Please navigate to the policy regarding Key Personnel for the definition of Key Personnel to guide your choice of whom to list on the Key Personnel list in all IRB protocol submissions.
Employees hired by Duke Temp Services (whether using Aerotek or any outside resource) can be added as internal Duke key personnel via a key personnel change.
Emeritus Professors can be added as internal Duke key personnel via a key personnel change, but they cannot serve as the Duke PI or Co-PI.
The IRB confirmed with University Counsel that Adjunct Faculty should be removed from internal key personnel lists in the iRIS system. Adjunct Faculty should be listed as outside key personnel if they are involved in a particular protocol at Duke. If the Adjunct Faculty is engaged in research and/or have access to PHI, please reach out to Minna Pak to request a reliance agreement.
To find out the process for adding a volunteer/unpaid intern to a study team, lease navigate to the DOCR website landing page to locate this institutional policy. You will need to open the "Study Start-Up Policies" accordion to find the policy.
In section 600 of iRIS, there is an External Key Personnel (KP) Tool with three questions to guide users in determining if/when outside personnel should be added to the application. Only personnel who are engaged in the research and relying on the DUHS IRB are to be added. Please also refer to the Key Personnel policy.
Items to attach in your submission when personnel are engaged:
- A fully signed reliance agreement
- Documentation of Human Subjects Certification for each individual.
MTA/DUA (if applicable): The IRB does not need signed copies of Material Transfer Agreements (MTAs)/Data Use Agreements (DUAs) to be uploaded in iRIS for transfers of data or samples. Rather, the research summary should include language indicating the expected transfer, what data/specimens will be transferred, any personal identifiers (including dates) being shared, entities/persons involved in the transfer, and assurance that data will be transferred only after an agreement has been finalized by the Office of Research Contracts (ORC) and is fully executed.
Agreements Contacts:
- MTA/DUA- contact the Office of Research Contracts (ORC)
- Reliance agreements- contact Minna Pak from the DUHS IRB
***Please note for studies in which the DUHS IRB is the single IRB (sIRB), the external site’s key personnel are not listed in section 600. Instead, a staff listing is used.