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Article
February 5, 1997

Protecting Human Subjects of Biomedical Research

JAMA. 1997;277(5):369. doi:10.1001/jama.1997.03540290021009

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Abstract

CONGRESS and the White House are weighing tighter measures to protect human subjects of biomedical research. At issue is adherence to the so-called common rule.

The common rule is the core of the regulations governing research on human subjects; essentially, it requires that agencies engaged in such research set up committees to review research proposals for possible risk or harm (JAMA. 1996;276:1627). The common rule sets out the requirements for informed consent and institutional review board oversight. It has been adopted by 17 federal departments and agencies that conduct or sponsor biomedical and behavioral research on humans.

Addressing a meeting of the National Bioethics Advisory Commission, Chris Kline, a staff member of the US Senate Committee on Governmental Affairs, said the committee is preparing legislation that would require all government agencies to adhere to the common rule. The legislation would stipulate criminal sanctions for violations. The White House is preparing

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