Ethical and Practical Concerns about IRB Restrictions on the Use of Research Data

Mark Barnes, Judith Carrithers, Jeremy Sugarman

Research output: Contribution to journalArticlepeer-review

Abstract

In response to researcher noncompliance with ethical and regulatory provisions governing research with humans, protocol deviations, and unanticipated problems with research, institutional review boards (IRBs) or institutions sometimes impose restrictions on the use of research data, although specific cases in which this happens are unlikely to be known publicly. We review IRB policies at top research institutions in the United States about restrictions on the use of research data and describe potential reasons for restricting the use of such data in the context of ensuring compliance with human subjects research standards. We also discuss ethical considerations related to restricting the use of research data and argue that IRBs have limited regulatory authority to take such actions. Finally, we offer recommendations regarding decision-making about restricting the use of research data and call for additional guidance in this area.

Original languageEnglish (US)
Pages (from-to)29-34
Number of pages6
JournalEthics and Human Research
Volume42
Issue number6
DOIs
StatePublished - Nov 1 2020

Keywords

  • human subjects research
  • institutional review boards
  • research compliance
  • research data
  • research ethics

ASJC Scopus subject areas

  • Health(social science)
  • Medicine(all)

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