* Asbestos School Hazard Detection Act of 1980 (ASHDC), 20 U.S.C. p. 3601-3611 (1982).

Asbestos Hazard Emergency Response Act of 1986 (AHERA), Pub. L. No. 99-519, p. 211, 100 Stat. 2970 (to be codified at 15 U.S.C. p. 2641).

Civil Service Reform Act of 1978 (CSRA), Pub. L. No. 96-454, 92 Stat. 1111 (codified as amended in scattered sections of 5 U.S.C.).

Department of Defense Amendments of 1984, 10 U.S.C. p. 1587 (Supp. III 1985).

• Exec. Order 12196, 45 Fed. Reg. 1279 (1980).

Source: U.S. Congress. Senate. Uniform Health and Safety Whistleblowers Protection Act. Hearings on S. 2095, 100th Cong., 2d Sess., July 26, 1988. Washington, U.S. Govt.

Asbestos Hazard Emergency Response Act of 1986. AHERA, Pub. L. No. 99-519. Sec. 211, 100 Stat. 2970 (to be codified at 15 U.S.C., Sec. 2641). Clean Air Act (CAA), 42 U.S.C., Sec. 7622, 1982. Comprehensive Environmental Response.

CERCLA, 42, U.S.C., Sec. 9601, 1982.

Compensation and Liability Act of 1980.

Department of Defense Authorization Act of 1987. Publ. L. No. 99-661, Sec. 942, 100 Stat. 3816. (to be eodified at 10 U.S.C., Sec. 2409)

i

Energy Reorganization Act of 1974. ERA, 42 U.S.C., Sec. 5851, 1982.

Federal Mine Safety and Health Act of 1977. FMSHA, 30 U.S.C., Sec. 215, 1982.

Federal Railroad Safety Authorization Act of 1980. FRSAA, 45 U.S.C., Sec. 421, 1982.

International Safe Containers Act. ISCA, 46 U.S.C., Sec. 1501, 1982.

Labor Management Relations Act. LMRA, 29 U.S.C., Sec. 141, 1982.

Migrant Seasonal and Agricultural Worker Protection Act. MSAWPA, 29 U.S.C., Sec. 1855,

1982.

National Labor Relations Act. NLRA, 29 U.S.C., Seca. 151-169, 1982 and Supp. III 1985. 1 Williams-Steiger Occupational Safety and Health Act of 1970. OSHA, 29 U.S.C., Sec. 651,

1982.

Safety Drinking Water Act. SDWA, 42 U.S.C., Sec. 300, 1982.

Surface Mining Control Reclamation Act of 1977. SMCRS, 30 U.S.C., Sec. 1293, 1982. Surface Transportation Assistance Act of 1982. STAA, 49 U.S.C., Sec. 2305, Supp. III 1985. Solid Waste Disposal Act, SWDA, 42 U.S.C., Sec. 6971, 1982.

Toxic Substances Control Act. TSCA, 15 U.S.C., Sec. 2601, 1982.

'Federal Water Polution Control Act of 1972. FHWPCA, 22 U.S.C., Sec. 1251, 1982.

SOURCE: U.S. Congress. Senate. Uniform Health and Safety Whistlers Protection Act. Hearings on S.2095. 100th Cong., 2d Sess., July 26, 1988. Washington, U.S. Govt. Print. Off., 1988. p. 121.

*The limitation periods refer to the time for filing a complaint with the investigative agency, rather than for seeking judicial review.

CRS-35

An institution's handling of investigations can certainly be improved with experience. But experience is a function of both time and opportunity. If the incidence of cases of misconduct is as rare as most scientists believe, then a university's opportunity to develop the expertise needed to handle scientific misconduct investigations effectively, fairly, and in a timely manner is also rare. Hence, based on economies of scale, it may be a more efficient use of human resources to centralize the responsibility for investigations in a central office like the Office of Scientific Integrity.

DHHS has established two offices, an Office of Scientific Integrity, located in NIH, and an Office of Scientific Review, located in DHHS. The former will monitor and, when necessary, conduct PHS investigations. In addition, it will make recommendations regarding the allegations to the Assistant Secretary for Health (ASH). The latter office will adjudicate cases. Specifically, it will review investigations to ensure that documentations sufficiently support recommendations and recommend to the ASH sanctions as appropriate, among other things. The justification for organizationally separating the two functions is the principle of due process. The one who judges a case should be unbiased, and thereby make decisions only on relevant facts. One who investigates a case might not be able to make an unbiased decision because in the process of investigating the case, he can uncover facts which are not germane to the issue at hand. In principle, the mere knowledge of irrelevant facts can unduly cloud one's judgment. However, since the OSIR only reviews and makes recommendations about sanctions, some may question the necessity of its independent existence. Indeed, critics of this arrangement view it as bureaucratic overkill; they recommend the establishment of a single office, with an Advisory Council to include scientists attached to it and located in either DHHS or the Inspector General's Office at DHHS. This office would, among other things, perform both the investigative and adjudicative functions.

Some critics of university-sponsored investigations suggest that another justification for the creation of a central, Federal office of investigations is the academic science community's unwillingness to investigate allegations of scientific misconduct. Others argue that although the community may have been unwilling to do investigations in the past, sound policy should be based on a current assessment of this factor. During the last year or two, various parties within the scientific community have addressed the issue of scientific misconduct. Most of this activity has occurred as a result of congressional pressure. Still, the science community does appear to be more willing than it did in the past to address the issue. The Congress may wish to continue exercising oversight to help insure the adoption and implementation of

APPENDIX 3

association of american
medical colleges

The Maintenance Of High Ethical Standards In The Conduct Of Research

Suite 200, One Dupont Circle, N.W., Washington, D.C. 20036

23-941 0-90-16

AAMC Ad Hoc Committee on the
Maintenance of High Ethical Standards

in the Conduct of Research

JULIUS R. KREVANS, M.D., Chairman, Dean, University of California, San Francisco, School of Medicine

JAMES W. BARTLETT, M.D., Medical Director and Associate Dean for Clinical Affairs, University of Rochester, School of Medicine and Dentistry

STUART BONDURANT, M.D., Dean, University of North Carolina at Chapel Hill School of Medicine

DAVID BROWN, M.D., Professor, Department of Laboratory Medicine/Pathology/Pediatrics, University of Minnesota Medical School

NATHAN HERSHEY, Professor of Health Law, University of Pittsburgh, Graduate School of Public Health

ROBERT HILL, Ph.D., Chairman, Department of Biochemistry, Duke University Medical Center

HAROLD HINES, President, Ryan Insurance Group

ARNOLD S. RELMAN, M.D., Editor, New England Journal of Medicine

JEFFREY SKLAR, M.D., Ph.D., Assistant Professor of Pathology, Department of Pathology, Stanford University School of Medicine

LEROY WALTERS, Ph.D., Director, Center for Bioethics, Kennedy Institute, Georgetown University