TAG ARCHIVES FOR Question of the Month

4
Jun2018

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

16
Mar2018

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

21
Feb2018

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

8
Jan2018

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