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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.

Advisory Committees↗

Medical investigators' views about ethics and fraud in medical research.

The objective of this study was to ascertain the views and attitudes of medical investigators on medical ethics, and ethics and fraud in medical research. We sent postal questionnaires to all principal investigators whose study protocols had been assessed by their regional medical ethics committee for biomedical research (mid-Norway) in the years 1986-92 (n = 159). The response rate was 70% (n = 119). Some 80% agreed that ethical considerations had influenced their research and 12% that they would have had ethical scruples today about some of their previous projects. One in ten agreed that they might have achieved better results if they could have paid less attention to ethics. About 70% of the respondents found that the committee's comments were useful and relevant, but most agreed only in part. Around 85% agreed fully or in part that scientific quality is an important ethical element of any project and that researchers put more effort into their study protocol when they knew it would be evaluated by an ethics committee. One in six (18%) respondents agreed fully or in part that they had been exposed to scientific misconduct. Also, 27% knew about one or more cases of fraud or misconduct while 42% stated that this knowledge was not public. We concluded that ethics in medicine and medical research have an important and increasing role among investigators with little or no theoretical background and training in ethics. Scientific fraud and misconduct in medicine is a growing concern among researchers, who welcome a professional body that can manage allegations and cases of fraud.

Advisory Committees↗

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↗

Extraversion, neuroticism, immoral judgment and criminal behaviour.

The present study examines delinquent behaviour by integrating two approaches until now employed separately: Eysnck's theory linking delinquency to extraversion and neuroticism, and Kohlberg's theory of moral development and its connection to moral behaviour. The study analyzes the relations between extraversion, neuroticism and moral judgment, as well as their independent and/or interactive effect upon the development of anti-social behaviour. The relationships are tested by retrospective measurements of personality traits and moral judgment in three groups: delinquency (N = 203), control (N = 82) and comparative (N = 407) groups. Findings show that criminals are higher than control subjects in neuroticism and immoral judgment but not in extraversion. Similar relationships were found between criminals and the comparative group, with one exception: here extraversion was found to be positively related to delinquency, both independently and interactively with neuroticism. The implications of these results for differential development of anti-social behaviour are discussed.

Antisocial Personality Disorder↗

A retrospective analysis of ethics knowledge in physical therapy (1970-2000).

BACKGROUND AND PURPOSE: Purtilo, Guccione, and others have noted that increased clinical autonomy for physical therapists presents more complex ethical dilemmas. The body of literature examining physical therapy ethics, however, is relatively small and has not been analyzed. The primary purposes of this research were: (1) to use multiple perspectives to describe and analyze literature examining ethics in physical therapy from 1970 to 2000, (2) to develop a model to describe the evolution of knowledge of ethics in physical therapy during this period, and (3) to compare the proposed model with the evolutionary models proposed by Purtilo in physical therapy and by Pellegrino in bioethics. SAMPLE: The sample consisted of peer-reviewed journal articles cited in the MEDLINE or Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases between 1970 and 2000 or referenced in Ethics in Physical Therapy. METHODS: A two-phase mixed quantitative and qualitative method was used to analyze publications. In the quantitative phase, the author sorted publications into a priori categories, including approach to ethics, author, decade, country of publication, role of the physical therapist, and component of morality. During the qualitative phase of the research, the author analyzed and sorted the publications to identify common themes, patterns, similarities, and evolutionary trends. These findings were compared with the evolutionary models of Pellegrino and Purtilo. RESULTS: The 90 publications meeting inclusion criteria were predominantly philosophical, using the "principles" perspective; focused on the patient/client management role of the physical therapist; and addressed the moral judgment component of moral behavior. As predicted by Purtilo's model, the focus of identity evolved from self-identity to patient-focused identity, with increasing representation of societal identity. Recurrent themes included the need to further identify and clarify physical therapists' ethical dilemmas, the interrelationship between clinical and ethical decision making, and the changing relationship with patients. DISCUSSION AND CONCLUSION: Although knowledge of ethics grew steadily between 1970 and 2000, this retrospective analysis identified gaps in our current knowledge. Further research is needed to address the unique ethical problems commonly encountered in all 5 roles of the physical therapist; patient perspectives on ethical issues in physical therapy; variety in ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in physical therapy.

Ethics, Clinical↗

Narrative, literature, and the clinical exercise of practical reason.

Although science supplies medicine's "gold standard," knowledge exercised in the care of patients is, like moral knowing, a matter of narrative, practical reason. Physicians draw on case narrative to store experience and to apply and qualify the general rules of medical science. Literature aids in this activity by stimulating moral imagination and by requiring its readers to engage in the retrospective construction of a situated, subjective account of events. Narrative truths are provisional, uncertain, derived from narrators whose standpoints are always situated, particular, and uncertain, but open to comparison and reinterpretation. Reading is thus a model for knowing in both morality and clinical medicine. While principles remain essential to bioethics and science must always inform good clinical practice, the tendency to collapse morality into principles and medicine into science impoverishes both practices. Moral knowing is not separable from clinical judgment. While ethics must be open to discussion and interpretation by patients, families, and society, it is nevertheless substantively and epistemologically an inextricable part of a physician's clinical practice.

Ethics↗

Nurse participation in ethical decision making in the clinical setting.

Nurses, in their day-to-day practice, are required to combine clinical expertise with skill in moral judgment. Because of the nurse's unique relationship with the patient and a collaborative practice with the physician, the nurse often is at the forefront of identifying ethical dilemmas. In addition to identification of the ethical dilemma, the nurse often actively participates in the decision-making process. Ethical decision-making models bear some resemblance to the nursing process. The nurse plays an active role in each step of assessment, planning, implementation, and evaluation. An increasing number of nurses are formally participating in ethical decision making as a member of hospital ethics committees. The three primary tasks of these committees are: (1) education; (2) policy development; and (3) case consultation. Nursing ethics committees also are being developed to address issues specific to nursing, such as nurse staffing ratios and allocation of nursing resources. Nurses can use ethical rounds or retrospective case studies to perpetuate the study of ethics at the bedside.

Decision Making↗

Observers' reactions to genetic testing: the role of hindsight bias and judgements of responsibility.

In 3 studies, we examined the effect of birth outcome on observers' reactions to genetic testing. Participants read a scenario in which a woman declined to take a genetic screening test and subsequently gave birth to a child with a genetic disorder (negative outcome) or a healthy child (positive outcome). Retrospective judgments of the likelihood that the child would have a genetic disorder were higher given negative than positive outcome knowledge under conditions of high genetic risk. Moreover, the more likely a negative outcome was perceived to be, the more responsible the mother was held for not taking the genetic screening test. Consistent with Weiner's (1993) theory, responsibility judgments were linked to displeasure and sympathy, with sympathy in turn being related to help judgments.

Adult↗

The one-of-us effect in decision evaluation.

Judgment-by-outcomes denotes basing retrospective evaluation of decisions on the valence of their outcomes (success versus failure). Although decisions are typically evaluated in social contexts, so far judgment-by-outcomes has been studied without regard to this context. This study examines the moderating effect of evaluator's identification with the decision maker (the one-of-us-effect) on the influence of outcome information on the evaluation of Arab and Jewish subjects were presented with two cases recounting operations by either Arab or Jewish underground directed against the British authorities in Palestine. One case was a success (from the underground's point of view) and one ended in failure. Consistent with the one-of-us effect, identification with the decision maker variably canceled the influence of outcome information altogether, accentuated or weakened its influence, or determined which outcome constituted successful and unsuccessful outcomes. The one-of-us effect exercised a differential influence over different facets of decision evaluation, influencing most strongly the assignment of sanctions (in-group decision makers were mostly rewarded, out-group decision-makers were mostly punished regardless of outcomes). Next, in order of potency, the effect influenced the evaluation of decision justification, the evaluation of the decision maker, and the evaluation of the quality of decision process.

Adolescent↗

Ethics education and physician morality.

Medical ethics education remains an important venue of moral education. In spite of the intensity of these efforts, the desired outcomes of medical ethics education remain obscure, undefined and largely untested. In the first part of this study, the goals of medical ethics are operationalized along cognitive, behavioral and attitudinal dimensions. This includes a written moral judgment test, a survey of ethical confidence, competence and interest, attitudinal surveys of physician assisted suicide, and aggressive treatment of newborns and, finally, self-reported behavior about the frequency of pro-bono work and treatment of self-abusive patients. Medical ethics education is operationalized by the type, scope and intensity of ethics education throughout a physician's education and subsequent career. Data were collected by a questionnaire distributed to the staff of a large urban hospital in 1996 (n = 200, response rate = 41%). Causal models measure the effects of medical education. The results suggest that ethics education plays an important but limited role in the attainment of these cognitive, attitudinal and behavioral outcomes. While some outcomes such as moral development, and ethical confidence are unaffected by ethics education, other attitudinal and behavioral objectives, such as ethics interest and pro-bono work are positively associated with formal ethics training as well as with demographic variables such as religious observance and age. Ethics education does not function as an isolated factor but as part of a web of interrelated factors that influence educational outcomes. In addition, it is clear that ethics education resists quantitative analysis to some extent. Rather, it is sometimes viewed as a discipline that is studied for its own sake with the hope that it may contribute to one's all around character in a way that cannot be directly assessed. These implications are explored in the conclusion of the paper.

Adult↗