YALE UNIVERSITY
HUMAN SUBJECTS COMMITTEE
Request to Renew
100 FR13R (2016-1)
If you have questions about completing this form, contact the HRPP office, 203-785-4688, or
hrpp@yale.edu.
HSC Protocol Number:
Title of Research Project:
Principal Investigator:
Yale Academic Appointment:
Department:
Campus Address:
Campus Phone:
E-mail:
Protocol Correspondent Name & Address:
Campus Phone:
E-mail:
Faculty Advisor: (required if PI is a student, resident, fellow or other trainee)
Yale Academic Appointment:
Email:
Campus Phone:
Current Research Team Members and Their Affiliation:
Name
Affiliation:
NetID
Yale/Other Institution
(Identify)
Role:
Role:
Role:
Role:
Role:
Role:
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Role:
Role:
Are all Yale-affiliated individuals listed on this protocol employees of Yale University? ☐YES ☐NO
If NO, indicate which study personnel are not: Click here to enter text.
For any Yale-affiliated study personnel who are not Yale employees, are they covered by a personal services
agreement? Click here to enter text.
As the Principal Investigator of this research project, I certify the following:
 That the information provided in this application is complete and accurate.
 That I assume full responsibility for the protection of human subjects and the proper conduct of the research.
 That subject safety is of paramount concern, and every effort is made to protect subjects’ rights and welfare.
 That the research is performed according to ethical principles and in compliance with all federal, state and
local laws, as well as Yale University policies regarding the protection of human subjects.
 That all members of the research team are kept apprised of the research goals and progress of the study.
 That I will obtain continuing approval from the HSC for this research study and obtain approval for any
subsequent revisions prior to initiating any revision of the project.
 That I will report to the HSC any unanticipated problems involving risk to participants (including serious
unanticipated adverse events at least possibly related to the protocol) in accordance with Yale HRPP policies.
 I will identify a qualified successor should I cease my role as principal investigator and will facilitate a
smooth transfer of investigator responsibilities.
____________________________________
Signature of PI
_________________________
Signature of Faculty Advisor*(if necessary)
Date
__________________
Print name of Advisor
Date
*Faculty Advisor is in compliance with the requirements set forth by the University according to the
Faculty Handbook requirements for serving as a PI, and qualifies to serve as the faculty advisor of
this project. Faculty Advisor assumes all of the roles and responsibilities of a Principal Investigator
even though the student may be called a PI.
Investigator Interests:
Does the principal investigator, or do any research personnel who are responsible for the design, conduct
or reporting of this project or any of their family members (spouse or dependent child) have an incentive
or interest, financial or otherwise, that may affect the protection of the human subjects involved in this
project, the scientific objectivity of the research or its integrity? Note: The Principal Investigator
(Project Director), upon consideration of the individual’s role and degree of independence in carrying
out the work, will determine who is responsible for the design, conduct, or reporting of the research.
See Disclosures and Management of Personal Interests in Human Research
http://www.yale.edu/hrpp/policies/index.html#COI
☐ Yes
☐ No
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Do you or does anyone on the research team who is determined by you to be responsible for the design,
conduct or reporting of this research have any patent (sole right to make, use or sell an invention) or
copyright (exclusive rights to an original work) interests related to this research protocol?
☐ Yes
☐ No
If yes to either question above, list names of the investigator or responsible person:
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale University
individuals who are responsible for the design, conduct or reporting of research must have a current
financial disclosure form on file with the University’s Conflict of Interest Office. Yale New Haven
Hospital personnel who are listed as co-investigators on a protocol with a Yale University Principal
Investigator must also have a current financial disclosure form on file with the University’s Conflict of
Interest Office. If this has not been done, the individual(s) should follow this link to the COI Office
Website to complete the form: http://www.yale.edu/coi/
NOTE: The requirement for maintaining a current disclosure form on file with the University’s Conflict
of Interest Office extends primarily to Yale University and Yale-New Haven Hospital
personnel. Whether or not they are required to maintain a disclosure form with the University’s
Conflict of Interest Office, all investigators and individuals deemed otherwise responsible by the
PI who are listed on the protocol are required to disclose to the PI any interests that are specific to
this protocol.
1. Funding Source: Indicate ALL of the CURRENT and ACTIVE funding source(s) for this study.
Click here to enter text.
Has the funding source changed since this HSC application was last renewed? ☐ Yes ☐ No
2. Protocol History
a. When was this HSC application first approved? Click here to enter text.
b. When was approval for this HSC application last renewed? Click here to enter text.
3. Lapse in IRB approval
Has IRB approval of the study lapsed (expired) since the last annual renewal? Yes ☐
No ☐
If yes, explain why IRB approval was not achieved in time to ensure continuous approval of the
protocol. Click here to enter text.
If yes, during this lapse period have any subjects been

Recruited
Yes ☐ No ☐ Number of subjects: Write here
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Enrolled
Yes ☐ No ☐ Number of subjects: Click here to enter
Seen for study interventions (e.g. counseling)
Yes ☐ No ☐ Number of subjects: Click here to enter

Seen for research interaction, (e.g., conducting screening or interviews, collection of urine, blood
or hair sample, asking for informed consent to use medical records)
Yes ☐ No ☐ Number of subjects: Click here to enter text.

Seen for follow-up or treatment Yes ☐ No ☐ Number of subjects: Click here to enter text.


During this lapse period has there been any:
Collection of data
Yes ☐ No ☐
Data analysis
Yes ☐ No ☐
Sharing of Data
Yes ☐ No ☐
Other (Describe): Click here to enter text.
What corrective actions are planned to prevent this type of deviation from occurring in the future? Click
here to enter text.
It is a violation of federal regulation and University policy to continue to conduct research
activities once IRB approval for a study has lapsed unless permission is granted by the Yale IRB
to continue research interventions. Such permission will be granted by the IRB when
discontinuing the research interventions may jeopardize the health or welfare of a participant.
Contact the Yale HRPP office immediately if permission is required to continue research
interventions on a study participant.
Under no circumstances can federal funds be expended on research and research-related activities
during a lapse period. If this study is federally funded, you must immediately contact your Grant
and Contract Administration (GCA) and Grants and Contract Financial Administration (GCFA)
representatives.
4. Progress of the study to date: Please explain the study progress since the last full approval (initial or
annual).
Click here to enter text.
5. Publications/ Dissemination: Please list any publications (published or in press) derived from this
study in the past year as well as any informal dissemination of results that have been conducted in the
past year or are planned in the coming year, beyond the published peer-reviewed scientific literature
process. (e.g., newsletters, presentations at professional meetings, universities, or in community
settings)
Click here to enter text.
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6. What is the current status of the project?
☐ No enrollment to date because…
☐ The study is still in proposal stage
☐ The protocol is approved for a Secondary Data Analysis only
☐ Other: Click here to enter text.
☐ Active open to Enrollment
☐ Enrollment progressing as planned
Enrollment within target range (N) for the study? YES ☐ NO ☐
☐ Slower than planned, which may require study extension or reduction of planned number of
subjects
☐ Enrollment closed
Date enrollment closed: Click here to enter text.
☐ Participants still completing research interventions
☐ Follow up only (describe nature of follow-up)
☐ Data analysis only (the data was collected for this study
Note: If the study is in data analysis only and all of the data being analyzed is de-identified, submit a
Request to Close form, and not a renewal application.
7. Enrollment:
What is the targeted enrollment (HSC approved number needed to complete the research) for this
protocol? Click here to enter text.
Since the last HSC annual review, how many subjects have participated? Click here to enter text.
7a. Enrollment of non-English speaking individuals:
Since the beginning of the study, how many non-English speaking individuals have been enrolled using
a short form for consent purposes? Provide number and the language of translation in the table below.
Language
Number of subjects enrolled using short form
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8. Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs), including Adverse
Events (AEs):
8a. Please account only for those events that were:
Unexpected – in terms of nature, specificity, severity or frequency given 1) the
research procedures describe and 2) the characteristics of the subject population
being studied, AND
Possibly or definitely related to the participation in the research AND
Suggest that the research places subjects or others at a greater risk of harm (or were
serious).
Since the last continuing review (i.e., last renewal),
(1) How many UPIRSOs (including AEs) have occurred at Yale? Click here to enter text.
(2) How many UPIRSOs (including AEs) have resulted in a temporary or permanent interruption of
study activities by the Principal Investigator or sponsor (e.g., suspension of enrollment) to avoid
potential harm to subjects? Click here to enter text.
(3) How many INTERNAL events were reported to the Yale IRB? [event occurred at a site under
the jurisdiction of the Yale IRB (IRB of record)]:Click here to enter text.
(4) How many EXTERNAL events were reported to the Yale IRB? [event occurred at a site NOT
under the jurisdiction of the Yale IRB (at another institution in a multicenter study)]: Click here to enter text.
NOTE: External events that do not meet the reporting requirements (e.g., not related or not
involving risk) and that are not relevant to the protection of Yale research subjects or others should
NOT be reported to the IRB.
(5) If the Yale Principal Investigator is the study chair for a multi-center study, how many UPIRSOs
(including AEs) have occurred at all participating sites? Click here to enter text.
(6) Were each of these events reported to a Yale IRB and other organizations as appropriate?
Yes ☐ No ☐
(7) Are there any updates to previously reported UPIRSOs (including AEs) that should be reported
to a Yale IRB?
Yes ☐ No ☐
If yes, please include such updates.
8b. Attach, in summary form, a list of all related internal and external events involving risk to subjects
or others that occurred since the last renewal but did not meet prompt reporting requirements. [See
IRB Policy 710 for more information]. If appropriate, such summary may be a simple brief statement that
events have occurred at the expected frequency and level of severity as previously documented.
In lieu of a summary of external events, a current safety monitoring report can be submitted if the study has
safety monitoring in place.
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9. Frequency/Magnitude: Is the frequency and/or magnitude of expected side effects different from
what was anticipated? Yes ☐ No ☐ If yes, please explain: Click here to enter text.
10. Complaints: Have there been any complaints received in the past year relating to this study (e.g.,
complaints from subjects, study staff, employees or others who have knowledge of the study, or relating
to the conduct of the study)?
Yes ☐ No ☐ If yes, how many? Click here to enter text.
Please describe the complaint(s) and resolution.
Click here to enter text.
11. Protocol Deviations/Noncompliance:
a. In the past year, how many protocol deviations/instances of noncompliance have occurred at Yale
(or another site if Yale serves as the lead site or coordinating center) that required prompt
reporting to the HSC? Click here to enter text.
b. In the past year, how many protocol deviations/instances of noncompliance have occurred at Yale
(or another site if Yale serves as the lead site or coordinating center) that did NOT require prompt
reporting to the HSC? Click here to enter text.
List all deviations that occurred in the past year (regardless of whether or not they were previously
reported) below (adding additional lines to the table if needed) or include the below table as an
attachment.
Date of
Subject
Brief Description
Corrective and
Did the deviation/
Date
Deviation/
Study ID
of deviation/
Preventative Action
noncompliance
Reported to
noncompliance number
noncompliance
(CAPA) measure
require prompt
HSC
implemented
reporting to the HSC (if applicable)
(if appropriate)
(yes/no)
c. Were all deviations/instances of noncompliance that required prompt reporting submitted to the
HSC per University policy and other organizations as appropriate? Yes ☐ No ☐ N/A☐
If no, please explain.Click here to enter text.
d. Are there any updates to previously reported protocol deviations/instances of
noncompliance? Yes ☐ No ☐ N/A☐
If yes, please summarize. Click here to enter text.
12. Study Audits/Reviews: Was this study audited during this last year by OHRP or external sponsor?
Yes ☐ No ☐
If yes, please attach the report provided and your response (if applicable).
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13. Amendment History: Have any protocol amendments been approved in the past year?
Yes ☐ No ☐ If yes, state dates and purpose of amendment (e.g., August 201X, dose
modification; September 201X, new investigator added). Click here to enter text.
14. Risk/Benefit Ratio: Since the last HSC review has anything occurred or is there any new
information which may affect the risk/benefit ratio, either from the literature or from the Principal
Investigator’s findings? Yes ☐ No ☐ If yes, please explain: Click here to enter text.
15. Confidentiality/Privacy: Have the methods and procedures used to safeguard the confidentiality
and privacy of subjects and their data as outlined in the approved protocol been adhered to?
Yes ☐ No ☐ If no, please explain the mechanisms that will be implemented to ensure the proper use
and continued protection of these data: Click here to enter text.
16. Certificate of Confidentiality: Does this study have Certificate of Confidentiality?
Yes ☐ No ☐ If yes, what is the expiration date of the Certificate? MM/DD/YY
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