Valuing risk: The ethical review of clinical trial safety

Kennedy Institute of Ethics Journal 14 (4):369-393 (2004)
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Abstract

: Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risks encountered and more attuned to the priorities of trial subjects

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References found in this work

Risk Society: Towards a New Modernity.Ulrich Beck, Mark Ritter & Jennifer Brown - 1993 - Environmental Values 2 (4):367-368.
Ethics and regulation of clinical research.Robert J. Levine - 1981 - Baltimore: Urban & Schwarzenberg.
Rehabilitating Equipoise.Paul B. Miller & Charles Weijer - 2003 - Kennedy Institute of Ethics Journal 13 (2):93-118.
Deliberating about Bioethics.Amy Gutmann & Dennis Thompson - 1997 - Hastings Center Report 27 (3):38-41.

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