Society's Choices Social and Ethical Decision Making in Biomedicine (1995) / Chapter Skim
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1. Introduction
1. Introduction
Pages 27-42
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From page 27... ...
More and more, the ethical implications of such issues as health care delivery and commercialization of biotechnology are being pursued in a public fashion. The recent Clinton administration task force on health care reform involved ethicists as consultants; the ethical aspects of academic-industry relationships in the biotechnology indust~y was the subject of recent congressional hearings.
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From page 28... ...
For example, cloning a human being is viewed as an ethical issue whereas international trade agreements typically are not even though both involve moral choices and affect the vital interests of Americans. Nearly every public issue requires moral judgments in its resolution.
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From page 29... ...
This deliberation may draw on many resources: actual experience in the use of these technologies and in the practice of medicine; the personal values and life experiences of participants; bodies of formal analysis, such as economics and the law, which reflect and systematize moral judgments; and, not least, the intellectual and scholarly resources of the field of ethics. This report emphasizes the wide variety of settings in which these deliberations are occurring and the diversity of intellectual resources that can be brought to bear on public moral discourse.
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From page 30... ...
It was in the sphere of human studies research that the ethical dimensions of biomedicine and the need for public involvement in defining these dimensions was first recognized. Biomedical Research Involving Human Subjects The use of human beings as research subjects has ancient roots.
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From page 31... ...
One such statement was issued in 1953 by the Clinical Center at NIH. Titled "Group Considerations for Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Universal Hazards," these were the first federal guidelines for human studies research and the first official statement requiring committee review of human studies protocols.
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From page 32... ...
While the creation of research review committees raised public and investigator consciousness about the ethical dimensions of biomedical research, the revelation in 1972 of the Tuskegee Syphilis Study, an observational study of untreated syphilis in black men, begun in 1932, revealed the need for even clearer guidelines and more forceful measures for compliance. A now-infamous litany of ethical abuses characterized the study: no informed consent was obtained from the participants, the men were steered away from treatment even after the discovery in the 1940s that penicillin could effectively treat the disease, and they were deceived into believing
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From page 33... ...
These recommendations were reflected in formal policies promulgated in 1971 in the DHEW publication entitled "Institutional Guide to the DHEW Policy on Protection of Human Subjects," mentioned above. In 1973, the Senate Committee on Labor and Public Welfare held a series of hearings regarding human experimentation that included discussion of such issues as research on human fetuses, sterilization of the mentally retarded, and use of prisoners (Senate Committee on Labor and Public Welfare, 1973~.
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From page 34... ...
This concern was directed not only at the potential for the recurrence of blatant abuse, but also at routine questions of disclosure and decisional authority. The newfound interest in greater patient autonomy posed a serious challenge to the historical authority of physicians, who had previously seen patient participation in medical decision making as largely discretionary.
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From page 35... ...
Partly as a result of these decisions, the traditional model of medical practice, characterized by paternalism and authoritarianism, eventually gave way to a new model of informed consent, where the competent patient's decision-making authority became primary. Ironically, the triumph of patient autonomy raised a new set of ethical quandaries.
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From page 36... ...
In 1973, the American Hospital Association published the Patient Bill of Rights, the first explicit statement of the rights of patients and the responsibilities of physicians and medical institutions. Considered by many to be a landmark in the quest for patient autonomy, the bill acknowledged patients' rights to complete and current information in terms that they can understand, to informed consent prior to treatment, to refusal of treatment, and to be advised of and refuse to participate in experimental treatments (American Hospital Association, 1973~.
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From page 37... ...
At a major private teaching hospital in the same city, patients may be dialyzed at lower symptomatic levels (perhaps even before they feel ill from renal failure) , since reimbursement and private resources allow it.
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From page 38... ...
Operating under the threat of malpractice, physicians sometimes perform procedures that are medically unnecessary or marginal in order to protect themselves from the accusation that they did not do everything possible. Inappropriate use of tests and technology carries its own risks to patient health and raises the overall costs of health care, as do the large amounts of money paid by physicians for malpractice premiums.
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From page 39... ...
Academic-Industry Relationships in Biotechnology Recent dramatic changes in the research and development relationships between industry and academia threaten to upset the time-honored traditions of the biomedical sciences. In the past, academic scientists provided a constant stream of basic biomedical research and a cadre of new investigators as a source of renewed talent.
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From page 40... ...
This need is starkly illustrated by a controversial proposed agreement between Sandoz Pharmaceutical Corporation and Scripps Research Institute, which is being renegotiated under pressure from both the NIH and Congress. The agreement would have given Scripps more than $300 million over 10 years, starting in 1997, in exchange for worldwide license to all Scripps medical or manufacturing inventions (excluding existing research agreements)
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From page 41... ...
These issues demonstrate how social changes can have ethical implications. The issues have attracted public attention, and will do so increasingly, because of concern on the public's part that scientists maintain their honesty and integral (so that the innovations can be reliably beneficial)
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From page 42... ...
1982. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship.
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