Ethics Committee experience with emergency exception from informed consent protocols

Nicole Deiorio, Katie B. McClure, Maria Nelson, Kenneth (John) McConnell, Terri Schmidt

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

SINCE 1996, u.s. FEDERAL REGULATIONS allow research without informed consent to study emergency conditions, if there is currently no satisfactory treatment for the condition, no time to obtain advance consent from the patient or representative, and if there is community involvement through a public disclosure and community consultation process. REB experiences since then are unknown. We surveyed REB chairpersons at the 126 United States medical schools to quantify reviewed protocols and identify attitudes about the rule, to better understand the rule's impact on REBs. Sixty-nine surveys were returned (55%). Fifty-two respondents reviewing human research had heard of the Rule. Forty-eight percent (25/52) had reviewed such a study; 40% of those had rejected at least one. Seventy-eight percent believe the rule protects human subjects, and 88% feel prepared to implement them. REB views differed from public opinion on how best to enact notification and consultation.

Original languageEnglish (US)
Title of host publicationEmergency Research Ethics
PublisherTaylor and Francis
Pages261-268
Number of pages8
Volume4
ISBN (Electronic)9781315256634
ISBN (Print)9781409446811
DOIs
Publication statusPublished - Mar 2 2017

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Keywords

  • Guidelines
  • Informed consent
  • Research ethics
  • Research ethics committees
  • Resuscitation
  • United States Food and Drug Administration

ASJC Scopus subject areas

  • Social Sciences(all)

Cite this

Deiorio, N., McClure, K. B., Nelson, M., McConnell, K. J., & Schmidt, T. (2017). Ethics Committee experience with emergency exception from informed consent protocols. In Emergency Research Ethics (Vol. 4, pp. 261-268). Taylor and Francis. https://doi.org/10.4324/9781315256634