U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled (...) persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that arenot, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions. (shrink)

In what is clearly an important development related to research integrity and the protection of human research subjects, the U.S. government has instituted two new training requirements as a condition of receiving federal financial support. First, the National Institutes of Health is requiring, as a condition of funding, that key research personnel involved in human subject research complete education “in the protection of human subjects.” Evidence that key personnel have completed this training must be provided in NIH grant applications or (...) contract proposals.The NIH education policy will eventually be superseded by a more broadly applicable instructional policy for the “responsible conduct of research,” which will be promulgated by the Department of Health and Human Service's Office of Research Integrity and the Public Health Service. The instructional policy will apply to all persons engaged in any research or research training with PHS support. Presently, the only version of the policy is in draft form. (shrink)