RELYING INVESTIGATOR ASSURANCE
Study Title:
As the Relying Investigator (RI), I have ultimate responsibility for the performance of this study at the Relying
Institution, the protection of the rights and welfare of the human subjects, and strict adherence by the coinvestigators and research personnel conducting research at my institution to all Reviewing Institutional Review
Board (IRB) requirements, federal regulations, state statutes, and Reviewing institutional policies and
procedures for research involving human subjects.
I hereby assure the following:
1. The information provided in this RI Worksheet is accurate to the best of my knowledge.
2. All named individuals on this worksheet have read and understand the procedures outlined in the protocol
and their role on the study.
3. All named individuals on this worksheet have completed their home institution’s Human Research
Protections educational requirement and have been made aware of the "Common Rule" (45 CFR Part 46),
applicable Food and Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312 and 812), have read
the Belmont Report available on the Office for Human Research Protections website.
I, as the RI, and all my co-investigators and research personnel involved in the research at my
institution agree to comply with all applicable requirements for the protection of human subjects in
research including, but not limited to, the following:
1. Obtaining the legally effective informed consent or assent of all human subjects and/or consent of their
legally authorized representatives (unless waived) and using only the currently approved, stamped consent
form (if applicable). Obtaining HIPAA Research Authorization from human subjects or their legally
authorized representatives, as applicable (unless waived).
2. Making no changes to the approved protocol or consent form without the PPI first submitting the changes
for review and approval by the Reviewing IRB, unless the changes are necessary to eliminate an apparent
immediate hazard to subjects. Changes made to eliminate hazards to subjects must be reported by the PPI
to the Reviewing IRB according to the Reviewing IRB’s policies and procedures.
3. Reporting any unanticipated problems involving risk to subjects or others, and potential noncompliance
through the PPI to the Reviewing IRB in accordance Reviewing IRB’s policies and procedures. In addition,
HIPAA privacy violations must be PROMPTLY disclosed to the local Privacy Officer. There are specific
time requirements for reporting these breaches of confidentiality, which, if not met, may result in monetary
damages to the PPI and the institution.
4. Responding appropriately to subjects’ complaints or requests for information about the study; and reporting
through the PPI to the Reviewing IRB any subject complaints that are not resolvable by the study team.
5. Promptly providing the Reviewing IRB with any information requested relative to the research.
6. Obtaining continuing approval from the Reviewing IRB prior to study expiration (Providing information about
the progress of the study at my institution to the PPI who then submits for continuing approval from the
Reviewing IRB. If the PPI fails to apply for continuing review, IRB approval will automatically expire at all
sites, and all human research activities must cease until IRB approval is obtained).
7. Promptly and completely complying with an IRB decision to suspend or terminate its approval for some or
all research activities.
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8. Submitting to a routine review of human subject research records in an effort to ensure in part that human
subject research activities are conducted in accordance with regulations, laws and institutional policies
regarding the protection of human subjects.
9. Having the PPI file a final report with the Reviewing IRB by at the conclusion of this study.
___________________________
Typed Name of RI
___________________________
Signature of RI
Date
___________________________
Typed Name of UCI Faculty Sponsor
(if a UCI Faculty Sponsor is required)
___________________________
Signature of UCI Faculty Sponsor
_________
Date
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