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Health Aff (Millwood). 2018 Oct;37(10):1605-1614. doi: 10.1377/hlthaff.2018.0501.

A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.

Author information

1
William B. Feldman ( wbfeldman@bwh.harvard.edu ) is a research fellow at Harvard Medical School and a fellow in the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, in Boston, Massachusetts.
2
Spencer Phillips Hey is a faculty member and codirector of research ethics at the Harvard Center for Bioethics and a research scientist in the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.
3
Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.

Abstract

In 1996 the Food and Drug Administration (FDA) created an "exception from informed consent" (EFIC) pathway for trials conducted on people incapacitated by life-threatening conditions with a therapeutic time window too narrow for reliable surrogate consent. The goals were to promote therapeutic innovation and encourage rigorous but ethical experimentation on this vulnerable population. To evaluate outcomes of this pathway, we reviewed the complete FDA docket of EFIC trials from the past two decades, encompassing forty-one trials. Among the 46,964 patients included in this review, ninety-six percent were enrolled without consent, and fewer than 1 percent withdrew before the primary endpoint. Two (8 percent) of the twenty-four superiority trials demonstrated a benefit from the experimental interventions. Many interventions were associated with adverse effects, including increased mortality, neurological deficits, and myocardial infarctions. Nearly one-third of US patients in EFIC trials were African American. While EFIC trials have yielded medical advances, investigators in future trials must pay better attention to managing withdrawals and ensuring fair demographic representation.

KEYWORDS:

Ethical Issues; Minority Health

PMID:
30273035
DOI:
10.1377/hlthaff.2018.0501

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