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An IRB Authorization Agreement (IAA) assigns the responsibility for the review of research required under a Federal Wide Assurance (FWA)* to one or more IRBs. This IRB can assume this responsibility for another institution, or can cede this responsibility to another IRB.

*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.

An IAA is put in place when the collaborating institution has an FWA, although it might not have a registered IRB if ceding review to Tufts. An IAA can also be put in place if both institutions have registered IRBs, but it makes more sense for one IRB to take on oversight. Please refer to the OHRP website for more information about IAAs.

Requests for IAAs 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 IRB Authorization Agreement (IAA)

For Tufts Health Sciences IRB to cede or assume IRB oversight of your research study, submit the following:

  • FORM 10: IAA/IIA Request Form
  • A copy of the study protocol
  • A copy of the informed consent forms (ICFs) for the study.  For IAAs of new studies that utilize an ICF, submit the following:
  • 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
      1. Specify in the protocol/Site-Specific Appendix the research activity that will occur at this proposed new site
    • Submit revised ICFs (modifying the HIPAA and Confidentiality sections, as applicable)
  • Research COI form for the PI as well as COI forms from research team members who have indicated a “YES” response in any field on the form.
  • Refer to the Harvard Catalyst Reliance Agreement instructions page if the IAA falls under the existing Harvard Catalyst Reliance Agreement.

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