An assessment of the human subjects protection review process for exempt research

Jonathan D. Loe, D. Alex Winkelman, Christopher T Robertson

Research output: Contribution to journalReview article

4 Scopus citations

Abstract

Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform.

Original languageEnglish (US)
Pages (from-to)481-491
Number of pages11
JournalJournal of Law, Medicine and Ethics
Volume44
Issue number3
DOIs
StatePublished - Jan 1 2016

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

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