DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB E-2 þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Allen Buchanan DATE: January 10, 1995 RE: Ethical Criteria I. EXPLICIT POLICIES OF AGENCIES AT THE TIME (e.g., the Wilson Memorandum, Atomic Energy Commission Memoranda?) Rationale: Institutionally created obligations, role-responsibilities of persons in authority at institutions are to be fulfilled, unless there are weighty countervailing moral considerations. II. LEGALLY EXPLICIT FIDUCIARY OBLIGATIONS OF GOVERNMENT INSTITUTIONS AND OF PERSONNEL WITHIN THEM (e.g., the Fernald School) TO PROTECT AND SERVE THE INTERESTS OF THEIR CHARTERS (legislation and operating charters for state institutions) Rationale: At least in a reasonably just system and when the particular explicit institution obligations (e.g., to protect and serve the interests of mentally impaired individuals, as at the Fernald School) are morally unexceptionable and even morally laudable, there is a prima facie moral obligation to discharge these institutional obligations, at least where participation in the institution (on the part of the personnel) is voluntary. III. PROFESSIONAL CODES AT THE TIME (in particular, Hippocratic Medical Ethics, Explicit endorsement of the Nuremberg Code by the AMA and other medical organizations) Rationale: Self-imposed obligations, quid pro quo for professional privilege and status. 1 IV. INTERNATIONAL HUMAN RIGHTS AGREEMENTS IN WHICH THE U.S. PARTICIPATED AT THE TIME, AND WHICH IMPOSE REQUIREMENTS OF CONSENT OR OF INFORMED CONSENT FOR HUMAN EXPERIMENTATION Rationale: A ratified international treaty or convention becomes the domestic law of the United States; and there is a prima facie obligation to obey the law of the land; especially on the part of officials who are sworn to uphold the law of the land, at least if the general character of the legal system is morally acceptable, and the agencies charged with adjudication and enforcement of the laws are legitimate. (The U.S. did sign the European Covenant on Civil and Political Rights in 1966(?)) V. UNCONTROVERSIAL BASIC MORAL STANDARDS THAT ENJOYED NEAR UNIVERSAL ENDORSEMENT AT THE TIME (e.g., prohibition against lying and deception; prohibition against inflicting harm or risk without consent [or at least without prospect of therapeutic benefit]; prohibition against exploitation, especially taking advantage of the vulnerable) Rationale: These common moral rules enjoy wide cross-cultural support, throughout history, being included in most if not all religious and philosophical ethical traditions, and being included in many legal systems in one form or another. VI. MORAL STANDARDS PECULIAR TO OR ESPECIALLY IMPORTANT IN A DEMOCRATIC POLITICAL SYSTEM (e.g., presumption against secrecy as an obstacle to accountability; nondiscrimination in the distribution of the burdens and benefits of providing for national security, serving the public interest, etc.) Rationale: General compliance with these norms is necessary for the well-functioning of a democratic system and for preserving the basic equality of citizens such a system is committed to. 2