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Baruch A. Brody, PhD; Laurence B. McCullough, PhD; Richard R. Sharp, PhD

JAMA. 2005;294:1411-1414.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

An international consensus for protecting the rights and interests of research subjects has emerged in a process that began with the Declaration of Helsinki¹ and continues in the development of official guidelines² as well as a growing scholarly literature.³ Despite this consensus, legitimate ethical controversies persist. This article discusses points of consensus and controversy in clinical research ethics, focusing on substantive, rather than procedural, concerns.

Foundations of the Consensus System

The consensus system requires independent review of research protocols and informed consent of subjects or their surrogates. Independent review examines such issues as adequacy of study design, minimization of risk, risk-benefit ratio, protection of confidentiality, promotion of informed decision making by subjects, potential conflicts of interest, and equitable selection of subjects. Through the informed consent process, potential subjects decide for themselves about enrolling.

This system, which draws its strength from foundations in such . . . [Full Text of this Article]

Author Affiliations: Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Tex.

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