National Institutes of Health Clinical Center


Ethics of Clinical Research

Informed Consent

Informed consent is a fundamental norm of research ethics and a central feature of most ethical research. Despite the considerable attention given to informed consent in research, there remain important and unsettled issues and growing evidence that the ideal of valid informed and voluntary consent is difficult to achieve.

Questions remain about the general theory of informed consent, and about how much the validity of consent is threatened by misunderstanding or inadequate comprehension or by compromised voluntariness. Evidence indicates that many research subjects have an inadequate understanding of certain aspects of research, such as randomization or the use of controls and often confuse study participation with routine medical care, a "therapeutic misconception."

The Departments research, both conceptual and empirical, aims to address some of the unanswered questions about the meaning and validity of informed consent, and how the process of informed consent is implemented in research practice. Ongoing research is addressing how subject comprehension relates to the validity of consent, how to respond in the face of presumed therapeutic misconception, the importance of manipulation, the appropriateness and influence of offers and incentives on participation, and methods of improving subject understanding. Departmental research has also focused on the ethics of research without consent, such as experimental emergency research and medical records research, and on the ethics of research employing deception.

The Department's research initiatives aim to better understand informed consent, the ethical challenges inherent in research informed consent, and methods for obtaining informed consent that promote the interests of research participants. These issues are important to research of all kinds and plague researchers, regulators, and others who are concerned with research.

Department members have published several books and book chapters about informed consent, including a recent book, edited by Miller and Wertheimer, — The Ethics of Consent: Theory and Practice, which was described as "...the most important book on consent in at least 20 years...". (JAMA 2010;303(24):2531-2532)

The Department has also published dozens of papers on informed consent and related topics in peer review journals including the NEJM, the Hastings Center Report, Journal of Law, Medicine and Ethics, JAMA, and the Journal of Medical Ethics.

Topics include:

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