In collaboration with First Clinical Research, we bring you the Clinical Research Ethics Question of the Month: You are a member of an IRB reviewing a study of a marketed drug for treating depression. Previous studies of this drug have shown minimal side effects. They have also shown a very high, enduring placebo effect. In fact, the symptoms of most study participants improved, regardless of whether they received the study drug or the placebo. This study has a twist: The goal is not to assess the efficacy of the drug, but to assess the efficacy of participating in a study of the drug. In other words, the study itself is the treatment under investigation. Read more
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You are on a jury in a courtroom trial. The plaintiff is suing "everyone" for serious injuries received when she was hit by a car driven by the subject. The subject was in a clinical study of a medication that might cause drowsiness. A witness has testified that the subject appeared to be asleep at the time of the crash. Read more
This month's scenario: You are on a committee tasked with advising the FDA on whether certain past actions unrelated to clinical research should disqualify a physician from conducting clinical studies. Read more
You are the chairperson of a central IRB. You have learned that one of the sites in a study you oversee is achieving subject recruiting and retention rates far superior to that of other sites. An investigation has found nothing unethical or unusual about the site’s activities — the subjects just find the investigator’s personality irresistible. Read more
Scientists have created entities using artificial intelligence technology. These “betas” appear to have human-like intelligence and emotions so they could, for example, serve as companions for people who are lonely. The scientists want to conduct psychological experiments on them to improve their performance and reliability. While betas are not protected by human subjects protection regulations, the scientists have asked your institutional review board to review the ethics of the experiments anyway. Read more