Open Menu Close Menu Open Search Close Search

Individual Investigator Agreements (IIAs) bind independent investigators or investigators at institutions that do not already have agreements with the federal government through a Federal Wide Assurance* (FWA) to have their human subjects research reviewed by an IRB.  Most investigators working at academic institutions in the United States will already be bound by these agreements and an IRB Authorization Agreement (IAA) will be required instead.  Please refer to the OHRP website for more information on IIAs.

*An FWA is an agreement between an institution and the U. S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) which requires IRB review of human subjects research as a condition of eligibility for federal grants.

Independent Investigator Agreement

Tufts will consider a request for an Independent Investigator Agreement when the research team member is:

  • Not otherwise an employee or agent of Tufts Medical Center / Tufts University;
  • Conducting collaborative research activities outside the facilities of Tufts Medical Center / Tufts University; and
  • Not acting as an employee of any institution with respect to his or her involvement in the research being conducted by Tufts Medical Center / Tufts University.
  • Any payment will be made directly to the collaborating independent investigator, if applicable.

Note: If 2 or more independent investigator agreements are required for investigators at a single institution, institutional investigator agreements (IIAs) may be required.

Institutional Investigator Agreements

Tufts will consider a request for an Institutional Investigator Agreement when the research team member is:

  • Not otherwise an employee or agent of Tufts Medical Center / Tufts University;
  • Conducting collaborative research activities outside the facilities of Tufts Medical Center / Tufts University;
  • Acting as an employee or agent of an institution that does not have an FWA (with respect to his or her involvement in the research being conducted by Tufts Medical Center / Tufts University); and
  • Employed by, or acting as an agent of, an institution that does not have an FWA and that does not routinely conduct human subjects research.
  • Any payment will be made to the collaborating institution, if applicable.

Note: If the institution routinely conducts human subjects research, then an IIA is not appropriate and the institution must obtain an FWA and execute an IAA for the study.

Requests for IIAs are considered by the IRB on a case-by-case basis subject to the approval of the IRB Chair and the designated Institutional Official (Vice President for Research Administration at Tufts Medical Center or Vice Provost for Research at Tufts University).

To Request an Individual Investigator Agreement (IIA) for Tufts Health Sciences IRB to cede or assume IRB oversight of an investigator, please submit the following:

  • FORM 10: IAA/IIA Request Form
  • A copy of each independent or institutional investigator’s curriculum vitae.
  • A copy of the study protocol
  • A copy of the informed consent forms (ICFs) for the study
  • If the IAA is for an active study that has already been reviewed and approved by the Tufts Health Sciences IRB:
    • Submit a revised protocol/Site Specific Appendix, and any other study documents that require revisions to reflect the addition of the new site(s) and/or new study personnel
      • Specify in the protocol/Site-Specific Appendix the research activity that will occur at the new site(s) and/or new study personnel
    • Submit revised ICFs (modifying the HIPAA and Confidentiality sections, as applicable

Related Links: