If you plan to share or receive specimens or data to/from external entities, you will need to address the additional requirements described below. Your protocol or application must describe how you will meet these requirements. Guidance regarding what items you must address can be found in the protocol templates or via consultation with IRB staff.

Note: If the samples being shipped or received will include dates of service associated with the provision of health care or laboratory tests (such as date of collection and date of processing) the data comprises a limited data set of protected health information (PHI) and a data use agreement (DUA) is needed. The requirement for a DUA can be achieved using a stand-alone template or through incorporation of language into the Material Transfer Agreement (MTA) which meets the requirement of HIPAA at 45 CFR 164.514(e). For more information about what is described below, see these pages about sharing and receiving data.

Sending Specimens or Data to Other Sites

If your approved protocol or application does not already address sending specimens or data to other sites, you must submit a change to obtain IRB approval before sending the specimens or data. Guidance regarding what items you must address can be found in the protocol templates or via consultation with IRB staff. Whether the researcher receiving specimens or images must obtain IRB approval depends on several factors:

1. Will the items be analyzed solely as a professional service?
2. Will the items being sent be completely anonymized (i.e., no one can trace them back to the individual from whom they were derived) to external personnel who is not a collaborator?
3. Will the items being sent be coded and the code will not be released to the external researcher who is not a collaborator?
4. Will the items be identifiable to any personnel at any site?

If the answer to any of the first three questions is yes, IRB oversight may not be required for those receiving the items. In the fourth case, IRB review is likely required. Since these can be complex determinations, we encourage you to contact the IRB office for assistance.

Receiving Specimens or Data from Other Sites

If you are planning research involving existing specimens or data received from other sites or researchers certain items must be addressed in your protocol or IRB application. If you have a currently approved IRB application which does not specifically state that specimens or data will be received from a specific site or researchers, a change must be submitted to the IRB before the items can be received. Guidance regarding what items you must address can be found, in the protocol templates, or via consultation with IRB staff. For more information on receiving samples or data more generally including when agreements must be in place, please review the Guidance on Receiving Human Subjects Research Data from an External Entity page.