Informed Consent and Standard of Care

What Must Be Disclosed

Ruth Macklin, Lois Shepherd

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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
Volume13
Issue number12
DOIs
StatePublished - Dec 2013

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Consent Forms
Standard of Care
Informed Consent
United States Office of Research Integrity
National Institutes of Health (U.S.)
Research

Keywords

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

ASJC Scopus subject areas

  • Health Policy
  • Issues, ethics and legal aspects

Cite this

Informed Consent and Standard of Care : What Must Be Disclosed. / Macklin, Ruth; Shepherd, Lois.

In: American Journal of Bioethics, Vol. 13, No. 12, 12.2013, p. 9-13.

Research output: Contribution to journalArticle

Macklin, Ruth ; Shepherd, Lois. / Informed Consent and Standard of Care : What Must Be Disclosed. In: American Journal of Bioethics. 2013 ; Vol. 13, No. 12. pp. 9-13.
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