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HHS REGULATIONS ON PROTECTING HUMAN SUBJECTS

The Department of Health and Human Services has promulgated regulations for the protection of human research subjects, enforced through the creation of institutional review boards (IRBs) at each participating institution. They apply to all research done by covered institutions or individuals, including research done outside the United States. The regulations stipulate the composition and duties of an IRB, establish standards for informed consent, provide for sanctions against institutions and individuals who violate the regulations, and require more intensive scrutiny of research involving fetuses, in vitro fertilization, pregnant women, prisoners, and children. These regulations do not supersede other state and federal laws; they create additional duties for persons involved in research involving human subjects.

Researchers who run afoul of these regulations can lose their current research funding, can become ineligible for future funding, and can be forced to repay funds improperly expended. In practical terms, a researcher who is disciplined under the regulations will be at a disadvantage for future funds from HHS and other government agencies. Researchers in competitive areas may find it impossible to continue their careers as principal investigators. For this reason, it is imperative that every person contemplating research involving human subjects have a basic understanding of the HHS regulations.

In this chapter, the regulations have been edited and paraphrased for easier reading. This abridged presentation is intended to help researchers understand when they must submit their research design to an IRB and the general constraints of the IRB process. The general provisions of these regulations probably will be constant; nevertheless, their details are subject to change. Any physician engaged in covered research should consult with the appropriate IRB for current regulations.

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