Informed Consent and Standard of Care: What Must Be Disclosed

Ruth Macklin, Lois Shepherd

Research output: Contribution to journalArticlepeer-review

31 Scopus citations


The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (2) the meaning and application of the concept of "standard of care" in the context of research; and (3) the proper role of OHRP. Examination of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of "standard of care" may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements.

Original languageEnglish (US)
Pages (from-to)9-13
Number of pages5
JournalAmerican Journal of Bioethics
Issue number12
StatePublished - Dec 2013


  • IRB (institutional review board)
  • human subjects research
  • informed consent
  • research ethics
  • risk/benefit analysis

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy


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