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ACHRE Report

Part I

Chapter 4

Introduction

An Ethical Framework

Applying the Ethical Framework

Chapter 4: Footnotes

1 . International declarations of human rights that would otherwise be relevant to an evaluation of human experimentation, such as the Covenant on Civil and Political Rights (1966), were articulated after the human radiation experiments with which we are mainly concerned, with the significant exception of the Nuremberg Code, as discussed in chapter 2.

2 . The Advisory Committee is aware that questions such as precisely what ethical principles should be considered "basic," how they are related to those less basic, and how the basic ethical principles are known are among the most controversial and difficult in moral philosophy. For the Advisory Committee's limited purposes, a comprehensive and systematic moral theory is not required and is, in any case, far beyond the scope of this report. We have rather settled on a list of immediately recognizable and widely accepted ethical principles that are not usually thought to require justification themselves and that should be included in any adequate moral theory.

3 . Some view promise keeping as a basic ethical principle on a par with the prohibition against deception. It may also be seen as grounded in one or more of the basic ethical principles on our list of six, such as those concerning deception and treating people as mere means.

4 . The President's Commission functioned from 1978 to 1983, under the Carter and Reagan administrations, and produced a number of influential reports and recommendations concerning medical ethics and health care policy.

5 . It may be argued that historical ethical relativism reduces to cultural ethical relativism. On this position, the notion that even basic ethical principles vary by era is part of a more general claim that what is really at stake is different "world views," and these different world views may exist at the same time but in cultures that are different from one another in certain crucial respects. On this analysis, in other words, the temporal factor is not the essential one. However, some find it easier to reject historical ethical relativism than cultural ethical relativism, for they find it plausible that essentially the same values operative in, say, the United States in the 1990s were operative in the 1950s, but not that essentially the same values that are operative in the United States in the 1990s are also operative in China in the 1990s.

6 . In its report on the CIA and Army psychochemical experiments, the U.S. Senate found that

[i]n the Army's tests, as with those of the CIA, individual rights were . . . subordinated to national security considerations; informed consent and follow-up examinations of subjects were neglected in efforts to maintain the secrecy of the tests.

U.S. Congress, The Select Committee to Study Governmental Operations with Respect to Intelligence Activities, Foreign and Military Intelligence [Church Committee report], report no. 94-755, 94th Cong., 2d Sess. (Washington, D.C.: GPO, 1976), book 1, 411l. However, even in the light of the Army's own analysis of its LSD experiments, presented in a 1959 staff study by the U.S. Army Intelligence Corps (USAINTC), the operative legal principles should not have permitted the resulting practices to take place:

It was always a tenet of Army intelligence that the basic American principle of dignity and welfare of the individual will not be violated . . . In intelligence, the stakes involved and the interests of national security may permit a more tolerant interpretation of moral-ethical values, but not legal limits, through necessity . . . [emphasis added].

USAINTC Staff Study, Material Testing Program EA 1729 (15 October, 1959), 26. The staff study's distinc,tion between the flexibility of "moral-ethical values" and "legal limits" is puzzling.

7 . U.S. Army Inspector General, Use of Volunteers in Chemical Agent Research (Army IG report) (Washington D.C.: GPO, 1975).

8 . David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991), 32-50.

9 . Rothman writes of the CMR's deliberations on the gonorrhea proposal: "It [the CMR] conducted a remarkably thorough and sensitive discussion of the ethics of research and adopted procedures that satisfied the principles of voluntary and informed consent. Indeed, the gonorrhea protocols contradict blanket assertions that in the 1940s and 1950s investigators were working in an ethical vacuum." Ibid., 42-43.

10 . Michael Walzer, Just and Unjust Wars (New York: Basic Books, 1977).

11 . Another factor often important in assessments of blame is duress. All systems of ethics recognize that people cannot be blamed for actions that violate basic ethical principles if they acted under duress. Duress includes manipulation, blackmail, or threats of physical harm. There is no evidence that any particular individual involved in the human radiation experiments functioned under conditions of duress.

12 . Ruth Faden and Tom Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

13 . For example, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published ten reports. Many of these recommendations were enacted into federal regulation. U.S. Congress, Office of Technology Assessment, Biomedical Ethics in U.S. Public Policy--Background Paper, OTA-BP-BBS-105 (Washington, D.C.: GPO, June 1993), 10.

14 . Scholendorff v. Society of New York Hospital, 211 N.Y. 2d (1914).

15 . Salgo v. Leland Stanford, Jr., University Board of Trustees, 317 P.2d 170 (1957).

16 . In each case we assume that the principles or policies in question were morally sound; if not, anyone who refused to take part in unethical experiments performed in accordance with them acted, in retrospect, in a praiseworthy manner.

17 . Again, with regard to the elements of an ethical framework suited to the intentional releases, we note that different justifications are used to evaluate the risks to collectives or communities as against those used to evaluate risks to individuals.

18 . Note, however, that the intended scope of the policy was not always clear. Also, if the government or an agency had no policy at all concerning the use of human subjects but did conduct such research, then the absence of a policy would itself be objectionable.

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