Individual Investigator Agreement

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)

Name of Institution with the Federalwide Assurance (FWA): __________

Applicable FWA Number: __________

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 (https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html)or other ethical principles under which the FWA-holding institution operates; 2) the U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46 (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46); 3) the FWA and applicable Terms of the FWA (https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html) 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) relied upon for the review of research under this agreement and will accept the final authority and decisions of the IRB, including but not limited to directives to terminate participation in designated research activities.
  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 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 approval 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.

The investigator acknowledges that they are primarily responsible for safeguarding the rights and welfare of each research subject.

Investigator Signature: ____________

Date: ____________

Last Name: ____________

First Name: ____________

Middle Initial: ____________

Degree(s): ____________

Address: ____________

City: ____________

State/Province: ____________

Zip/Country: ____________

Phone: ____________

FWA Institutional Official (or Designee): ____________

Date: ____________

Last Name: ____________

First Name: ____________

Middle Initial: ____________

Institutional Title:

Address: ____________

City: ____________

State/Province: ____________

Zip/Country: ____________

Phone: ____________

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