IRB #:
Date of IRB Expiration:
Principal Investigator:
Study Title:
Vanderbilt University Institutional Review Board
Behavioral and Social Sciences
Application for Continuing Review or Study Closure
STATUS OF THE RESEARCH
Check the ONE choice that best describes the current state of this research study:
No participants have been enrolled to date. Have other sites enrolled? Yes No
Recruitment and/or enrollment of new participants or review of records continue.
Study is no longer enrolling, but participants are still involved in research-related activities.
Are consent forms needed for re-consenting purposes?
Yes
No
Study is no longer enrolling and participants have completed research-related activities. The study remains
active only for long-term follow-up.
Study enrollment is permanently closed, participants have completed all research-related activities, and
long-term follow-up has been completed. The remaining research activities are limited only to data analysis
that may require contact with information to which you would not normally have access (e.g., medical
records, academic records, etc.).
Close the study. Enrollment and follow-up are complete and no further contact with participants or
information to which you would not normally have access is anticipated. Please provide/attach a final
study report, including final enrollment numbers, the reason for closure, and any related
publications.
1. VU ENROLLMENT NUMBERS
A.
Maximum number of participants previously approved by the VU IRB to be consented by this PI for
the life of the study. *Note: The totals in columns 3 and 5 of the table below should not exceed this number.
B.
Please provide ALL information requested in the table below. If the study has been active for only one year,
columns five and six DO NOT apply.
*Note: These numbers should reflect participants enrolled by the VU Principal Investigator and/or additional
personnel involved in the study.
1
Category/Group
(e.g., parents,
children, teachers,
adults)
2
Number Directly
Solicited
(applies only to
survey studies)
3
Number
Consented
Within the
Last IRB
Approval Period
4
Number of
Withdrawals
Within the
Last IRB
Approval Period
5
* Number
6
* Number of
Consented
Since Beginning
the Study
Withdrawals
Since Beginning
the Study
N/A
N/A
N/A
N/A
Insert additional rows if needed.
TOTALS
Enter totals from
columns above
N/A
Behavioral and Social Sciences Application for Continuing Review or Study Closure (Form #1129)
Form Revision Date: April 27, 2012
Form Replaces Version Dated: June 30, 2011
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IRB #:
Date of IRB Expiration:
Principal Investigator:
Study Title:
2. SUMMARY OF PROGRESS WITHIN THE LAST IRB APPROVAL PERIOD
Please answer the following questions. If any questions do not apply to your study, please check “No.”
A.
Yes
No
i. Within the last approval period, was the study open to enrollment?
If “Yes”, answer 2.A.ii. If “No”, continue to 2.B.
ii.
Yes No Within the last approval period, were participants enrolled in the study?
If “No”, provide a summary describing the reason(s) for no enrollment.
B.
Yes
No
Within the last approval period, have there been any participants who withdrew (including PI
initiated withdrawals), dropped out, or were lost to follow-up?
If “Yes”, attach a narrative summary describing the reasons for the withdrawals.
C.
Yes
No
Within the last approval period, have you had any problems recruiting participants?
If “Yes”, attach a narrative summary describing the problems recruiting subjects.
D.
Yes
No
Within the last approval period, have there been any participant complaints regarding the
research?
If “Yes”, attach a narrative summary describing the complaints.
E.
Yes
No
Within the last approval period, has any literature relevant to the research been published that
might change the understanding of the risks and/or benefits of the study?
If “Yes”, attach copies of the publications and a narrative summary.
F.
Yes
No
Within the last approval period, have there been any interim findings, including manuscripts,
abstracts, and publications?
If “Yes”, attach copies of publications and/or citations and a narrative summary.
G.
Yes
No
Within the last approval period, have there been any progress reports on the research, such
as those submitted to funding agencies?
If “Yes”, attach copies of the progress reports and a narrative summary.
H.
Yes
No
Within the last approval period, have there been any progress reports from participating nonVU sites?
If “Yes”, attach copies of the reports and a narrative summary.
I.
Yes
No
Since the most recent IRB continuing review approval* have there been any other information
relevant to this research discovered, especially information about the risks and benefits
associated with the research that may affect the participant’s willingness to continue
participation?
If “Yes”, attach copies of the information and a narrative summary.
J.
Yes
No
Within the last approval period, have all unanticipated problems involving risk to participants or
others that require prompt reporting to the IRB been reported?
If “No”, provide the IRB with the required reports within 5 business days.
K.
Yes
No
Within the last approval period, has the adverse event profile experienced by participants
differed from that expected? (“Adverse event” means any untoward or undesired outcome of
the research, including both serious and non-serious events, expected and unexpected events,
and events related and unrelated to the research.)
If “Yes”, attach a narrative summary describing how the adverse event profile differs from
expected.
Behavioral and Social Sciences Application for Continuing Review or Study Closure (Form #1129)
Form Revision Date: April 27, 2012
Form Replaces Version Dated: June 30, 2011
2 of 3
IRB #:
Date of IRB Expiration:
Principal Investigator:
Study Title:
L.
Yes
No
Is an Independent Safety Monitor or Data Safety Monitoring Board (DSMB) assigned to
periodically review data from this study for risks to participants?
If “Yes”, how often does the monitor or board perform a review?
Yes No Within the last approval period, has the Independent Safety Monitor or Data
Safety Monitoring Board (DSMB) provided any reports of its reviews?
If “Yes”, attach the report(s) and a narrative summary.
3.
INFORMED CONSENT DOCUMENT INFORMATION
Yes
No
Did the IRB require use of a written informed consent document for this study?
If “Yes”, submit a copy of the currently approved informed consent document AND a clean copy of the
identical informed consent document for approval and date stamping for use during the next approval period.
(Note: If the study is closed to enrollment, do not attach consent forms).
4. BUDGETARY AUTHORIZATION
Yes
No
Is this continuing review for an Industry-Supported study? (If so, it is expected that the sponsor
will pay the IRB continuing review fee of $750.) If “No,” skip to item 5.
For VU/VUMC:
Please charge my account as follows:
Center Number:
Account Number:
For VSRH, IEI or other non-Vanderbilt sites, payment is required as specified in the signed MOU:
I have attached a check payable to the “VU IRB” in the amount of $750.
Check requested—I will forward to the IRB when received.
5. INVESTIGATOR’S CONFLICT OF INTEREST (COI) STATEMENT
Yes
No Has a new conflict of interest developed for the Principal Investigator or key study personnel?
Assessment should include anyone listed as Principal Investigator or other research personnel on
the IRB application.
If “Yes”, has this COI been reviewed by the VU Conflict of Interest Committee?
Behavioral and Social Sciences Application for Continuing Review or Study Closure (Form #1129)
Form Revision Date: April 27, 2012
Form Replaces Version Dated: June 30, 2011
Yes
No
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