Remedies for Human Subjects of Cold War Research: Recommendations of the Advisory Committee

Journal of Law, Medicine and Ethics

Volumn 24, Issue 2, 1996, Pages 118-126

  Mastroianni, Anna ^a   Kahn, Jeffrey ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS; ARTICLE; ATOMIC ENERGY COMMISSION; BIOMEDICAL AND BEHAVIORAL RESEARCH; CIVIL RIGHTS; COLD WAR; COMPENSATION; DEPARTMENT OF DEFENSE; GOVERNMENT; HUMAN; HUMAN EXPERIMENT; HUMAN RIGHTS; LEGAL ASPECT; MEDICAL ETHICS; PATIENT SELECTION; POLITICS; RADIATION INJURY; RESEARCH SUBJECT; SOCIAL BEHAVIOR; TWENTIETH CENTURY; UNITED STATES;

ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS; ATOMIC ENERGY COMMISSION; BIOMEDICAL AND BEHAVIORAL RESEARCH; COLD WAR; DEPARTMENT OF DEFENSE; TWENTIETH CENTURY;

ADVISORY COMMITTEES; CIVIL RIGHTS; COMPENSATION AND REDRESS; ETHICS, MEDICAL; FEDERAL GOVERNMENT; GOVERNMENT AGENCIES; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; NONTHERAPEUTIC HUMAN EXPERIMENTATION; PATIENT SELECTION; POLITICS; RADIATION INJURIES; RESEARCH SUBJECTS; SOCIAL RESPONSIBILITY; UNITED STATES;

EID: 0030157651     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1996.tb01844.x     Document Type: Article

References (36)

1. The Advisory Committee members were: Ruth Faden, Ph.D., M.P.H., Chair; Kenneth Feinberg, J.D.; Eli Glatstein, M.D.; Jay Katz, M.D.; Patricia King, J.D.; Susan Lederer, Ph.D.; Ruth Macklin, Ph.D.; Lois Norris; Nancy Oleinick, Ph.D.; Henry Royal, M.D.; Philip Russell, M.D.; Mary Ann Stevenson, M.D., Ph.D.; Duncan Thomas, Ph.D.; and Reed Tuckson, M.D. The staff effort was directed by the team of: Daniel Guttman, J.D., Executive Director; Jeffrey Kahn, Ph.D., M.P.H., Associate Director; and Anna Mastroianni, J.D., Associate Director.
2. Advisory Committee on Human Radiation Experiments, Exec. Order No. 12,891, 59 Fed. Reg. 2935 (1994).
3. Advisory Committee on Human Radiation Experiments, Final Report (Washington, D.C.: U.S. Government Printing Office, 1995): at 5-6.
4. The focus on research that offered no or disputed potential benefit was not intended to imply that a conclusion can be drawn that all research offering the prospect of medical benefit was ethically performed during this time. Id. at 772.
5. From 1945 through 1947, Manhattan Project researchers injected eighteen human subjects with plutonium, five with polonium, and six with uranium. Another set of experiments took place between 1953 and 1957, in which eleven subjects were injected with uranium. Id. at 264, 268.
6. The great majority the approximately 4,000 experiments in the Advisory Committee's database were tracer experiments, and little information is known about most of them. The Committee's analysis focused on the government's policies for distribution of radioisotopes and protecting subjects from risk. Id. at 229.
7. The Advisory Committee analyzed twenty-one "non-therapeutic" radiation experiments with children conducted between 1944 and 1974. These twenty-one were selected from eighty-one pediatric radiation experiments identified by the Committee from government documents and in the medical literature. The eighty-one did not constitute all the pediatric radiation research conducted during the time, although the Committee believed them to be fairly typical examples of such research. Of the eighty-one, thirty-seven were judged to be "nontherapeutic," and twenty-one of these were conducted or funded by the federal government and so fell under the charge of the Committee. Id. at 321.
8. The Advisory Committee's consideration of total body irradiation began by looking at a 1967 National Academy of Sciences "retrospective study" of total body irradiation exposures, which collected records on more than 2,000 exposures from forty-five U.S. and Canadian institutions. The Committee then focused on approximately twenty research studies published between 1940 and 1974 on the use of total body irradiation in the United States. Id. at 368.
9. In a series of experiments carried out between 1963 and 1973, 131 prisoners in Oregon and Washington submitted to experimental testicular irradiations. The experiments had national security and other societal goals, but no potential for therapeutic benefit for the subjects. Id. at 421.
10. Id. at 786-88.
11. Id.
12. Id. at 805.
13. Pub. Law No. 103-150, 107 Stat. 1510 (1993).
14. Civil Liberties Act of 1988, Pub. Law No. 100-383, 102 Stat. 903 (1988).
15. Radiation Exposure Compensation Act, Pub. Law No. 101-426, 104 Stat. 920 (1990).
16. These awards included $750,000 authorized by Congress in 1976 to be paid to the family of Frank Olson because he died as a result of CIA-sponsored LSD experiment; $703,000 authorized by court order in 1987 to be paid to the family of Harold Blauer because he died as a result of his part in a secret U.S. Army experiment involving mescaline; and $750,000 authorized by court order in 1988 to be paid to nine Canadians for their participation in nonfatal CIA-sponsored brainwashing experiments.
17. See J.H. Jones, Bad Blood (New York: Free Press, 2nd ed., 1993): at 217, 277 citing to U.S. District Court in Alabama, "Stipulation of Settlement," Charles W. Pollard, et al. v. United States of America, et al., No. 4126-N.
18. See J.H. Jones, Bad Blood (New York: Free Press, 2nd ed., 1993): at 217, 277 citing to U.S. District Court in Alabama, "Stipulation of Settlement," Charles W. Pollard, et al. v. United States of America, et al., No. 4126-N.
19. This is Recommendation 3 in the Final Report. See Advisory Committee, supra note 3, at 805-07. Recommendations are renamed here for clarity.
20. Id. at 805.
21. The Advisory Committee intentionally settled on a "personal and individualized" apology after exploring three options: (1) a general public apology; (2) a personalized form letter apology; and (3) a personal and individualized apology written specifically to address that person's experiences.
22. Some who became residents of the Fernald School were not diagnosed as mentally retarded but were labeled as such by virtue of having resided there.
23. This is Recommendation 2 in the Final Report. See Advisory Committee, supra note 3, at 803-05.
24. Id. at 803.
25. Id. at 785-86.
26. Id. at 803.
27. This is Recommendation 1 in the Final Report. See id. at 801-02.
28. Id. at 801.
29. Id. at 802.
30. Advisory Committee on Human Radiation Experiments, The Human Radiation Experiments (New York: Oxford University Press, 1996): at xviii-xix.
31. The hearing was chaired by Senator Ted Stevens (R-AK) on March 12, 1996. Human Radiation Experiments: Hearing of the Senate Governmental Affairs Committee, 104th Cong., 2d Sess. (1996).
32. See, for example, In re Cincinnati Radiation Litigation, 874 F. Supp. 796 (S.D. Ohio 1995) (total body irradiation experiments on cancer patients); Mousso v. University of Rochester, No. 95-CV-6288T (W.D.N.Y. filed June 16, 1995) (plutonium injection experiments); Heinrich v. Sweet, No. CV95-3845 (E.D.N.Y. filed Sept. 21, 1995) (uranium injection experiments on hospitalized patients); Bibeau v. Pacific Northwest Research Foundation, No. 95-006410-HO (D. Or. filed Dec. 4, 1995) (testicular irradiation experiments on prisoners); and Shattuck v. Massachusetts Institute of Technology, No. 95-12605GAO (D. Mass. filed Dec. 18, 1995) (radioisotope experiments on institutionalized children).
33. In August 1996, it was reported that the parties in a 1994 class action lawsuit, concerning total body irradiation experiments, had reached a $4.25 million settlement. This action was brought by the families of the University of Cincinnati radiation experiment subjects against the University of Cincinnati, the City of Cincinnati, federal project officers, and fifteen individual defendants, including physicians and researchers. The settlement is subject to approval by the court. Associated Press, "Lawyers Gather Support for Settlement in Radiation Testing," Columbia Dispatch, Aug. 30, 1996, at 7B. Also in August 1996, it was reported that some of the defendants had agreed to a settlement in the case of experiments involving radioactive tracers in over 800 pregnant women at Vanderbilt University. Monsanto Company, who allegedly shipped the radioactive iron, and the federal government reportedly agreed to a $100,000 settlement. C. Trevison, "Radiation Settlement Sought; Would Allow Payments by Monsanto, Federal Government," The Tennessean, Aug. 10, 1996, at 4B. Two other defendants, the Tennessee Department of Health and the Nutrition Foundation in Washington, earlier reportedly paid $100,000 and $125,000 to settle claims against them. C. Miller, "40s VU Test Didn't Explain Risk: Attorneys," Nashville Banner, July 2, 1996, at B2. No settlement has been reached with Vanderbilt University, its medical center, or the Rockefeller Foundation. See Trevison, id. at 4B.
34. To augment the lessons learned through its findings, the Advisory Committee also undertook three research projects on the state of contemporary human subjects research. These projects, their findings, and the Committee's recommendations that grew out of them can be found in the Final Report. Advisory Committee, supra note 3, at chs. 14-18. Discussion of these projects can be found in N. Kass and J. Sugarman, "Are Research Subjects Adequately Protected? A Review and Discussion of Information Gathered by the Advisory Committee on Human Radiation Experiments," Kennedy Institute of Ethics Journal, 6 (1996): 271-82.
35. To augment the lessons learned through its findings, the Advisory Committee also undertook three research projects on the state of contemporary human subjects research. These projects, their findings, and the Committee's recommendations that grew out of them can be found in the Final Report. Advisory Committee, supra note 3, at chs. 14-18. Discussion of these projects can be found in N. Kass and J. Sugarman, "Are Research Subjects Adequately Protected? A Review and Discussion of Information Gathered by the Advisory Committee on Human Radiation Experiments," Kennedy Institute of Ethics Journal, 6 (1996): 271-82.
36. Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission, Exec. Order No. 12,975, 60 Fed. Reg. 52,063 (1995). Priority items for consideration by the National Bioethics Advisory Commission (NBAC) are human subjects protection and genetic information. NBAC has a two-year term, subject to extension, and will operate in full public view under the Federal Advisory Committee Act. Although it will report to the National Science Technology Council, a body that advises the Office of Science and Technology Policy, it will be administered through DHHS. Appointment of fifteen of the eighteen members of NBAC was announced on July 19, 1996.