Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

ABSTRACT

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

KEYWORDS:

• Data management
• empirical studies of research ethics
• ethics and public policy
• human subjects ethics
• human subjects regulation and oversight
• informed consent
• public policy
• research ethics
• translational research

Additional information

Funding

This article was supported by a contract from the Patient Centered Outcomes Research Institute (PCORI) (P122013-499A). The views expressed do not necessarily represent the views of PCORI or PCORnet.