Historically, medically-oriented research has dominated the ethical discussions that underlie federal regulations around human subjects protections. 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
While it may be a common complaint among researchers that IRBs overregulate, many IRBs opt to “uncheck the box” by building additional flexibility into the regulations that allows them to reduce investigator burden while still ensuring equivalent protections for human subjects. Read more
This week’s Research Ethics Roundup looks at a top Food and Drug Administration (FDA) official’s speech on real world evidence, a National Academies report that highlights the lack of guidance for the research community on the security concerns around dual-use research, how and why the All of Us Research Program is working with traditionally marginalized communities, and the effectiveness of Animal and Plant Health Inspection Service (APHIS) inspections of Agricultural Research Service facilities. Read more
Study teams and regulatory teams have different perspectives when it comes to executing research protocols, due simply to the different day-to-day responsibilities of a study team member versus a regulatory team member. While the ultimate goal of any research protocol is to generate new knowledge while protecting the rights and welfare of research subjects, sometimes study and regulatory teams differ on how to best achieve this goal. I have been fortunate enough to have worked as both a study and regulatory team member and have gained insight into how these teams differ and how they can best work together to ensure that research protocols run smoothly and achieve the highest standards of ethical research conduct. 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