Penn Medicine and Penn Audit, Compliance and Privacy have developed a new guidance on the sharing of data and biospecimens with third parties. This guidance was shared with faculty on Wednesday, November 3. It is important that the Penn Medicine research community be familiar with this guidance when submitting proposals to the IRB.
The guidance is available online here: https://oacp.upenn.edu/penn-medicine-guidance-on-sharing-data-and-biological-samples-with-third-parties.
How will this impact IRB review? The IRB will review applications for ANY proposed disclosures of data or biospecimens. You may be asked to:
- Ensure clear and consistent descriptions of the intended primary use(s) and any follow-up (i.e., secondary) use(s) in the IRB documents (i.e., protocol, consent, application) in alignment with the guidance. As the guidance notes, “It is not permissible to share data or samples for unspecified purposes.” Therefore, intended uses should be detailed in study documents.
- Execute an agreement in Penn ERA or Research Inventory System (RIS) through the appropriate contracting office, even if the sharing of data and biospecimens is de-identified: Office of Research Services (ORS), Office of Research Support Services (ORSS), Office of Clinical Research (OCR) Clinical Trials Contracting Unit (CTCU), Abramson Cancer Center Contracts Division, or Penn Center for Innovation (PCI).
The IRB will place notes in approval letters reminding study teams that it is the responsibility of the team to ensure that permission to share specimens and/or data outside of the institution has been sought and that IRB approval does not constitute such permission. Likewise, the protocol and consent must be consistent with any associated agreements or contracts in place for the sharing of data and/or specimens. Given that agreements may be finalized after IRB approval, submission of a modification to the IRB may be required if the study documents are not in alignment with the agreement.
Questions about the guidance should be directed to the contacts designated within the Guidance document. Please do not direct questions to the IRB unless you have questions about IRB review processes surrounding the guidance.