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.
With certain delineated exceptions, the HHS regulations apply to all research conducted with HHS funds, both inside and outside the United States. All institutions receiving HHS funding in any area must have an ethical policy governing all human research conducted at that institution, regardless of the source of funding. Many institutions have also assured HHS that all research in the institution, irrespective of HHS funding, will be reviewed and conducted pursuant to the HHS regulations. These regulations require investigators supervising cooperative research projects to ensure that all other participants abide by the HHS regulations:
Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. [45 C.F.R. § 46.114 (1998).]