Collaborative Research with Another Institution
Drs. Meyer and Parkman
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 with an institution that has a federalwide assurance (FWA), 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.
If you will be collaborating with an institution that does not have an FWA or an individual that is not affiliated with an FWA-holding institution, please see the tab “Individual Investigator Agreements” below.
Not sure if who you will be collaborating with has an FWA? The Office for Human Research Protection (OHRP) has a database of all FWA-holding institutions on their website.
- What is a Reliance Agreement?
- Advantages
- Is my study eligible?
- How to submit a request
- Template Language for Grant Proposals
- What happens next?
- Individual Investigator Agreements
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.
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.
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. |
|
|
|
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.
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:
- 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.
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.
Individual Investigator Agreements
Every institution that regularly conducts human subjects research and receives money from the U.S. federal government is required to have a federalwide assurance, or FWA. The FWA is a commitment to the government that all research conducted by the institution will be held to the standards of the federal regulations for the protection of human subjects.
However, there are some institutions that do not regularly conduct human subjects research and do not receive money from the federal government. There may also be individuals that are not affiliated with an FWA-holding institution that may work on a research study. These institutions and individuals may be from the community or located internationally.
When an FWA-holding institution, like Harvard University Area (HUA), works with other institutions that have a FWA, it is possible to use a reliance agreement, also known as an IRB Authorization Agreement (IAA). An IAA is only possible when all institutions involved in a research study have an FWA. An IAA permits one institution to rely on another institution for IRB review thereby preventing duplication of IRB effort.
As mentioned, not all institutions or individuals have an FWA. In these situations, an FWA-holding institution may provide IRB review for the institution or individual by using an Individual Investigator Agreement (IIA). What the IIA does is permit the FWA-holding institution to extend its FWA to cover this institution or individual; basically, making this institution or individual as their agent.
If the HUA IRB is willing to extend the HUA FWA to an institution or individual via an IIA, the following documents must be reviewed:
-
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (see http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html) or other internationally recognized equivalent (see section B.1. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html)
- The HHS regulations for the protection of human subjects at 45 CFR part 46 (see http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html) or other procedural standards designated by a non-U.S. institution under its FWA (see section B.3. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html)
- The FWA and applicable Terms of the FWA for the assured institution
- The relevant institutional policies and procedures for the protection of human subjects of the assured institution.
Following, the HUA IRB will require the institution or individual to sign an IIA. You can find the HUA IIA in the ESTR Library (be sure to be logged in with your Harvard Key!). Click on the tab “Templates and Forms” and look for the document “HRP-225-FORM-Individual Investigator Agreement”.
You can learn more about the IIA on the OHRP website