TAG ARCHIVES FOR Question of the Month


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


You are a member of an IRB reviewing a Phase 2 study for cardozamine, a new drug for treating stress. One of the exclusion criteria in the protocol is: “Educated or employed as an attorney.” The cover letter on the application explains that the study sponsor has been sued on three occasions by attorneys who were study subjects, and does not want it to happen again. You have no other information to make your decision and no clever way to dodge it. Read more


You are a member of the board at Florida Central IRB. You are reviewing a vaccine study for Zika2, a deadly infectious disease that has recently emerged in Florida and is spreading fast. The only clinical study discussed in the Investigator’s Brochure was conducted in Brazil, where Zika2 originated. It provides scientifically sound evidence that supports the proposed study. However, you have just learned that, because of the emergency situation in Brazil, the investigators made the decision to conduct their study without regulatory or ethics committee approval, in a vulnerable population, and without informed consent. The Brazilian manufacturer and investigators will not be involved in the proposed study. Time is of the essence. Will you vote to approve the study? Read more


The zombie apocalypse has arrived and is threatening the survival of the human race. Researchers have developed a treatment that might restore zombies to normal health and non-infectivity. There is a reasonable probability that the treatment will work as a cure but not as a protective measure. Failure of the treatment would be fatal for the subject. Potential study participants will not have the capacity to give consent. To the contrary, they will vigorously resist participation. No other possible treatments are known. There are no functioning governmental authorities, so the fate of humanity rests on your IRB. Time is of the essence. Read more


In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.

This month's question:

Researchers have identified a previously unknown but fairly common viral disease in certain developing countries: infant maternalitis, in which an infant is born with a serious allergy to the mere presence of his or her mother. For reasons that are not understood, [...] Read more

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