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
I recently screened for a clinical trial in which the consent form indicated that the product might make me feel "fizzy." I knew it meant to say dizzy, but I continue to enjoy the thought of how delightful it must be to feel fizzy! We don't usually think of the emerging threat of typos and bad grammar as a human subjects issue, but here’s why we should. Read more
The AER20 keynote address from Wylie Burke, MD, PhD, discussed the implications of the lack of diversity in research. This is a real problem in genetic research: how can a full range of genetic variants be studied if a non-diverse population is assessed? In community research, when obtaining consent, a researcher must make sure the community is fully informed about the extent of the research. Read more
As hospitals have become essential treatment centers for COVID-19 patients, clinical trial participants have become increasingly averse to attending check-ups and monitoring visits at these sites. Telemedicine is now being recognized not only as an option for those who do not have convenient access to healthcare, but also as a means by which clinical trials can be accomplished. Read more
On October 29, the Final NIH Policy for Data Management and Sharing was published. It will require “researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing (DMS) Plan” and will apply to any NIH-funded or -conducted research that generates scientific data. It will be effective as of January 25, 2023. The final rule isn’t perfect: there is no mandate to share data, and grantees will need guidance on crucial questions of communicating these complex issues to participants. Nevertheless, the rule represents a positive step toward expanded, responsible sharing of data, which is critical to both good science and just treatment of research subjects. Read more
