Human Subjects
Case 1: Competence for Informed Consent
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Case 4 | Case 5

The institutional review board (IRB) receives a proposal to study a promising new drug for the treatment of Alzheimer's disease. The proposal is for a double-blinded clinical trial in which some patients will receive a placebo and others will receive a new drug treatment. Based on earlier studies of the drug, patients may experience improvement in memory and other cognitive functioning, although not without risk. The drug can exacerbate hypertension in people already prone to the condition, and if doses modestly exceed clinically effective levels, severe kidney damage can result. In general, the drug seems more effective for those people who are in the early to middle stages of the disease. Participants will be recruited through Alzheimer's support groups and advertisements placed in the newspaper. Prospective participants will be interviewed to see that they fit the desired profile. Interviews of the patients with Alzheimer's disease will involve asking a series of questions designed to assess the extent of the patient's impairment and sense of orientation to the environment. The patients selected to participate in the trial will be paid $300 for their time and trouble.


  1. The prospective patients are likely to have varying degrees of cognitive impairment. How can the investigator ensure that the patients adequately understand the objectives, risks, and benefits of their participation?

  2. If cognitive impairment is severe, then according to the study protocol a relative will be asked to provide informed consent. Should this be allowed?

  3. Are precautions needed to protect against desperate family members who may try to coerce their relative with Alzheimer's disease to participate in such a study? If so, what steps can be taken to ensure that such coercion does not happen.

  4. Do the potential benefits to society outweigh or diminish the need to protect the rights and autonomy of the person with Alzheimer's Disease?


This case is modified from Case H1 (p. 145) of the Teaching the Responsible Conduct of Research Through a Case Study Approach handbook prepared by the Association of American Medical Colleges (Korenman SG and Shipp AC, 1994)