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
While the FDA and OHRP share a mission in protecting volunteers in research, the FDA has a unique responsibility as a public health and consumer protection agency. The dual mission is reflected in the purpose for Investigational New Drug and Investigational Device Exemption regulations which propose to assure safety and rights of subjects, permit evaluation of a drug’s safety and effectiveness, and encourage discovery and development of useful devices intended for human use. Read more
On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials. Because the guidance is a draft, its content is open for public discussion and comment. Earlier this week, PRIM&R submitted comment to the FDA explaining how the guidance, while welcome, might be improved. Comments are due June 13, 2022, and we encourage others to submit their own comments (and feel free to borrow from ours)! Read more
In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning protocols were quick to give not-human subject research determinations because the application was presented as a software development project. More recently, many IRBs improperly issue exempt determinations because the application is presented as a secondary-use data project. Read more
Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed three AER21 sessions on implementing OHRP and FDA regulations. In each session, the presenters dismantled any fear I had surrounding interaction with regulatory entities by offering rubber-meets-the-road application of regulatory requirements and resources to be properly prepared. Read more
