New Study Review - Internal Use Only
University of California, Irvine- Institutional Review Board
REVIEWER’S CHECKLIST – New Study
Protocol HS#:
eAPP#:
Tabled Resubmission
Expedited
Full Committee
Lead Researcher:
Title:
HRP ADMINISTRATIVE CHECKIST
YES
Required Signatures Received
Consent Document(s) Received
YES
COMMENTS
NO
NO
YES
NO
YES
NO
YES
NO
YES
NO
Human Subjects section of Federal Grant
Application/Proposal Received
YES
NO
Copy of DHHS-approved Consent
document and Protocol Received
YES
NO
Permission Letters / Off-Site Research
Agreement Received
YES
NO
YES
NO
Special Population(s) Identified
Recruitment Material Received
Data Collection Instrument Received
Source of Funding Identified
Waiting for Signatures
___ Consent(s)
___ Assent(s)
___ Study Info Sheet(s)
Appendix G (&O): Use of Deception
Appendix O: Waiver or Alteration of Informed Consent
Appendix P: Waiver of Written Informed Consent
Appendix Q: Use of Short Form Consent
Appendix B: Pregnant Women / Neonates
Appendix C: Prisoners
Appendix D: Children
Appendix E: Cognitively Impaired / Medically Incapacitated
Specify:
If Federally funded, a copy of the "Human Subjects” section of funding
proposal is required
If DHHS funded and not investigator initiated, this is required
Specify:
PHI Accessed, Created or Disclosed
Referred to COIOC
Referred for Scientific Review
Other Ancillary Committee Clearances
Received
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Appendix A: Non-UCI Site
Appendix H: International Research
Appendix I: Field Work
___ HIPAA Authorization Form(s) received
Appendix T: Partial Waiver of HIPAA Authorization
Appendix T: Total Waiver of HIPAA Authorization
YES
NO
YES
NO
YES
NO
Specify:
Date:
CTPRMC Approval/Exemption
hSCRO Approval
IBC Approval
RSC Approval
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Master (Sponsor) Protocol Received
Drug / Biologic or Medical Device Identified
Investigator’s Brochure Received
All Appendices Received
YES
NO
YES
NO
YES
NO
YES
NO
Version:
Appendix J: Drug / Biologic Study
Appendix K: Device Study
Version:
Appendix L: Use of Placebo or Sham Procedure
Appendix M: Storage of Data/Specimens for Future Research
Appendix N: Genetic Testing
Appendix S: Data Safety Monitoring Plan
HRP ADMINISTRATIVE COMMENTS
**If you have any questions or would like assistance with this review, please feel free to contact me at (949) 824-XXXX or at
XXXX@uci.edu. Thanks – XXXX
ADMINISTRATIVE QUESTIONS AND NOTES FOR THE IRB
Notes for the IRB:
Questions for the IRB:
1. Question X?
YES
NO
(Please comment as necessary):
2. Appendix T: A partial waiver of HIPAA for recruitment purposes is requested. Please review Appendix T.
In order to waive HIPAA Authorization, the IRB must determine that the study meets all of the following criteria:
 The use or disclosure of PHI involves no more than minimal risk
 Granting of the waiver will not adversely affect privacy rights and welfare of the individuals whose records will be
used
 The project could not practicably be conducted without a waiver
 The project could not practicably be conducted without use of PHI
 The privacy risks are reasonable relative to the anticipated benefits of research
 An adequate plan to protect identifiers from improper use and disclosure is included in the research proposal
 An adequate plan to destroy the identifiers at the earliest opportunity, or justification for retaining identifiers, is
included in the research proposal
 The project plan includes written assurances that PHI will not be re-used or disclosed for other purposes
 Whenever appropriate, the subjects will be provided with additional pertinent information after participation
Is the request for a partial waiver acceptable?
YES
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NO
(Please comment as necessary):
ADMINISTRATIVE COMMENTS FOR THE LEAD RESEARCHER (LR)
UCI IRB REVIEWER’S CHECKLIST
A. Criteria for IRB Review and Approval: Please review the federal criteria for IRB approval and indicate whether the research meets
each criterion by checking the appropriate box. List any concern that you would like communicated to the researcher in the
corresponding comment box or in the open space below.
(Criteria for IRB approval of research in accordance with 45 CRF 46.111, 21 CFR 56.111 and UCI Policy)
CRITERIA FOR IRB REVIEW AND APPROVAL
1
The IRB has the expertise needed to review this
research.
2
I, the IRB reviewer, have a conflicting interest with this
protocol.
3
The statement of purpose/hypothesis is adequate.
4
Study personnel appear appropriate and qualified.
COMMENTS
YES
NO
YES
NO
YES
NO
YES
NO
If no, contact IRB staff to arrange consultation
with expert.
If yes, contact HRP staff ASAP to arrange for reassignment of this protocol.
Risk/Benefit Assessment – Risks include possible physical, psychological, economic, social and legal harms.
Risks to subjects are minimized by using procedures
YES NO
5
which are consistent with sound research design and
which do not unnecessarily expose subjects to risk.
Risks to subjects are minimized, whenever appropriate,
YES NO N/A
6
by using procedures already being performed on the
subjects for diagnostic or treatment purposes.
Risks to subjects are reasonable in relation to both:
N
YES NO
/
 anticipated benefits, if any, to subjects; and
7
 the importance of the knowledge that may
reasonably be expected to result.
Subject Selection
Selection of subjects is equitable in relation to the
YES NO
8
purposes of the research and the setting in which the
research will be conducted.
Selection of subjects (i.e., inclusion/exclusion criteria) is
YES NO
9
appropriate based on the research and the setting in
which the research will be conducted.
YES NO N/A
The recruitment process minimizes the potential for
10
undue influence or coercion.
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Compensation - neither the amount of payment nor the
proposed method and timing of disbursement is coercive
or presents potential for undue influence.
YES
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NO
N/A
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Recruitment materials are appropriate.
Informed Consent
Informed consent is sought from each prospective subject
or the subject's legally authorized representative and
13
appropriately documented in accordance with, and to the
extent required by 45 CFR 46.116 and 45 CFR 46.117,
and 21 CFR 50.25 and 21 CFR 50.27 as applicable.
Subject Protections
The research plan makes adequate provision for
monitoring the data collected to ensure the safety of
subjects.
14
For > minimal risk studies, UCI requires investigators
conducting clinical investigations to at a minimum, have a
DSM plan.
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
15
The research plan makes adequate provisions to protect
the privacy of subjects.
YES
NO
16
The research plan makes adequate provisions to maintain
the confidentiality of data.
YES
NO
YES
NO
YES
NO
17
The research does involve subjects likely to be
vulnerable to coercion or undue influence, such as:
children, prisoners, pregnant women, mentally disabled
persons, or economically / educationally disadvantaged
persons.
If YES, the research plan does include additional
safeguards to protect their rights and welfare.
B. Risk Assessment:
Virtually no risk [Exempt Registration]
If Virtually No Risk, indicate all corresponding Category(ies):
No more than Minimal Risk [Expedited review]
If Minimal Risk, indicate all corresponding Category(ies):
Greater than Minimal Risk [Full Committee review]
Please provide a rationale for any change in the risk assessment (e.g., from Expedited to Full Committee or vice versa).
C. IRB Recommendation:
Approve
Minor Changes
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Tabled to Full Committee
Send a Copy of Tabled Memo to Department Chair
Tabled to Subcommittee
Send a Copy of Tabled Memo to Department Chair
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Disapprove
Please provide a rationale below if recommendation is to restrict or disapprove the research.
D. IRB Review cycle:
12 months
6 months*
3 months*
3 years
Other*:
_______________
* Please provide a rationale below if recommended review cycle is less than 12 months.
E.
Reviewer Comments:
Reviewer’s Signature
Date
Note: The information provided on this form may be preliminary and may not necessarily reflect the discussion and final decision and/or
recommendation of the Committee.
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