The research ethics community mourns the loss of Charles R. McCarthy, PhD, a giant of the research ethics field and a beloved member of the PRIM&R family, who passed away on October 14, 2022, at the age of 96. ”Charlie,” as he was known to all who were lucky enough to know and work with him, served on the PRIM&R Board of Directors from 1993 to 2011. He was awarded PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics in 2003, became a Distinguished Leader of PRIM&R in 2012, and was recognized as a Pillar of PRIM&R in 2021. Charlie was a true founding father of the field of human research protections. While at the NIH in the early 1970s, Charlie helped to draft the National Research Act for the US Congress. Enacted in 1974, the National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and required that Department of Health Education and Welfare (DHEW) create human subjects protection regulations. Charlie served as the DHEW liaison to the National Commission, which went on to create the Belmont Report, and drafted for DHEW the first set of regulations for the protection of human subjects of research. Read more
Critical role IRBs could play in shaping health outcomes in minority groupsTags:
But how can IRBs engage communities while operating within the boundaries of their current regulatory role? Do IRBs have an ethical obligation to be proactive in ensuring diversity in clinical trials? Indeed, IRBs are uniquely positioned to influence research practices toward an equitable and more inclusive research world. Perhaps, the FDA and HHS should consider revisiting the scope of responsibilities of IRBs to provide broader latitude for making a greater impact on public health. The questions in this blog are the types of engaging thoughts I plan to discuss during the 2022 PRIM&R Annual Conference. I am most grateful that PRIM&R is providing a forum to discuss these important thoughts and expect more ideas will be generated as we continue the journey of straightening the path towards health equity for all. Read more
Expanded Access for Tecovirimat (TPOXX): An Explainer for IRB and other regulatory professionalsTags:
IRB and other research regulatory professionals in the United States may not be familiar with Tecovirimat (TPOXX). This explainer is intended to acquaint them with basic facts about TPOXX and the efforts currently underway to 1) use it to treat patients with monkeypox and 2) collect efficacy and safety information concerning such use. This explainer deals with both the US Centers for Disease Control and Prevention (CDC)-run Expanded Access program for TPOXX and the only trial of Tecovirimat as a treatment for monkeypox currently underway in the United States, the Study of Tecovirimat for Human Monkeypox Virus (STOMP). This explainer is up-to-date as of October 25, 2022. Read more
Meet the PRIMR22 Blog Squad
PRIM&R is pleased to introduce the members of the Blog Squad for the 2022 PRIM&R Annual Conference. The Blog Squad is comprised of PRIM&R members who will share their insights before, during, and after the conference.
Stay tuned as they share their conference insights on Ampersand.
Casey Mumaw, CIP, has worked in the IU Human Research Protection Program for the last eleven years and earned his CIP credentials nine years ago. At IU, his role [...] Read more
FDA releases draft guidance on ethical consideration for pediatric clinical investigationsTags:
On September 25, the US Food and Drug Administration (FDA) released a draft guidance, “Ethical Considerations for Clinical Investigations for Medical Products Involving Children.” The draft guidance is intended to help industry, sponsors, and IRBs when considering enrolling children in clinical investigations of drugs, biological products, and medical devices. Public comments are being accepted until December 27, 2022. Read more
Do the 3Rs need to evolve for modern translational research with mice?Tags:
Circling back to the 3Rs, if 90% or more of most research studies are already using mice, should we expand the 3Rs and ask the IACUC to interpret the use of mice more judiciously for research? Reproducibility, repeatability, rigor, relevance and rationalization all start with ‘R’ and in today’s world may potentially be more important factors to consider than replacement, reduction, or refinement. As an animal resources director, IACUC Chair and research investigator, I fully recognize these questions are ‘hot button topics’ that are both sensitive and often controversial. This is especially true if the science using mice isn’t peer-reviewed by an external agency and the IACUC is also charged with (in some manner) evaluating the science behind the use of animals. Smaller institutions, which have fewer resources and scientists conducting large-scale experiments with mice, are probably at an even bigger disadvantage when faced with expanding the 3Rs to determine if the use of animals is justified in an unfunded scientific proposal. Read more