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
TAG ARCHIVES FOR Question of the Month
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
You are a member of an IRB reviewing a study protocol for a new artificial heart that, if approved by the FDA, will likely save many lives. The study sponsor, a very small company, plans to test the device in patients who will probably die without the device. It cannot afford to test the device with an adequate sample size, so it proposes to increase the sample size with funds raised by auctioning off the right to participate. Any delay in approval will likely cost lives. You have no other information to make your decision and no clever way to dodge it. How will you vote? Read more
You are the principal investigator/owner at an independent clinical research site that is struggling financially. The first person you enrolled in a cardiology study had a serious stroke after one week in the study. The person had no history of strokes or related conditions. After unblinding, your SAE report to the very large CRO identified the study drug as causation. After a heated discussion, the CRO’s medical monitor says he will “overrule” your conclusion and report the SAE (on your behalf) to the IRB and FDA with unknown causation. To prevent further issues, the study will be closed at your site. Should you tell somebody about the situation? Read more
You are the director of human research protection at a community hospital. You have one IRB with seven members. Six of the members are physicians with staff privileges at your hospital. The seventh member, a representative from the community, just resigned from the IRB. Six qualified people have applied to fill the empty seat: a bioethicist, a minister, a former study participant, a community leader, a sociologist, and a member of a disadvantaged group served by the hospital. Because of a hospital policy that is set in stone, you can accept only one new IRB member. Read more