Medical testing: Issues and ethics

Forum for Applied Research and Public Policy

Volumn 12, Issue 3, 1997, Pages 90-101

  Mossman, Kenneth L ^a  

^a ARIZONA STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; COLD WAR; DEPARTMENT OF DEFENSE; ETHICS; FINANCIAL MANAGEMENT; GOVERNMENT; GOVERNMENT REGULATION; HISTORY; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MORALITY; NUREMBERG CODE; POLICY; RADIATION; RESEARCH SUBJECT; RISK ASSESSMENT; SCIENTIFIC MISCONDUCT; SOLDIER; STANDARD; UNITED STATES; VULNERABLE POPULATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; COLD WAR; DEPARTMENT OF DEFENSE; NUREMBERG CODE;

ADVISORY COMMITTEES; DISCLOSURE; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; HISTORY, 20TH CENTURY; HUMANS; INFORMED CONSENT; MILITARY PERSONNEL; NONTHERAPEUTIC HUMAN EXPERIMENTATION; PUBLIC POLICY; RADIATION; RESEARCH SUBJECTS; RESEARCH SUPPORT; RETROSPECTIVE MORAL JUDGMENT; RISK ASSESSMENT; SCIENTIFIC MISCONDUCT; UNITED STATES; VULNERABLE POPULATIONS;

EID: 0142025015     PISSN: 08878218     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. The author would like to thank Nancy M.P. King of the University of North Carolina School of Medicine for her helpful comments during the preparation of this manuscript.
2. Those injected with plutonium included: one patient at the Manhattan Engineering District Hospital in Oak Ridge, Tennessee; 11 patients at Strong Memorial Hospital in Rochester, New York; three patients at Billings Hospital of the University of Chicago; and three patients at the University Hospital of the University of California in San Francisco. Excreta were collected from patients and sent to Los Alamos National Laboratory in New Mexico for analysis.
3. Exposure of the U.S. Population from Diagnostic Medical Radiation (Bethesda, MD: National Council on Radiation Protection and Measurements, Report No. 100, 1989).
4. Advisory Committee on Human Radiation Experiments Final Report (Washington, DC: U.S. Government Printing Office [GPO], No. 061-000-00-848-9).
5. For a summary of human radiation experiments supported by the U.S. government, see Interim Report of the Advisory Committee on Human Radiation Experiments (Washington, DC: DOE, Advisory Committee on Human Radiation Experiments, 1994) and Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records (Springfield, VA: National Technical Information Service, DOE/EH-0445, 1995). For examples of tracer studies see J. Bronner et al., "Studies in Calcium Metabolism: Effect of Food Phytates on Calcium-45 Uptake in Children on Low-Calcium Breakfasts," Journal of Nutrition 54 (December 1954), pp. 523-542; K. Rodahl and G. Bang, Thyroid Activity in Men Exposed to Cold (Ladd Air Force Base, AK: U.S. Air Force Arctic Aeromedical Laboratory, Tech. Report 57-36, 1957).
6. For a summary of human radiation experiments supported by the U.S. government, see Interim Report of the Advisory Committee on Human Radiation Experiments (Washington, DC: DOE, Advisory Committee on Human Radiation Experiments, 1994) and Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records (Springfield, VA: National Technical Information Service, DOE/EH-0445, 1995). For examples of tracer studies see J. Bronner et al., "Studies in Calcium Metabolism: Effect of Food Phytates on Calcium-45 Uptake in Children on Low-Calcium Breakfasts," Journal of Nutrition 54 (December 1954), pp. 523-542; K. Rodahl and G. Bang, Thyroid Activity in Men Exposed to Cold (Ladd Air Force Base, AK: U.S. Air Force Arctic Aeromedical Laboratory, Tech. Report 57-36, 1957).
7. For a summary of human radiation experiments supported by the U.S. government, see Interim Report of the Advisory Committee on Human Radiation Experiments (Washington, DC: DOE, Advisory Committee on Human Radiation Experiments, 1994) and Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records (Springfield, VA: National Technical Information Service, DOE/EH-0445, 1995). For examples of tracer studies see J. Bronner et al., "Studies in Calcium Metabolism: Effect of Food Phytates on Calcium-45 Uptake in Children on Low-Calcium Breakfasts," Journal of Nutrition 54 (December 1954), pp. 523-542; K. Rodahl and G. Bang, Thyroid Activity in Men Exposed to Cold (Ladd Air Force Base, AK: U.S. Air Force Arctic Aeromedical Laboratory, Tech. Report 57-36, 1957).
8. For a summary of human radiation experiments supported by the U.S. government, see Interim Report of the Advisory Committee on Human Radiation Experiments (Washington, DC: DOE, Advisory Committee on Human Radiation Experiments, 1994) and Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records (Springfield, VA: National Technical Information Service, DOE/EH-0445, 1995). For examples of tracer studies see J. Bronner et al., "Studies in Calcium Metabolism: Effect of Food Phytates on Calcium-45 Uptake in Children on Low-Calcium Breakfasts," Journal of Nutrition 54 (December 1954), pp. 523-542; K. Rodahl and G. Bang, Thyroid Activity in Men Exposed to Cold (Ladd Air Force Base, AK: U.S. Air Force Arctic Aeromedical Laboratory, Tech. Report 57-36, 1957).
9. See W.H. Langham et al., "Distribution and Excretion of Plutonium Administered Intravenously to Man," Health Physics 38 (June 1980), pp. 1031-1060 (republished from the earlier Los Alamos Scientific Laboratory Report LA-1151).
10. See M. Rowley et al., "Effect of Graded Doses of Ionizing Radiation on the Human Testis," Radiation Research 59 (September 1974), pp. 665-678.
11. See K.M. Bowman et al., "Thyroid Function in Mental Disease Measured with Radioactive Iodine 1-13," The American Journal of Psychiatry 106 (February 1950), pp. 561-572, for an example of a medical diagnostic experiment.
12. See W.B. Looney et al., "A Clinical Investigation of the Chronic Effects of Radium Salts Administered Therapeutically," American Journal of Roentgenology, Radium Therapy, and Nuclear Medicine 73 (June 1955), pp. 1006-1037; J.H. Lawrence et al., "Chronic Myelogenous Leukemia," Journal of the American Medical Association 136 (March 1948), pp. 672-677.
13. See W.B. Looney et al., "A Clinical Investigation of the Chronic Effects of Radium Salts Administered Therapeutically," American Journal of Roentgenology, Radium Therapy, and Nuclear Medicine 73 (June 1955), pp. 1006-1037; J.H. Lawrence et al., "Chronic Myelogenous Leukemia," Journal of the American Medical Association 136 (March 1948), pp. 672-677.
14. Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records (Springfield, VA: NTIS, DOE/EH-0445, 1995).
15. Argonne National Laboratory Memorandum (December 21, 1972), as quoted in Inspection Report (Washington, DC; AEC, Report No. 44-2-326, August 16, 1974).
16. Memorandum from N.F. Barr to A.W. Trivelpiece, director, Office of Energy Research, DOE, June 30, 1982.
17. K. Rodahl and G. Bang, Thyroid Activity in Men Exposed to Cold (Ladd Air Force Base, AK: Air Force Arctic Aeromedical Laboratory Tech. Report 57-36, 1957).
18. See Anchorage Daily News, May 10, 1995. The claim filed by the North Slope Borough contends that 79 Inupiaq villagers were given doses of iodine-131 without their consent or knowledge. The claim further states that the research was unethical and placed the subjects at risk. North Slope residents have worried about the rising cancer rates that have been detected in their communities over the past 30 years.
19. J. Bronner et al., "Studies in Calcium Metabolism: Effect of Food Phytates on Calcium-45 Uptake in Children on Low-Calcium Breakfasts," Journal of Nutrition 54 (December 1954), pp. 523-542.
20. The Advisory Committee on Human Radiation Experiments came before Congress on 10 occasions between January and May 1994. However, this was not the first time Congress explored the subject. In fact, congressional hearings examining radiation and human research date back to 1957.
21. Trials of War Criminals Before the Nuremberg Military Tribunals (Washington, DC: GPO, vols. I and II, 1948). The full code contains 10 principles.
22. See Department of Health and Human Services, "Protection of Human Subjects," Code of Federal Regulations 45, Part 46 (June 18, 1991).
23. Protection of human subjects in research settings was first codified in U.S. federal regulation in 1974 (Code of Federal Regulations 45, Part 46, 1974). The foundation for these regulations was the Nuremberg Code (United States v. Karl Brandt et al., August 19, 1947; see Trials of War Criminals Before the Nuremberg Military Tribunals [The Medical Case], pp. 181-182, Military Tribunal I, 1947) and the Declaration of Helsinki, issued by The World Medical Association (WMA) in 1964; WMA, "Human Experimentation: Code of Ethics of the World Medical Association, Declaration of Helsinki," British Medical Journal 2 [1964], p. 177. U.S. federal regulations also are based on the Belmont Report by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human subjects of Research," Federal Register 44 (April 1979), pp. 23192-23197. The Belmont Report extends the ethical foundations as established in the Nuremberg Code and the Declaration of Helsinki to require that research designs reflect an equitable selection of subjects and equitable distribution of research benefits and risks. The federal Common Rule was published in June 1991 and governs all federal regulations for protection of human subjects in research projects taking place under the auspices of any federal department or agency. See Department of Health and Human Services, "Part 46-Protection of Human Subjects," Code of Federal Regulations 45 (June 18, 1991).
24. Protection of human subjects in research settings was first codified in U.S. federal regulation in 1974 (Code of Federal Regulations 45, Part 46, 1974). The foundation for these regulations was the Nuremberg Code (United States v. Karl Brandt et al., August 19, 1947; see Trials of War Criminals Before the Nuremberg Military Tribunals [The Medical Case], pp. 181-182, Military Tribunal I, 1947) and the Declaration of Helsinki, issued by The World Medical Association (WMA) in 1964; WMA, "Human Experimentation: Code of Ethics of the World Medical Association, Declaration of Helsinki," British Medical Journal 2 [1964], p. 177. U.S. federal regulations also are based on the Belmont Report by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human subjects of Research," Federal Register 44 (April 1979), pp. 23192-23197. The Belmont Report extends the ethical foundations as established in the Nuremberg Code and the Declaration of Helsinki to require that research designs reflect an equitable selection of subjects and equitable distribution of research benefits and risks. The federal Common Rule was published in June 1991 and governs all federal regulations for protection of human subjects in research projects taking place under the auspices of any federal department or agency. See Department of Health and Human Services, "Part 46-Protection of Human Subjects," Code of Federal Regulations 45 (June 18, 1991).
25. Protection of human subjects in research settings was first codified in U.S. federal regulation in 1974 (Code of Federal Regulations 45, Part 46, 1974). The foundation for these regulations was the Nuremberg Code (United States v. Karl Brandt et al., August 19, 1947; see Trials of War Criminals Before the Nuremberg Military Tribunals [The Medical Case], pp. 181-182, Military Tribunal I, 1947) and the Declaration of Helsinki, issued by The World Medical Association (WMA) in 1964; WMA, "Human Experimentation: Code of Ethics of the World Medical Association, Declaration of Helsinki," British Medical Journal 2 [1964], p. 177. U.S. federal regulations also are based on the Belmont Report by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human subjects of Research," Federal Register 44 (April 1979), pp. 23192-23197. The Belmont Report extends the ethical foundations as established in the Nuremberg Code and the Declaration of Helsinki to require that research designs reflect an equitable selection of subjects and equitable distribution of research benefits and risks. The federal Common Rule was published in June 1991 and governs all federal regulations for protection of human subjects in research projects taking place under the auspices of any federal department or agency. See Department of Health and Human Services, "Part 46-Protection of Human Subjects," Code of Federal Regulations 45 (June 18, 1991).
26. Protection of human subjects in research settings was first codified in U.S. federal regulation in 1974 (Code of Federal Regulations 45, Part 46, 1974). The foundation for these regulations was the Nuremberg Code (United States v. Karl Brandt et al., August 19, 1947; see Trials of War Criminals Before the Nuremberg Military Tribunals [The Medical Case], pp. 181-182, Military Tribunal I, 1947) and the Declaration of Helsinki, issued by The World Medical Association (WMA) in 1964; WMA, "Human Experimentation: Code of Ethics of the World Medical Association, Declaration of Helsinki," British Medical Journal 2 [1964], p. 177. U.S. federal regulations also are based on the Belmont Report by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human subjects of Research," Federal Register 44 (April 1979), pp. 23192-23197. The Belmont Report extends the ethical foundations as established in the Nuremberg Code and the Declaration of Helsinki to require that research designs reflect an equitable selection of subjects and equitable distribution of research benefits and risks. The federal Common Rule was published in June 1991 and governs all federal regulations for protection of human subjects in research projects taking place under the auspices of any federal department or agency. See Department of Health and Human Services, "Part 46-Protection of Human Subjects," Code of Federal Regulations 45 (June 18, 1991).
27. Protection of human subjects in research settings was first codified in U.S. federal regulation in 1974 (Code of Federal Regulations 45, Part 46, 1974). The foundation for these regulations was the Nuremberg Code (United States v. Karl Brandt et al., August 19, 1947; see Trials of War Criminals Before the Nuremberg Military Tribunals [The Medical Case], pp. 181-182, Military Tribunal I, 1947) and the Declaration of Helsinki, issued by The World Medical Association (WMA) in 1964; WMA, "Human Experimentation: Code of Ethics of the World Medical Association, Declaration of Helsinki," British Medical Journal 2 [1964], p. 177. U.S. federal regulations also are based on the Belmont Report by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human subjects of Research," Federal Register 44 (April 1979), pp. 23192-23197. The Belmont Report extends the ethical foundations as established in the Nuremberg Code and the Declaration of Helsinki to require that research designs reflect an equitable selection of subjects and equitable distribution of research benefits and risks. The federal Common Rule was published in June 1991 and governs all federal regulations for protection of human subjects in research projects taking place under the auspices of any federal department or agency. See Department of Health and Human Services, "Part 46-Protection of Human Subjects," Code of Federal Regulations 45 (June 18, 1991).
28. K.L. Mossman, "The Human Radiation Experiments: The Real Issues," Health Physics 68 (June 1995), pp. 757-760.
29. Department of Health and Human Services, "Protection of Human Subjects," Code of Federal Regulations 45, Part 46 (June 18, 1991).
30. A.M. Capron, "Informed Consent in Catastrophic Disease Research and Treatment," University of Pennsylvania Law Review 123 (December 1974), pp. 340-437, and H. Schuck, "Rethinking Informed Consent," The Yale Law Journal 103 (January 1994), pp. 899-959.
31. A.M. Capron, "Informed Consent in Catastrophic Disease Research and Treatment," University of Pennsylvania Law Review 123 (December 1974), pp. 340-437, and H. Schuck, "Rethinking Informed Consent," The Yale Law Journal 103 (January 1994), pp. 899-959.
32. The federal Common Rule (Department of Health and Human Services, Federal Policy for the Protection of Human Subjects, Code of Federal Regulations 45 [June 18, 1991], Part 46) requires that additional safeguards be included in any research involving subjects likely to be open to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Department of Health and Human Services regulations contain specific provisions for research involving fetuses, pregnant women, prisoners, and children (Code of Federal Regulations 45, Part 46, Subparts B, C, and D). In addition, the Department of Health and Human Services's Office for Protection from Research Risks publishes a guidebook, Protecting Human Research Subjects, that discusses issues of concern for all these groups and others - including the cognitively impaired, elderly, terminally ill, students, and employees.
33. The federal Common Rule (Department of Health and Human Services, Federal Policy for the Protection of Human Subjects, Code of Federal Regulations 45 [June 18, 1991], Part 46) requires that additional safeguards be included in any research involving subjects likely to be open to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Department of Health and Human Services regulations contain specific provisions for research involving fetuses, pregnant women, prisoners, and children (Code of Federal Regulations 45, Part 46, Subparts B, C, and D). In addition, the Department of Health and Human Services's Office for Protection from Research Risks publishes a guidebook, Protecting Human Research Subjects, that discusses issues of concern for all these groups and others - including the cognitively impaired, elderly, terminally ill, students, and employees.
34. The federal Common Rule (Department of Health and Human Services, Federal Policy for the Protection of Human Subjects, Code of Federal Regulations 45 [June 18, 1991], Part 46) requires that additional safeguards be included in any research involving subjects likely to be open to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Department of Health and Human Services regulations contain specific provisions for research involving fetuses, pregnant women, prisoners, and children (Code of Federal Regulations 45, Part 46, Subparts B, C, and D). In addition, the Department of Health and Human Services's Office for Protection from Research Risks publishes a guidebook, Protecting Human Research Subjects, that discusses issues of concern for all these groups and others - including the cognitively impaired, elderly, terminally ill, students, and employees.
35. P.F. Hahn et al., "Iron Metabolism in Human Pregnancy as Studied with the Radioactive Isotope Fe59," American Journal of Obstetrics and Gynecology 61 (March 1953), pp. 477-486; M.J. Rowley et al., "Effect of Graded Doses of Ionizing Radiation on the Human Testis," Radiation Research 59 (September 1974), pp. 665-678; F. Bronner et al., "Studies in Calcium Metabolism: The Fate of Intravenously Injected Radiocalcium in Human Beings," Journal of Clinical Investigation 35 (January 1956), pp. 78-88.
36. P.F. Hahn et al., "Iron Metabolism in Human Pregnancy as Studied with the Radioactive Isotope Fe59," American Journal of Obstetrics and Gynecology 61 (March 1953), pp. 477-486; M.J. Rowley et al., "Effect of Graded Doses of Ionizing Radiation on the Human Testis," Radiation Research 59 (September 1974), pp. 665-678; F. Bronner et al., "Studies in Calcium Metabolism: The Fate of Intravenously Injected Radiocalcium in Human Beings," Journal of Clinical Investigation 35 (January 1956), pp. 78-88.
37. P.F. Hahn et al., "Iron Metabolism in Human Pregnancy as Studied with the Radioactive Isotope Fe59," American Journal of Obstetrics and Gynecology 61 (March 1953), pp. 477-486; M.J. Rowley et al., "Effect of Graded Doses of Ionizing Radiation on the Human Testis," Radiation Research 59 (September 1974), pp. 665-678; F. Bronner et al., "Studies in Calcium Metabolism: The Fate of Intravenously Injected Radiocalcium in Human Beings," Journal of Clinical Investigation 35 (January 1956), pp. 78-88.
38. Code of Federal Regulations 45, Part 46 (June 18, 1991).