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.

Reliance Agreements

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.	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).
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). For investigators who are not themselves PI eligible, include a PI eligible Faculty Sponsor as a study team member. See more on PI eligibility. 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.

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.

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).

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).
    - For investigators who are not themselves PI eligible, include a PI eligible Faculty Sponsor as a study team member. See more on PI eligibility.
  - 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 the SmartIRB reliance web page. (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.

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 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.
The HHS regulations for the protection of human subjects at 45 CFR part 46 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.
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

Collaborative Research with Another Institution

Reliance Agreements

What is a Reliance Agreement? expand_more

What Are the Potential Advantages of an IAA? expand_more

Is my study eligible? expand_more

How To Submit a Request expand_more

STEP 1:

STEP 2:

STEP 3:

Template Language for Grant Proposals expand_more

What Happens Next? expand_more

Individual Investigator Agreements expand_more