PROJECT PRINCIPAL INVESTIGATOR ASSURANCE
Study Title:
As Project Principal Investigator (PPI) at the Reviewing IRB site, I have ultimate responsibility for the
performance of this study, the protection of the rights and welfare of the human subjects, and strict adherence
by all co-investigators and research personnel 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 application is accurate to the best of my knowledge.
2. All named individuals on this research study have read and understand the procedures outlined in the
protocol and their role on the study.
3. All named individuals on this project 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 PPI, and all co-investigators and research personnel involved in the research 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 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 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
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 (As the PPI, I will gather
study information from the RI(s) then submit for continuing approval from the Reviewing IRB. If as the PPI I
fail to apply for continuing review, IRB approval will automatically expire at all institutions, 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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Project Principal Investigator (PPI) Assurance Statement 06-01-2013 version
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. Filing a final report with the Reviewing IRB by at the conclusion of this study.
___________________________
Typed Name of PPI
___________________________
Signature of PPI
Date
___________________________
Typed Name of UCI Faculty Sponsor
(if a UCI Faculty Sponsor is required)
___________________________
Signature of UCI Faculty Sponsor
_________
Date
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Project Principal Investigator (PPI) Assurance Statement 06-01-2013 version