IRB of Record

Conducting Collaborative Research with Other Institutions

An IRB of Record or IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research. These agreements help to economize on the IRB review and approval process by limiting the IRB review to one institution. IAAs are sometimes referred to as IRB of Records, but mean the same thing. When signing the IAA, one institution is designated the lead IRB or IRB of Record.

Required Documents

Please complete the IRB of Record Request Form (DOCX) whenever you are requesting an IRB of Record, and provide an agreement template appropriate for the relationship (GW lead or GW rely). You may use the templates provided below, you may use a template provided by the collaborating institution, or you may request the use of an online reliance agreement platform such as SMART IRB or IREx.

Anyone covered by the IAA may not begin any work on the project until IRB approval has been granted AND the agreement has been signed by all parties.

GW Lead

GW should be the IRB of record if a GW investigator is the prime awardee of a grant or other funding, or if the majority of research activities will take place at GW with other institutions collaborating. If you are requesting GW be the IRB of Record, please complete this form: IAA for GW Lead. You will also need to work with the relying site to complete the Institutional Profile and Study Local Context Form (DOCX).

GW Rely

Another institution may be best served as IRB of Record if all research activities are taking place there, or if GW personnel are providing support for a funded project elsewhere. Examples of this would be a GW investigator providing data analysis on identifiable data but all other research activities take place at other institutions. If you are requesting another institution to be the IRB of Record, please complete this form: IAA for GW Reliance.

After obtaining an IAA you will need to do the following:

If GW is the IRB of Record, you should continue to correspond with the GW IRB as you would normally do, such as submitting renewals, modifications, or closure requests.

If the other institution has been designated the IRB of Record, you should correspond with the other institution and submit renewals, modifications, and closure requests in accordance with their local procedures. You must contact the GW IRB if any of the following occurs:

  • Change in risk level for study;
  • Subject complaint;
  • Unanticipated problem involving risk to subjects or others;
  • Suspension or termination of the research by the investigator, IRB, or sponsor;
  • Change in PI;
  • Change in funding arrangements;
  • Change in GW staff roles and responsibilities; OR
  • Closure of the study.

*Note: Exempt research studies are not eligible for an IAA. You must submit to each institution who is engaged in human subjects research in accordance with their local policies and procedures.

IRB of Record FAQs:

How do I request an IAA at GW?

  1. The PI or primary contact should contact both institutions to determine if an IAA is appropriate. Research determined to be exempt cannot enter into this sort of agreement.
  2. Once both institutions agree to enter into the agreement, complete the appropriate IAA form and IRB of Record Request form.
    • If GW is to be lead, no other documents should be necessary as we will have already  reviewed the study.
    • If GW is to rely, please submit the other institution’s IRB approval and any other study related documents, such as consents.
  3. Submit all pertinent documents to [email protected]. An IRB staff member will route for signatures accordingly. Please be certain to have the form completed in its entirely prior to submission. View Federalwide Assurance and IRB numbers.
  4. After signatures from both intuitions have been obtained, provide GW with a final copy for our records.

What is the timeframe for an IAA?

It varies by institution. IAAs generally take a couple of weeks for processing, but the timeframe is ultimately driven by the availability of the Institutional Officials who are responsible for signing these agreements.

How long do IAAs last?

IAAs last for the duration of the research study or for however long the collaborator remains engaged in human subjects research. They need not be updated unless an expiration date is provided or the principal investigator (PI) or study information changes.