External Study Team Members

External members who are to be engaged in human subjects research can be added to a Georgetown protocol, but require specific steps.

Georgetown IRB can provide regulatory oversight for external collaborators through the use of a reliance agreement with the collaborator’s institution. The collaborators must be affiliated with another institute that holds an FWA. If your desired collaborator does not have an institutional affiliation, an individual investigator reliance agreement may be available on a case-by-case basis.

If you are interested in requesting a reliance agreement please fill out: Reliance Request Form

1. Submit the “Reliance Request Form.”
   1. The Georgetown IRB will review this form and determine if reliance is appropriate. You may be contacted to provide additional information. 
   2. If approved, you will receive the “Reliance Confirmation Letter” and a blank reliance agreement. This agreement should be partially executed by the relying institution and provided to the GU IRB with your submission. 
2. Creation of IRB submission in the Georgetown-MedStar IRB system
   1. Basic Study Information
      1. Question 4. What kind of study is this?
         1.  Select “Multi-site or Collaborative study”
      2. Question 5. Will an external IRB act as the IRB of record for this study?
         1. Select “No”
      3. Question 6. Will your IRB act as the single IRB of record for other participating sites?
         1. Select “Yes”
   2. Local Study Team Members
      1. Under the terms of the reliance agreement, the relying institution will provide training and conflict of interest review. As the agreement is with the institute rather than individuals, the individual collaborators should not be listed. 
   3. Study Related Documents versus Local Site Documents
      1. Documents that will be utilized at Georgetown should be placed in Local Site Documents.
         1. The partially executed reliance agreement and Reliance Confirmation Letter should be included in this section. 
      2. Documents to be used across all collaborators should be placed in Study-Related Documents.
3. Georgetown IRB Pre-Review
   1. Georgetown IRB will go through the standard IRB pre-review process
   2. The partially executed reliance agreement will be fully executed by Georgetown to be attached to your submission.
4. Georgetown Review
   1. The submission will go through the standard IRB review process.
   2. The relying IRB collaborators should check with their local IRB for any local requirements.

1. Submit the “Reliance Request Form.”
   1. The Georgetown IRB will review this form and determine if reliance is appropriate. You may be contacted to provide additional information. 
   2. If approved, you will receive the “Reliance Confirmation Letter” and a blank reliance agreement. This agreement should be partially executed by the relying institution and provided to the GU IRB with your submission. 
2. Create your Modification in the IRB system
   1. Modification scope
      1. Please select “Other parts of the study”
   2. Basic Study Information
      1. Question 4. What kind of study is this?
         1.  Select “Multi-site or Collaborative study”
      2. Question 5. Will an external IRB act as the IRB of record for this study?
         1. Select “No”
      3. Question 6. Will your IRB act as the single IRB of record for other participating sites?
         1. Select “Yes”
3. Local Study Team Members
   1. Under the terms of the reliance agreement, the relying institution will provide training and conflict of interest review. As the agreement is with the institute rather than individuals, the individual collaborators should not be listed. 
   2. Study Related Documents versus Local Site Documents
      1. Documents that will be utilized at Georgetown should be placed in Local Site Documents.
         1. The partially executed reliance agreement and Reliance Confirmation Letter should be included in this section. 
      2. Documents to be used across all collaborators should be placed in Study-Related Documents.
4. Georgetown IRB Pre-Review
   1. Georgetown IRB will go through the standard IRB pre-review process
   2. The partially executed reliance agreement will be fully executed by Georgetown to be attached to your submission.
5. Georgetown Review
   1. The submission will go through the standard IRB review process.
   2. The relying IRB collaborators should check with their local IRB for any local requirements.

• Previous Georgetown student
  • Yes. A reliance agreement is needed with the ex-Georgetown student’s new affiliated institution. If the ex-student is not affiliated with an FWA-covered institution, an IIA may be appropriate for them to continue to be engaged in human subjects research. 
• Sponsored University Affiliate (SUA)
  • Depends. If the individual holding a SUA is a collaborator associated with an institution, then a reliance agreement is necessary. A SUA does not circumvent the need for a reliance agreement. 
  • In certain circumstances, a SUA may be treated as a Georgetown study member and not require a reliance agreement. For example:
    • A volunteer intern with a Georgetown volunteer agreement. This includes student volunteers conducting research outside of their academic requirements.
    • Contracted worker being paid with Georgetown funds
    • If you are unsure, please contact IRBoard@georgetown.edu
• Collaborators not engaged in human subjects research
  • Depends. Collaborators not engaged in human subjects research may not need IRB oversight. Please provide detailed information regarding the role and tasks of the collaborators in the Reliance Request Form. If there does not appear to be engagement in human subject research a reliance agreement is not necessary, the IRB office will alert you.