Quesiton : An investigator is recruiting subjects for a study of a new antidepressant drug. The investigator has targeted a population of patients who might clearly benefit but who are also institutionalized for a variety of psychiatric conditions. The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study. Which of the following issues of vulnerability should be of most concern to the IRB?A. The patients have clinical depression which is a difficult disease to treat.B. The patients are institutionalized.C. The patients are probably illiterate.D. The patients may have experience participating in research.
Answer: B. The patients are institutionalized.
Most relevent text from all around web: An investigator is recruiting subjects for a study of a new antidepressant drug. The investigator has targeted a population of patients who might clearly benefit but who are also institutionalized for a variety of psychiatric conditions. The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study. Which of the following issues of vulnerability should be of most concern to the IRB?A. The patients have clinical depression which is a difficult disease to treat.B. The patients are institutionalized.C. The patients are probably illiterate.D. The patients may have experience participating in research.
The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study . Which of the following issues of vulnerability should be of most concern to the IRB? A . The patients have clinical depression which is a difficult disease to treat. B . The patients are institutionalized. C .
While the study is ongoing a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following ? Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research ...
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Conducting Outpatient and Inpatient Clinical Research Using Legend or Investigational New Drugs ... Investigator Dispensing and Study Drug Management Requirements. A. Maintaining a Drug Accountability Record. The investigator must maintain records of the product's delivery to the study site the inventory at the site the use by each subject ...
that the clinical investigator ha...
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