Sharing of Data and Specimens
A criterion of IRB approval is that participant confidentiality is protected. Therefore, investigators are responsible for informing the IRB of any disclosures of participant data or samples outside the institution. This should be reflected in the HSERA application and/or a standalone protocol, if one exists. Additionally, best practice calls for informing participants of such disclosures, unless the IRB has approved a waiver of informed consent / HIPAA authorization. Likewise, the protocol and consent must be consistent with any associated agreements or contracts in place for the sharing of data and/or specimens.
Agreements for the Sharing of Data and Specimens
There are different agreements required to be executed for the sharing of data and specimens.
Agreement Types
Data Use Agreement (DUA)
A written agreement that establishes how a limited dataset will be transferred from a HIPAA covered entity to an intended recipient and establishes the ways in which the information may be used and how it will be protected. A limited dataset excludes all Protected Health Information (PHI) except for the following: (1) elements of dates including age and (2) geographic information at the zip code, town or city level.
Business Associates Agreement (BAA)
A written agreement that establishes how a dataset with identifiable protected health information (PHI) will be transferred from a HIPAA covered entity to an intended recipient and establishes the ways in which the information may be used and how it will be protected.
Material Transfer Agreement
A written agreement that establishes how specimens will be transferred to an intended recipient.
Penn Medicine Guidance on Sharing Data and Biological Samples with Third Parties
Penn Medicine and Penn Audit, Compliance and Privacy have developed a guidance on the sharing of data and biospecimens with third parties. The IRB places 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.
Execution of Agreements
All agreements are executed through Penn ERA or the Penn Research Inventory System (RIS). All agreements are executed by the contract offices below.
Contract Offices
Grants / Federal funding / Non-Profit Funding
Agreements for grants, non-profit, or other federal funding is are executed through the Office of Research Services (ORS) or the Office of Research Support Services (ORSS).
Office of Research Services (ORS)
Office of Research Support Services (ORSS)
Industry / Corporate Sponsored Clinical Trials
Industry sponsored clinical trial agreements are executed through the Office of Clinical Research (OCR) Legal Services (previously CTCU) or Abramson Cancer Center Contracts Division for Hematology/Oncology.
OCR Legal Services
Industry / Corporate Sponsored Non-Clinical Trial
Industry sponsored research agreements (SRAs) for non-clinical trials are executed through Penn Center for Innovation (PCI), Office of Clinical Research (OCR) Legal Services (previously CTCU), or Abramson Cancer Center Contracts Division for Hematology/Oncology.
Penn Center for Innovation (PCI)
OCR Legal Services
Questions?
- All questions about contract and agreement execution should be directed to the applicable contracts office.
- Questions about the OACP guidance should be directed to the contacts designated within the Guidance document.