Agnew, Bruce. "NIH Will Tighten Controls on Human Research," The Journal of NIH


Agnew, Bruce. "NIH Will Tighten Controls on Human Research," The Journal of NIH
Research, 3 (September 1991), pp. 54-55.

NIH's Office for Protection from Research Risks (OPRR) has the ultimate authority to examine
virtually all biomedical research in this country. Its change is to make certain that human subjects
are not unnecessarily placed at risk. The office may best be described as a IRB at the highest
level of government.

OPRR has charged that there have been subjects placed at risk in French studies of AIDS in
Africa and that American scientists participated in that research. Bernadine Healy considers the
charges "of grave concern." She has ordered an immediate audit of all intramural and extramural
research. It would appear that this specific research is one that "falls between the cracks" in that
American researchers felt that they were not REALLY involved with the treatment of individual
patients and, therefore, they were not subject to the rules.

Gallo's laboratory and other major facilities at NIH have been accused by OPRR of conducting
research without looking after the protection of subjects. That same office suggests that its rules
may be variously interpreted by "scientists" in the conduct of their research. The standards
should be more clearly spelled out. Scientists are upset. As one put it, "The result of all this is
going to be to dramatically increase research on E. coli." (p. 55) Big Names scientists still tend to
regard subjects as a bunch of S's.