5
Dec2022

I was working at my first “real” full-time job after college as a research assistant on clinical trials for Alzheimer’s disease when the HIPAA Privacy Rule first rolled onto the scene (let’s not do the math on this, it makes me feel old). I remember many in the research community having one of two immediate reactions to the new requirements: either “Oh my gosh, this is going to bring research to a screeching halt” or “This is completely unnecessary; we already get informed consent from participants so why do we need HIPAA?” While this is all ancient history now, and we obviously know that neither was research in the U.S. hobbled nor was HIPAA abandoned, it [...] Read more

28
Nov2022

How many of you can relate to this? I’m sure I’m not alone! To paraphrase a common idiom, “We may not have it all together, but together we have . . . most of it.” So, let’s all meet up at the all virtual  2022 PRIM&R Annual Conference(PRIMR22) December 12 -15 with workshops December 6 & 8! There is a packed agenda with crossover content for the entire research community.  Read more

8
Nov2022

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

4
Nov2022

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

31
Oct2022

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