Cognitively impaired subjects

Article Abstract:

For some time, the use of human subjects in medical research has raised a number of ethical questions. Issues regarding research on patients who are cognitively impaired have not received much attention, but this type of research poses a particularly difficult problem for researchers. Because it is often essential to have the participation of these subjects in clinical studies, the question arises as to how to handle these cases, considering the individuals who are involved are not in a position to grant informed consent. Patients with conditions such as Alzheimer's disease, irreversible coma, and schizophrenia often suffer mental impairment and may be incapable of making any rational decisions. The American College of Physicians has set forth a position paper which addresses this issue. The rights and needs of this class of patients concerning their participation in research studies are emphasized, and four general positions are asserted and discussed. It is suggested that the patient may consent to participate in research prior to the loss of cognitive function. A mechanism could be developed to carry out the patient's wishes once he reaches the point of impairment. In the absence of such an advance directive, a legally authorized representative or surrogate may be entrusted to make decisions on behalf of the patient, presumably acting always in the patient's best interests. For patients who are institutionalized, special protections should be devised. It is suggested that this may consist of a institutional review board that would carefully consider each case and then make a recommendation. Finally, a national review body should be set up to devise guidelines and to oversee nontherapeutic research involving cognitively impaired subjects. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Industry reimbursement for entering patients into clinical trials: legal and ethical issues

Article Abstract:

When a promising new drug is developed, there is a period prior to marketing during which it is tested in controlled clinical trials, often in university or major medical centers. The pharmaceutical company may fund these studies, and often pay the costs for every patient enrolled in the study. These payments support the medical care of the patient, the costs of collecting and managing the research data, and expenses including researchers' time and laboratory supplies. However, these payments are often greater than the amount of money actually spent on the clinical study, and the researcher may use this money for laboratory supplies for other studies, or for travel expenses to scientific meetings and symposia. Therefore, a potential for conflict of interest exists on the part of the clinical researcher who conducts such studies. If the researcher perceives that a clinical research project is helping to support his laboratory, he might be more inclined to go forward than he might if the patients' welfare were the only deciding criterion. It is suggested that researchers must inform the patient about the source of funding for such research studies and of the possibility of conflict of interest. It is also suggested that the administration of the research funds be taken out of the hands of the researcher, so that any excess monies would not directly benefit the researcher, thereby reducing the opportunities for conflict of interest. (Consumer Summary produced by Reliance Medical Information, Inc.)

Economic aspects, Clinical trials, Medical research, editorial

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The Nazi doctors and Nuremberg: some moral lessons revisited

Article Abstract:

Periodic reminders about the atrocities committed by Nazi doctors at Auschwitz and the political context that encouraged them may prevent similar occurrences from happening again. An important lesson learned from this experience is the necessity of informed consent from all human participants in any study or treatment. A tight balance must also be maintained between regulation and independence of the medical profession by and from the government or economy. Recent breaches of medical ethics by scientists in the US point to the need for continued education.

Editorial, Analysis, Nuremberg Code, 1947

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