Individual Investigator Agreement Sample

Version Date: 02/28/2020

Sample Commitment Statement of an Individual Investigator to Institutional Human Subject
Protection Policies and IRB Oversight (institutions may use this text or develop their own
agreement)

Individual Investigator Agreement
Name of Institution with the Federalwide Assurance (FWA):
_______________________________
Applicable FWA #: ________________
Individual Investigator’s Name:
____________________________________________________
Specify Research Covered by this Agreement:
__________________________________________

(1) The above-named Individual Investigator has reviewed: 1) The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research (or other
internationally recognized equivalent; see section B.1. of the Terms of the Federalwide
Assurance (FWA) for International (Non-U.S.) Institutions); 2) the U.S. Department of
Health and Human Services (HHS) regulations for the protection of human subjects at 45
CFR part 46 (or other procedural standards; see section B.3. of the Terms of the FWA for
International (Non-U.S.) Institutions); 3) the FWA and applicable Terms of the FWA for the
institution referenced above; and 4) the relevant institutional policies and procedures for the
protection of human subjects.
(2) The Investigator understands and hereby accepts the responsibility to comply with the
standards and requirements stipulated in the above documents and to protect the rights and
welfare of human subjects involved in research conducted under this Agreement.
(3) The Investigator will comply with all other applicable federal, international, state, and local
laws, regulations, and policies that may provide additional protection for human subjects
participating in research conducted under this agreement.
(4) The Investigator will abide by all determinations of the Institutional Review Board (IRB)
designated under the above FWA and will accept the final authority and decisions of the
IRB, including but not limited to directives to terminate participation in designated research
activities.

Version Date: 02/28/2020

(5) The Investigator will complete any educational training required by the Institution and/or the
IRB prior to initiating research covered under this Agreement.
(6) The Investigator will report promptly to the IRB any proposed changes in the research
conducted under this Agreement. The investigator will not initiate changes in the research
without prior IRB review and approval, except where necessary to eliminate apparent
immediate hazards to subjects.
(7) The Investigator will report immediately to the IRB any unanticipated problems involving
risks to subjects or others in research covered under this Agreement.
(8) The Investigator, when responsible for enrolling subjects, will obtain, document, and
maintain records of informed consent for each such subject or each subject’s legally
authorized representative as required under HHS regulations at 45 CFR part 46 (or any other
international or national procedural standards selected on the FWA for the institution
referenced above) and stipulated by the IRB.
(9) The Investigator acknowledges and agrees to cooperate in the IRB’s responsibility for initial
and continuing review, record keeping, reporting, and certification for the research
referenced above. The Investigator will provide all information requested by the IRB in a
timely fashion.
(10) The Investigator will not enroll subjects in research under this Agreement prior to its review
and approval by the IRB.
(11) Emergency medical care may be delivered without IRB review and approv al to the extent
permitted under applicable federal regulations and state law.
(12) This Agreement does not preclude the Investigator from taking part in research not covered
by this Agreement.
(13) The Investigator acknowledges that he/she is primarily responsible for safeguarding the
rights and welfare of each research subject, and that the subject’s rights and welfare must
take precedence over the goals and requirements of the research.

Investigator Signature: ___________________________________________ Date
_______________
Name: ______________________________________________________ Degree(s):
_____________
(Last)
(First)
(Middle Initial)
Address: __________________________________________________ phone #:
________________
___________________________________________________

Version Date: 02/28/2020

(City)

(State/Province)

(Zip/Country)

FWA Institutional Official (or Designee): ________________________________ Date
___________
Name: ______________________________________________ Institutional Title:
_______________
(Last)
(First)
(Middle Initial)
Address: __________________________________________________ phone #:
________________
___________________________________________________
(City)
(State/Province)
(Zip/Country)