Please note in iRIS this form is no longer uploaded but part 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. In this same amendment, you will need to also revise the research summary to include 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 will have access to Duke PHI, an agreement/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 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 Central 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 on the Outside Key Personnel smartform in iRIS. Unpaid interns and volunteers must also be listed on the Outside Key Personnel smartform in iRIS--click here for policy.
Please note: if you are the coordinating center for a multi-site study or if Duke is serving as the Central IRB, you can upload the following form (staff listing) below into the submission packet and do not need to fill out the outside key personnel smartform embedded in iRIS. You also in these cases do not need to upload CITI completion reports.