Study Questions

1. Joel Martin, a pediatrician at a residential facility for mentally retarded children, has been approached by the Modern Pharmaceutical Company. The company would like Dr. Martin to enroll children aged 4 to 7 in one of their clinical trials for a new drug to treat conjunctivitis (pinkeye). Dr. Martin recognizes that the children's parents would be able to give informed consent or refusal on behalf of their children, that risks have been minimized, and that overall, the study drug is likely to help the participants. He is concerned, however, about the drug companies' decision to enroll retarded children before healthy children in the community. Modern's representative points out that the incidence of conjunctivitis in the facility is very high and so provides an excellent setting for the study to be completed quickly. Dr. Martin considers the population of the facility extremely vulnerable. The ethical principle that underlies Dr. Martin's concerns is:

(A) Autonomy

(B) Beneficence

(C) Nonmaleficence

(D) Justice

(E) Medical neediness

2. The main ethical problem with medical research in economically developing nations in which subjects are medically underserved is that:

(A) Subjects are frequently not compliant, as they do not understand the importance of the study, raising ethical issues about risks and benefits for the subjects that complete the study.

(B) Researchers cannot generalize from the outcome with a medically underserved population to draw conclusions that would be applicable in the United States because of the numerous other variables that affect the outcome of the study.

(C) Subjects are not asked to give informed consent, as they cannot understand the complexities of a research study.

(D) Subjects are included in studies of treatments that are not available in underserved countries but are available in the United States, raising issues of equity and fairness toward disadvantaged populations.

(E) Subjects are deprived access to medical treatments that would be available in their country were they not part of a randomized, placebo-controlled study.

3. When does a conflict of interest occur?

(A) When an individual's private goals are inconsistent with that person's official responsibilities

(B) When an individual's research interests are in conflict with the research of an individual in another institution or corporation

(C) When two researchers want to do research in the same area but there is only enough available funding for one researcher to do the research adequately

(D) When an individual has a conflict between his or her research interests and the requirements set forth by the Nuremberg Code

4. Susan Brown, a community-based internist in Little Town, U. S. A., has received a letter inviting her to become a consultant to the Modern Pharmaceutical Company. Modern would like Dr. Brown to attend a medical consultants' meeting at the Golden Sunset Resort, an elegant resort about an hour away from Little Town. The agenda includes a Saturday morning presentation by representatives from Modern, with time over lunch for the medical consultants to give feedback to the company representative about the company's products. The rest of the weekend is unscheduled time for Dr. Brown to enjoy the resort. Dr. Brown will be paid $1000 for her consulting services. When considering whether or not to attend Dr. Brown should: (A) Decide whether she thinks she would be biased toward Modern products by the company's generosity; if she believes she can remain objective, it is acceptable to attend.

(B) Determine whether she feels favorably toward Modern's product line; if she already prescribes Modern products and prefers them to the competition's, she cannot be biased by their presentations, so there is no ethical issue in attending.

(C) Consider how important it is for drug companies to be able to get feedback on their products from physicians and attend to ensure that the company gets accurate information.

(D) Consider that her time is valuable, so she deserves to be compensated by Modern.

(E) Consider the guidelines by the American Medical Association and choose not to attend under the stated conditions.

5. A helpful criterion suggested by the American College of Physicians when considering the ethical appropriateness of a particular interaction between a physician and industry is to:

(A) Determine whether the interaction violates any laws or statutes; if not, the action is acceptable.

(B) Determine whether one would be willing to have the arrangement generally known; if not, the action should be avoided.

(C) Determine whether the action compromises the profit margin of the pharmaceutical company and therefore is not in the interest of the shareholders; if so, the action should be avoided.

(D) Determine whether patient care is negatively affected; if not, the action is ethically acceptable.

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