Informed consent and the old-fashioned conscience of the physician-investigator.
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Confidentiality has been argued to be a cornerstone both of medical and social research encounters, particularly because of the protection it offers for patients and informants. In practice the idea of confidentiality is fractured. Professional interests in the organisation of medical work, and concerns for the collective interest amongst social researchers may lead to individual confidentiality being undermined. In addition discrepancies in the ethical positions and practices of social researchers and those in biomedicine may produce further problems for the maintenance of confidentiality.
The traditional identification of physicians as either clinician or researcher is challenged by the emergence of randomized clinical trials (RCTs) where research and clinical care are performed simultaneously. A mail survey using a self-administered questionnaire, the Physician Orientation Profile, was conducted of 101 physicians from the Collaborative Ocular Melanoma Study (COMS), a set of trials which compares surgical removal of the eye with radiation in the treatment of medium sized eye cancers. A 95% response rate was obtained; follow-up telephone interviews were conducted with 87% of respondents. Key findings suggest that RCTs challenge traditional definitions of physician's 'core task,' because they participate in a social process that requires them to integrate the formerly disparate and sometimes competing roles of researcher and clinician. Three implications of this integration are discussed: amending the expert reward system, altering customary clinical practice and redefining reference groups for professional interaction.
Relatively little consideration has heretofore been given to the interaction between Western clinical research ethics and non-Western ethical expectations. How should any conflict that might arise when a biomedical investigator and a research subject come from different cultural settings and have different ethical expectations be addressed? Which ethics should govern such trans-cultural clinical research? The answers to these questions are of increasing importance because many countries of the developing world are presently sites of field testing of biomedical agents sponsored and administered by countries of the developed world, especially in the context of the AIDS pandemic. Drawing mainly on examples from Asian medical systems and settings, I elucidate four possible ethical models to guide the conduct of transcultural biomedical research. Two assume that research ethics are culturally relative and two assume that a unified, universalistic conceptualization of research ethics is possible. All four, however, are problematic and are to a large extent deficient. The cause of the deficiencies of these models lies, I argue, in the way that ethics are ordinarily conceived. The proper approach to ethical conflict recognizes that culture shapes (1) the content of ethical precepts, (2) the form of ethical precepts, and (3) the way ethical conflict is handled. Medical ethics may be viewed in cross-cultural perspective as a form of 'local knowledge', and any differences in such knowledge between cultures--since such differences will not conveniently disappear--must be engaged and negotiated.
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This paper describes the ethical dilemmas which the authors encountered when conducting qualitative research with samples consisting of a small number of participants. Ethical conflicts are explored in terms of the principles of autonomy, non-maleficience, and beneficience with examples from the authors' research experiences. Although there are no definitive resolutions to these conflicts, the paper may increase awareness of the special concerns which require further study and debate.
A study of the help-seeking behaviours of alcohol dependent and problem drinking women raised a number of ethical issues. It had been anticipated that the design of the study and the construction and approval of appropriate consent forms would eliminate the majority of problems. While this was true, a number of unforeseen points emerged during the course of the study related to interviewing women, discussing emotive issues and the responsibilities of the researcher vis-à-vis their samples. This paper discusses the issues raised using specific examples drawn from the research study.
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Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific questions are raised about the difficulties of informed consent in different cultural settings and whether there is any role for community involvement. Discussants debate whether drug and vaccine trials not approved in an industrialised country are ever defensible if performed in a third-world setting. Potential conflicting priorities between investigators are discussed and ideas regarding conflict resolution are offered.
Three major tasks face the researcher in a medical experiment employing prisoners as experimental subjects. Understanding the nature of the subject, crossing the territorial boundary, and obtaining informed consent are prerequisites for the successful implementation of research in the prison and rely heavily on the personal integrity of the invesitgator.
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The Center for Research on the Acts of Man conducted a survey of the use of alcohol among the Inupiat of Barrow, Alaska, in 1979. The study resulted in grievances among many individuals and institutions associated with the community. In a retrospective analysis of the factors contributing to these misalliances, the author raises important ethical and procedural questions to be considered carefully in future projects of this nature.
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