New Exempt Study Review - Internal Use Only
University of California, Irvine – Institutional Review Board
REVIEWER’S CHECKLIST – New Study Exempt Research
Protocol HS#:
eAPP#:
Lead Researcher:
Title:
HRP ADMINISTRATIVE CHECKIST
YES
Required Signatures Received
Consent Document(s) Received
YES
COMMENTS
NO
NO
Waiting for Signatures
___ Consent(s)
___ Assent(s)
___ Study Info Sheet(s)
Informed Consent Not Required – No Subject Contact
Documented Informed Consent Not Required
Appendix G: Use of Deception
Appendix B: Pregnant Women / Neonates
Appendix D: Children
Appendix E: Cognitively Impaired / Medically Incapacitated
YES
NO
YES
NO
YES
NO
YES
NO
Human Subjects section of Federal Grant
Application/Proposal Received
YES
NO
Permission Letters / Off-Site Research
Agreement Received
YES
NO
YES
NO
YES
NO
YES
NO
CTPRMC Approval/Exemption
hSCRO Approval
YES
NO
Appendix M: Storage of Data/Specimens for Future Research
Appendix N: Genetic Testing
Special Population(s) Identified
Recruitment Material Received
Data Collection Instrument Received
Source of Funding Identified
Specify:
If Federally funded, a copy of the "Human Subjects” section of funding
proposal is required
Specify:
PHI Accessed, Created or Disclosed
Referred to COIOC
Other Ancillary Committee Clearances
Received
All Appendices Received
Appendix A: Non-UCI Site
Appendix H: International Research
Appendix I: Field Work
Appendix T: Total Waiver of HIPAA Authorization
Specify:
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
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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
NO
(Please comment as necessary):
ADMINISTRATIVE COMMENTS FOR THE LEAD RESEARCHER (LR)
UCI IRB
REVIEWER’S CHECKLIST
REVIEWERS:
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A.
Please specify whether you have a conflict of interest that would require you to be recused for the review of this protocol. If you do
have a conflict, please contact HRP staff ASAP to arrange for reassigning this protocol.
I DO NOT HAVE A CONFLICT OF INTEREST ON THIS PROTOCOL
I DO HAVE A CONFLICT OF INTEREST ON THIS PROTOCOL
B.
Please review and specify if the research meets UCI’s Ethical Criteria outlined below by checking the corresponding box. Please
document each concern you would like to be communicated to the LR in the corresponding comments box or in the open space below.
CRITERIA FOR EXEMPT REGISTRATION
BACKGROUND AND RESEARCH DESIGN


RISK/BENEFIT ANALYSIS



Statement of purpose/hypothesis is adequate
Study personnel appear appropriate/qualified
YES
Risks are relatively non-existent
Potential direct benefit to subjects or societal benefit included
Acceptable risk/benefit relationship
YES
NO
Comments:
NO
Comments:
SUBJECT RECRUITMENT
SUBJECT PROTECTION
Selection of subjects is appropriate (inclusion/exclusion
criteria)
 Selection of subjects is equitable
 Recruitment procedures are proper (undue influence or
coercion is minimized, compensation is not coercive,
recruitment materials are appropriate)

YES
NO




Unanticipated Problem reporting is adequately addressed
Provisions to protect subject privacy are adequate
Provisions to maintain confidentiality are appropriate
Addt’l Protections for Vulnerable Populations are addressed
YES
N/A
Comments:
NO
Comments:
INFORMED CONSENT

Is an informed consent process appropriate?
YES*
NO, provide a rationale below
N/A
*If an informed consent process is appropriate, the researcher will disclose:





That the activity involves research
A description of the procedures
That participation is voluntary
There are adequate provisions to maintain privacy and confidentiality
The name and contact information for the researcher
YES
NO
Rationale/Comments:
C.
Risk Assessment:
Virtually no risk [Exempt Registration]
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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 Exempt to Expedited or Full Committee).
D. IRB Recommendation:
E.
Exempt Registration Confirmed
Revisions/Clarifications Required
Requires Expedited Review
Requires Full Committee Review
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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