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Collaborative Research with Another Institution

meyer and parkman
Drs. Meyer and Parkman

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 Convened IRB review) involving human subjects, it may be possible to establish an IRB Authorization Agreement (IAA) 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.

Poppies

What is a Reliance Agreement?

  • 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.

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What are the potential advantages of an IAA?

  • 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.

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Is My Study Eligible?

  • 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 enter into an IAA with that institution. (This is because Harvard University follows the guidance of the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) on “Engagement of Institutions in Human Subjects Research”, which indicates that reliance agreements only apply to non-exempt research.)
  • Do the activities taking place at the site in question (including your collaborator’s site, or the Harvard University site) engage that institution? For example, whether researchers will be:
    • Obtaining informed consent;
    • Interacting/intervening with study participants (including helping with study design)
    • Receiving direct funding
    • Analyzing identifiable data
  • If the answer is "yes" to both questions above, an IAA may be possible.


How to submit a request

STEP 1:

Decide if you would like to propose that Harvard serve as Relying or Reviewing IRB. (Direct awards, research activities, existing IRB approvals, and leadership should be considered.)
 

STEP 2:

When Harvard is RELYING on Another Institutions IRB

When Harvard is REVIEWING

If Harvard is proposed to RELY on another institution's review, complete an External IRB request in ESTR. Full instructions can be found here: https://estrsupport.fss.harvard.edu/ExternalIRB.

  • If Harvard is proposed to REVIEW on behalf of another institution, the study team will need to ensure that their application indicates this, by either submitting their study accordingly, or creating a Modification (if creating a study modification, Other Parts AND Study Team Member should be checked – more information can be found here: https://estrsupport.fss.harvard.edu/mod-smartform).
  • Your study should reflect the following:
    • BASIC STUDY INFORMATION:
      • The PI for this record should be the Harvard affiliated investigator (the individual whose activities are proposed to be covered under External IRB review).
      • Indicate that this is a “Multi-site/Collaborative” project.
        • Once the study is marked as collaborative, a new question will appear to ask whether an external IRB will act as the IRB of record, to which you should answer “Yes”.
    • STUDY TEAM MEMBERS:
      • List only those who will be conducting research on behalf of HUA
    • STUDY RELATED DOCUMENTS:
      • Upload a copy of the IRB approval letter from the IRB of record (the IRB to which you are requesting that HUA relies on) and any other study-related documents (including consent forms, protocol, recruitment, etc.)
  • Your study should reflect the following:
    • BASIC STUDY INFORMATION:
      • Indicate that this is a "Multi-site/Collaborative" project.
        • Once the study is marked as collaborative, two new questions will appear to ask a) whether an external IRB will act as the IRB of record, to which you should answer “No”, then b) whether Harvard will act as the IRB of record, to which you should indicate “Yes”.
      • The protocol document should include information in the Collaborations section about collaborators.
    • STUDY TEAM MEMBERS:
      • Ensure that the non-Harvard study team members are listed on the HRP-220 – Non-Harvard Study Personnel form (which can be downloaded directly from that page in ESTR). Then ensure that all ethics training certificates and the HRP-220 are uploaded under Question 2.

STEP 3:

Once your request has been submitted, Harvard IRB will determine reliance eligibility, and then connect with the Reviewing/Relying institution to execute the reliance agreement.

  • In some cases, you may be asked to create a reliance request through the SmartIRB online system (which is where the reliance will be executed, and documented). This request will be used to document reliance agreements with institutions that are signed onto SmartIRB. If you know that your collaborator's institution uses SmartIRB to document reliance agreements, please complete this request by visiting: https://smartirb.org/reliance/. (Please note that the SmartIRB request should be created by the lead institution's PI.) **

**Note: When the reliance will only involve collaborators across the university (HUA, HMS, HSPH) the Harvard Master Agreement is used. The Harvard Master Agreement is a standing document between the Harvard IRBs that acts like a permanent reliance agreement: it outlines the conditions for reliance, the responsibilities for each researcher, as well as the general terms and conditions of the reliance. When the Harvard Master IAA is used, you do not need to create a separate reliance request through the SmartIRB reliance system.

 

Cherry Blossoms
 

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

  • 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:
    1. Both IRBs will require documentation
    2. 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.

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Grant Submission Plan Language

In the application/proposal for research funding, the applicant/offeror is expected to submit a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites. The HUA IRB has developed Grant Template Language which can be used to describe the use of HUA as the sIRB. 

See HUA Grant Submission Plan Language