"Special Scrutiny": A Targeted Form of Research Protocol Review

Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler, Jeremy Sugarman

Research output: Contribution to journalReview articlepeer-review

23 Scopus citations


Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) research that involves initial experiences of translating new scientific advances into humans, especially when the intervention is novel, irreversible, or both; 2) research with a known or credible risk for significant harm (death or serious disability are the clearest examples) to research participants as a consequence of the experimental intervention and with no potential for offsetting direct medical benefit; or 3) research with a protocol that raises ethical questions about research design or implementation for which there is no consensus. Special scrutiny recognizes that not all research protocols are equally ethically challenging and aims to provide appropriate protection for all research participants.

Original languageEnglish (US)
Pages (from-to)220-223
Number of pages4
JournalAnnals of internal medicine
Issue number3
StatePublished - Feb 3 2004

ASJC Scopus subject areas

  • Internal Medicine


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