When Transferring Data or Samples to External Entities or Persons

The IRB does not need signed copies of contracts/Material Transfer Agreements (MTAs)/Data Use Agreements (DUAs) to be uploaded in iRIS for transfers of data or samples.  Rather, the research summary in your IRB application should include language indicating the expected transfer, what data/specimens will be transferred, and entities/persons involved in the transfer.  For example:

“The study team at Duke will transfer de-identified data to Johns Hopkins for external analysis once appropriate agreements between Duke and JHU have been fully executed.”

Likewise, study teams do not need to upload external vendor agreements or releases, particularly when sending de-identified samples for analysis.  Instead, include this sentence in your research summary in iRIS:

“No samples will be sent for external analysis until appropriate agreements between Duke and the vendor have been fully executed.”

Note the following exception:  the IRB reviewer may request a copy of an agreement as part of his/her review.

If you have any questions, please check in with your IRB specialist.