Please navigate to the policy regarding Key Personnel Qualifications 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.
Complete the outside key personnel section in iRIS and submit to the IRB by creating a regular amendment in iRIS. 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.
In this same amendment, please revise the Research Summary to explain the role of the outside key personnel. Describe what type of data the personnel will have access to (for example, John Doe who is a faculty member at XYZ University will help with manuscript preparation. He will only have access to de-identified study data).
If the outside key personnel will have access to PHI, submit a fully executed agreement and upload into the submission packet. Please note: if an external site IRB approval is submitted, and that external site's IRB is serving as the IRB-of-record for the outside key personnel, then credentialing for the outside key personnel is not needed. Please also note to refer to the following process/policy if Duke is serving as the Central IRB since credentialing requirements differ in this situation as well.
Agreements:
- Data Use agreement (DUA)* - Contact the Office of Research Contracts (ORC)
- Material Transfer Agreement (MTA)* - Contact the Office of Research Contracts (ORC)
- Individual Investigator Agreement (IIA)** - Contact Minna Pak-IRB Office
- IRB Authorization Agreement for a single protocol (IAA)** – Contact Minna Pak-IRB Office