This blog summarizes the major provisions of the second NPRM, which is focused primarily on harmonizing language, definitions, and informed consent requirements in 21 CFR 50—Protection of Human Subjects, and on harmonizing provisions around continuing review, IRB review generally, and IRB membership, in 21 CFR 56—Institutional Review Boards. Read more
Since I started working for our IRB in 2010, we have seen an increase of studies using software and medical apps. The uses of the software vary greatly and involve using software to monitor sleep, physical activity, diet diary, mental health among many other uses. This makes the application of device regulation quite confusing, and discussion, with case examples, among IRB professionals can be incredibly useful in exploring how best to apply the regulations and guidance. Read more
Last week, PRIM&R submitted comments in response to a request for information (RFI) on a draft report issued by the federal Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. Comments on the draft report are due February 20, 2019, and we encourage you to consider submitting your own comments. The community is welcome to cite PRIM&R’s comments or borrow any of the points we make Read more
Have you been keeping up with PRIM&R in the news? Here are some recent articles written or contributed to by PRIM&R’s executive director, Elisa A. Hurley, PhD, regarding lab animal oversight and the revised Common Rule. Read more
PRIM&R recently submitted comments in response to National Institutes of Health (NIH)’s March 14 request for information (RFI) on how best to improve the coordination of regulations and policies with respect to research with laboratory animals as prompted by a mandate in the 21st Century Cures Act. Comments on the RFI are due June 12, and I wanted to share what PRIM&R submitted in case the comments are helpful as you consider developing and submitting your own comments to NIH, which is coordinating the RFI with the Food and Drug Administration and the Department of Agriculture (USDA). Read more
