Outside Duke Key Personnel Form

In iRIS the outside key personnel form is in section 600 of the application.

If your study includes outside key personnel, you would fill out the outside key personnel section in iRIS by creating a regular amendment if the initial application has already been approved. In this same amendment, you will need to also revise the research summary (last section) to include their role, activities and what type of data they will have access to (PHI, de-identified data, anonymous) or state they will not have access to any data.  If outside key personnel are engaged in research and/or will have access to Duke PHI, a reliance agreement or IRB site approval will also be needed. If the site intends to rely on the Duke IRB as the IRB of record, please contact Minna Pak for the appropriate reliance agreement.  For Material Transfer Agreements (MTA) or Data Use Agreements (DUA), please contact the Office of Research Contracts (ORC).

You will also need to attach the documentation of Human Subjects Certification for each individual (it can be from their own institution) in the submission packet. This is required in most circumstances but not all--for example when Duke is serving as the Single IRB--it is not required for sites to provide their key personnel CITI reports.

Please list adjunct faculty members and affiliates  who are serving on a study as outside key personnel in iRIS

Furthermore, unpaid interns, unpaid Duke undergraduates and volunteers must also be listed on the outside key personnel in iRIS. Please navigate to the DOCR website landing page to locate this institutional policy regarding the process for adding Duke students, unpaid volunteers, and visiting trainees/interns to study personnel.  You will need to open the "Study Start-Up Policies" accordion to find the policy.

Please note: If Duke is serving as the Single IRB, you can upload the document below called a "staff listing" into the iRIS submission packet and do not need to fill out the outside key personnel (section 600) embedded in iRIS.  You also in these cases do not need to upload CITI completion reports.