Anticipated Ethics and Regulatory Challenges in PCORnet

The National Patient-Centered Clinical Research Network

Joseph Ali, Robert Califf, Jeremy Sugarman

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)79-96
Number of pages18
JournalAccountability in Research
Volume23
Issue number2
DOIs
StatePublished - Mar 3 2016

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moral philosophy
privacy
data network
online survey
leadership
health

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

ASJC Scopus subject areas

  • Education
  • Library and Information Sciences

Cite this

Anticipated Ethics and Regulatory Challenges in PCORnet : The National Patient-Centered Clinical Research Network. / Ali, Joseph; Califf, Robert; Sugarman, Jeremy.

In: Accountability in Research, Vol. 23, No. 2, 03.03.2016, p. 79-96.

Research output: Contribution to journalArticle

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