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NIOSH IRB-HSRB Continuing Review/Renewal Template_CDC 0.1379+0.1251+0.1370
0.1379
Centers for Disease Control and Prevention
NIOSH IRB (HSRB)
Date Received:
07/01/2015
Signature Page for Human Research Review
Anniversary Date: 07/15/2015
__________
Use this signature page when submitting HRPO forms to your center-level Human Subjects
Contact. When submitting materials with these forms, please consecutively number all pages,
beginning with the protocol title page and followed by consent form(s) and ancillary documents. See HRPO Guide:
Overview for further details. NOTE: IRB (Institutional Review Board) refers to the NIOSH IRB-HSRB (National
Institute for Occupational Safety and Health (NIOSH), Human Subjects Review Board (HSRB) of the CDC Human
Research Protection Office (HRPO).
Protocols and Related Documentation
1
Protocol Identifiers
CAN#: _____________
(optional)
927ZLDK
Leave protocol ID blank if not yet assigned.
CDC Protocol ID: HSRB __________________________
Protocol Version Number: ____
14-DSHEFS-01XP
2 Version Date: ____________
07/02/2014
Protocol Title:
Effect of Wellness Grant on Worker Health and Safety
___________________________________________________________________________________________________
Amendment Number (if applicable): _______
2
Key CDC Personnel
Name and Degrees
User ID
CDC SEV #
CDC NC/Division
Primary Contact
__________________________
Alysha Meyers, PhD
__________________________
513-841-4208
______
itm4
____________
15452
_________________
NIOSH/ DSHEFS
Principal Investigator
__________________________
Alysha Meyers, PhD
__________________________
513-841-4208
______
itm4
____________
15452
_________________
NIOSH/ DSHEFS
(First Name Last Name, Degrees)
Phone Number (required)
Phone Number (required)
SEV # is CDC’s Scientific Ethics Verification Number. CDC NC/Division is the national center or equivalent and division
or equivalent, or coordinating center or office if submitted at that level.
3
Forms Submitted with this Signature Page
Check all that apply in the appropriate column.
IRB-Reviewed Protocols
Exempted Protocols (All shaded will not apply here)
0.1250: Initial Review by IRB
0.1250X: Initial Review for Exemption
0.1251: Continuing Review of Approved Protocol
0.1251X: Continuing Review of Exempted Protocol
0.1252: Review of Changes to Approved Protocol
0.1252X: Review of Changes to Exempted Protocol
0.1254: Incident Report
0.1254S: Supplemental Adverse Event Report
0.1253: End of Human Research Review
0.1253: End of Human Research Review
0.1370: CDC’s Research Partners
0.1370: CDC’s Research Partners
0.1371: CDC Rely on a Non-CDC IRB
0.1372: Outside Institution Rely on a CDC IRB
0.1373: CDC Cover an Individual Investigator
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4
Signatures
As principal investigator, I hereby accept responsibility for conducting this CDC-sponsored research project in an ethical
manner, consistent with the policies and procedures contained in CDC's Procedures for Protection of Human Research
Participants, and to abide by the principles outlined in federal policies for the protection of human subjects at 45 CFR part
46, 21 CFR part 50, and 21 CFR part 56.
Signature
Date Signed
Remarks
Principal CDC Investigator:
____________
06/26/2015
Digitally signed by Alysha R. Meyers -S (Affiliate)
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000591443, cn=Alysha R. Meyers -S
(Affiliate)
Date: 2015.06.26 16:31:15 -04'00'
Alysha R. Meyers -S
(Affiliate)
__________________________________________________________
_______________________
As a supervisor of the principal investigator, I hereby accept responsibility for ensuring that this CDC-sponsored research
project is conducted in an ethical manner, consistent with the policies and procedures contained in CDC's Procedures for
Protection of Human Research Participants, and to abide by the principles outlined in federal policies for the protection of
human subjects at 45 CFR part 46, 21 CFR part 50, and 21 CFR part 56.
Signature
Date Signed
Remarks
PI is Team Lead
Team Lead:
____________
07/01/2015
Steven J. Wurzelbacher -S
Digitally signed by Steven J. Wurzelbacher -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001263232, cn=Steven J. Wurzelbacher -S
Date: 2015.07.01 10:06:30 -04'00'
Branch Official (e.g., Chief or Senior Scientist):
Brian D. Curwin -S (Affiliate)
Division Official (e.g., Director or ADS):
TROUT.DOUGLAS.B.1015465804
____________
07/01/2015
PI is Branch Official
____________
07/01/2015
PI is Division Official
Digitally signed by Brian D. Curwin -S (Affiliate)
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000088646, cn=Brian D. Curwin -S (Affiliate)
Date: 2015.07.01 10:55:30 -04'00'
Digitally signed by TROUT.DOUGLAS.B.1015465804
DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USPHS,
cn=TROUT.DOUGLAS.B.1015465804
Date: 2015.07.01 11:13:01 -04'00'
I concur that this CDC-sponsored research project is consistent with the policies and procedures contained in CDC's
Procedures for Protection of Human Research Participants and with other applicable CDC and national center policies.
Signature
Date Signed
Remarks
/Chair NIOSH IRB-HSRB:
____________
Other Clearance Official:
____________
(e.g., Confidentiality Officer, Coordinating Center/Office Official)
THIS SECTION FOR CDC/NIOSH IRB-HSRB OFFICE USE ONLY:
Expedited Review
; Minimal Risk
; as provided for in 45CFR46.110.
(b) (1) category(s) _____________________________________________________
Approved Review
for one year; Renewal Date: __________
CDC 0.1250 cites Estimated Subject # is ___________ Subject # to Date is ___________
Approved/Amended Subject # is ___________
COMMENTS: _______________________________________________________
Full/Convened Board Review Approved
Meeting Date Approval: __________
5
Additional Comments
___________________________________________________________________________________________________
6
Reminder Regarding Other Regulatory Clearance Processes
The principal investigator is responsible for obtaining other regulatory reviews as needed, which may include OMB
clearance under the Paperwork Reduction Act (PRA) for federally sponsored information collections. Approval by or
exemption from the IRB is unrelated to OMB clearance requirements under the PRA. For more information on whether your
study requires clearance under PRA or other regulations, please consult the appropriate officials within your national center.
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0.1251 Centers for Disease Control and Prevention
Request for Continuing Review of
IRB-Approved Protocol
Use this form to submit a protocol for continuing review by a CDC IRB (Ex. NIOSH IRB-HSRB)
or a non-CDC IRB. [See 45 CFR 46.109(e).] See HRPO Guide: IRB Review Cycle for further
details on how to complete this form.
1
Protocol Identifiers
CDC Protocol ID: HSRB __________________________
Protocol Version Number: ____
14-DSHEFS-01XP
2 Version Date: ____________
07/02/2014
Protocol Title:
Effect of Wellness Grant on Worker Health and Safety
___________________________________________________________________________________________________
2
Key CDC Personnel
No change in key CDC personnel. When checked or not, please cite all CDC and NIOSH investigators.
Name and Degrees
User ID
CDC SEV #
CDC NC/Division
Primary Contact
__________________________
Alysha Meyers, PhD
______
itm4
____________
15452
_________________
NIOSH/ DSHEFS
Principal Investigator
__________________________
Alysha Meyers, PhD
______
itm4
____________
15452
_________________
NIOSH/ DSHEFS
Investigator 2
__________________________
Steve Wurzelbacher, PhD
______
srw3
____________
4169
_________________
NIOSH/ DSHEFS
Investigator 3
__________________________
Tim Bushnell, PhD
______
plb4
____________
12294
_________________
NIOSH/ OD
Investigator 4
__________________________
Steve Bertke, PhD
______
inh4
____________
6664
_________________
NIOSH/ DSHEFS
Investigator 5
__________________________
Chia Wei, PhD
______
ycj4
____________
1765
_________________
NIOSH/ DSHEFS
(First Name Last Name, Degrees)
(required)
(required)
SEV # is CDC’s Scientific Ethics Verification Number. CDC NC/Division is the national center (or equivalent) and division
(or equivalent), or coordinating center or office if submitted at that level.
Continue list here of all other CDC and NIOSH investigators, if any. Include name and degrees, user ID, CDC SEV #,
CDC NC/Division:
Kaori Fujishiro, Phd, fnd3, SEV#1765, NIOSH/DSHEFS
___________________________________________________________________________________________________
3
CDC’s Research Partners
Research partners include all direct and indirect recipients of CDC funding (e.g., grants, cooperative agreements, contracts,
subcontracts, purchase orders) and other CDC support (e.g., identifiable private information, supplies, products, drugs, or
other tangible support) for this research activity, as well as collaborators who do not receive such support. On continuing
review, HRPO needs current information on partners that have been added or dropped since the last review and partners
that, as of the last review, were receiving support for nonexempt research. See HRPO Guide: CDC’s Research Partners for
further details.
All CDC partners must be listed on form CDC 0.1370.
Check one of the following.
No research partners are reported with this submission. (Checked when there are no non-CDC partners.)
Research partners (non-CDC) are listed on form CDC 0.1370, which accompanies this form.
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4
Study Participants—Cumulative Demographic Frequencies
Have any participants been enrolled in the last 12 months?
Yes
No (If no, still report total subject # to date.)
Report estimated counts (rather than percentages). Include participants at domestic and foreign sites. [Note: All subcategory totals should be equal; total subject numbers are counted from beginning of study conduct until the date
completing this form. See also HRPO Guide: IRB Review Cycle for definitions.]
Number of Participants
__________
1,472,054__
Location of Participants
Participating at Domestic Sites
Participating at Foreign Sites
________
____
1,472,054
____________
Sex/Gender of Participants
Female
Male
Sex/Gender Not Available
________
____
736,027
________
____
736,027
____________
Ethnicity of Participants
Hispanic or Latino
Not Hispanic or Latino
Ethnicity Not Available
____________
____________
________
____
1,472,054
Race of Participants
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
More Than One Race
Race Not Available
____________
____________
____________
____________
____________
____________
________
____
1,472,054
CDC Form 0.1250 initial review, #5 cited 1,472,054 number estimated subjects. To exceed subject # cited on CDC
0.1250, an amendment request (CDC forms 0.1252+ 0.1379) needs to be completed/submitted to the NIOSH IRB-HSRB for
review/approval. Comments on Demographics:
Effect of Wellness Grant on Worker Health and Safety
___________________________________________________________________________________________________
5
Study Status—Participant Involvement
5.1 Contact Status
“Contact” means intervention or interaction with participants, such as recruitment, screening, obtaining consent,
enrollment, and collection of data and biological specimens directly from participants. Check one of the following.
Study is not designed to involve research-related contact with participants (e.g., research using existing records); study
activities involve only access to or analysis of data or biological specimens and writing reports.
Study is designed to involve contact with participants. Check one of the following:
Contact with participants has not yet begun. (If checked, include a cc current consent with submission.)
Contact with participants has begun and continues; this may include follow-up for debriefing or notification of
results. (If checked, include a cc current consent with submission.)
Contact with participants is completed; study activities involve only data analysis or report writing.
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5.2 Consent Status
“Consent” includes adult consent, child assent, and parental permission. Check one of the following.
The IRB previously waived all requirements both to obtain and to document consent in this study.
Although not waived, there is no further need to obtain or document consent (e.g., enrollment is complete).
Participants will be asked to provide consent (with or without documentation).
If you check the third box, please include all current consent, assent, and parental permission materials (e.g., scripts,
documents) from each study site with this submission.
6
Study Status—Overall Conduct [Please complete all summaries.]
Summary of research activities to date. Briefly summarize study progress and interim findings. Include the number of
potential subjects who declined enrollment and the number who withdrew from the study. If this study involves a registrable
clinical trial, summarize registration status. [Citing “none” for this summary is incomplete.]
The only human subjects related aspect of this project is a secondary analysis of workers' compensation claims data
provided by the Ohio Bureau of Workers' Compensation. We have no direct contact or interaction with human subjects.
Evaluation of pre-intervention and one year of post-intervention employer data is underway. Final analyses of all
post-intervention data for this project will not be possible until 2020 at the earliest.
___________________________________________________________________________________________________
Summary of study changes reviewed and approved since the last continuation. Do not include changes submitted with or
before approval of this continuation but not yet approved.
Continue
None.
___________________________________________________________________________________________________
Summary of any recent literature or other information relevant to the research study (not limited to information with CDC
co-authorship).
Continue
None.
___________________________________________________________________________________________________
Summary of all adverse events to date. In particular, address adverse events that were serious, unexpected (or more frequent
or severe than expected), or at least possibly related to the research.
Continue
None.
___________________________________________________________________________________________________
Summary of (a) incidents that are not adverse events and (b) other substantial concerns since last continuation.
Continue
None.
___________________________________________________________________________________________________
List and include copies of progress or monitoring reports on safety or compliance (e.g., site monitor, safety review, DSM
report, multi-center trial report, but not reports to PGO).
Continue
Not applicable.
___________________________________________________________________________________________________
Summary of remaining research activities, emphasizing future contact with subjects, use of identifiable private data and
biological specimens, and preparation of primary reports. [Citing “none” for this summary is incomplete.]
The only human subjects related aspect of this project is a secondary analysis of workers' compensation claims data
provided by the Ohio Bureau of Workers' Compensation. We have no direct contact or interaction with human subjects.
We will continue to receive additional workers' compensation claims data on an annual basis throughout this study, at least
___________________________________________________________________________________________________
through 2020.
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7
Regulation and Policy
7.1 Mode of IRB Review on CDC’s Behalf
Location of IRB (Check one.):
CDC IRB (Ex. NIOSH IRB/HSRB)
Non-CDC IRB through IRB Authorization Agreement [Submit form CDC 0.1371 if this is a new request.]
Institution or Organization Providing IRB Review: ___________________________________________________
IRB Registration Number (if known): _______________
Federal-Wide Assurance Number (if any): _______________
IRB-Determined Level of Risk to Subjects (Check one.):
Minimal
Greater than Minimal
Suggested Level of IRB Review (Check one.):
See HRPO Worksheet for Expedited Review for detailed assistance. If relying on a non-CDC IRB, please indicate the level
of review that you think is appropriate under human research regulations.
Convened-board review is suggested.
Reason for Convened Review: ___________________________________________________________________
Expedited review is suggested, under the following categories (Check all that apply.):
1a Study of drugs not requiring Investigational New Drug exemption from FDA
1b Study of medical devices not requiring Investigational Device Exemption from FDA
2a Collection of blood from healthy, nonpregnant adults; below volume limit, minimally invasive
2b Collection of blood from other adults and children; below volume limit, minimally invasive
3
Prospective noninvasive collection of biological specimens for research purposes
4
Collection of data through routine, noninvasive procedures, involving no general anesthesia, sedation, xrays, or microwaves
5
Research that uses materials collected solely for nonresearch purposes
6
Collection of data from voice, video, digital, or image recordings made for research purposes
7
Research that uses interview, program evaluation, human factors, or quality assurance methods
Continuing review of research previously approved by the convened IRB (8a, 8b, 8c, or 9) where:
8a The research is permanently closed to the enrollment of new subjects; all subjects have
completed all research-related interventions; and the research remains active only for long-term
follow-up of subjects
8b No subjects have been enrolled and no additional risks have been identified
8c The remaining research activities are limited to data analysis
9
Continuing review of research, not under IND/IDE, where categories 2 through 8 do not apply but the IRB
has determined and documented at a convened meeting that the research involves no greater than minimal
risk and no additional risks have been identified
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8
Material Submitted with this Form
Check all that apply. Describe additional material in the comments section. Required items are indicated. Optional items
may be requested by HRPO or the IRB.
Complete protocol (required if research poses more than minimal risk to subjects, is under IND/IDE, or has changed in
the past 12 months)
Consent, assent, and permission documents or scripts (required if consent will be sought in the future from prospective
subjects or their representatives [see section 5.2])
Other information for recruits or participants (e.g., ads, brochures, flyers, scripts; required if consent will be sought in the
future from prospective subjects or their representatives)
Data collection instruments (e.g., questionnaires, interview scripts, record abstraction tools; required if protocol has
changes in the past 12 months)
Certification of IRB approval or exemption for research partners (required only for partners being added or for
supported/nonexempt partners)
Progress and monitoring reports (recommended when available)
9
Additional Comments (Cover Memo content can go here.)
For Item 7.1 boxes 6 & 7 were checked in relation to the structured interview that we will be conducting to collect
employer level data (no human subjects data) to achieve our Specific Aim 3, as described on page 12 of the protocol
document. We usually collect digital voice recordings of these interviews.
___________________________________________________________________________________________________
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0.1370 Centers for Disease Control and Prevention
CDC’s Research Partners
Use this form to report current information on CDC’s research partners whenever a partner
institution or individual is added or information changes. Supply individual name and completed
ethics training documentation only for investigators collaborating with CDC under an individual
investigator agreement (IIA). See HRPO Guide: CDC’s Research Partners and either the HRPO
Worksheet for Basic Tracking of Research Partners or the HRPO Worksheet for Advanced
Tracking of Research Partners for details on how to complete this form.
Leave protocol ID blank if not yet assigned.
CDC Protocol ID: HSRB __________________________
Protocol Version Number: ____
14-DSHEFS-01XP
2 Version Date: ____________
07/02/2014
Protocol Title:
Effect of Wellness Grant on Worker Health and Safety
___________________________________________________________________________________________________
NOTE: Each partner below reflects either a non-CDC Institution or non-CDC Individual so all fields cannot be
completed. At minimum, please provide the name of the Institution/Individual; their City/State; and briefly cite in the
Comments field their role in this research (what they will do) and include your estimate of engaged or not. Engaged means
either to: 1) interact/intervene with subjects; or 2) access private/identifiable information; or 3) receive federal funds.
Partner 1
Partner 2
Institution Name: _________________________________
OHBWC
Institution Location: _______________________________
Columbus, OH
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Engaged/Non-Exempt
Financial Support: ________________________________
Contract/Subcontract
Support Award Number: ___________________________
200-2014-M-60212
Support End Date: ____________
07/31/2015
Nonfinancial Support: _____________________________
Identifiable Private Information
FWA Number: ___________________________________
00017192
SEV Number (IIA only): __________
IRB Review Status: _______________________________
Relying On CDC IRB
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
OHBWC=Ohio Bureau of Workers' Compensation (would not fit in
Institution Name field above)
________________________________________________
________________________________________________
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Partner 3
Partner 4
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
________________________________________________
________________________________________________
Partner 5
Partner 6
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
________________________________________________
________________________________________________
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Partner 7
Partner 8
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
________________________________________________
________________________________________________
Partner 9
Partner 10
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
Institution Name: _________________________________
Institution Location: _______________________________
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Regulatory Coverage: _____________________________
Financial Support: ________________________________
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):
________________________________________________
________________________________________________
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Return
So far we conducted six employer interviews to gather information about employers' resources being used to supplement
their wellness grant funds.
Return
Return
Return
Return
Return
Return
Return
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NIOSH IRB-HSRB Continuing Review/Renewal Template_CDC 0.1379+0.1251+0.1370
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CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
Page 12 of 12
14-DSHEFS-01XP
Version 1.0 2006-04-13
CDC Protocol ID: HSRB __________________________
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| File Type | application/pdf |
| File Title | NIOSH IRB-HSRB Renewal Tmplate |
| Author | CDC User;[email protected] |
| File Modified | 2015-07-01 |
| File Created | 2013-11-29 |