Lead Researcher:
Study Title:
HS #
Appendix O
REQUEST FOR A WAIVER OF INFORMED CONSENT
TO REQUEST APPROVAL FOR A WAIVER (I.E., NO CONSENT FROM THE SUBJECTS) OR
ALTERATION OF INFORMED CONSENT (E.G., WITHHOLD REQUIRED ELEMENT OF INFORMED
CONSENT), THE RESEARCH MUST MEET THE CRITERIA BELOW:
The IRB may, in some specific instances, approve a consent procedure which does not include, or which
alters, some or all of the elements of informed consent, or waive the requirements to obtain informed
consent (or parental permission) altogether in accordance with 45 CFR 46.116(c-d)
Please read the applicable HRP webpage for information about waivers or alterations of the informed
consent process.
Section 1: LEVEL OF REVIEW
Does the research qualify for Exempt review (i.e., there is virtually no risk to subjects and it falls within
one of the six (6) federally-defined exempt categories).
Yes - skip the remaining questions. Research that qualifies for Exempt review is "exempt" from
federal regulations; however the UCI IRB is required to confirm Exempt status.
No - the research qualifies for Expedited or Full Committee review (continue to Section 2).
Section 2: FDA REGULATIONS
Is the research subject to FDA regulations? (i.e., the research involves drugs or biologics, or the
research involves testing the safety and/or efficacy of medical devices).
Yes – If yes, the research is subject to FDA regulations and a waiver/alteration of informed
consent cannot be granted.
(Return to the Procedures link in the blue bar and “uncheck” Waiver or Alteration of Informed
Consent)
No - the research is not subject to FDA regulations (complete the remaining questions).
(Complete Section 3 or 4, depending on your rationale for requesting the waiver).
Section 3: RESEARCH INVOLVES NO MORE THAN MINIMAL RISK TO SUBJECTS
Complete the questions below (A-D) if you are requesting IRB approval of a consent procedure that does
not include, or which alters, some or all of the elements of informed consent, or you are requesting a
waiver of the requirement to obtain informed consent.
A. Explain why the research qualifies as minimal risk (i.e., explain why the research qualifies for
Expedited review):
B. Provide a rationale for why the waiver or alteration will not adversely affect the rights and welfare of
the subjects:
C. Explain why the research could not be practicably carried out without the waiver or alteration:
Lead Researcher:
Study Title:
HS #
D. If appropriate, describe how the subjects will be provided with additional pertinent information about
the research after participation:
Description:
Not applicable
Section 4: RESEARCH OR DEMONSTRATION PROJECT IS CONDUCTED BY OR SUBJECT TO
THE APPROVAL OF STATE OR LOCAL GOVERNMENT OFFICIALS
Complete the questions below (E-G) if you are requesting IRB approval of a consent procedure that does
not include, or which alters, some or all of the elements of informed consent, or you are requesting a
waiver of the requirement to obtain informed consent.
E. The research or demonstration project is to be conducted by or subject to the approval of state or
local government officials.
Yes – If yes, complete the remaining questions
No - the waiver/alteration of informed consent cannot be granted.
F.
The research is designed to study, evaluate, or otherwise examine: (CHOOSE ONE)
Public benefit or service programs
Procedures for obtaining benefits or services under those programs
Possible changes in or alternatives to those programs or procedures
Possible changes in methods or levels of payment for benefits or services under those
programs
G. Explain why the research could not practicably be carried out without the waiver or alteration.