What is a Reliance Agreement?

_{Ketubbah (prenuptial agreement), Nizza Monferrato, 1782 (New York Public Library Digital Collections, Dorot Jewish Division)}

• Also known as an IRB Authorization Agreement (IAA), it is an arrangement made between two or more IRBs enabling one (or more than one) institution to rely on the review of another IRB.
• IAAs may be arranged to aid research collaborations, where there are co-investigators who are engaged in the research but affiliated with different institutions.
• IAAs are created on a study-specific basis.

What are the potential advantages of an IAA?

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• Review takes place by only one IRB, streamlining:

Review of the initial application

Modifications

Renewals

…..for the life of the study

• Adding a collaborator in a later phase? You might wish to request that the collaborator's IRB cede review to the Harvard IRB, which would preclude the need for IRB review at that institution.

Is my study eligible for consideration?

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• Is the overall study subject to Expedited or Convened IRB review (i.e. not Exempt)?

If an Exempt determination has been made by your collaborator's IRB, it will not be possible to entertain an IAA with that IRB.

• Do your outside collaborators’ activities engage their institutions? For example, through:

Obtaining informed consent;

Collection of data on participants;

Analysis of identifiable data

• If the answer is "yes" to both questions above, an IAA may be possible.

Uncertain whether you can or should request an IAA for your study? 

Contact your Reliance Coordinator, Laura Henderson at laura_henderson@harvard.edu to discuss your situation.

How do I submit a request?

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• Decide if you would like to propose that Harvard serve as Reviewing or Relying IRB.

• Find out if your collaborator’s institution has signed onto the SmartIRB platform through this link: https://smartirb.org/participating-institutions/

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).

• If Harvard is proposed to RELY, complete an External IRB in ESTR:

See Navigating ESTR on this webpage for quick tips.

Full instructions can be found here: https://estrsupport.fss.harvard.edu/ExternalIRB 

• If Harvard is proposed to REVIEW, your ESTR application will include the following:

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

What is the process by which the IRBs consider and act on the cede request?

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• Reliance coordinators in the respective IRBs communicate to consider the request:

Is it possible?

Is it a desirable arrangement? Are the institutions willing?

Is the direction of the cede request appropriate?

• Evaluation of related submissions:

Both IRBs will require documentation

Local context review to be conducted by the relying IRB

• IAA is finalized through SmartIRB or by paper/email:

Institutional Official or designee at each institution signs: IAA becomes fully executed

• Finalization of IAA in ESTR: Confirmation of External IRB/IRB approval OR confirmation of IAA is part of approval (of Initial application or Modification) under Harvard IRB review.

Tips for Navigating ESTR (IAA specific)

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External IRB applications in ESTR (where it is proposed that Harvard IRB rely on an External IRB):

• Note that the PI for this record should be the Harvard affiliated investigator (the individual whose activities are proposed to be covered under External IRB review).
• For investigators who are not themselves PI eligible, include a PI eligible Faculty Sponsor as a study team member.
• When filling in the SmartForm sections for a new application, select "YES" to question 7 (Will an External IRB act as the IRB of Record for this study?)
• If IRB approval has been granted, upload a copy of this letter.
• NOTE: there will be two items created with two numbers (IRB18-xxxx/SITE18-xxxx). It will be necessary to provide some duplicative information in the SmartForm for the SITE.
• The PI will need to navigate to the SITE and click the red arrow on the left of the screen to "submit" the item to the IRB. Note that the application will not be received by the IRB office until the SITE is submitted.

For initial applications and modifications (where it is proposed that Harvard review the activities of collaborators at other institutions):

• The cede request form or SmartIRB request should be included with the submission, within the "pSite" that is linked to the main study submission.
• Activities taking place by collaborators of relying institutions will need to be described.
• Each collaborating institution that will rely on Harvard IRB review will be a separate pSite.
• Local context review will need to be incorporated in the overall review process.
• The Harvard IRB must incorporate approval of the IAA before activities at the pSite can commence.