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
Tremendous progress continues to be made against the Emperor of All Maladies, cancer. One of the most exciting areas of progress involves immunotherapy, a treatment strategy that harnesses the natural ability of the body’s own immune cells to attack and kill tumor cells. A lot of extremely hard work has gone into this research, so I was thrilled to learn that the Food and Drug Administration (FDA) just announced on August 30 its first approval of a promising type of immunotherapy called CAR-T cell therapy for kids and young adults with B-cell acute lymphoblastic leukemia (ALL)—the most common childhood cancer in the U.S. Read more
In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest. Read more