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Abstract

The Food and Drug Administrations's (FDA) efforts in all areas of informed consent are designed to ensure that patients receive complete and accurate information about risks and benefits, efficacy and safety, side effects and adverse reactions, and alternatives. This paper covers FDA's role in informed consent for clinical trials, highlights FDA's informed consent requirements, and discusses FDA's role in patient information and product labeling.

Keywords

Informed consent Clinical trials Patient information Product labeling

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References

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The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Federal Register. April 18, 1979;79:12065.

45 CRF 21 § 46.

21 CRF § 50.

21 CRF § 50.20.

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21 CRF § 50 and § 56.

Kessler

David

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10.

Kessler

David

Statement of April 16, 1992.

11.

Kessler

David

Opening statement before FDA general and plastic surgery devices panel meeting, February 18, 1992.

Informed Consent: The Food and Drug Administration Perspective

Abstract

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References