TAG ARCHIVES FOR Question of the Month


You are the chief human research protections officer at a prestigious academic medical center (AMC). You have just discovered that two doctors on your staff have been secretly conducting a clinical study on their patients. The doctors have broken every rule in the human subjects protection book. They did not even tell their patients they were in a clinical study, and some of them died. The president of the AMC has called a meeting this afternoon where you will have to explain the situation and make your recommendations. What a nightmare! To complicate things, it turns out that the study treatment is an astonishing medical breakthrough that can save thousands of lives. The doctors want to submit a paper to a major medical journal by the end of the week. A Nobel Prize could be in order. Read more


You are a member of an IRB that is reviewing a study on the effectiveness of placebo “treatments.” It is well known that different sizes, shapes and colors of pills cause different levels of the placebo effect, which also varies by the therapeutic indication and the country/culture. The investigators want to test the placebo effect across a broad range of diseases and countries. The placebo pill will be presented as a “booster” to their current treatment--not a placebo.  Read more


You are a member of an IRB that is reviewing a diagnostic study for a new viral disease, PVD, that, in exactly 50% of those infected, causes Polaiteir dementia. The PVD virus has infected the entire population. Dementia does not evidence itself until age 70. If detected before age 30, it can be treated successfully. The experimental test is believed to be 100% accurate in identifying who will get dementia. However, it has the unique “quantum” effect of flipping the medical condition of the person tested. A person who would not have gotten dementia will leave the test and later get dementia, and vice versa. In other words, the test itself will cure 50% of those tested, and give dementia to the other 50%. The test can be taken only once. In either case, study participants will learn whether they have the condition, and can then plan their lives accordingly. In addition, results from the study will tell the researchers how to end the quantum flipping effect. Read more


You are the chairperson of an IRB overseeing a study comparing three diabetes drugs. Some of the study participants have been talking about the study on social media. The investigator believes their posts have affected study enrollment, adherence and retention. How should the investigator deal with study participants who are sharing their study experiences online? Read more

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