TAG ARCHIVES FOR revised common rule

15
Jan2019

Despite the partial government shutdown, it’s business as usual at the Office for Human Research Protections (OHRP), and the revised Common Rule will go into effect, as planned, less than a week from today, on January 21, 2019. Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))." Though it’s coming about six months later than would have been ideal, this is the most useful guidance related to the revised Rule released to date.   Read more

20
Dec2018

The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2019. I arrived in sunny San Diego early morning Wednesday, November 14, for the 2018 Advancing Ethical Research Conference (AER18) on a mission to learn everything I could about these federal policy changes. Read more

19
Nov2018

The IRB Administrator 201 portion of PRIM&R’s IRB Administrator Boot Camp was very insightful and provides a good opportunity to apply critical thinking skills to real life scenarios faced by other IRBs. The presentations on implementation of the revised Common Rule and single IRB review considerations are particularly relevant with regard to the anticipated changes. A great deal of templates and samples were provided as examples of how other institutions are attempting to navigate the Common Rule changes and this is certainly an area in which IRBs can learn from each other. Read more

8
Nov2018

I had the pleasure of attending PRIM&R’s IRB Administrator Boot Camp (including IRB 101 and 201) in Chicago and it was a great experience! All of us are facing new challenges and uncertainties with the Common Rule update and it is difficult to anticipate how changes will be implemented in the future. It was reassuring to hear that other institutions are optimistic about future transitions, especially concerning the not-so-distant single IRB mandate. Read more