(The body of the report, which had to be finished on a short, 6-month timetable, was 22 pages in length, excluding the summary.)

In addition to sometimes critical reports on the system for protecting human participants in research, the system has also come under public scrutiny and criticism after the deaths of several research participants. For example, a story in the New York Times about the death of Ellen Roche, a healthy volunteer at Johns Hopkins University, reported that information about the research “sketch[ed] a picture of an experiment that went amiss” (Altman, 2001, p. A16). The story also described the difficulties in obtaining information about the circumstances surrounding the death. The September 1999 death of Jesse Gelsinger in a gene therapy trial likewise prompted many critical stories (see, e.g., Halim, 2000 and Stolberg, 1999).

As noted above, federal officials have temporarily suspended or restricted federally funded or regulated research at several major academic institutions (see Exhibit 3.1 of NBAC, 2001b, pp. 54–56). Although some criticized these actions as being too extreme, they dramatically underscored a new commitment by officials to identify and correct deficiencies in the protection of human participants in research and recognized this protection as “an absolutely critical foundation” of research involving humans (Koski, 2001, p. 1). Federal officials have also undertaken a number of more positive actions to improve the protection of human participants in research, as discussed below.


The committee that prepared the IOM report Responsible Research (IOM, 2003a) found that government data on compliance with policies on protection of human research participants were very limited. The present committee found that data specific to clinical research involving children were even more limited. Most of what follows describes the government’s compliance monitoring and enforcement activities in general. OHRP was able to provide some data on compliance problems related to clinical research involving children, but FDA could not.

As described in Chapter 1, both DHHS and FDA have reorganized their human research protection programs following the above-cited criticisms of the oversight of human research protections and the widely publicized instances of questionable or deficient research conduct. In June 2000, the Office for Protection from Research Risks became the more explicitly named Office for Human Research Protections (OHRP), and DHHS moved the unit from the National Institutes of Health (NIH) to the Office of the Secretary of DHHS (DHHS, 2000). In March 2001, the FDA established the Good Clinical Practices Program within the Office of Science and Health

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