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US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments.

The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.

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Research ethics and the medical profession. Report of the Advisory Committee on Human Radiation Experiments.

The Advisory Committee on Human Radiation Experiments was convened by President Clinton in January 1994 in response to allegations of unethical practices in radiation experiments involving human subjects that were sponsored by the US government between 1944 and 1974. The committee's Final Report was released in October 1995. In addition to analyzing the history of the ethics of medical research involving human subjects, the committee reviewed current federal policies and procedures for protection of human subjects. In this article, the committee's findings are discussed as they relate to the patient-physician relationship, the issue of trust, and the specific role of the physician-investigator in all types of human experimentation. The committee found evidence of discussion of the conduct of human research at the highest levels of the government and within the medical profession, particularly with regard to risk, during the 1940s and 1950s. However, in both federal policy and professional practice, requirements for consent were more likely to apply to "healthy volunteers" than to patient-subjects (ie, those with disease or illness). Today, consensus exists that duties to obtain informed consent apply to all human subjects, whether healthy or sick, regardless of the risk or potential for medical benefit from participation in the research and regardless of the nature of sponsorship or funding (eg, federal, military, or private). Based on a finding of serious deficiencies in the current system of protections for human subjects, the committee offers a number of recommendations, including changes in institutional review boards; in the interpretation of ethics rules and policies; in oversight, accountability, and sanctions for ethics violations; and in compensation for research injuries. More than public policy changes, however, the committee recommends that the medical profession intensify its commitment to the ethics of research involving human subjects.

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The Advisory Committee on Human Radiation Experiments. Reflections on a Presidential Commission.

Like the National Commission and the President's Commission, the Advisory Committee on Human Radiation Experiments was formed to carry out specific ethical tasks. Yet the committee also had an "openness" mission, a charge to investigate allegations that the U.S. government secretly exposed Americans to environmental releases of radiation. Eighteen months later- and after sixteen public meetings, more than 200 interviews, and the review of about 400,000 documents-the committee delivered a 925-page report to the president.

Advisory Committees↗

Are research subjects adequately protected? A review and discussion of studies conducted by the Advisory Committee on Human Radiation Experiments.

In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects.

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"The only feasible means." The Pentagon's ambivalent relationship with the Nuremberg Code.

Convinced that armed conflict with the Soviet Union was all but inevitable, that such conflict would involve unconventional atomic, biological, and chemical warfare, and that research with human subjects was essential to respond to the threat, in the early 1950s the U.S. Department of Defense promulgated a policy governing human experimentation based on the Nuremberg Code. Yet the policymaking process focused on the abstract issue of whether human experiments should go forward at all, ignoring the reality of humans subjects research already under way and leaving unanswered ethical questions about how to conduct such research. Documents newly released to the Advisory Committee on Human Radiation Experiments tell the story of the Pentagon policy.

Advisory Committees↗

Disagreement, consensus, and moral integrity.

The Advisory Committee on Human Radiation Experiments experienced some disagreements among its members in the course of its work. An epistemological controversy over the nature and degree of evidence required to draw ethical conclusions pervaded the Committee's deliberations. Other disagreements involved the proper role of a governmental advisory committee and the question of when it is appropriate to notify people that they were unknowing subjects of radiation experiments. In the end, the Committee was able to reach consensus on almost all of its findings and recommendations through a process that preserved the integrity of its members.

Advisory Committees↗

The mettle of moral fundamentalism: a reply to Robert Baker.

This article is a reply to Robert Baker's attempt to rebut moral fundamentalism, while grounding international bioethics in a form of contractarianism. Baker is mistaken in several of his interpretations of the alleged moral fundamentalism and findings of the Advisory Committee on Human Radiation Experiments. He also misunderstands moral fundamentalism generally and wrongly categorizes it as morally bankrupt. His negotiated contract model is, in the final analysis, itself a form of the moral fundamentalism he declares bankrupt.

Advisory Committees↗

Trust, The fragile foundation of contemporary biomedical research.

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient-subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient-subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

Advisory Committees↗

Looking back and judging our predecessors.

The Advisory Committee on Human Radiation Experiments has correctly argued that persons and institutions can sometimes be held responsible for actions taken more than a half-century ago, when practices and policies on the use of research subjects were strikingly different. In reaching its conclusions, the Committee did not altogether adhere to the language and commitments of its own ethical framework. In its Final Report, the Committee emphasizes judgments of wrongdoing, to the relative neglect of culpability; it discusses mitigating conditions that are exculpatory, but does not provide a thoroughgoing assessment of either culpability or exculpation. However, the Committee's shortcomings are mild in comparison to the deficiencies in the "Report of the UCSF Ad Hoc Fact Finding Committee on World War II Human Radiation Experiments" of the University of California at San Francisco. The latter report reaches no significant judgments of either wrongdoing or culpability. The findings that should have been reached by both committees are discussed.

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