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Informed Consent - Diminished Competency - Case H1

Monique Tavernier is meeting with the institutional review board (IRB) at the medical center where she works. She has designed a clinical protocol to study a promising new drug for the treatment of Alzheimer's disease. She must now answer the IRB's questions concerning how the protocol will be conducted and how concerns for patient safety will be handled.

In the proposal she forwarded to the IRB, Dr. Tavernier explained that this will be a double-blinded clinical trial in which some patients will receive a placebo and others will receive the new treatment. Based on earlier studies of the drug, Dr. Tavernier knows that patients may experience improvements in memory and other cognitive functioning, though not without risk. The drug can exacerbate hypertension in those already prone to the condition, and if doses modestly exceed clinically effective levels, severe kidney damage can result. In general, the drug seems most effective for those individuals who are in the early to middle stages of the disease. She will recruit this type of individual through Alzheimer's support groups and advertisements placed in the newspaper. Prospective patients will be interviewed to see that they fit the desired patient profile. Her interview will involve asking a series of questions designed to assess the extent of the patient's impairment and sense of orientation to the environment. Those selected to participate in the trial will be paid $300 for their time and trouble.

The IRB has many questions for Dr. Tavernier.

Questions:

  1. One IRB member asked, "You realize, Dr. Tavernier, that in spite of your focus on the earlier stages of the disease, your patients will have nonetheless cognitive impairments ranging widely in nature and severity. How will you be certain that your patients have understood the objectives, risks, and benefits of your protocol? Even patients that seem lucid and appear to understand your explanation may not retain the information you provide."; How might Dr. Tavernier handle this problem?
  2. Assume that Dr. Tavernier intended to seek consent from relatives in situations where the patient appeared unable to provide fully informed consent. Should a relative be permitted to do this on the patient's behalf! Who looks after the patient's interests in this instance? What are the legal requirements that should guide one's consideration of this issue?
  3. Another IRB member said, "I did a study involving Alzheimer's once. It's surprising how many families refuse to deal with the condition openly. How will you respond when well-intending relatives bring patients to your clinic asking that you either be oblique about the purposes of the study, or even lie to the Alzheimer's patient about the disease in question?" How should Dr. Tavernier respond? What are her obligations to the patient relative to providing information on the study?
  4. The same IRB member followed up on her question by stating, "Family members desperate to see their loved ones receive effective treatment may push patients in your direction with false hopes in mind. How can you ensure that your patients aren't being coerced to participate in your trial?" How might Dr. Tavernier deal with this potential problem?
  5. One IRB member stated, "I'm a little concerned about the financial incentive you are offering for participation in the study. Won't this money be more influential to the relative who refers the patient than to the patient herself?" What kinds of incentives or problems could be created by such an inducement in this instance?
  6. Society has an interest in the conduct of research on patients with Alzheimer's disease and other conditions that render patients incompetent. Discuss the balance between the protection of the rights and autonomy of the individual and the needs of society for scientific progress.
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