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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:
08/17/2015 8/21/15 e

Signature Page for Human Research Review

BChampagne

Anniversary Date: 09/21/2015
__________
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

927ZKFN
CAN#: _____________
(optional)

Protocol Identifiers

Leave protocol ID blank if not yet assigned.
CDC Protocol ID: HSRB __________________________
Protocol Version Number: ____ Version Date: ____________
HSRB-11-DSR-02XP
06/30/2015
Protocol Title:
Workplace Violence Prevention Programs in NJ Healthcare Facilities
___________________________________________________________________________________________________
Amendment Number (if applicable): _______
2

2

Key CDC Personnel
Name and Degrees

User ID

CDC SEV #

CDC NC/Division

Primary Contact

__________________________
Marilyn Ridenour
__________________________

______
dvn7

____________
840

_________________
NIOSH/ DSR

Principal Investigator

__________________________
Marilyn Ridenour
__________________________

______
dvn7

____________
840

_________________
NIOSH/ DSR

(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:
____________
08/17/2015

Marilyn L. Ridenour -S5

Digitally signed by Marilyn L. Ridenour -S5
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000258775, cn=Marilyn L. Ridenour -S5
Date: 2015.08.17 11:52:40 -04'00'

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
Remarks
Date Signed
PI is Team Lead
Team Lead:
____________
Branch Official (e.g., Chief or Senior Scientist):

James W. Collins -S

Division Official (e.g., Director or ADS):

Christine R. Schuler -S

____________
08/18/2015

PI is Branch Official

____________
08/18/2015

PI is Division Official

Digitally signed by James W. Collins -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000645040, cn=James W. Collins -S
Date: 2015.08.18 08:15:45 -04'00'

Digitally signed by Christine R. Schuler -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001711297, cn=Christine R. Schuler -S
Date: 2015.08.18 10:05:56 -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:
____________
09/17/2015
Contact with participants

Diane C. Morris -S
Other Clearance Official:

Digitally signed by Diane C. Morris -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000059265, cn=Diane C. Morris -S
Date: 2015.09.17 07:52:57 -04'00'

continues. Consent
included.

____________

(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) _____________________________________________________
5, 7
Approved Review
for one year; Renewal Date: __________
09/21/2016
CDC 0.1250 cites Estimated Subject # is ___________
Subject # to Date is ___________
2050
8070
Approved/Amended Subject # is ___________
8070
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.
CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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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
HSRB-11-DSR-02XP
CDC Protocol ID: HSRB __________________________
Protocol Version Number: ____ Version Date: ____________
06/30/2015
Protocol Title:
Workplace Violence Prevention Programs in NJ Healthcare Facilities
___________________________________________________________________________________________________

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

__________________________
Marilyn Ridenour

______
dvn7

____________
840

_________________
NIOSH/ DSR

Principal Investigator

__________________________
Marilyn Ridenour

______
dvn7

____________
840

_________________
NIOSH/ DSR

Investigator 2

__________________________
Dan Hartley

______
dsh3

____________
17813

_________________
NIOSH/ DSR

Investigator 3

__________________________
Scott Hendricks

______
sah5

____________
12713

_________________
NIOSH/ DSR

Investigator 4

__________________________

______

____________

_________________
NIOSH/

Investigator 5

__________________________

______

____________

_________________
NIOSH/

(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:
___________________________________________________________________________________________________

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.
CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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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
__________
8,070 __
Location of Participants
Participating at Domestic Sites
Participating at Foreign Sites

________
8,070____
________
0 ____

Sex/Gender of Participants
Female
Male
Sex/Gender Not Available

________
0 ____
________
0 ____
________
8,070____

Ethnicity of Participants
Hispanic or Latino
Not Hispanic or Latino
Ethnicity Not Available

________
0 ____
________
0 ____
________
8,070____

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

________
0 ____
________
0 ____
________
0 ____
________
0 ____
________
0 ____
________
0 ____
________
8,070____

1250 cites 2050 subjects increased to
4000 on 7/5/12; increased to 8070 6/20/13.

8,070
CDC Form 0.1250 initial review, #5 cited
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:
Workplace Violence Prevention Programs in NJ Healthcare Facilities

___________________________________________________________________________________________________

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.]

Nurse Survey completed. Home Healthcare Aide Survey completed.
50 hospital interviews conducted with chairs of workplace violence prevention committees.
___________________________________________________________________________________________________
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

Amendment approved on 7/30/2015: see the 6 modifications below that were approved. Continued on page 11.
___________________________________________________________________________________________________
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

N/A.
___________________________________________________________________________________________________
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.]

Continue

Conduct 40 nursing home interviews with the chairs of workplace violence prevention committees.
___________________________________________________________________________________________________
CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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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.)
Attached are forms 1379, 1251 and 1370 for renewal of study protocol HSRB-11-DSR-02XP. This protocol was
amended in July 2015. The amended protocol, which contains the consent and other relevant documents, is
also attached.

___________________________________________________________________________________________________
CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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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.
HSRB-11-DSR-02XP
CDC Protocol ID: HSRB __________________________
Protocol Version Number: ____ Version Date: ____________
06/30/2015
Protocol Title:
Workplace Violence Prevention Programs in NJ Healthcare Facilities
___________________________________________________________________________________________________
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: _________________________________
University of North Carolina
Institution Location: _______________________________
Chapel Hill, NC
Individual Name (IIA only): ________________________
Carri Casteel
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Engaged/Non-Exempt
Financial Support: ________________________________
Contract/Subcontract
HCCJB-2012-45372
Support Award Number: ___________________________
Support End Date: ____________
12/31/2015
Nonfinancial Support: _____________________________
No Nonfinancial Support
FWA Number: ___________________________________
4801
SEV Number (IIA only): __________
IRB Review Status: _______________________________
Review By Local IRB
03/11/2016
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):

Institution Name: _________________________________
Old Dominion University
Institution Location: _______________________________
Norfolk, VA
Individual Name (IIA only): ________________________
Jim Blando, Emily O'Haga
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Engaged/Non-Exempt
Financial Support: Contract/Subcontract
________________________________
HCCJB-2012-45374
Support Award Number: ___________________________
Support End Date: 12/31/2015
____________
Nonfinancial Support: _____________________________
No Nonfinancial Support
FWA Number: ___________________________________
00000273
SEV Number (IIA only): __________
IRB Review Status: _______________________________
Review By Local IRB
IRB Approval Expiration Date: ____________
03/12/2016
Comments (Their Role in this Research):

Engagement covered by local IRB documentation or
agreement to defer once approved. On file DCMorris
________________________________________________

Engagement covered by local IRB documentation or
agreement to defer once approved. On file DCMorris
________________________________________________

CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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Partner 3

Partner 4

Institution Name: _________________________________
University of North Carolina
Institution Location: _______________________________
Chapel Hill, NC
Individual Name (IIA only): ________________________
Maryalice Nocera
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Engaged/Non-Exempt
Financial Support: ________________________________
Contract/Subcontract
HCCJB-2012-45372
Support Award Number: ___________________________
Support End Date: ____________
12/31/2015
Nonfinancial Support: _____________________________
No Nonfinancial Support
FWA Number: ___________________________________
4801
SEV Number (IIA only): __________
IRB Review Status: _______________________________
Review By Local IRB
IRB Approval Expiration Date: ____________
03/11/2016
Comments (Their Role in this Research):

Institution Name: _________________________________
RTI
Institution Location: _______________________________
Research Triangle Park, NC
Individual Name (IIA only): ________________________
Anne Kenyon
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Not Engaged
Financial Support: ________________________________
Contract/Subcontract
Support Award Number: ___________________________
HCCJB-2012-43996
Support End Date: ____________
05/10/2013
Nonfinancial Support: _____________________________
No Nonfinancial Support
FWA Number: ___________________________________
3331
SEV Number (IIA only): __________
IRB Review Status: _______________________________
Review By Local IRB
IRB Approval Expiration Date: ____________
06/30/2013
Comments (Their Role in this Research):

Engagement covered by local IRB documentation or
agreement to defer once approved. On file DCMorris
________________________________________________

RTI completed the 2 surveys; not engaged.
________________________________________________

Partner 5

Partner 6

Institution Name: _________________________________
University of Iowa
Institution Location: _______________________________
Dr. Corine Peek-Asa
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Not Engaged
Financial Support: ________________________________
Grant
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
No Nonfinancial Support
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):

Institution Name: _________________________________
Health Professionals Allied Emplo
Institution Location: _______________________________
Emerson, NJ
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Not Engaged
Financial Support: ________________________________
No Financial Support
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
No Nonfinancial Support
FWA Number: ___________________________________
SEV Number (IIA only): __________
IRB Review Status: _______________________________
IRB Approval Expiration Date: ____________
Comments (Their Role in this Research):

Assisted with the initial study protocol which has
been completed. Not engaged.

Health Professionals Allied Employees assisted
with the nurse survey (completed); not engaged.

________________________________________________

________________________________________________

CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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Partner 7

Partner 8

Institution Name: _________________________________
State of NJ Div. of Consumer Affairs
Institution Location: _______________________________
Trenton, NJ
Individual Name (IIA only): ________________________
Reporting Status: _________________________________
Previously Reported
Regulatory Coverage: _____________________________
Not Engaged
Financial Support: ________________________________
No Financial Support
Support Award Number: ___________________________
Support End Date: ____________
Nonfinancial Support: _____________________________
No 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):

Not engaged.

________________________________________________

________________________________________________

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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6. Study Status - Overall Conduct: Summary of study changes reviewed and approved since the last continuation. cont.

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Modification 1: Attachment C1 (Nursing Home - Evaluation of Workplace Violence Prevention Program: Abstraction
form: revised by adding questions A. 1-3 and G. 1a-b from Attachment C2 Nursing Home - Committee Chair Interview
form; added Organizational-level Safety Climate questions (H. 1-16). Deleted 3 questions and added minor details for
clarification. Pages 35-42.
Modification 2: Attachment C2 (Nursing Home - Committee Chair Interview) will not be utilized as questions A. 1-3 and
G. 1a-b incorporated into Attachment C1. Pages 10, 43.
Modification 3: Attachment C3- Nursing Home Incident Information form will not be utilized since we will not be
collecting individual worker assault injury data. Pages 8, 10, 18, 48.
Modification 4: Not be requesting that nursing homes provide their workplace violence prevention policies and procedures.
Pages 8-9.
Modification 5: Nursing home recruitment target is increased to 40: 20 in New Jersey and 20 in Virginia. Pages 7-8.
Modification 6: Utilize workers compensation data for specific aim 3 for nursing home workers. Page 15.

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CDC 0.1379 (E), Revised December 2013, CDC Adobe Acrobat 10.1, S508 Electronic Version, June 2014
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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
HSRB-11-DSR-02XP
Version 1.0 2006-04-13
CDC Protocol ID: HSRB __________________________

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