The Harvard Catalyst Reliance Agreement supports institutions and investigators who propose multicenter studies. The goal of the agreement is to reduce duplicative IRB review.
In order to utilize the Harvard Catalyst Reliance Agreement for IRB review, both the ceding and assuming IRB must have signed on to the Master Reciprocal Common IRB Reliance Agreement. Tufts has signed on to the Harvard Catalyst Reliance Agreement. To find out if the institution you are collaborating with has signed this agreement, refer to the Harvard Catalyst website: https://catalyst.harvard.edu/programs/regulatory/reliance.html#sign.
In order for one IRB to assume (take on) oversight and the other IRB to cede (give up) oversight for a study under the Harvard Catalyst Reliance Agreement, you need to confirm the site you are working with is agreeable to this plan and you need to obtain approval from Tufts by submitting a request to the Tufts IRB.
First, contact your collaborator to confirm that their institution agrees to cede or assume oversight for this research study.
The Harvard Catalyst system forms can only be completed by someone with a HMS eCommons ID or Harvard PIN, meaning that the Harvard collaborator must complete the forms/process
Once the Tufts Health Sciences IRB has made a decision about whether or not to cede or assume oversight of this research study, you will need to let the Harvard collaborator know this decision so they can ask their IRB to enter it into the Harvard Catalyst system
If so, and your collaborator is not at a Harvard institution, then follow the directions below making note that your collaborator is a Harvard Catalyst Reliance Agreement Signatory Institution.
To submit a request for Tufts Health Sciences IRB to cede or assume IRB oversight of your research study through the Harvard Catalyst Reliance Agreement, please submit the following:
If the IAA is for a new study and you are requesting that Tufts assume oversight for the study, submit all other required new submission documents. Please refer to the IRB website for more information on what to submit for a new study
If the IAA is for an active study that has already been reviewed and approved by the Tufts Health Sciences IRB, please also:
Revise the protocol or Site Specific Appendix, and any other study documents that require revisions to reflect the addition of the new site, specifying the research activity that will occur at the new site
Revise the ICFs, as applicable, to modify the HIPAA and Confidentiality sections and to make any other changes to the ICFs