Answers

1. D. The principle of justice is a relevant consideration when subjects are selected for clinical research. It requires that members of a vulnerable population, such as institutionalized patients with mental retardation, not be exploited. The principle of autonomy would be most relevant to the parents' ability to consent or refuse on the child's behalf, something Dr. Martin thinks is handled satisfactorily. Dr. Martin believes risks have been minimized and the overall study drug is likely to help the participants, so the study has satisfied the principles of nonmalef-icence and beneficence. The principle of medical priority is not mentioned in the chapter and pertains to treating the most medically needy patients first, which is not at issue here.

2. D. An ethical issue arises when one includes medically underserved patients in a study without providing them with the level of care available to others. Problems with noncompliance, while potentially damaging to a study, do not pose ethical problems in medically underserved populations not encountered elsewhere. Effective study design can overcome problems with generalizing from one population to the next. Subjects everywhere should be provided with information at a level the subject can comprehend and asked to give informed consent. Subjects in medically underserved populations are not deprived of access to medical treatments that are available in their own country, only those that are available only elsewhere.

3. A. A conflict of interest occurs when an individual's personal interests conflict with official responsibilities, such as those required by one's profession. So, for example, a physician who owns shares in a drug company that is sponsoring a clinical trial in which the doctor enrolls patients may have a conflict of interest. Conflicts of interest do not generally pertain to conflicts between researchers or the requirements set forth by the Nuremberg Code.

4. E. The American Medical Association guidelines suggest that Dr. Brown should not attend. Clearly, the educational nature of the meeting is dubious. Even if we consider it a consultancy rather than an educational meeting, Dr. Brown's role as a "consultant" is not well specified, and the compensation for her consultancy may be seen as excessive. Although she may believe that she can remain objective despite the company's generosity, numerous studies show that prescribing patterns change in response to pharmaceutical company largesse. Similarly, the fact that she often prescribes their products does not mean that her objectivity cannot be compromised. For example, she may not consider new products from other companies as carefully because of her preference to keep prescribing Modern's products. While admittedly her time is valuable, the amount this company will spend on her expenses and honoraria far exceed what is reasonable.

5. B. Considering whether one would be willing to have an arrangement generally known is a quick test of the ethical appropriateness of an action. While some individuals may have a relatively low standard for what they would be willing to have publicly known, for most people this test can provide a useful guideline. The simple fact that an action falls within the law does not make it morally acceptable. Considerations of the profit margin for the pharmaceutical company shareholders is impor tant for company employees but bears little relevance on physician-pharmaceutical company interactions, in which the physician is supposed to be primarily a patient advocate. Finally, although patient care may not be directly affected by an action, the action may be ethically problematic if it gives the impression that the physician is under undue influence of the pharmaceutical company and thereby willing to put patient care behind company profit.

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