Updating IRB applications when Researcher(s) Leave U-M

1. Create and submit a termination report in eResearch
2. See below for general instructions when submitting the Termination.
3. Do not Amend to remove the exiting researcher.

1. Consult with the IRB at the new institution and apply for IRB approval
2. Keep the IRB application at U-M open until the IRB application at the new institution is approved
3. Once the IRB approval from the new institution is obtained, terminate the U-M IRB application appropriately. See below for general instructions when submitting the Termination.
4. Note: an Amendment to change the PI is not usually required for this scenario if the IRB approval from the new institution can be obtained before the appointment at U-M ends. If any delay in this transition process is expected, submit an Amendment to identify a new PI at U-M to ensure an appropriate transition.

1. Create and submit an Amendment to remove the exiting researcher
2. If the exiting researcher is the PI, identify the new PI with this Amendment. The new PI will be able to submit the Amendment. Also, consider keeping the exiting PI as a Co-I until their last day to ensure a smooth transition. They can be fully removed after the final date with U-M. If no new PI will take over, close the project (see above).
3. See below for general instructions when submitting the Amendments.

Option A

1. Consult with the IRB at the new institution and apply for IRB approval for the ongoing research activities
2. Submit an Amendment to remove the exiting researcher. Add the new institution as a participating site in Section 03-1. Upload IRB approval from the new institution when available.
3. If the study is currently federally funded, adding a new site might trigger ”single IRB” requirements depending on the activities done at the new site.

Option B

If there is no IRB at the new institution and/or if the exiting researcher would like to continue under U-M IRB oversight

1. Reach out to IRBMED as soon as possible
2. Clarify whether the exiting researcher will have an adjunct appointment with U-M
3. If there will be an adjunct appointment that supports ongoing research activities at U-M, an Amendment to update the role to “other” is usually required. As the adjunct appointments are usually temporary, the IRB application will need to be updated when the adjunct appointment ends. The IRB staff might consider adding a Manage Action Item (MAI) in eResearch for tracking purposes.
4. If there will NOT be an adjunct appointment, an Amendment to update the role will be needed.
   1. Remove the exiting researcher from their current role (PI or Co-I, etc.);
   2. Re-list them in the role of “other” (for external study team members).
   3. Follow all steps from IRBMED’s guidance on external study team members in the Amendment (completing an external collaborator checklist and uploading it in the IRB application, etc.)

Include the following relevant details. 
For Amendments, include these details in the Amendment coversheet. 
For Terminations, include these details within the Termination report (1.2 free text field).
 

1. Brief Background:

   “Effective _____ <date>, Dr. ABC is leaving U-M. He/she <will or will not> have an adjunct appointment with U-M. The purpose of this submission is to …. <remove or replace> the exiting researcher / terminate the IRB application at U-M etc.”

2. Status of Data and/or Materials:

   EITHER

   “<The data and/or materials collected in this IRB application will be destroyed.> No data or materials will be transferred outside the U-M. The exiting researcher will not have access to any data and/or materials.”

   OR

   “The data and/or materials collected in this IRB application may be transferred outside the U-M. Possible transfer outside U-M <is or is not> already reflected in approved informed consent document(s). We are currently working on appropriate data/material transfer agreements. We affirm that no data/material will leave U-M until appropriate agreements are finalized. Here is the UFA ID for data use agreements: …”

3. Status of participants: Provide additional details related to the status of the participants (how many are active, will they need to be notified, etc.) in the Amendment cover sheet question regarding possible re-consent. 
4. Review the table in Section I and provide additional information regarding the other units as applicable 
5. Review the table in Section II and identify the specific scenario

NOTE: Amendment and Termination should not both be prepared.

When editing the IRB application: 

1. Changing the exiting researcher role: 
   1. Update Section 01 (study team members)
   2. Open the Printer Friendly Version of the IRB application and use ‘Ctrl+Find’ to find any sections where the study team member leaving U-M is listed. eResearch Cross-Reference Table may be of use. 
2. Revising the study documents: 
   1. For investigator-initiated studies, update the study protocol to remove/replace the exiting researcher.
   2. If the enrollment or re-consenting is still open, update the informed consent documents and the recruitment documents to remove/replace the exiting researcher.
   3. Scan through the application to identify any other subject-facing materials and update them as appropriate.
   4. As always in eResearch, do not delete the whole document ‘stacks’: rather, ‘Upload Revision.’ 
3. Update Section 02 (funding and UFA(s)) as needed. 

1. Termination 
   1. Exempt studies: Termination is a separate, simpler process that can be completed by any study team member with Edit rights. See ITS step-by-step guide “Creating a Termination - Submit a request for terminating an exempt study.”
   2. Not Regulated projects: There is no eResearch function to terminate. Therefore, send a Post Correspondence (select IRBMED as a recipient) with the details outlined in Section III heading “For Amendments or Terminations” above. 
2. Amendment
   1. An Amendment is not generally required for Exempt/Not Regulated IRB applications unless changes could impact the previously issued Exempt/Not Regulated determinations. The study team changes typically will not impact the Exempt/Not Regulated determination. If the study team would like to keep the IRB application current, submit an Amendment for the changes related to study team membership. 
   2. Tips: See also Exempt Human Subjects Research, heading “What is an Exemption?,” subheading “How are Exempt studies regulated?”