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.
Tufts will consider a request for an Independent Investigator Agreement when the research team member is:
Note: If 2 or more independent investigator agreements are required for investigators at a single institution, institutional investigator agreements (IIAs) may be required.
Tufts will consider a request for an Institutional Investigator Agreement when the research team member is:
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: