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Office of Human Research

Office of the Vice Provost for Research

Reliance Process

Reliance is the process of using a single Institutional Review Board (IRB) for the review of research at multiple sites and/or conducted by investigators across multiple institutions.

  • The IRB that performs the IRB review is called the Reviewing IRB (IRB of Record).
  • The institution that cedes IRB review is called the Relying Institution. 

The Office for Human Research Protections within the U.S. Department of Health and Human Services oversees federal regulations that require the use of a single IRB for non-exempt federally-funded research.

When an IRB becomes the Reviewing IRB for another institution, a Reliance Agreement (RA), also known as an Institutional Authorization Agreement, is required. The Reliance Agreement documents the responsibilities of the Reviewing IRB and the Relying Institution to ensure that both understand the relationship and what is required of each. It is important to remember the Reviewing IRB is only taking on the role of the IRB, the Relying Institution remains responsible for ensuring all institutional requirements are met and for the conduct of the research. 

If a collaborating non-GW investigator is not affiliated with an FWA holding institution, an Individual Investigator Agreement (IIA) can be established between the George Washington University (GW) and the individual collaborator.

If you are collaborating with a non-GW institution to conduct your research, please read the information below to determine whether or not the relationship would qualify for a Reliance arrangement or Individual Investigator Agreement. If it does, you will need to complete a Reliance Request form.

Request Reliance Form (docx)

When is a Reliance Arrangement Appropriate? 

A Reliance arrangement or Individual Investigator Agreement is only appropriate when GW is conducting non-exempt research (research requiring expedited or convened board review).

GW researchers who are unsure whether their collaboration with a non-GW investigator meets the requirements for a Reliance arrangement or an Individual Investigator Agreement (IIA) may consider attending office hours or scheduling a consultation with Office of Human Research (OHR) staff. 

Before proceeding with your Reliance request, consider the information below to determine if a Reliance arrangement or IIA is appropriate.

Does your study meet the definition of Human Subject Research (HSR)?

If a not human subjects research (NHSR) determination is made, a Reliance arrangement or Individual Investigator Agreement is not appropriate.

To obtain a not human subjects research determination, complete the NHSR Determination Form and submit it to [email protected].

Do you expect your research will receive an exempt determination from GW IRB?

Typical exempt studies involve surveys, interviews, or analysis of previously collected identifiable information. Determinations regarding level of review are made during the review of your application in iRIS. 

If you anticipate your research will receive an exempt determination from the GW IRB, a Reliance arrangement or Individual Investigator Agreement is not appropriate.

Your non-GW collaborator should follow their institution’s procedures for review of research. The GW investigator should not add the non-GW colleague to the Study Personnel section of the GW IRB application. Instead, the GW PI should describe the collaboration, the investigator(s) and institution(s), and their engagement in the research within the iRIS application.

 

GW investigators seeking to initiate a Reliance arrangement or an Individual Investigator Agreement (IIA) must submit a Request Reliance Form (docx) to [email protected] (please include "Attn: Reliance" in the subject line of the email). Requests for Reliance should be submitted during the planning stages.

Each request is evaluated on a case-by-case basis. Requests for the GW IRB to become the Reviewing IRB are determined based on several factors:

  • funding source,
  • sponsor requirements,
  • home institution of the Lead (or Overall) Principal Investigator (PI),
  • number and location of participating sites,
  • location of research activities,
  • level of risk to participants, and
  • GW’s capability to provide sufficient oversight.

After receiving approval of your Reliance Request, follow these steps to ensure proper coordination and compliance for both reviewing and relying institutions. The specific steps differ based on whether GW is the Reviewing IRB or the Relying Institution, and there are distinct processes for establishing Individual Investigator Agreements (IIAs).

When GW is a Relying Institution

These actions may occur in tandem:

  • The Reviewing IRB will require a local context form, which will provide specifics about GW institution policy and institution-specific requirements (HIPAA, compensation for injury, etc.). The GW site PI should work with the OHR Staff Member and Reviewing IRB to complete this form and any other required documentation.
  • If GW investigators will consent participants, the consent document(s) form must include the GW Institutional Language. The GW PI must submit the Institutional Language document (docx) and red-lined GW-specific consent document(s) for review by OHR staff before submission to the Reviewing IRB for review and approval. 
  • Confirm Reliance
    • If using WCG or Advarra, no further steps are required, GW has Master Agreements in place with these organizations.
    • If the Reviewing IRB is using SMART IRB (see below).
    • If another method of Reliance will be used, please contact OHR staff.
When GW is the Reviewing IRB

Some of these actions may occur in tandem:

  • The research protocol should clearly indicate that GW is acting as the Reviewing IRB and include the following:
    • A list of collaborating sites, each site’s investigator, and the specific research activities that will occur at each relying site.
    • A description of the oversight plan to describe how the GW PI will oversee the research conducted at the relying institutions, considering communication, training, reporting, and both the site regulatory file and site study documentation.
  • The initial step is to obtain IRB approval for the GW site, which includes the main protocol and associated MODEL consent document(s). Once the main study at GW receives IRB approval, the next step is to obtain approval for the relying sites. The GW PI will be responsible for obtaining a completed Institutional Profile and Local Context Form (docx) from each relying institution. If consent will be obtained, site-specific consent document(s) will also need to be submitted for each relying institution using the MODEL consent document(s) approved by the GW IRB.
  • Reliance Agreements must be obtained from each Relying Institution. GW prefers to use the SMART IRB Agreement to document Reliance (see below).
  • Once a local context document, site-specific consent document(s), and Reliance are obtained for a Relying site, the GW PI or designee must submit a modification to the approved study in iRIS, which includes each of the documents, to add the relying site. Once the site (modification) is approved in iRIS, the GW PI is responsible for providing the approved materials to the relying site(s).
Using the SMART IRB Reliance Agreement

GW has signed onto the SMART IRB Reliance Agreement, which is a master reliance agreement that over 1,000 participating institutions have signed on to.

The Reviewing IRB is responsible for managing the SMART process.

If GW is the Relying Institution, the external Reviewing IRB is responsible for managing the SMART process. If the SMART IRB Reliance Agreement will be used to document reliance for a specific project, ensure the OHR staff is made aware. 

When GW is the Reviewing IRB, the GW PI or designated submitter is responsible for managing the SMART process.

  1. Request Access: Contact [email protected] if access is not granted promptly.
  2. Start SMART Reliance Request: The GW PI or designated submitter must Sign in to the SMART IRB online reliance system and submit a request.
    • Please view this short Reliance Walkthrough Video for an overview of the process.
    • The SMART Reliance Request requires basic information about the research, Relying sites, site PIs, and uploading all IRB-approved research protocol documents (e.g., protocols, consents, surveys, and recruitment materials).
    • The information submitted on the SMART IRB site must reflect the language in the Reliance Request form and the application in iRIS, where applicable.
Individual Investigator Agreements (IIAs)