Drs. Meyer and Parkman developing the experimental vaccine for Rubella, 1967 (National Library of Medicine Digital Collections)
The increasing prevalence of research collaborations, a phenomenon that can be seen across many disciplines, has prompted the development of mechanisms to facilitate and document those arrangements, including ensuring IRB review coverage. Indeed, the trend of review by a single IRB for research involving multiple institutions has been spurred by developments such as the NIH Single IRB Policy
This page is designed to function as a centralized resource regarding institutional agreements pertaining to research conducted in collaboration with individuals at other institutions. When Harvard investigators are conducting collaborative, non-exempt research (i.e., requiring Expedited or Full IRB review) involving human subjects, it may be possible to establish an IRB Authorization Agreement allowing one institution to rely on IRB review conducted by the other institution. This helps avoid duplicative review and streamlines the review process across research sites. The IAA delineates the responsibilities of both the relying and reviewing institutions, regarding research review, reporting, and oversight.
Click here to see the process by which a reliance agreement is created:
Ketubbah (prenuptial agreement), Nizza Monferrato, 1782 (New York Public Library Digital Collections, Dorot Jewish Division)
"Seated female fruit vendor holding a balance" (New York Public Library Digial Collections, Miriam and Ira D. Wallach Division of Art, Prints and Photographs)
Review of the initial application
…..for the life of the study
A petition writer outside a Jerusalem courthouse (Wikimedia Commons)
If an Exempt determination has been made by your collaborator's IRB, it will not be possible to entertain an IAA with that IRB.
Obtaining informed consent;
Collection of data on participants;
Analysis of identifiable data
Uncertain whether you can or should request an IAA for your study?
Contact your Reliance Coordinator, Laura Henderson at email@example.com to discuss your situation.
Judiciary scene: judge listening to witness; France 15th c., (New York Public Library Digital Collections, Mid-Manhattan Picture Collection)
If YES, submit a request here. Follow the "Investigators: Get Started" link to request access to submit a request.
If NO, include a cede request form in your ESTR submission (see below).
See Navigating ESTR on this webpage for quick tips.
Full instructions can be found here: https://estrsupport.fss.harvard.edu/ExternalIRB
For an initial application: creation of a pSite (standing for the institution that will cede review)
If the study is already approved: Modification to add a site; creation of pSite
Driving the golden spike at completion of the first transcontinental railroad, Promontory Summit, UT, 1869 (Wikimedia Commons)
Is it possible?
Is it a desirable arrangement? Are the institutions willing?
Is the direction of the cede request appropriate?
Both IRBs will require documentation
Local context review to be conducted by the relying IRB
Institutional Official or designee at each institution signs: IAA becomes fully executed
Maze in Alkborough, North Lincolnshire (Wikimedia Commons)
External IRB applications in ESTR (where it is proposed that Harvard IRB rely on an External IRB):
For initial applications and modifications (where it is proposed that Harvard review the activities of collaborators at other institutions):