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Foreword: Law, Medicine and Socially Responsible Research

Published online by Cambridge University Press:  24 February 2021

S. Rebecca Holmes-Farley  and
Michael A. Grodin
S. Rebecca Holmes-Farley
Affiliation:
Health Law Department, Boston University School of Public Health; 1982, Cornell University; 1986, Suffolk University Law School; 1998, Boston University School of Public Health
Michael A. Grodin
Affiliation:
Sociomedical Sciences and Community Medicine and Director of the Law, Medicine and Ethics Program, Boston University Schools of Medicine and Public Health; 1972, Massachusetts Institute of Technology; 1976, Albert Einstein College of Medicine; Postdoctoral training, 1978, University of California-Los Angeles; 1981, Harvard University
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American Journal of Law & Medicine , Volume 24 , Issue 2-3 , 1998 , pp. 153 - 162
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Copyright © American Society of Law, Medicine and Ethics and Boston University 1998

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References

1 See Rothman, David J., Research, Human: Historical Aspects, 4 ENCYCLOPEDIA BIOETHICS 2248, 2249-50 (1995)Google Scholar (describing the evolution of informed consent in Europe and the United States).

2 See 2 U.S. GOV't PRINTING OFFICE, TRIALS OF WAR CRIMINALS BEFORE THE NUERNBERG MILITARY TRIBUNALS UNDER CONTROL COUNSEL LAW NO. 10, at 171, 181-82 (1946-1949) (incorporating the first writing of the Nuremberg Code in judgment against Karl Brandt and other defendants in the “Doctors’ Trial“); The Nuremberg Code, reprinted in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 2 (George J. Annas & Michael A. Grodin eds., 1992) [hereinafter THE NAZI DOCTORS]; see also Michael A. Grodin, Historical Origins of the Nuremberg Code, in THE NAZI DOCTORS, supra, at 121, 122-40 (discussing the historical events and influences that led to the writing of the Nuremberg Code).

3 The first principle is further explained in the language which directly follows:

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

The Nuremberg Code, supra note 2, at 2.

4 In fact, U.S. violations were made part of the trial record when other countries’ questionable research was put into evidence by the defendants.

5 See Rothman, supra note 1, at 2251.

6 See id.

7 See id. at 2252.

8 See id.; see also Harkness, Jon M., Nuremberg and the Issue of Wartime Experiments on US Prisoners, 276 JAMA 1672 (1996)CrossRefGoogle Scholar (comparing research in U.S. state prisons during World War II with experimentation in Nazi concentration camps).

9 See Rothman, supra note 1, at 2252.

10 See id.

11 See Freedman, Benjamin, Research, Unethical, 4 ENCYCLOPEDIA BIOETHICS 2258, 2258 (1995)Google Scholar.

12 See generally PRESIDENT's ADVISORY COMMITTEE, FINAL REPORT OF THE ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS at xxi (1996) (reporting “unethical conduct by the U.S. government, and institutions funded by the government, in the use of, or exposure to, ionizing radiation in human beings“).

13 Although “all of the judges at the Doctors’ Trial were Americans, the prosecutors were American, the procedural rules followed were American, and the case itself was brought under the authority of the military governor of the American Zone,” the Nuremberg Code has not found much acceptance in U.S. courts. George J. Annas, The Nuremberg Code in U.S. Courts: Ethics Versus Expediency, in THE NAZI DOCTORS, supra note 2, at 201, 204 (arguing that the Nuremberg Code should be adopted by civil and criminal courts in the United States).

14 The now famous syphilis “studies” conducted on unwitting and impoverished African American males in Tuskegee, Alabama from 1932-1972 provide just one example of how minority groups were mistreated. The Tuskegee studies had as their objective watching the natural progression of the disease in African American men. The justification for failing to treat these men was that, because of their socioeconomic status, they would not have received treatment anyway. The subjects were led to believe they were being treated and, therefore, did not consent to have treatment withheld. Denying treatment after 1947, when penicillin became available, made the conduct of the investigators even more egregious. What is more, there is evidence that the men were dissuaded from seeking services where they might have received treatment with penicillin for other conditions (because it would have tainted the study). See JAMES H. JONES, BAD BLOOD: THE TUSKEGEE SYPHILIS EXPERIMENT (1993) (reporting the involvement of 399 syphilitic men in a U.S. Public Health Service study); see also Freedman, supra note 11, at 2258-59 (providing examples of unethical medical research in Germany, New Zealand, Japan and the United States, including the Tuskegee syphilis studies).

15 Beecher, Henry K., Ethics and Clinical Research, 274 NEW ENG. J. MED. 1354 (1966)CrossRefGoogle Scholar.

16 See supra note 14 and accompanying text.

17 45 C.F.R. §§ 46.101-.409 (1997).

18 There are estimated to be between 50,000 to 100,000 genes per haploid genome. See OFFICE OF TECHNOLOGY ASSESSMENT, MAPPING OUR GENES: GENOME PROJECTS: How BIG, How FAST? 24 (1988). It should be noted that the effort to sequence genes, in and of itself, need not provide any information about the genetic basis of disease. In fact, most diseases are thought to derive from a combination of environmental and polygenic factors.

19 If we are able to screen “at risk” populations and then institute therapeutic or preventative interventions during the detectable pre-clinical phase of disease, there is the hope that significant health improvements will inure to the community.

20 The term preexisting disease is used with great frequency in the literature, but it is often a misnomer in this context. Most genetic screening tests simply identify a particular mutation that may cause disease processes to develop in the future, depending on the presence of other genetic or environmental factors.

21 A watershed event in genetics occurred on February 23, 1997. On that date, the Roslin Institute in Scotland announced that somatic cell nuclear transfer had resulted in the birth of an apparently healthy lamb (“Dolly“). The published report can be found at Wilmut, I. et al., Viable Off-spring Derived from Fetal and Adult Mammalian Cells, 385 NATURE 810 (1997)CrossRefGoogle Scholar. Some heralded the success, claiming it paved the way for important research. Others reacted with alarm. President Clinton, for instance, issued an executive order immediately banning the use of federal funds for research regarding human cloning. He called for private companies to engage in a voluntary moratorium on human cloning and requested the National Bioethics Advisory Committee to issue a report outlining recommendations for a national policy on human cloning. See Rick Weiss, Clinton Forbids Funding of Human Clone Studies; Privately Financed Scientists Urged to Halt Work, WASH. POST, Mar. 6, 1997, at A10.

22 Genetic manipulation of plants and animals may, for instance, raise evolutionary concerns if our “tinkering” causes a lack of diversity or unforeseen susceptibility to certain pathogens.

23 The term pharming is used to describe the use of transgenic animals as bioreactors for the production of human pharmaceuticals. See KRIMSKY, SHELDON & WRUBEL, ROGER P., AGRICULTURAL BIOTECHNOLOGY AND THE ENVIRONMENT 192 (1996)Google Scholar.

24 For example, in 1997 significant objections were levied in some quarters against U.S.-sponsored HIV research in developing countries. See, e.g., Annas, George J. & Grodin, Michael A., Human and Maternal-Fetal HIV Transmission Prevention Trials in Africa, 88 AM. J. PUB. HEALTH 560, 561 (1998)CrossRefGoogle Scholar (criticizing these studies on the ground that they are exploitative because participating third world countries have no realistic prospect of affording the experimental intervention once it has proven to be beneficial).

The disputed clinical trials involved placebo-controlled testing of the regimen known as AIDS Clinical Trials Group Study 076 (ACTG 076). See id. at 560. The studies ostensibly were designed to identify whether alternative treatments or altered regimens of zidovudine (AZT) (i.e., shorter duration, different mode or timing of delivery) might prove beneficial in reducing the perinatal transmission of HIV to newborns in third world countries. Although it had been demonstrated that administration of AZT to pregnant women in the United States markedly reduced the rate of HIV transmission during delivery, third world countries could not afford and were not equipped to administer the protocol which had met with success in the United States. See id. at 561. Critics alleged that when a known therapeutic intervention exists (and is ethically required in the sponsoring country), using a placebo arm when the clinical trial is conducted outside the United States is inherently unethical. See id.; see also Angell, Marcia, The Ethics of Clinical Research in the Third World, 337 NEW ENG. J. MED. 847, 847 (1997)CrossRefGoogle Scholar (arguing that “[w]hen effective treatment exists, a placebo may not be used“); Leonard Glantz et al., A World of Research Subjects: Taking Benefits Seriously in Developing Countries, HASTINGS CENTER REP., forthcoming 1998 (arguing that a direct benefit should accrue to developing countries from successful research conducted in those countries by researchers from developed countries); Lurie, Peter & Wolfe, Sidney M., Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries, 337 NEW ENG. J. MED. 853 (1997)CrossRefGoogle Scholar (reviewing both sides of the ACTG 076 debate and arguing for an international normative standard for the conduct of clinical trials).

25 See National Institutes of Health Revitalization Act of 1993, Pub. L. No. 103-43, 107 Stat. 122, 133 (requiring inclusion of women and minority groups as research subjects). For the most recent version of this law, see 42 U.S.C.A. § 289a(c)(2) (West Supp. 1998). See also NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 59 Fed. Reg. 14,508, 14,509 (1994) (stating National Institutes of Health policy).

26 See George J. Annas & Michael A. Grodin, Medicine and Human Rights: Reflections on the Fiftieth Anniversary of the Doctors’ Trial, HEALTH & HUMAN RIGHTS, 1996, at 7; see also Michael A. Grodin et al., Medicine and Human Rights: A Proposal for International Action, HASTINGS CENTER REP., July-Aug. 1993, at 8, 11 (recommending the establishment of an international medical tribunal).

27 See Valery M. Gordon et al., Toward a More Comprehensive Approach to Protecting Human Subjects: The Interface of Data Safety Monitoring Boards and Institutional Review Boards in Randomized Clinical Trials, IRB: REV. HUMAN SUBJECTS RES., Jan.-Feb. 1998, at 1, 4.

28 See Annas, George J., Regulatory Models for Human Embryo Cloning: The Free Market, Professional Guidelines, and Government Restrictions, 4 KENNEDY INST. ETHICS J. 235, 245 (1994)CrossRefGoogle Scholar.

29 See Puma, John La, Physicians’ Conflicts of Interest in Post-Marketing Research: What the Public Should Know, and Why Industry Should Tell Them, in THE ETHICS OF RESEARCH INVOLVING HUMAN SUBJECTS: FACING THE 21ST CENTURY 203,206 (Vanderpool, Harold Y. ed., 1996)Google Scholar.

30 Informed Consent for Human Drugs and Biologies; Determination that Informed Consent Is Not Feasible, 55 Fed. Reg. 52,814 (1990) (codified at 21 C.F.R. pt. 50).

31 Waivers may be sought in situations involving either combat or the immediate threat of combat. See 21 C.F.R. § 50.23(d) (1997).