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).]
