In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018. One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more
This week’s Research Ethics Roundup looks at the first known US-based attempt of changing the DNA of embryos with CRISPR, the results of a large-scale wellness study, why researchers are challenging the notion that pregnant women are a “vulnerable” research population, and why European researchers are choosing to be transparent about their research with animals. Read more
For those of us in human research protections, the Common Rule changes were the most hotly anticipated item of 2016. The unveiling of the final changes on January 19, 2017 has been, for so many of us, a source of confusion, consternation, stress, and in some cases, relief. Read more
Ruth Faden, PhD, MPH, is director of the Johns Hopkins Berman Institute of Bioethics and a senior research scholar at the Kennedy Institute of Ethics at Georgetown University. She was co-recipient of PRIM&R’s Lifetime Achievement Award in 2011 with her husband, Tom L. Beauchamp.
When I was pregnant with my first child more than 30 years ago, I developed a serious medical problem (deep vein thrombosis) and was put on heparin, a blood thinner. With every injection, I worried about whether I was doing the right thing, [...] Read more
by Wendy Tate, PSM, CIP
By this time almost everyone is familiar with the advance notice of proposed rulemaking (ANPRM) that recommends vast changes to the human subject regulations known as the “Common Rule.” As I read the memorandum, table of changes, and 92-page document, one thing kept popping into my mind: What about the subparts?
Being “in the trenches” at a university that supports both medical and social/behavioral research, I find it frustrating to apply subpart B (research involving pregnant women) to non-biomedical research and/or minimal risk biomedical research. Granted, subpart B is not technically part of the “Common Rule,” and as such is not included in the recent ANPRM. [...] Read more
