A proposal for the effective international regulation of biomedical research involving human subjects

Stanford Journal of International Law

Volumn 34, Issue 1, 1998, Pages 163-205

  King, Kevin M ^a,b  

^a STANFORD LAW SCHOOL   (United States)

^b AMERICAN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES; HUMAN; HUMAN EXPERIMENT; HUMAN RIGHTS; INFORMED CONSENT; INTERNATIONAL COOPERATION; INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS; LEGAL APPROACH; LEGAL ASPECT; MEDICAL ETHICS; NUREMBERG CODE; PERSUASIVE COMMUNICATION; PRACTICE GUIDELINE; RESEARCH SUBJECT; STANDARD; VULNERABLE POPULATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES; INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS; LEGAL APPROACH; NUREMBERG CODE;

COERCION; GUIDELINES; HELSINKI DECLARATION; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; INFORMED CONSENT; INTERNATIONALITY; RESEARCH SUBJECTS; VULNERABLE POPULATIONS;

EID: 0032377206     PISSN: 07315082     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (211)

1. See United States v. Stanley, 483 U.S. 669, 671 (1987).
2. LSD is a hallucinogenic drug, the immediate effects of which include increased heart rate and blood pressure, changes in blood sugar level that may produce adrenaline-like stimulation, and hallucinogenic effects such as delusions, dreamlike fantasies and light phenomena. In chronic toxicity, LSD may produce serious after-effects, including relapses of hallucinogenic states and personality changes likened to "mental derangement" See FRANZ GERGEL & D.R.A. DAVIES, ALL ABOUT DRUGS 136 (1970); see also SIDNEY COHEN, DRUGS OF HALLUCINATION 211-12 (1965); AMERICAN PSYCHIATRIC ASSOCIATION, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (4th ed. 1994) (describing various hallucinogen-induced disorders).
3. LSD is a hallucinogenic drug, the immediate effects of which include increased heart rate and blood pressure, changes in blood sugar level that may produce adrenaline-like stimulation, and hallucinogenic effects such as delusions, dreamlike fantasies and light phenomena. In chronic toxicity, LSD may produce serious after-effects, including relapses of hallucinogenic states and personality changes likened to "mental derangement" See FRANZ GERGEL & D.R.A. DAVIES, ALL ABOUT DRUGS 136 (1970); see also SIDNEY COHEN, DRUGS OF HALLUCINATION 211-12 (1965); AMERICAN PSYCHIATRIC ASSOCIATION, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (4th ed. 1994) (describing various hallucinogen-induced disorders).
4. LSD is a hallucinogenic drug, the immediate effects of which include increased heart rate and blood pressure, changes in blood sugar level that may produce adrenaline-like stimulation, and hallucinogenic effects such as delusions, dreamlike fantasies and light phenomena. In chronic toxicity, LSD may produce serious after-effects, including relapses of hallucinogenic states and personality changes likened to "mental derangement" See FRANZ GERGEL & D.R.A. DAVIES, ALL ABOUT DRUGS 136 (1970); see also SIDNEY COHEN, DRUGS OF HALLUCINATION 211-12 (1965); AMERICAN PSYCHIATRIC ASSOCIATION, DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (4th ed. 1994) (describing various hallucinogen-induced disorders).
5. The intelligence community believed that it was necessary 'to conceal these activities from the American public in general,' because public knowledge of the 'unethical and illicit activities would have serious repercussions in political and diplomatic circles and would be detrimental to the accomplishment of its mission.'" Stanley, 483 U.S. at 688 n.4 (J. Brennan, dissenting) (citations omitted) (quoting a 1957 survey of the Technical Services Division by the CIA Inspector General).
6. Id. at 671.
7. See id.
8. See GERGEL & DAVIES, supra note 2, at 136.
9. Stanley's original suit, filed under the Federal Tort Claims Act (FTCA), alleged negligence in the administration, supervision, and subsequent monitoring of the drug testing program. See Stanley, 483 U.S. at 672. The district court, finding that Stanley was on active duty and participating in an Army program at all times when he was exposed to LSD, held that his claim was barred by the doctrine articulated in Feres v. United States, 340 U.S. 131 (1950). In Feres, the Supreme Court held that the government is not liable under the FTCA for injuries to servicemen arising incident to their military service. The Court of Appeals for the Fifth Circuit agreed with the district court that the Feres doctrine barred Stanley's FTCA claims, but held that the lower court should have dismissed for lack of jurisdiction rather than disposing of the case on the merits. See Stanley v. CIA, 639 F.2d 1146 (5th Cir. 1981). The court of appeals noted that Stanley's situation may give rise to constitutional claims under Bivens v. Six Unknown Federal Narcotics Agents, 403 U.S. 388 (1971), and remanded for consideration of any amendment the appellant might make. (Bivens stands for the proposition that violations of constitutional rights by federal officers can give rise to an action for damages even in the absence of a statute authorizing relief.) Stanley subsequently amended his complaint to add claims against unknown federal officers for violation of constitutional rights and alleged that the government's failure to warn or treat him after his discharge from the military constituted a separate tort which was not barred by Feres. The district court dismissed the FTCA claim, finding that the alleged negligence was not "separate and distinct from any acts occurring before discharge, so as to give rise to a separate actionable tort," Stanley v. United States, 549 F. Supp. 327, 329 (S.D. Fla. 1982). It refused, however, to dismiss the Bivens claims. The court of appeals affirmed the lower court's decision not to dismiss Stanley's Bivens claims and reinstated Stanley's FTCA claims, pointing to recent precedent that might have made the FTCA claims viable. The U.S. Supreme Court granted certiorari because of a split of authority among the circuits and because the court of appeals' decision to reinstate the FTCA claims seemed at odds with judicial practice. See Stanley, 483 U.S. at 676.
10. The Supreme Court was unanimous in holding improper the court of appeals' decision to reinstate Stanley's FTCA claims. With respect to the determination of Stanley's Bivens claims, the Court was more closely divided. The majority, however, believing uninvited intrusion into military affairs is inappropriate, held that Bivens claims should be disallowed whenever the injury arises out of activity "incident to service." Stanley, 483 U.S. at 683.
11. Justice Brennan, in a dissenting opinion joined by Justices Marshall and Stevens, noted: [I]t is important to place the Government's conduct in historical context The medical trials at Nuremberg in 1947 deeply impressed upon the world that experimentation with unknowing human subjects is morally and legally unacceptable. The United States Military Tribunal established the Nuremberg Code as a standard against which to judge German scientists who experimented with human subjects. Id. at 687 (Brennan, J., dissenting). In a separate dissent, Justice O'Connor noted: [T] he United States military played an instrumental role in the criminal prosecution of Nazi officials who experimented with human subjects during the Second World War ... and the standards that the Nuremberg Military Tribunals developed to judge the behavior of the defendants stated that the 'voluntary consent of the human subject is absolutely essential... to satisfy moral, ethical and legal concepts.' ... If this principle is violated the very least that society can do is to see that the victims are compensated, as best they can be, by the perpetrators. I am prepared to say that our Constitution's promise of due process of law guarantees this much. Id. at 710 (O'Connor, J., dissenting) (citation omitted). Despite the reverence with which they referred to the Nuremberg Code, neither dissent cited the Code as binding authority, nor did they cite to the human rights and humanitarian law conventions prohibiting human experimentation.
12. See generally HENRY K. BEECHER, RESEARCH AND THE INDIVIDUAL: HUMAN STUDIES 5-17 (1970); MAURICE H. PAPPWORTH, HUMAN GUINEA PIGS (1967) (recounting historical examples of human experimentation).
13. See generally HENRY K. BEECHER, RESEARCH AND THE INDIVIDUAL: HUMAN STUDIES 5-17 (1970); MAURICE H. PAPPWORTH, HUMAN GUINEA PIGS (1967) (recounting historical examples of human experimentation).
14. See infra notes 19-27 and accompanying text
15. The continued existence of abusive experimental practices since World War II is troubling. A brief list of examples conveys both the magnitude and the horrifying nature of the problem: • On December 21, 1990, the U.S. Food and Drug Administration (FDA) published a regulation permitting the Commissioner [of the FDA] to determine that the requirement for obtaining informed consent from all human subjects prior to use of an experimental drug or vaccine could be waived for Desert Shield participants when it was not feasible in "Certain battlefield or combat-related" situations. The Regulations noted that "combat-related" might mean only the threat of combat. George J. Annas & Michael A. Grodin, Introduction, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 5 (George J. Annas & Michael A. Grodin eds., 1992) [hereinafter THE NAZI DOCTORS]. • The October 18, 1990 issue of NATURE reported a World Health Organization investigation of claims that an untried AIDS treatment was being administered to children in Bucharest, Romania, in violation of international research ethics. See Steven Dickman & Peter Aldhous, WHO Concern Over New Drug, 347 NATURE 606, 606 (1990). • Newly unearthed secret documents revealed in 1991 that East Germany had for more than a decade been using "men, women, and children as human guinea pigs in a state-sponsored research program intended to perfect steroid hormone drugs." Steven Dickman, East Germany: Science in the Disservice of the State, 254 SCIENCE 26, 26 (1991). • From 1932 through 1972, 399 African Americans diagnosed with syphilis went untreated so that researchers could study the effects of the disease on humans. See JAMES H. JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT 1 (1981). • During the 1960s, twenty-two patients at the Jewish Chronic Disease Hospital were injected with human cancer cells without consenting to the procedure. See NATHAN HERSHEY & ROBERT D. MILLER, HUMAN EXPERIMENTATION AND THE LAW 6 (1976). • Between 1945 and 1963, an estimated 250,000 military personnel were exposed to large doses of radiation to determine the effectiveness of combat troops on a nuclear battlefield. See Jaffee v. United States, 663 F.2d. 1226 (3d Cir. 1981).
16. The continued existence of abusive experimental practices since World War II is troubling. A brief list of examples conveys both the magnitude and the horrifying nature of the problem: • On December 21, 1990, the U.S. Food and Drug Administration (FDA) published a regulation permitting the Commissioner [of the FDA] to determine that the requirement for obtaining informed consent from all human subjects prior to use of an experimental drug or vaccine could be waived for Desert Shield participants when it was not feasible in "Certain battlefield or combat-related" situations. The Regulations noted that "combat-related" might mean only the threat of combat. George J. Annas & Michael A. Grodin, Introduction, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 5 (George J. Annas & Michael A. Grodin eds., 1992) [hereinafter THE NAZI DOCTORS]. • The October 18, 1990 issue of NATURE reported a World Health Organization investigation of claims that an untried AIDS treatment was being administered to children in Bucharest, Romania, in violation of international research ethics. See Steven Dickman & Peter Aldhous, WHO Concern Over New Drug, 347 NATURE 606, 606 (1990). • Newly unearthed secret documents revealed in 1991 that East Germany had for more than a decade been using "men, women, and children as human guinea pigs in a state-sponsored research program intended to perfect steroid hormone drugs." Steven Dickman, East Germany: Science in the Disservice of the State, 254 SCIENCE 26, 26 (1991). • From 1932 through 1972, 399 African Americans diagnosed with syphilis went untreated so that researchers could study the effects of the disease on humans. See JAMES H. JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT 1 (1981). • During the 1960s, twenty-two patients at the Jewish Chronic Disease Hospital were injected with human cancer cells without consenting to the procedure. See NATHAN HERSHEY & ROBERT D. MILLER, HUMAN EXPERIMENTATION AND THE LAW 6 (1976). • Between 1945 and 1963, an estimated 250,000 military personnel were exposed to large doses of radiation to determine the effectiveness of combat troops on a nuclear battlefield. See Jaffee v. United States, 663 F.2d. 1226 (3d Cir. 1981).
17. The continued existence of abusive experimental practices since World War II is troubling. A brief list of examples conveys both the magnitude and the horrifying nature of the problem: • On December 21, 1990, the U.S. Food and Drug Administration (FDA) published a regulation permitting the Commissioner [of the FDA] to determine that the requirement for obtaining informed consent from all human subjects prior to use of an experimental drug or vaccine could be waived for Desert Shield participants when it was not feasible in "Certain battlefield or combat-related" situations. The Regulations noted that "combat-related" might mean only the threat of combat. George J. Annas & Michael A. Grodin, Introduction, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 5 (George J. Annas & Michael A. Grodin eds., 1992) [hereinafter THE NAZI DOCTORS]. • The October 18, 1990 issue of NATURE reported a World Health Organization investigation of claims that an untried AIDS treatment was being administered to children in Bucharest, Romania, in violation of international research ethics. See Steven Dickman & Peter Aldhous, WHO Concern Over New Drug, 347 NATURE 606, 606 (1990). • Newly unearthed secret documents revealed in 1991 that East Germany had for more than a decade been using "men, women, and children as human guinea pigs in a state-sponsored research program intended to perfect steroid hormone drugs." Steven Dickman, East Germany: Science in the Disservice of the State, 254 SCIENCE 26, 26 (1991). • From 1932 through 1972, 399 African Americans diagnosed with syphilis went untreated so that researchers could study the effects of the disease on humans. See JAMES H. JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT 1 (1981). • During the 1960s, twenty-two patients at the Jewish Chronic Disease Hospital were injected with human cancer cells without consenting to the procedure. See NATHAN HERSHEY & ROBERT D. MILLER, HUMAN EXPERIMENTATION AND THE LAW 6 (1976). • Between 1945 and 1963, an estimated 250,000 military personnel were exposed to large doses of radiation to determine the effectiveness of combat troops on a nuclear battlefield. See Jaffee v. United States, 663 F.2d. 1226 (3d Cir. 1981).
18. The continued existence of abusive experimental practices since World War II is troubling. A brief list of examples conveys both the magnitude and the horrifying nature of the problem: • On December 21, 1990, the U.S. Food and Drug Administration (FDA) published a regulation permitting the Commissioner [of the FDA] to determine that the requirement for obtaining informed consent from all human subjects prior to use of an experimental drug or vaccine could be waived for Desert Shield participants when it was not feasible in "Certain battlefield or combat-related" situations. The Regulations noted that "combat-related" might mean only the threat of combat. George J. Annas & Michael A. Grodin, Introduction, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 5 (George J. Annas & Michael A. Grodin eds., 1992) [hereinafter THE NAZI DOCTORS]. • The October 18, 1990 issue of NATURE reported a World Health Organization investigation of claims that an untried AIDS treatment was being administered to children in Bucharest, Romania, in violation of international research ethics. See Steven Dickman & Peter Aldhous, WHO Concern Over New Drug, 347 NATURE 606, 606 (1990). • Newly unearthed secret documents revealed in 1991 that East Germany had for more than a decade been using "men, women, and children as human guinea pigs in a state-sponsored research program intended to perfect steroid hormone drugs." Steven Dickman, East Germany: Science in the Disservice of the State, 254 SCIENCE 26, 26 (1991). • From 1932 through 1972, 399 African Americans diagnosed with syphilis went untreated so that researchers could study the effects of the disease on humans. See JAMES H. JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT 1 (1981). • During the 1960s, twenty-two patients at the Jewish Chronic Disease Hospital were injected with human cancer cells without consenting to the procedure. See NATHAN HERSHEY & ROBERT D. MILLER, HUMAN EXPERIMENTATION AND THE LAW 6 (1976). • Between 1945 and 1963, an estimated 250,000 military personnel were exposed to large doses of radiation to determine the effectiveness of combat troops on a nuclear battlefield. See Jaffee v. United States, 663 F.2d. 1226 (3d Cir. 1981).
19. The continued existence of abusive experimental practices since World War II is troubling. A brief list of examples conveys both the magnitude and the horrifying nature of the problem: • On December 21, 1990, the U.S. Food and Drug Administration (FDA) published a regulation permitting the Commissioner [of the FDA] to determine that the requirement for obtaining informed consent from all human subjects prior to use of an experimental drug or vaccine could be waived for Desert Shield participants when it was not feasible in "Certain battlefield or combat-related" situations. The Regulations noted that "combat-related" might mean only the threat of combat. George J. Annas & Michael A. Grodin, Introduction, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 5 (George J. Annas & Michael A. Grodin eds., 1992) [hereinafter THE NAZI DOCTORS]. • The October 18, 1990 issue of NATURE reported a World Health Organization investigation of claims that an untried AIDS treatment was being administered to children in Bucharest, Romania, in violation of international research ethics. See Steven Dickman & Peter Aldhous, WHO Concern Over New Drug, 347 NATURE 606, 606 (1990). • Newly unearthed secret documents revealed in 1991 that East Germany had for more than a decade been using "men, women, and children as human guinea pigs in a state-sponsored research program intended to perfect steroid hormone drugs." Steven Dickman, East Germany: Science in the Disservice of the State, 254 SCIENCE 26, 26 (1991). • From 1932 through 1972, 399 African Americans diagnosed with syphilis went untreated so that researchers could study the effects of the disease on humans. See JAMES H. JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT 1 (1981). • During the 1960s, twenty-two patients at the Jewish Chronic Disease Hospital were injected with human cancer cells without consenting to the procedure. See NATHAN HERSHEY & ROBERT D. MILLER, HUMAN EXPERIMENTATION AND THE LAW 6 (1976). • Between 1945 and 1963, an estimated 250,000 military personnel were exposed to large doses of radiation to determine the effectiveness of combat troops on a nuclear battlefield. See Jaffee v. United States, 663 F.2d. 1226 (3d Cir. 1981).
20. See generally LAW REFORM COMM'N OF CANADA, BIOMEDICAL EXPERIMENTATION INVOLVING HUMAN SUBJECTS, WORKING PAPER No. 61 (1989) [hereinafter BIOMEDICAL EXPERIMENTATION] .
21. See M. Cheriff Bassiouni et al., An Appraisal of Human Experimentation in International Law and Practice: The Need for International Regulation of Human Experimentation, 72 J. CRIM. L. & CRIMINOLOGY 1597, 1598 (1981) (noting that "the influence of human experimentation permeates not only medicine and other biological sciences but also behavioral, sociological, political, economic, and military endeavors").
22. See Robert Mulford, Note, Experimentation on Human Beings, 20 STAN. L. REV. 99, 100 (1967).
23. See generally BEECHER, supra note 10, at 6-7.
24. See generally RICHARD CARTER, BREAKTHROUGH: THE SAGA OF JONAS SALK (1966).
25. See Bassiouni et al., supra note 14, at 1602; see also BIOMEDICAL EXPERIMENTATION, supra note 13, at 1.
26. Before World War II, experimentation on humans was regulated at the national level, if at all. For example, in the United States human experimentation was governed by malpractice law. At that time, the physician's role was almost exclusively therapeutic; there was little blurring of pure research and the treatment of patients. Today, the situation is fundamentally different. The doctor may now also be a researcher and the patient a subject See HERSHEY & MILLER, supra note 12, at 2-3.
27. See Christian Pross, Nazi Doctors, German Medicine, and the Historical Truth, in THE NAZI DOCTORS, supra note 12, at 32, 32-47.
28. See id. at 36-37 ("The abundant availability of human guinea pigs among people labeled as 'inferior' or 'subhuman' was exploited by doctors as a unique opportunity for scientific research.").
29. During the war, the Nazis conducted human-based experiments in a variety of areas including hypothermia, dehydration, high altitude, tests of biowarfare agents, the physiological effects of famine, methods of sterilization and castration, experimental vaccines, limb and bone transplants, and various diseases including hepatitis, malaria, and spotted fever. See United States v. Brandt, Two Trials of War Criminals Before the Nuremberg Military Tribunal Under Control Council Law No. 10, at 181 (1949).
30. See Robert N. Proctor, Nazi Doctors, Racial Medicine, and Human Experimentation, in THE NAZI DOCTORS, supra note 12, at 17, 26.
31. For more detailed descriptions of individual defendants and their alleged crimes, see Indictment in the case of United States v. Brandt, reprinted in Alexander Mitscherlich & Fred Mielke, Judgment and Aftermath, in THE NAZI DOCTORS, supra note 12, at 63-65, 95-101.
32. See id. at 181. The opening statement of the trial, delivered by Brigadier General Telford Taylor, Chief of Counsel for the prosecution, outlined the nature of the charges against the defendants: The defendants in this case are charged with murders, tortures, and other atrocities committed in the name of medical science. The victims of these crimes are numbered in the hundreds of thousands. A handful only are still alive; a few of the survivors will appear in this courtroom. But most of these miserable victims were slaughtered outright or died during the course of tortures to which they were subjected. For the most part they are nameless dead. To their murderers, these wretched people were not individuals at all. They came in wholesale lots and were treated worse than animals. .... ... The defendants in the dock are charged with murder, but this is no mere murder trial. We cannot rest content when we have shown that crimes were committed and that certain persons committed them. To kill, to maim, and to torture is criminal under all modern systems of law. These defendants did not kill in hot blood, nor for personal enrichment Some of them may be sadists, who killed and tortured for sport, but they are not all perverts. They are not ignorant men. Most of them are trained physicians and some of them are distinguished scientists. Yet these defendants, all of whom were fully able to comprehend the nature of their acts, and most of whom were exceptionally qualified to form a moral and professional judgment in this respect, are responsible for wholesale murder and unspeakably cruel tortures. Telford Taylor, Opening Statement of the Prosecution, December 9, 1946, reprinted in THE NAZI DOCTORS, supra note 12, at 67, 67-68.
33. Not only were the judges American, the prosecutors and the procedural rules followed were also American. Moreover, the case was brought under the authority of the military governor of the American Zone. See George J. Annas, The Nuremberg Code in U.S. Courts: Ethics Versus Expediency, in THE NAZI DOCTORS, supranote 12, at 201, 201.
34. For details on individual sentences and commutations, see Alexander Mitscherlich & Fred Mielke, Epilogue: Seven Were Hanged, in THE NAZI DOCTORS, supra note 12, at 105, 105-07.
35. See generally The Nuremberg Code, reprinted in THE NAZI DOCTORS, supra note 12, at 2.
36. Norman Howard-Jones, Human Experimentation in Historical and Ethical Perspectives, 16 SOC. SCI. & MED. 1429, 1436 (1982) . Ironically, the Code's only legal precursor was a German circular issued in 1931 entitled Regulations on New Therapy and Human Experimentation. This German document contained almost all of the points subsequently cited in the Nuremberg Code including the ethical standards of medicine, informed consent, and risk-benefit analysis. See Michael A. Grodin, Historical Origins of the Nuremberg Code, in THE NAZI DOCTORS, supra note 12, at 121, 129-32.
37. Norman Howard-Jones, Human Experimentation in Historical and Ethical Perspectives, 16 SOC. SCI. & MED. 1429, 1436 (1982) . Ironically, the Code's only legal precursor was a German circular issued in 1931 entitled Regulations on New Therapy and Human Experimentation. This German document contained almost all of the points subsequently cited in the Nuremberg Code including the ethical standards of medicine, informed consent, and risk-benefit analysis. See Michael A. Grodin, Historical Origins of the Nuremberg Code, in THE NAZI DOCTORS, supra note 12, at 121, 129-32.
38. See Annas & Grodin, supra note 12, at 3 ("[A]II contemporary debate on human experimentation is grounded in Nuremberg....").
39. Article 1 of the Code expressly provides that the "voluntary consent of the human subject is absolutely essential." The Nuremberg Code, supra note 28, art 1. Consent is the focus point for many questions concerning the ethical and legal characteristics of human experimentation. In drafting this provision, the tribunal was concerned with fraud and coercion. The voluntary consent contemplated by the tribunal entailed more than an unwitting willingness to participate in the study. Article 1 requires the individuals responsible for the experiment to inform the test subject of the purpose and general nature of the experiment, as well as of any risks to the health or well-being of the subject stemming from the subject's participation in the study. See id. art 1. Moreover, consent is revocable. Article 9 allows the test subject to withdraw her consent at any stage in the experiment See id. art 9.
40. In addition to obtaining the informed consent of the test subject, the Code requires researchers to adhere to minimum procedural standards in the design and implementation of any study involving human subjects. Specifically, the Code requires that the experiment be conducted by qualified individuals and be designed and conducted to minimize the research subject's pain and suffering. See id. arts. 4, 8. It also requires human experimentation to be preceded by animal testing and based on a sound understanding of the problem to be tested. See id. art. 3.
41. See id. art. 10 (requiring that the researcher terminate the experiment if there is "probable cause" to believe that the experiment will result in injury, disability or death). It should be noted that, in light of the extensive U.S. influence over the trial at Nuremberg, the probable cause contemplated by the tribunal almost certainly refers to a preponderance of the evidence.
42. Article 6 of the Code requires scientists to weigh the risks posed to the research subject against the likely benefits to society. See id. art 6.
43. Despite the extensive American influence over the proceedings, the Code does not constitute binding authority over U.S. courts as evidenced by the Code's treatment in the Stanley case. See United States v. Stanley, 483 U.S. 669, 685, 687 (1987).
44. See Convention for the Amelioration of the Condition of the Wounded and Sick in Armies in the Field, Aug. 22, 1864, reprinted in DIETRICH SCHINIDLER & JIRI TOMAN, THE LAWS OF ARMED CONFLICT 63 (3d ed. 1988).
45. See Geneva Convention of 1906 for the Amelioration of the Condition of the Wounded and Sick in Armies in the Field, July 6, 1906, 35 Stat 1885, 202 Consol. T.S. 144.
46. See Geneva Convention for the Amelioration of the Condition of the Wounded and Sick in Armies in the Field, July 27, 1929, 47 Stat. 2074, 118 L.N.T.S. 303.
47. See Geneva Convention for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field, Aug. 12, 1949, 6 U.S.T. 3114, 75 U.N.T.S. 31 [hereinafter First Geneva Convention]; Geneva Convention for the Amelioration of the Condition of the Wounded, Sick and Shipwrecked Members of Armed Forces at Sea, Aug. 12, 1949, 6 U.S.T. 3217, 75 U.N.T.S. 85 [hereinafter Second Geneva Convention]; Geneva Convention Relative to the Treatment of Prisoners of War, Aug. 12, 1949, 6 U.S.T. 3316, 75 U.N.T.S. 135 [hereinafter Third Geneva Convention]; Geneva Convention Relative to the Protection of Chilian Persons in Times of War, Aug. 12, 1949, 6 U.S.T. 3516, 75 U.N.T.S. 287 [hereinafter Fourth Geneva Convention].
48. See Geneva Convention for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field, Aug. 12, 1949, 6 U.S.T. 3114, 75 U.N.T.S. 31 [hereinafter First Geneva Convention]; Geneva Convention for the Amelioration of the Condition of the Wounded, Sick and Shipwrecked Members of Armed Forces at Sea, Aug. 12, 1949, 6 U.S.T. 3217, 75 U.N.T.S. 85 [hereinafter Second Geneva Convention]; Geneva Convention Relative to the Treatment of Prisoners of War, Aug. 12, 1949, 6 U.S.T. 3316, 75 U.N.T.S. 135 [hereinafter Third Geneva Convention]; Geneva Convention Relative to the Protection of Chilian Persons in Times of War, Aug. 12, 1949, 6 U.S.T. 3516, 75 U.N.T.S. 287 [hereinafter Fourth Geneva Convention].
49. See Geneva Convention for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field, Aug. 12, 1949, 6 U.S.T. 3114, 75 U.N.T.S. 31 [hereinafter First Geneva Convention]; Geneva Convention for the Amelioration of the Condition of the Wounded, Sick and Shipwrecked Members of Armed Forces at Sea, Aug. 12, 1949, 6 U.S.T. 3217, 75 U.N.T.S. 85 [hereinafter Second Geneva Convention]; Geneva Convention Relative to the Treatment of Prisoners of War, Aug. 12, 1949, 6 U.S.T. 3316, 75 U.N.T.S. 135 [hereinafter Third Geneva Convention]; Geneva Convention Relative to the Protection of Chilian Persons in Times of War, Aug. 12, 1949, 6 U.S.T. 3516, 75 U.N.T.S. 287 [hereinafter Fourth Geneva Convention].
50. See Geneva Convention for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field, Aug. 12, 1949, 6 U.S.T. 3114, 75 U.N.T.S. 31 [hereinafter First Geneva Convention]; Geneva Convention for the Amelioration of the Condition of the Wounded, Sick and Shipwrecked Members of Armed Forces at Sea, Aug. 12, 1949, 6 U.S.T. 3217, 75 U.N.T.S. 85 [hereinafter Second Geneva Convention]; Geneva Convention Relative to the Treatment of Prisoners of War, Aug. 12, 1949, 6 U.S.T. 3316, 75 U.N.T.S. 135 [hereinafter Third Geneva Convention]; Geneva Convention Relative to the Protection of Chilian Persons in Times of War, Aug. 12, 1949, 6 U.S.T. 3516, 75 U.N.T.S. 287 [hereinafter Fourth Geneva Convention].
51. See Bassiouni et al., supra note 14, at 1659 (noting that the purpose in drafting the Conventions was "to establish a humanitarian law of armed conflict which aims at protection of noncombatant military personnel and Civilians who do not participate in the hostilities").
52. See Sharon Perley et al., The Nuremberg Code: An International Overview, in THE NAZI DOCTORS, supra note 12, at 149, 153.
53. First Geneva Convention, supra note 39, art. 12 (emphasis added); see also Second Geneva Convention, supra note 39, art. 12.
54. First Geneva Convention, supra note 39, art. 12 (emphasis added); see also Second Geneva Convention, supra note 39, art. 12.
55. Third Geneva Convention, supra note 39, art. 13.
56. Fourth Geneva Convention, supra note 39, art. 32.
57. 3 JEAN DE PREUX, COMMENTARY: GENEVA CONVENTION RELATIVE TO THE TREATMENT OF PRISONERS OF WAR 141 (Jean S. Pictet ed. & A.P. de Heney trans., 1960).
58. Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of International Armed Conflicts, June 8, 1977, 1125 U.N.T.S. 3, 16 I.L.M. 1391 [hereinafter Protocol 1]; Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of Non-International Armed Conflicts, June 8, 1977, 1125 U.N.T.S. 609, 16 I.L.M. 1742 [hereinafter Protocol 2].
59. Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of International Armed Conflicts, June 8, 1977, 1125 U.N.T.S. 3, 16 I.L.M. 1391 [hereinafter Protocol 1]; Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of Non-International Armed Conflicts, June 8, 1977, 1125 U.N.T.S. 609, 16 I.L.M. 1742 [hereinafter Protocol 2].
60. See Protocol 1, supra note 46, art 11.
61. CLAUDE PILLOUD ET AL., COMMENTARY ON THE ADDITIONAL PROTOCOLS 150 (Yves Sandoz et al. eds., 1987).
62. Id. at 157.
63. Article 2, common to all four of the Geneva Conventions, provides in part: [T]he present Convention shall apply to all cases of declared war or of any other armed conflict which may arise between two or more of the High Contracting Parties, even if the state of war is not recognized by one of them. The Convention shall also apply to all cases of partial or total occupation of the territory of a High Contracting Party, even if the said occupation meets with no armed resistance. First Geneva Convention, supra note 39, art 2; Second Geneva Convention, supra note 39, art. 2; Third Geneva Convention, supra note 39, art. 2; Fourth Geneva Convention, supra note 39, art. 2.
64. See Military and Paramilitary Activities in and Against Nicaragua (Nicar. v. U.S.), 1986 I.C.J. 14 (June 27) (holding that the rules under. Article 3 common to the Geneva Conventions are applicable to both internal and international armed conflicts). Article 3(1) provides in part [T] he following acts are and shall remain prohibited at any time and in any place whatsoever with respect to [persons taking no active part in the hostilities]: (a) violence to life and person, in particular murder of all kinds, mutilation, cruel treatment or torture. .... (c) outrages upon personal dignity, in particular, humiliating and degrading treatment.... First Geneva Convention, supra note 39, art. 3(1); Second Geneva Convention, supra note 39, art. 3(1); Third Geneva Convention, supra note 39, art. 3(1); Fourth Geneva Convention, supra note 39, art 3(1).
65. See Military and Paramilitary Activities in and Against Nicaragua (Nicar. v. U.S.), 1986 I.C.J. 14 (June 27) (holding that the rules under. Article 3 common to the Geneva Conventions are applicable to both internal and international armed conflicts). Article 3(1) provides in part [T] he following acts are and shall remain prohibited at any time and in any place whatsoever with respect to [persons taking no active part in the hostilities]: (a) violence to life and person, in particular murder of all kinds, mutilation, cruel treatment or torture. .... (c) outrages upon personal dignity, in particular, humiliating and degrading treatment.... First Geneva Convention, supra note 39, art. 3(1); Second Geneva Convention, supra note 39, art. 3(1); Third Geneva Convention, supra note 39, art. 3(1); Fourth Geneva Convention, supra note 39, art 3(1).
66. See Military and Paramilitary Activities in and Against Nicaragua (Nicar. v. U.S.), 1986 I.C.J. 14 (June 27) (holding that the rules under. Article 3 common to the Geneva Conventions are applicable to both internal and international armed conflicts). Article 3(1) provides in part [T] he following acts are and shall remain prohibited at any time and in any place whatsoever with respect to [persons taking no active part in the hostilities]: (a) violence to life and person, in particular murder of all kinds, mutilation, cruel treatment or torture. .... (c) outrages upon personal dignity, in particular, humiliating and degrading treatment.... First Geneva Convention, supra note 39, art. 3(1); Second Geneva Convention, supra note 39, art. 3(1); Third Geneva Convention, supra note 39, art. 3(1); Fourth Geneva Convention, supra note 39, art 3(1).
67. See Military and Paramilitary Activities in and Against Nicaragua (Nicar. v. U.S.), 1986 I.C.J. 14 (June 27) (holding that the rules under. Article 3 common to the Geneva Conventions are applicable to both internal and international armed conflicts). Article 3(1) provides in part [T] he following acts are and shall remain prohibited at any time and in any place whatsoever with respect to [persons taking no active part in the hostilities]: (a) violence to life and person, in particular murder of all kinds, mutilation, cruel treatment or torture. .... (c) outrages upon personal dignity, in particular, humiliating and degrading treatment.... First Geneva Convention, supra note 39, art. 3(1); Second Geneva Convention, supra note 39, art. 3(1); Third Geneva Convention, supra note 39, art. 3(1); Fourth Geneva Convention, supra note 39, art 3(1).
68. See Military and Paramilitary Activities in and Against Nicaragua (Nicar. v. U.S.), 1986 I.C.J. 14 (June 27) (holding that the rules under. Article 3 common to the Geneva Conventions are applicable to both internal and international armed conflicts). Article 3(1) provides in part [T] he following acts are and shall remain prohibited at any time and in any place whatsoever with respect to [persons taking no active part in the hostilities]: (a) violence to life and person, in particular murder of all kinds, mutilation, cruel treatment or torture. .... (c) outrages upon personal dignity, in particular, humiliating and degrading treatment.... First Geneva Convention, supra note 39, art. 3(1); Second Geneva Convention, supra note 39, art. 3(1); Third Geneva Convention, supra note 39, art. 3(1); Fourth Geneva Convention, supra note 39, art 3(1).
69. For further discussion of human experimentation as a form of cruel, inhuman, ordegrading treatment, see infra notes 70-81 and accompanying text.
70. See LOUIS HENKIN, THE RIGHTS OF MAN TODAY 18S (1978).
71. Universal Declaration of Human Rights, GA Res. 217, U.N. GAOR, 3d Sess., U.N. Doc. A/810 (1948).
72. International Covenant on Civil and Political Rights, GA Res. 2200, U.N. GAOR, 21st Sess., Supp. No. 16, U.N. Doc. A/6316 (1966) [hereinafter ICCPR].
73. International Covenant on Economic, Social and Cultural Rights, GA Res. 2200, U.N. GAOR, 21st Sess., Supp. No. 16, U.N. Doc. A/6316 (1966) [hereinafter ICESCR].
74. ICCPR, supra note 55, art. 7. Although the Covenant was not adopted by the U.N. General Assembly until 1966, its origins date back to 1947 and the earliest sessions of the United Nations Commission on Human Rights. The influence of the Nuremberg trial of Nazi doctors on the emerging body of human rights law can be seen even before the conclusion of the proceedings. In June 1947, two months before the tribunal would render its decision, the United Kingdom's Representative to the Drafting Commission of the International Bill of Human Rights proposed that no person shall be subjected to, among other things, "any form of physical mutilation or medical or scientific experimentation against his will." Commission on Human Rights, Drafting Committee, International Bill of Rights, Proposals Submitted by the United Kingdom Representative, Proposal 1 E/CN.4/AC.1/4/Add.1, June 18, 1947; see also Perley et al., supra note 41, at 149, 153 ("[T]hese proposals were submitted on ... two months before the judgment in the Nuremberg trial was issued. However, as the trial commenced on December 8, 1946, one may well assume that representatives from the United Kingdom had heard Ivy's testimony and were greatly influenced by it.") (citations omitted). In addition, in May 1948, just eight months after promulgation of the Nuremberg Code, the French government submitted a Draft Declaration on Human Rights to the U.N. Commission. Article 5 of the Declaration stated: "[I]t shall be unlawful to subject any person to any form of physical mutilation or medical or scientific experimentation against his will." Id.
75. See African Charter on Human and Peoples' Rights, June 27, 1981, art. 5, Org. of African Unity Doc. CAB/LEG/67/3/Rev. 5 (1981), reprinted in 21 I.L.M. 59, 60 (1982) ("Every individual shall have the right to the respect of the dignity inherent in a human being and to the recognition of his legal status. All forms of exploitation and degradation [sic] of man[,] particularly slavery, slave trade, torture, cruel, inhuman or degrading punishment and treatment shall be prohibited.") [hereinafter African Charter]; American Convention on Human Rights, Nov. 22, 1969, art. 5(2), 1144 U.N.T.S. 123, 146 (1978) ("No one shall be subjected to torture or to cruel, inhuman, or degrading punishment or treatment. All persons deprived of their liberty shall be treated with respect for the inherent dignity of the human person.") [hereinafter American Convention]; ICCPR, supra note 55, art 7; European Convention for the Protection of Human Rights and Fundamental Freedoms, Nov. 4, 1950, art. 3, 213 U.N.T.S. 221, 224 (entered into force Sept. 3, 1953) ("No one shall be subjected to torture or to inhuman or degrading treatment or punishment,") [hereinafter European Convention]; Universal Declaration of Human Rights, supra note 54, art. 5 ("No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment."). The American Convention and the African Charter contain general declarations about the inherent dignity of human beings. None of the provisions has been authoritatively interpreted or applied by competent independent international institutions. See PAUL SIEGHART, THE LAWFUL RIGHTS OF MANKIND 100-01 (1985).
76. See African Charter on Human and Peoples' Rights, June 27, 1981, art. 5, Org. of African Unity Doc. CAB/LEG/67/3/Rev. 5 (1981), reprinted in 21 I.L.M. 59, 60 (1982) ("Every individual shall have the right to the respect of the dignity inherent in a human being and to the recognition of his legal status. All forms of exploitation and degradation [sic] of man[,] particularly slavery, slave trade, torture, cruel, inhuman or degrading punishment and treatment shall be prohibited.") [hereinafter African Charter]; American Convention on Human Rights, Nov. 22, 1969, art. 5(2), 1144 U.N.T.S. 123, 146 (1978) ("No one shall be subjected to torture or to cruel, inhuman, or degrading punishment or treatment. All persons deprived of their liberty shall be treated with respect for the inherent dignity of the human person.") [hereinafter American Convention]; ICCPR, supra note 55, art 7; European Convention for the Protection of Human Rights and Fundamental Freedoms, Nov. 4, 1950, art. 3, 213 U.N.T.S. 221, 224 (entered into force Sept. 3, 1953) ("No one shall be subjected to torture or to inhuman or degrading treatment or punishment,") [hereinafter European Convention]; Universal Declaration of Human Rights, supra note 54, art. 5 ("No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment."). The American Convention and the African Charter contain general declarations about the inherent dignity of human beings. None of the provisions has been authoritatively interpreted or applied by competent independent international institutions. See PAUL SIEGHART, THE LAWFUL RIGHTS OF MANKIND 100-01 (1985).
77. See Ian Kennedy, Patients, Doctors, and Human Rights, in HUMAN RIGHTS FOR THE 1990s: LEGAL, POLITICAL AND ETHICAL ISSUES 84 (Robert Blackburn & John Taylor eds., 1991). Not only does the principle of bodily integrity impose constraints on government or state action (i.e., it gives rise to negative rights), but it also provides the foundation for the assertion of positive rights against the government See ICESCR, supra note 56, arts. 10-12.
78. These interests are reflected in the state's parens patriae power (the state's authority to care for those that cannot care for themselves) and its police power (the authority to protect citizens from harm). As a result, the principle of bodily integrity is increasingly implicated in a diverse range of state activities including vaccination and public health programs, family planning and population control programs, law enforcement activities, and the treatment of prisoners.
79. See Kennedy, supra note 59, at 84; see also, e.g., Washington v. Harper, 494 U.S. 210, 236 (1990) (holding that prison officials were within their authority to forcibly medicate a mentally ill inmate); Schmerber v. California, 384 U.S. 757, 758-59 (1966) (holding that evidence obtained via an involuntary blood sample was not obtained unreasonably); Jacobson v. Massachusetts, 197 U.S. 11, 29-30 (1905) (holding that a compulsory vaccination program is necessary for the public health).
80. See LOUIS HENKIN, THE INTERNATIONAL BILL OF RIGHTS: THE COVENANT ON CIVIL AND POLITICAL RIGHTS 18-19 (1981).
81. See African Charter, supra note 58, art 4 ("Human beings are inviolable. Every human being shall be entitled to respect for his life and the integrity of his person. No one may be arbitrarily deprived of this right."); id. art 5 ("Every individual shall have the right to the respect of the dignity inherent in a human being and to the recognition of his legal status. All forms of exploitation and degredation [sic] of man[,] particularly slavery, slave trade, torture, cruel, inhuman or degrading punishment and treatment shall be prohibited."); American Convention, supra note 58, art 5(1) ("[E]very person has the right to have his physical, mental, and moral integrity respected."); ICCPR, supra note 55, art 7; Universal Declaration of Human Rights, supra note 54, art 3 ("[E]veryone has the right to life, liberty and the security of person.").
82. Torture is generally defined as an "aggravated and deliberate form of cruel, inhuman or degrading treatment or punishment" Declaration on the Protection of All Persons from Being Subjected to Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, G.A. Res. 3452, U.N. GAOR, 30th Sess., Supp. No. 34, art 1(2), U.N. Doc. A/10034 (1976) (adopted Dec. 9, 1975) [hereinafter U.N. Declaration on Torture].
83. See African Charter, supra note 58, art 4; American Convention, supra note 58, art 5; ICCPR, supra note 55, art 6; European Convention, supra note 58, art 2; Universal Declaration of Human Rights, supra note 54, art 3; see also SIEGHART, supra note 58, at 109-10.
84. See American Convention, supra note 58, art 4; ICCPR, supra note 55, art 6(2); European Convention, supra note 58, art 2(2); Universal Declaration of Human Rights, supra note 54, art 11; see also SIEGHART, supra note 58, at 109-10. Only the African Charter does not provide an exception for the death penalty or death resulting from the necessary use efforce.
85. See American Convention, supra note 58, art 4; ICCPR, supra note 55, art 6(2); European Convention, supra note 58, art 2(2); Universal Declaration of Human Rights, supra note 54, art 11; see also SIEGHART, supra note 58, at 109-10. Only the African Charter does not provide an exception for the death penalty or death resulting from the necessary use efforce.
86. In Association X v. United Kingdom, No. 7154/75, 14 Eur. Comm'n H.R. Dec. & Rep. 31 (1978), the European Commission on Human Rights determined that the phrase "shall be protected by law" of Article 2 of the European Convention for the Protection of Human Rights and Fundamental Freedoms requires the state to not only refrain from taking life intentionally, but to take affirmative actions to protect life. In Association X, the Commission determined that a state complied with its obligation to protect life under the European Convention if it established a system of control and supervision to limit possible deaths in the context of a voluntary vaccination scheme.
87. See X v. United Kingdom, App. No. 8416/79, 19 Eur. Comm'n H.R. Dec. & Rep. 244 (1980). In this case, the European Commission on Human Rights expressed doubt as to whether the term "everyone" in Article 2(1) of the European Convention included an unborn child. See id. at 249-51. The Commission determined that even if the term applied to a fetus, it would be subject to limitations. See id. at 252-53; see also Case No. 2141 (Baby Boy Case), Inter-Am. C.H.R. 25, OEA/ser. L./V./II.54, doc. 9 rev. 1 (1981) (holding that a decision reversing the conviction of a medical practitioner for terminating a pregnancy does not violate the right to life guarantee of the American Declaration of the Rights and Duties of Man, Chapter 1, Article I).
88. In Munn v. Illinois, 94 U.S. 113 (1877), Justice Field interpreted the expression "deprived of life" to refer to more than just death: By the term "life" as here used [in the Fourteenth Amendment to the U.S. Constitution], something more is meant that mere animal existence. The inhibition against its deprivation extends to all those limbs and faculties by which life is enjoyed. The prohibition equally prohibits the mutilation of the body by the amputation of an arm or. leg, or the putting out of an eye, or the destruction of any other organ of the body through which the soul communicates with the outer world. The deprivation not only of life, but of whatever God has given to every one with life, for its growth and enjoyment, is prohibited by the provision in question, if its efficacy be not frittered away by judicial decision. Id. at 142; see also Simon-Herold v. Austria, App. No. 4340/69, 38 Eur. Comm'n H.R. Dec. & Rep. 18 (1971). In Simon-Herold, the European Commission declared admissible (without determining the merits) a prisoner's complaint that his prison conditions and the negligence of prison officials resulted in, among other things, pneumonia and the paralysis of one arm in violation of his right to life. "See id. at 27.
89. See supra note 58; see also Andrew McEntee, Law and Torture, in A GLIMPSE OF HELL 1, 4 (Duncan Forrest ed., 1996).
90. See McEntee, supra note 70, at 4.
91. See id.
92. See The Greek Case, 1969 Y.B. Eur. Conv. on H.R. (Eur. Comm'n on H.R.).
93. Id. at 186.
94. Id.
95. Id.
96. The U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment defines torture as: any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a confession, punishing him for an act he or a third person has committed or is suspected of having committed, or intimidating or coercing him or a third person, or for any reason based on discrimination of any kind, when such pain or suffering is inflicted by or at the instigation of or with the consent or acquiescence of a public official or other person acting in an official capacity. It does not include pain or suffering arising only from, inherent in or incidental to lawful sanctions. U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Apr. 18, 1988, S. TREATY DOC. No. 100-20 (1986), 23 I.L.M. 1027, 1027, amended in 24 I.L.M. 535 (adopted Dec. 10, 1984) [hereinafter U.N. Convention Against Torture]; see also Inter-American Convention to Prevent and Punish Torture, Dec. 9, 1985, art. 2, AG/RES. 783 (xv-0185), reprinted in 25 I.L.M. 519 ("[T]orture shall be understood to be any act intentionally performed whereby physical or mental pain or suffering is inflicted on a person for purposes of criminal investigation, as a means of intimidation, as a personal punishment, as a preventive measure, as a penalty, or for any other purpose."). The U.N. Declaration on Torture states: [T] orture means any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted by or at the instigation of a public official on a person for such purposes as obtaining from him or a third person information or confession, punishing him for an act he has committed or is suspected of having committed, or intimidating him or other persons. It does not include pain or suffering arising only from, inherent in or incidental to, lawful sanctions to the extent consistent with the Standard Minimum Rules for the Treatment of Prisoners. U.N. Declaration on Torture, supra note 64, art 1(1); see also EDWARD PETERS, TORTURE 1-3 (1985) (drawing a common element from definitions of torture from the third, thirteenth, seventeenth, and twentieth centuries: "torment inflicted by a public authority for ostensibly public purposes"); PAUL SIEGHART, THE INTERNATIONAL LAW OF HUMAN RIGHTS 162 (1983) ("[T]he word 'torture' is often used to describe inhuman treatment which has a purpose ...."); Brent Sorensen & Inge Kemp Genefke, Medical Aspects of Torture, in THE INTERNATIONAL FIGHT AGAINST TORTURE 11, 12 (Antonio Cassese ed., 1991) (identifying the aim of torture as destruction of personality, identity, and soul of a human being).
97. The U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment defines torture as: any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a confession, punishing him for an act he or a third person has committed or is suspected of having committed, or intimidating or coercing him or a third person, or for any reason based on discrimination of any kind, when such pain or suffering is inflicted by or at the instigation of or with the consent or acquiescence of a public official or other person acting in an official capacity. It does not include pain or suffering arising only from, inherent in or incidental to lawful sanctions. U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Apr. 18, 1988, S. TREATY DOC. No. 100-20 (1986), 23 I.L.M. 1027, 1027, amended in 24 I.L.M. 535 (adopted Dec. 10, 1984) [hereinafter U.N. Convention Against Torture]; see also Inter-American Convention to Prevent and Punish Torture, Dec. 9, 1985, art. 2, AG/RES. 783 (xv-0185), reprinted in 25 I.L.M. 519 ("[T]orture shall be understood to be any act intentionally performed whereby physical or mental pain or suffering is inflicted on a person for purposes of criminal investigation, as a means of intimidation, as a personal punishment, as a preventive measure, as a penalty, or for any other purpose."). The U.N. Declaration on Torture states: [T] orture means any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted by or at the instigation of a public official on a person for such purposes as obtaining from him or a third person information or confession, punishing him for an act he has committed or is suspected of having committed, or intimidating him or other persons. It does not include pain or suffering arising only from, inherent in or incidental to, lawful sanctions to the extent consistent with the Standard Minimum Rules for the Treatment of Prisoners. U.N. Declaration on Torture, supra note 64, art 1(1); see also EDWARD PETERS, TORTURE 1-3 (1985) (drawing a common element from definitions of torture from the third, thirteenth, seventeenth, and twentieth centuries: "torment inflicted by a public authority for ostensibly public purposes"); PAUL SIEGHART, THE INTERNATIONAL LAW OF HUMAN RIGHTS 162 (1983) ("[T]he word 'torture' is often used to describe inhuman treatment which has a purpose ...."); Brent Sorensen & Inge Kemp Genefke, Medical Aspects of Torture, in THE INTERNATIONAL FIGHT AGAINST TORTURE 11, 12 (Antonio Cassese ed., 1991) (identifying the aim of torture as destruction of personality, identity, and soul of a human being).
98. The U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment defines torture as: any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a confession, punishing him for an act he or a third person has committed or is suspected of having committed, or intimidating or coercing him or a third person, or for any reason based on discrimination of any kind, when such pain or suffering is inflicted by or at the instigation of or with the consent or acquiescence of a public official or other person acting in an official capacity. It does not include pain or suffering arising only from, inherent in or incidental to lawful sanctions. U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Apr. 18, 1988, S. TREATY DOC. No. 100-20 (1986), 23 I.L.M. 1027, 1027, amended in 24 I.L.M. 535 (adopted Dec. 10, 1984) [hereinafter U.N. Convention Against Torture]; see also Inter-American Convention to Prevent and Punish Torture, Dec. 9, 1985, art. 2, AG/RES. 783 (xv-0185), reprinted in 25 I.L.M. 519 ("[T]orture shall be understood to be any act intentionally performed whereby physical or mental pain or suffering is inflicted on a person for purposes of criminal investigation, as a means of intimidation, as a personal punishment, as a preventive measure, as a penalty, or for any other purpose."). The U.N. Declaration on Torture states: [T] orture means any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted by or at the instigation of a public official on a person for such purposes as obtaining from him or a third person information or confession, punishing him for an act he has committed or is suspected of having committed, or intimidating him or other persons. It does not include pain or suffering arising only from, inherent in or incidental to, lawful sanctions to the extent consistent with the Standard Minimum Rules for the Treatment of Prisoners. U.N. Declaration on Torture, supra note 64, art 1(1); see also EDWARD PETERS, TORTURE 1-3 (1985) (drawing a common element from definitions of torture from the third, thirteenth, seventeenth, and twentieth centuries: "torment inflicted by a public authority for ostensibly public purposes"); PAUL SIEGHART, THE INTERNATIONAL LAW OF HUMAN RIGHTS 162 (1983) ("[T]he word 'torture' is often used to describe inhuman treatment which has a purpose ...."); Brent Sorensen & Inge Kemp Genefke, Medical Aspects of Torture, in THE INTERNATIONAL FIGHT AGAINST TORTURE 11, 12 (Antonio Cassese ed., 1991) (identifying the aim of torture as destruction of personality, identity, and soul of a human being).
99. The U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment defines torture as: any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a
100. The U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment defines torture as: any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person for such purposes as obtaining from him or a third person information or a confession, punishing him for an act he or a third person has committed or is suspected of having committed, or intimidating or coercing him or a third person, or for any reason based on discrimination of any kind, when such pain or suffering is inflicted by or at the instigation of or with the consent or acquiescence of a public official or other person acting in an official capacity. It does not include pain or suffering arising only from, inherent in or incidental to lawful sanctions. U.N. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Apr. 18, 1988, S. TREATY DOC. No. 100-20 (1986), 23 I.L.M. 1027, 1027, amended in 24 I.L.M. 535 (adopted Dec. 10, 1984) [hereinafter U.N. Convention Against Torture]; see also Inter-American Convention to Prevent and Punish Torture, Dec. 9, 1985, art. 2, AG/RES. 783 (xv-0185), reprinted in 25 I.L.M. 519 ("[T]orture shall be understood to be any act intentionally performed whereby physical or mental pain or suffering is inflicted on a person for purposes of criminal investigation, as a means of intimidation, as a personal punishment, as a preventive measure, as a penalty, or for any other purpose."). The U.N. Declaration on Torture states: [T] orture means any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted by or at the instigation of a public official on a person for such purposes as obtaining from him or a third person information or confession, punishing him for an act he has committed or is suspected of having committed, or intimidating him or other persons. It does not include pain or suffering arising only from, inherent in or incidental to, lawful sanctions to the extent consistent with the Standard Minimum Rules for the Treatment of Prisoners. U.N. Declaration on Torture, supra note 64, art 1(1); see also EDWARD PETERS, TORTURE 1-3 (1985) (drawing a common element from definitions of torture from the third, thirteenth, seventeenth, and twentieth centuries: "torment inflicted by a public authority for ostensibly public purposes"); PAUL SIEGHART, THE INTERNATIONAL LAW OF HUMAN RIGHTS 162 (1983) ("[T]he word 'torture' is often used to describe inhuman treatment which has a purpose ...."); Brent Sorensen & Inge Kemp Genefke, Medical Aspects of Torture, in THE INTERNATIONAL FIGHT AGAINST TORTURE 11, 12 (Antonio Cassese ed., 1991) (identifying the aim of torture as destruction of personality, identity, and soul of a human being).
101. See Ireland v. United Kingdom, 25 Eur. Ct. H.R. (ser. A) (1978). In this particular case, the European Commission of Human Rights and the European Court of Human Rights were confronted with the task of applying Article 3 of the European Convention to five interrogation techniques employed by U.K. security forces in Northern Ireland. These techniques included wallstanding, in which detainees were forced to spend hours standing in a "stress position" against a wall; hooding; subjection to noise; and deprivation of sleep, food, and water.. See Id. para. 96. Although the Commission unanimously determined that the combined use of the techniques constituted inhuman treatment rising to the level of torture, the European Court overruled it. The court determined that although the use of the techniques "undoubtedly amounted to inhuman and degrading treatment" in violation of Article 3, they did not "occasion suffering of the particular intensity and cruelty implied by the word torture." Id. paras. 167-68.
102. See U.N. Convention Against Torture, supra note 77, art. 1(1) ("It does not include pain or suffering arising only from, inherent in or incidental to, lawful sanctions ...."); U.N. Declaration on Torture, supra note 64, art. 1(1) (1975); see also McEntee, supra note 70, at 1, 4-5.
103. The Greek Case, 1969 YB. Eur. Conv. on H.R. (Eur. Comm'n on H.R.) 186.
104. Tyrer v. United Kingdom, 26 Eur. Ct. H.R. (ser. A) at 16 (1978); X v. Federal Republic of Germany, App. No. 8518/79, 20 Eur. Comm'n H.R. Dec. & Rep. 193, 193 (noting that "forced administration of medicines to a mentally abnormal prisoner in a psychiatric hospital, subject to judicial control, [does not constitute degrading treatment] ").
105. Declaration of Geneva, World Medical Association [WMA] 2d Assembly (Sept 1948), reprinted in 1 WORLD MED. ASS'N. BULL. 34 (1949). Although the Declaration does not contain an explicit reference to Nuremberg, the oath was first published as part of a statement adopted by the WMA. General Assembly entitled War Crimes and Medicine: The German Betrayal and a Restatement of the Ethics of Medicine. See The Dedication of the Physician, 1 WORLD MED. ASS'N BULL. 4, 13 (1949).
106. Declaration of Geneva, World Medical Association [WMA] 2d Assembly (Sept 1948), reprinted in 1 WORLD MED. ASS'N. BULL. 34 (1949). Although the Declaration does not contain an explicit reference to Nuremberg, the oath was first published as part of a statement adopted by the WMA. General Assembly entitled War Crimes and Medicine: The German Betrayal and a Restatement of the Ethics of Medicine. See The Dedication of the Physician, 1 WORLD MED. ASS'N BULL. 4, 13 (1949).
107. International Code of Medical Ethics, WMA 3d Assembly (Oct. 1949), reprinted in Report on Medical Ethics, 1 WORLD MED. ASS'N BULL. 108, 111 (1949).
108. See Perley et al., supra note 41, at 149, 155.
109. Principles for Those in Research and Experimentation, WMA 8th Assembly (Sept.-Oct. 1954), reprinted in Organizational News, 2 WORLD MED. J. 12, 14 (1955).
110. Declaration of Helsinki, WMA 18th Assembly (June 1964), reprinted in 8 WORLD MED. J. 281 (1964) [hereinafter Declaration of Helsinki I].
111. Id. § II(1).
112. Id. (emphasis added).
113. Declaration of Helsinki, WMA 29th Assembly (Oct. 1975), reprinted in THE NAZI DOCTORS, supra note 12, at 333 [hereinafter Declaration of Helsinki II]; Declaration of Helsinki, WMA 35th Assembly (Oct. 1983), reprinted in 30 WORLD MED. J. inside front & back covers (1984) [hereinafter Declaration of Helsinki III]; Declaration of Helsinki, WMA 41st Assembly (Sept. 1989), reprinted in THE NAZI DOCTORS, supra note 12, at 339-42 [hereinafter Declaration of Helsinki IV].
114. See Declaration of Helsinki IV, supra note 89, § I(9).
115. Id. § I(10).
116. See id. § I(2).
117. Id.
118. Id. § II(1).
119. Id. § II(3).
120. See id. § II (5).
121. World Health Org. & Council for Int'l Org. of Med. Science, Proposed International Guidelines for Biomedical Research Involving Human Subjects, reprinted in HUMAN EXPERIMENTATION AND MEDICAL ETHICS 387 (Zbigniew Bankowski & Norman Howard-Jones eds., 1982) [hereinafter Proposed International Guidelines].
122. World Health Org. & Council for Int'l Org. of Med. Science, Proposed International Guidelines for Biomedical Research Involving Human Subjects, reprinted in HUMAN EXPERIMENTATION AND MEDICAL ETHICS 387 (Zbigniew Bankowski & Norman Howard-Jones eds., 1982) [hereinafter Proposed International Guidelines].
123. See Perley et al., supra note 41, at 149, 160-61.
124. International Ethical Guidelines for Biomedical Research Involving Human Subjects, reprinted in ETHICS AND RESEARCH ON HUMAN SUBJECTS: INTERNATIONAL GUIDELINES 231 (Z. Bankowski & R.J. Levine eds., 1993) [hereinafter International Ethical Guidelines].
125. International Ethical Guidelines for Biomedical Research Involving Human Subjects, reprinted in ETHICS AND RESEARCH ON HUMAN SUBJECTS: INTERNATIONAL GUIDELINES 231 (Z. Bankowski & R.J. Levine eds., 1993) [hereinafter International Ethical Guidelines].
126. See Proposed International Guidelines, supra note 97, at 404 (The limited application of the informed consent procedure, and its vulnerability to abuse, render it inadequate as an exclusive means of protecting the human rights and welfare of research subjects, and it fails most decisively when the population from which the subjects are drawn is most vulnerable.").
127. See International Ethical Guidelines, supra note 99, at 37.
128. See id.
129. Proposed International Guidelines, supra note 97, at 404 (discussing the rationale of the drafters of Guideline 14).
130. International Ethical Guidelines, supra note 99, at 11.
131. See id. at 20, 22, 24, 33.
132. See id. at 36.
133. See id.
134. See id. at 25.
135. See id.
136. Id. at 43-44.
137. Said. at 43.
138. Between 1980 and 1992, more than 55 countries adopted legislation or took other measures to regulate human experimentation. See Richard J. Kelly et al., The Regulation of Research on Human Subjects: A Decade of Progress, in ETHICS AND RESEARCH ON HUMAN SUBJECTS: INTERNATIONAL GUIDELINES, supra note 99, at 127.
139. The Nuremberg Code, supra note 28, art. 1.
140. See id.
141. See Declaration of Helsinki IV, supra note 89, § I (11); International Ethical Guidelines, supra note 99, at 13.
142. See Declaration of Helsinki IV, supra note 89, § II(5) ("If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee ....").
143. The Declaration of Helsinki IV does recommend that results from research not conducted in accordance with its principles not be published. See Declaration of Helsinki IV, supra note 89, § I(8). This provision, however, is merely intended to serve as a professional sanction against researchers and professionals who violate the provisions of the Declaration. No mention is made of possible legal repercussions. See generally Declaration of Helsinki IV, supra note 89.
144. See Kelly et al., supra note 112, at 127.
145. Again, it is interesting to note that prior to World War II, Nazi Germany was the only country with national standards regulating the use of human subjects in scientific experimentation. See supra note 29. Of course, laws and regulations are meaningless without the will and resources to enforce them.
146. See infra text accompanying note 171.
147. Large scale-human rights violations in the area of human experimentation are still taking place. For example, between 1945 and 1963 an estimated 250,000 U.S. military personnel engaging in maneuvers were exposed to large doses of radiation, as part of a study to determine the effectiveness of combat troops under nuclear battlefield conditions. See Veterans' Claims for Disabilities from Nuclear Weapons Testing: Hearing Before the Senate Comm. on Veterans Affairs, 96th Cong. 2 (1979) . Typically positioned one to three miles from the point of detonation, the soldiers were not issued protective clothing and were not warned about the possible dangers of high level radiation exposure. See THOMAS H. SAFFER & ORVILLE E. KELLY, COUNTDOWN ZERO 43, 152 (1982) (giving first-person accounts of these military exercises).
148. Large scale-human rights violations in the area of human experimentation are still taking place. For example, between 1945 and 1963 an estimated 250,000 U.S. military personnel engaging in maneuvers were exposed to large doses of radiation, as part of a study to determine the effectiveness of combat troops under nuclear battlefield conditions. See Veterans' Claims for Disabilities from Nuclear Weapons Testing: Hearing Before the Senate Comm. on Veterans Affairs, 96th Cong. 2 (1979) . Typically positioned one to three miles from the point of detonation, the soldiers were not issued protective clothing and were not warned about the possible dangers of high level radiation exposure. See THOMAS H. SAFFER & ORVILLE E. KELLY, COUNTDOWN ZERO 43, 152 (1982) (giving first-person accounts of these military exercises).
149. These three basic principles are often cited in connection with human experimentation. See Perla D. Santos Ocampo, Research on Subjects Incompetent to Consent: Children, in HUMAN EXPERIMENTATION AND MEDICAL ETHICS, supra note 97, at 89, 90-91.
150. See Declaration of Helsinki II, supra note 89, § I(2). The terminology for these independent bodies varies from country to country. For example, in the United States they are referred to as Institutional Review Boards and in Canada as Ethical Review Committees. In the CIOMS Guidelines, the committees are referred to as Ethical Review Committees.
151. See International Ethical Guidelines, supra note 99, at 37.
152. Declaration of Helsinki IV, supra note 89, § I(2).
153. See, e.g., the comments of Dr. J. F. Farber during the fifteenth CIOMS Round Table Conference: I think some people misinterpreted the Helsinki Declaration. Nowhere is there question of permission being granted by an independent body, an ethical review body, essential to ethics review committees and might even form a majority [of the committee]. WORKING GROUP ON HUMAN EXPERIMENTATION, MEDICAL RESEARCH COUNCIL OF CANADA, REP. No. 6, ETHICAL CONSIDERATIONS IN RESEARCH INVOLVING HUMAN SUBJECTS 43 (1978).
154. Prior to the tribunal's decision at Nuremberg, the consent of the test subject does not appear to have been a fundamental principle of scientific ethics. Few theorists had focused on the role of the researcher and the right of human subjects. One of the most influential was Claude Bernard, a contemporary of Pasteur who, at the emergence of modern medical science, wrote: It is our duty and our right to perform an experiment on man whenever it can save his life, cure him or gain him some personal benefit The principle of medical and surgical morality, therefore, consists in never performing on man an experiment which might be harmful to him to any extent, even though the result might be highly advantageous to science, i.e., to the health of others. CLAUDE BERNARD, AN INTRODUCTION TO THE STUDY OF EXPERIMENTAL MEDICINE 101 (Henry Copley Greene trans., Macmillan Co. 1927) (1865). Bernard's focus was on the rights and duties of the researcher; he made no mention of either the autonomy of subject or the need to obtain consent The perspective of Bernard, which viewed the status of the subject as secondary to the work of the physician or researcher, was widely held prior to the Nuremberg trial.
155. See The Nuremberg Code, supra note 28, art 1.
156. See Declaration of Helsinki IV, supra anote 89, §I(1)-(3). Although Section 1(5) of the 1989 Declaration recognizes that "[c]oncern for the interests of the subject must always prevail over the interests of science and society," id. § I(5), closer examination of the Declaration reveals that the interests of the subject are never defined. Rather, it is left to the researcher to interpret the subject's interests. Section I(3) of the Declaration states that "[t]he responsibility for the human subject [rests] with a medically qualified person" (as opposed to sharing responsibility between a medically qualified person and the patient subject). Id. § I(3).
157. See Perley et al., supra note 41, at 149, 155, 158 (noting that the Nuremberg Code makes the voluntary consent requirement absolute, while the Declaration of Helsinki sets less stringent consent requirements in order to balance the interests of the subject and the researcher).
158. The Nuremberg Code, supra note 28, art. 1.
159. Id.
160. See Perley et al., supra note 41, at 155-56.
161. See id. at 156.
162. William J. Curran, Subject Consent Requirements in Clinical Research: An International Perspective for Industrial and Developing Countries, in HUMAN EXPERIMENTATION AND MEDICAL ETHICS, supra note 97, at 35, 41. See also Henry Beecher, Some Guiding Principles for Clinical Investigation, 195 JAMA 1135-36 (suggesting that the investigator should strive to achieve adequate understanding by the subject, even if this can rarely be fully accomplished).
163. William J. Curran, Subject Consent Requirements in Clinical Research: An International Perspective for Industrial and Developing Countries, in HUMAN EXPERIMENTATION AND MEDICAL ETHICS, supra note 97, at 35, 41. See also Henry Beecher, Some Guiding Principles for Clinical Investigation, 195 JAMA 1135-36 (suggesting that the investigator should strive to achieve adequate understanding by the subject, even if this can rarely be fully accomplished).
164. See Declaration of Helsinki I, supra note 86, § III(2).
165. Declaration of Helsinki II, supra note 89, § I(9). This general language has survived successive versions of the Declaration. See Declaration of Helsinki IV, supra note 89, § I(9).
166. International Ethical Guidelines, supra note 99, at 14. The majority of human experimentation takes place in the United States. It is not surprising then that the United States maintains an elaborate set of regulations to ensure the rights of research subjects. It may be useful to compare the existing international standards with the U.S. Department of Health and Human Service (DHHS) regulations. The DHHS regulations require, with respect to informed consent, that the researcher, in a language understandable to the subject or the subject's representative, provide the following information: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental (2) A description of any reasonably foreseeable risks or discomforts to the subject (3) A description of any benefits to the subject or to others which may reasonably be expected from the research (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained (7) An explanation of whom [sic] to contact for answers to pertinent questions about the research and research subject's rights, and whom [sic] to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 45 C.F.R. § 46.116(a) (1996). The regulations provide, however, that an independent committee may alter or eliminate one or more of the elements of informed consent if certain strict criteria are met. See id. § 46.116(d) (1996) (outlining the necessary criteria).
167. The need for such a restriction has been recognized in the United States. See id. § 46.116.
168. See supra text accompanying notes 131-32.
169. See HERSHEY & MILLER, supra note 12, at 58-62, 147.
170. See Declaration of Helsinki IV, supra note 89, § I(11); International Ethical Guidelines, supra note 99, at 13.
171. See Jay Katz, The Consent Principle of the Nuremberg Code: Its Significance Then and Now, in THE NAZI DOCTORS, supra note 12, at 227, 232; Howard-Jones, supra note 29, at 1436.
172. See Bassiouni et al., supra note 14, at 1613.
173. The Nuremberg Code, supra note 28, art. 1.
174. Declaration of Helsinki IV, supra note 89, § I(10).
175. The commentary to Guideline 10 states that "[t]o the extent that these and other classes of people have attributes resembling those of classes identified as vulnerable [i.e., children, individuals with mental or behavior problems, prisoners, members of developing communities and pregnant and nursing women], the need for special protection of their rights and welfare should be considered." International Ethical Guidelines, supra note 99, at 31. The commentary, however, does not define "special protection." See id.
176. See id. at 20.
177. See id at 22.
178. See id. at 24.
179. See id. at25.
180. See id. at 33.
181. See id. at 20, 22, 24, 25, 33.
182. The Guidelines require that inducements be approved by an ethical review committee and "not be so large ... as to induce prospective subjects to consent to participate in the research against their better judgment." Id. at 18. The Guidelines fail to address, however, that different subjects have differing levels of need, with the result that a small inducement for one individual may be overwhelming to another.
183. Some scholars have questioned the right of an individual to voluntarily subject him or herself to potentially harmful treatment. See Bassiouni et al., supra note 14, at 1612-13 (noting that "volunteers" may in fact be lured by compensation, regardless of the personal risk). Moreover, voluntarily subjecting oneself to torture does not relieve the torturer from liability. See McEntee, supra note 70, at 7, 8 (noting that derogation of the prohibition against torture is not permitted).
184. This is essentially the approach adopted by the U.S. DHHS. Under DHHS regulations governing the use of human subjects in scientific and medical experimentation, vulnerable populations are defined as "children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons." 45 C.F.R. § 46.111 (a) (3) (1996). The regulations contain protections tailored to the individual needs of pregnant women, prisoners, and children. See 45 C.F.R. § 46 subpts. B, C & D (1996). However, there are no protections devoted specifically to the mentally disabled or economically or educationally disadvantaged. See id.
185. This definition is based on the definition used in the CIOMS Guidelines. See International Ethical Guidelines, supra note 99, at 11.
186. The DHHS regulations provide insight into the issues raised by research activities involving the use of pregnant women, fetuses and human in vitro fertilization. See 45 C.F.R. § 46.206 (1996). They provide an excellent model for more specific international regulations dealing with these subjects. In addition to general limitations on all research activity involving any one of these suspect categories of subjects, the regulations provide protections tailored to the particular issues associated with each of these sets of subjects. See id. §§ 46.207-.211. The general limitations applicable to each of the groups strictly prohibit the use of inducements offered to terminate a pregnancy for purposes of furthering a research activity. See id. § 46.206. In addition, the basic limitations provide that no research activity involving pregnant women, fetuses, or human in vitro fertilization may be undertaken unless: (1) the study has been preceded by appropriate research on animals and nonpregnant individuals; (2) barring therapeutic research focused on the health needs of the mother or the particular fetus, the risk to the fetus is minimal, and, in all cases, poses the least possible risk in light of the objectives sought; (3) the researchers do not exercise any role in decisions concerning the termination of the pregnancy or the viability of the fetus at termination; and (4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant women are introduced into the procedure for terminating the pregnancy solely in the interests of the research activity. See id. § 46.206. Whatever latitude is left researchers under the general limitations on research involving pregnant women, fetuses, and human in vitro fertilization is revoked under subsequent provisions tailored to each group. For example, the regulations pertaining to the use of pregnant women in research activities prohibits the use of pregnant women as test subjects unless the research is therapeutic in nature and directed at the health needs of the mother, or the fetus is placed at minimal risk. See id. § 46.207. Likewise, no fetus in utero may be involved in research activity unless the purpose of the activity is to meet the health needs of the particular fetus and the fetus will be subjected to the minimal risk necessary to effectuate the objective of the treatment See id. § 46.208. Until the viability of a fetus ex utero is ascertained, it may not be involved as a test subject unless: (i) the research activity poses no additional risk to the fetus and the purpose of the activity is the development of important biomedical knowledge that cannot be obtained elsewhere, or (ii) the purpose of the research activity is to enhance the possibility of survival of the fetus to the point of viability. Furthermore, no nonviable fetus may be involved as a subject in research unless the vital functions of the fetus will not be artificially maintained, experimental activities which would terminate the heartbeat or respiration of the fetus will not be used, and the purpose of the research is the development of knowledge that cannot be obtained elsewhere. See id. § 46.209. To ensure that the provisions laid out in the regulations are closely adhered to, the regulations call for an independent committee to oversee the informed consent process and to monitor and evaluate the research activities "to determine if any unanticipated risks have arisen." Id. § 46.205 (a) (2). In addition, the regulations call for the creation of an Ethical Advisory Board to serve as advisors to the Secretary of the DHHS on ethical issues raised in connection with research proposals or by general policies or guidelines. See id. § 46.204(a)-(b).
187. See supra text accompanying notes 144-45.
188. This is a less drastic approach than that adopted by drafters of the Nuremberg Code, which prohibits the use of legally incompetent individuals in scientific and medical research. See supra text accompanying note 132. The blanket prohibition against the use of legally incompetent populations as research subjects in potentially dangerous experiments may be compared to the approach advocated by the DHHS regulations. The DHHS regulations draw a distinction between children and mentally handicapped individuals. Special protections are provided in the regulations for children, but not for the mentally handicapped.
189. Note that military personnel are not declared vulnerable under the CIOMS Guidelines or the DHHS regulations. See generally International Ethical Guidelines, supra note 99; 45 C.F.R. § 46 (1996) (noting lack of references to military personnel). Military personnel, like prisoners, are inherently in a position of dependency stemming from the hierarchical structure of military command. Moreover, history illustrates their vulnerability. For example, between 1945 and 1963, an estimated 250,000 military personnel were exposed to large doses of radiation to determine the effectiveness of combat troops on a nuclear battlefield. See Jaffee v. United States, 663 F.2d 1226 (3d Cir. 1981) (involving exposure of soldiers to nuclear radiation during atomic weapons testing); see also United States v. Stanley, 483 U.S. 669 (1987) (involving exposure of unknowing soldier to LSD); Schurman v. United States, 490 F. Supp. 429 (E.D. Va. 1980) (involving exposure of unknowing soldier to mustard gas); Thornwell v. United States, 471 F. Supp. 344 (D.D.C. 1979) (regarding soldiers used to test die effects of LSD without their knowledge).
190. This concern differs from that raised by the case of James Stanley. See supra notes 1-9 and accompanying text. The Stanley case involved an individual whose informed consent was never requested. In this context we are not as concerned with the lack of informed consent, which is a well-established violation of international ethical and legal standards, as with the ability of the potential subject to provide truly voluntary consent in a situation where he or she is vulnerable to coercion.
191. The approach advocated is very similar to the approach adopted in the DHHS regulations with respect to prisoners. See 45 C.F.R. §§ 46.301-306 (1996). The DHHS regulations do not considerjnilitary personnel to be a vulnerable population. See id. § 46 (noting the absence of reference to military personnel). The regulations require the independent committee to take on an expansive role when overseeing research involving prisoners. The independent committee is required to ensure, inter alia, that (i) the inducements offered in exchange for prisoner participation do not impair the prisoner's ability to weigh the risks associated with the experiment; (ii) the risks are approximate to those that would be accepted by nonprisoner volunteers; (iii) the procedures for selecting volunteers within the prison are fair to all prisoners and "immune from arbitrary intervention by prison authorities or prisoners;" (iv) information is presented in language that the prisoner understands; and (v) parole boards will not take into account the prisoner's participation in the research and the prisoner is informed of this fact. Id. § 46.305. By limiting the types of research in which prisoner participation is involved, however, the DHHS regulations actually provide greater protection than the approach recommended in this Note. According to the regulations, biomedical or behavioral research conducted or funded by DHHS may employ prisoners as test subjects only where: (1) The institution responsible for the conduct of the research has certified to the Secretary that the Institutional Review Board has approved the research ... and (2) In the judgment of the Secretary the proposed research involves solely the following: (i) Study of die possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects (iii) Research on conditions particularly affecting prisoners as a class ... provided that the study may proceed only after the Secretary has consulted with appropriate experts ... and published notice, in the Federal Register, of his intent to approve such research; or (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject [i.e., therapeutic research]. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from" the research, the study may proceed only after the Secretary has consulted with appropriate experts ... and published notice, in the Federal Register, of his intent to approve such research. Id. § 46.306.
192. Although the "economically and educationally disadvantaged" fall under the DHHS definition of vulnerable population, the regulations do not contain special protections tailored to the specific needs of the group. See id. § 46.111 (a) (3) (listing vulnerable populations that do receive specific, tailored protections).
193. See International Ethical Guidelines, supra note 99, at 10.
194. See id. at 10-11.
195. See International Ethical Guidelines, supra note 99, at 25.
196. The other is the ICESCR. See ICESCR, supra note 56; see HENRY J. STEINER & PHILIP ALSTON, INTERNATIONAL HUMAN RIGHTS IN CONTEXT: LAW, POLITICS, MORALSSOO (1996).
197. DOMINIC MCGOLDRICK, THE HUMAN RIGHTS COMMITTEE 13 (1991).
198. See ICCPR, supra note 55, arts. 2(1), (2).
199. See id. art. 2(3).
200. See id. art. 28(1).
201. See id. art. 40(1). Article 40(1) requires parties to the covenant to submit reports within one year of entry into force of the covenant and thereafter at the request of the Committee. See id. 178 See id. art. 40(4).
202. See STEINER & ALSTON, supra note 172, at 535 (noting that "84 of the 131 state parties to the ICCPR were also parties to this First Optional Protocol").
203. See id. (citing the Committee's own procedural rules).
204. See id. at 536.
205. See id. at 535.
206. See Torkel Opsahl, The Human Rights Committee, in THE UNITED NATIONS AND HUMAN RIGHTS 369, 427 (Philip Alston ed., 1992) (describing this function as a settled interpretation of the Committee's role).
207. See 1994 Report of the Human Rights Committee, U.N. GAOR, Hum. Rts. Comm., 49th Sess., Supp. No. 40 ¶¶377, 459, U.N. Doc. A/49/40 (1994).
208. Although the Committee publishes its decisions (or "views"), the Committee does not explain its reasoning to the same extent as a trier of fact in legal decisions. Consequently, the Committee's "views" do not constitute a source of binding case law. See Opsahl, supra note 183, at 421.
209. See id.
210. Many authorities have argued that this characteristic is common to international human rights law in general. See, e.g., Louis Henkin, International Law: Politics, Values and Functions, in STEINER & ALSTON, supra note 172, at 350-54.
211. The enforcement machinery contained in the treaties is only binding on parties to those agreements. The content of the ICCPR principles linking human experimentation to cruel, inhuman, or degrading treatment may be imported into regional conventions, such as the European Convention for the Protection of Human Rights and Fundamental Freedoms and the American Convention on Human Rights, as persuasive authority. Unlike the ICCPR enforcement structure, the enforcement structure under these regional conventions used human rights courts to interpret the respective conventions and adjudicate alleged violations. See European Convention, supra note 58, art 19; American Convention, supra note 58, ch. VIII. By importing the principles of the proposed protocol into their own interpretations of cruel, inhuman, and degrading treatment, these courts may help the proposed standards for human experimentation become established international law.