
Section D: Data Collection
Direct person-to-person solicitation
Clinician/Nurse
Co-Investigator/Collaborator
For Recruitment guidance, see HIC
Primary Care Provider
policy/procedures: “Recruitment of
Principal Investigator
Research Participants,” “Advertising for
Research Nurse
Research Participants,” and “Finder’s Fee.”
Research Assistant
Resident/Fellow
Student/Student Assistant
For VA Studies: recruitment of non-Veterans
Psychology Student Pool
is allowed only when there are insufficient
WSU Pipeline If checked, complete Appendix B and
Veterans available to complete the study.
complete the optional CITI module for Internet
Research if not already complete.
How will participants be recruited? (Check all
that apply)
N/A
Internet If checked, complete Appendix B and
complete the optional CITI module for Internet
Research if not already complete.
Other (specify):
Advertisement (state
posting location and
attach verbatim copies)
Notice/flyer (state
posting location and
attach verbatim copies)
37
N/A
Provide a narrative description of the
recruitment procedures and informed
consent process including measures to
protect personal privacy.
a. Describe recruitment procedures
For behavioral research: note that teachers,
service providers, or supervisors cannot recruit
their own students, clients, employees, etc.
Verify that the study introduction will
include: (1) the study involves research, (2)
the topic of research, (3) the time
commitment required, (4) the basic
procedures (e.g., interview, survey,
observation, etc.) and (5) study participation
is voluntary.
Dr. Diamond will review the medical record of
women who arrive in the Labor and Delivery service
at Hutzel to give birth. He will determine if the sex
of their fetus is known. For those women who will
give birth to a male baby, Dr. Diamond will approach
them and tell them that we are conducting a research
study which is examining the potential for
environmental factors to negatively affect their male
babies. Dr. Diamond will then ask if they are willing
to hear about the study.
Page 15 of 21
Form Date: 04-08-09
#
b. Describe the informed consent
process including measures to protect
personal privacy. (Note: Consent
process begins when a potential
research participant is initially
contacted.)
If HIPAA applies (research that will be
accessing medical records): state who
will introduce the study to participants
and specify their clinical relationship, if
any, to the participants (i.e., employer,
teacher, service provider, etc.)
d. Describe any safeguards in place for
PI and/or recruiters to protect
participants likely to be vulnerable to
coercion or undue influence.
c.
38
Medical/Behavioral Protocol Summary Form
Section D: Data Collection
Women who have agreed to hear about the study will
be asked at the end of this presentation if they and
their male babies would like to potentially
participate. If they say yes, the approved informed
consent will be given to them and they will be asked
to read it, have it read to them or translated, if
needed. After all of their questions about the study
and related issues are answered, they will be asked to
sign the informed consent document.
N/ A
Dr. Diamond
N/ A
Potential participants can refuse to be in the study
Participants can withdraw from the study at any time
(until unmarked foreskin and urine are matched - no
patient identifiers will be recorded - and transported
to the study laboratory)
There will be no loss of privacy
Section E: Consent of Research Participants
Identify the personnel who will be responsible for
obtaining informed consent of the participants.
(Check all that apply).
NOTE: These individuals must be among those
identified as “key personnel” in question #7.
Principal Investigator
Co-Investigator/Collaborator
Research Nurse
Research Assistant
Resident/Fellow
N/A
Other (specify):
39
Will more than one consent document (consent,
assent, parental permission form, information sheet)
be used?
If Yes, in total how many will be used?
No
40
Select the type of Consent/Assent that will be used (check all that apply).
Yes
N/A
NOTE: Attach copies of all consents / assents / information sheets / oral scripts that will be used.
a. Written Consent/Parental Permission:
Adult participants
Parents or guardians
Page 16 of 21
N/A
Form Date: 04-08-09
Section E: Consent of Research Participants
b. Assent for children
c.
Internet Information Sheet
d. Information Sheet (indicate who it will be
given to):
Medical/Behavioral Protocol Summary Form
Written (age 13-17)
Oral (age 7-12)
Information Sheet (age 13-17)
Adult participants
Parents or guardians
If either is checked, complete Appendix B and complete the
optional CITI module for Internet Research if not already
complete.
Adult participants
Parents or guardians
i.
State rationale for use of an
Information Sheet rather than a
Written Consent.
e. Oral informed consent using a script that will
be read to potential participants:
i.
41
State rationale for use of an Oral
rather than Written Consent.
ii.
Describe how oral consent will be
documented.
Will a Non-English consent/assent/information sheet
be used?
Adult participants
Parents or guardians
No
Yes
No
Yes
No
Yes
N/ A
NOTE: Refer to the HIC Policy: “Informed Consent
Involving Non-English Speaking Participants.”
If Yes, specify language(s)
42
43
FOR MEDICAL RESEARCH ONLY: Is a waiver of
consent for emergency situations being
requested?
See HIC policy available at
http://www.hic.wayne.edu/HRPP_Manual/116_Planned_Emergency_Research.pdf
If Yes, explain the rationale for waiver of
consent in emergency situations, and
describe the consent process.
Is a waiver of consent for other reasons (e.g., chart
review, database analysis) being requested?
See federal regulations 45 CFR 46.116(d) and
46.408(c) available at
www.hic.wayne.edu/hicreg.html
If Yes:
a. Is the risk more than minimal?
b. Will the waiver adversely affect the rights
and welfare of the research participants?
No
Yes
No
Yes
Page 17 of 21
Form Date: 04-08-09
N/ A
N/ A
Medical/Behavioral Protocol Summary Form
Section E: Consent of Research Participants
c.
No
Yes
Can the research be practicably carried out
without the waiver?
No
Yes
d. Will the participants be provided with
additional pertinent information after
participation, if appropriate?
N/ A
e. Provide protocol-specific justification for
requesting a waiver of consent.
f.
Are you requesting a waiver of the
requirement to obtain written
documentation of the consent process?
(Consent will be obtained, but there will
be no signed form documenting consent)
i.
#
44
No
Yes
If yes, provide a written
description of the information to
be provided orally to subjects.
Section F: Confidentiality
How will the research participants/documents/
specimens be identified on case report forms,
questionnaires, survey tools, field notes, data
collection tools, etc.?
NOTE: Social Security numbers, medical
record numbers, employee numbers, or
school identification numbers can be directly
linked to individuals and must NOT be used as
a code number.
Is there a list that contains information that
can link the code name/number to a specific
participant / document / specimen?
No identifier (i.e., no one can identify a
participant/document/specimen from the information recorded)
Go to Q #45
Coded Identifier (i.e., a code name/number that could be used to
identify a participant/documents/specimens)
Must answer questions a-e
Other (describe):
No
Each paired set of samples
(maternal and newborn urine
plus the foreskin and handprint)
will received a unique identifier
that are matched and recorded
for this sample set. However,
this sample set will not be
linked to any hospital record or
other source that could link it to
a particular patient. Hence,
these samples will all be
anonymous.
Yes
If Yes:
Page 18 of 21
Form Date: 04-08-09
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Medical/Behavioral Protocol Summary Form
Section F: Confidentiality
a. what is the media format of the list
(e.g., paper, electronic, etc.)
b. Where will the list be kept?
c.
State who will have access to the list
and for what purpose.
d. Describe the provisions for
maintaining confidentiality, including
the storage of the participants’
identifiers (i.e., master list) and data
(e.g., audio and video tapes).
e. Describe the plans for eventual
disposal of the participants’
identifiers (i.e. master list) and data.
45
Where will the original signed informed
consent(s)/assent(s) be kept?
N/ A
NOTE: Signed consent documents cannot be
stored with the master list.
46
a. State location
PI's office
b. State provisions for confidentiality
The file cabinet will be locked at all times
Who, other than study personnel (at DMC,
KCI,VA) , WSU Human Investigation Committee,
Food and Drug Administration [FDA], Office for
Human Research Protections [OHRP], and/or
Office of Civil Rights [OCR] will have access to
the research data? (CHECK ALL THAT APPLY)
Sponsor
N/ A
National Cancer Institute
Cooperative group
Other (Explain):
47
Could any part of this research activity result in
the potential identification of:
a. Child/elder abuse
b. Reportable communicable diseases
(please refer to
http://www.michigan.gov/documents/Reportable_
Disease_Chart_2005_122678_7.pdf
c. Criminal activities
No
No
Yes*
Yes*
N/ A
No
Yes*
N/ A
*IF “YES”, THIS MUST BE NOTED IN THE RISK SECTION OF THE CONSENT DOCUMENTS
NOTE: For information on obtaining a Certificate of Confidentiality, refer to:
http://grants.nih.gov/grants/policy/coc/index.htm
#
Section G: Benefits and Risks to Research Participants
Page 19 of 21
Form Date: 04-08-09
N/ A
#
Section G: Benefits and Risks to Research Participants
48 Describe the benefits, if any, to the research
Medical/Behavioral Protocol Summary Form
N/ A
participants for involvement in this project.*
(*NOTE: Financial compensation or free testing,
in any form, is not a “benefit.”)
49 Describe the benefits to society (if any) that may
result from participation in this research project.
Evidence that a ubiquitous envirnomental factor is
associated with a potentially important change in a
gene associated with sexual development.
N/ A
50 Describe the nature and degree of potential risks to research participants in lay terms. Include all risks identified in the protocol
and/or Investigator’s Brochure. Do not cut and paste from the consent form.
See Glossary under “risk” on the HIC website for a description of the different types of risk.
a. Physical*
b. Psychological*
c. Social*
d. Economic*
e. Legal*
* NOTE: ALL THE ABOVE IDENTIFIED RISKS AND BENEFITS ARE TO BE LISTED IN THE INFORMED CONSENT
51 What precautions will be taken to minimize each of
N/ A
N/ A
N/ A
N/ A
N/ A
the risks described above?
#
52
N/ A
Section H: Study Design
Does this study provide compensation for research
participants?
No
Yes
N/ A
No
Yes
N/ A
(HIC policy available at
www.hic.wayne.edu/hicpol/compens.htm)
a. If Yes, describe the type and total amount
of compensation and
b. Specify the amount and milestone for
each payment:
53
Will the research participants incur any additional
expenses for experimental or protocol specific
diagnostic tests or procedures?
a. If Yes, explain.
54
FOR MEDICAL RESEARCH ONLY: Will any
marketed drugs, experimental/investigational
drugs, chemotherapeutic drugs, biological
products, recombinant DNA (plasmid or nonplasmid), infectious agents, diagnostic agents or
medical devices be used?
No
Page 20 of 21
Yes (Complete Appendix F)
Form Date: 04-08-09
N/ A
#
55
Section H: Study Design
Medical/Behavioral Protocol Summary Form
Will research participants be exposed to imaging,
MRI’s, PET Scans or diagnostic radiation (e.g., xrays, CT scans, etc.)?
No
Yes (Complete Appendix G)
N/ A
56. Will biological specimens (e.g., blood, urine,
tissue, organs, cell lines, fetal tissue, etc.) or
standard of care laboratory results be used
as part of this study?
No
Yes (Complete Appendix H)
N/ A
No
Yes (Complete Appendix H)
Refer to HIC policy on research studies
involving biological specimens available at
www.hic.wayne.edu/hicpol/specim.htm
57
Is a specimen repository bank being
established?
Page 21 of 21
Form Date: 04-08-09
N/ A
| File Type | application/pdf |
| File Title | Medical/Behavioral Protocol Summary Form |
| Author | Patti Webber |
| File Modified | 2012-11-07 |
| File Created | 2012-08-29 |