Question

An investigator wants to conduct a funded study of the safety of a vaccine to prevent hepatitis C involving prisoners as subjects. Prisoners will receive either vaccine or placebo and then be asked to complete surveys and undergo physical exams to assess for adverse effects. In order to ensure that subjects will report side effects and cooperate with exams, prisoners who are judged by the guards to be most compliant and well behaved are nonrandomly assigned to the experimental arm; others are assigned to the control (placebo) arm. To encourage participation, prisoners are offered better meals and the opportunity for better‑paying jobs in the prison.

Are there any aspects of this study that you object to? Why? Identify those objectionable aspects. (There can be multiple answers)


A. Prisoners may consent to participation simply to obtain better meals and a better paying job (undue influence).

B. This study does not necessarily put the "interest of the subject ahead of the interests of science and society."

C. The study is funded, which would assume that the interests are purely financial instead of for the safety of the subjects, and thus the results cannot be trusted.

D. The guards will sell the vaccines to sick prisoners to supplement their income illegally.

E. Prisoners are too different from the general population, so we would not be able to make inferences about the general population based on the study's results.

F. This is a non‑randomized clinical trial.

Answer 1

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