Human subjects research.

Abstract

In the ScienceScope item “Broader oversight for research on humans?” (31 Jan., p. 605) it is stated that for “Army scientists doing classified studies … following the Common Rule is voluntary.” On the contrary, it is mandatory for the Army and all other Department of Defense researchers to follow the regulations set forth in the Common Rule “which requires that researchers obtain approval for human experiments from an institutional review board, fully inform test subjects about the risks, and obtain subjects' written consent.” As a federal agency and as part of the Department of Defense, the Army is (i) one of the 16 agencies to work for adoption of the Common Rule, and (ii) one of the agencies that adopted the Common Rule in 1991. Title 32, Code of Federal Regulations , Part 219, is the Common Rule for the Department of Defense. All Army and Department of Defense biomedical human subject research, whether classified or nonclassified, intramural or extramural, is subject to the Common Rule. The Army and Department of Defense are also subject to the Food and Drug Administration's oversight of investigational medical product research and use involving humans. While it is correct that “ `there is no law saying that all research involving human subjects must have informed consent,' “ the implication cannot be made that informed consent is therefore not required or obtained. In the mid-1970s, both the National Institutes of Health and the Army instituted major changes in regulations governing the oversight of human subject research. The changes, including requirements for informed consent, are enforced, and they continue to be strengthened and clarified in response to concerns of the scientific and lay community.