TAG ARCHIVES FOR OHRP

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 Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))."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

27
Dec2018

Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust in the research enterprise. Responsible Conduct of Research (RCR) principles are broad, and provide scientists and scholars from every discipline with a guiding framework of professional responsibilities. Many IRB professionals and members may not realize that “protection of human subjects” is one of the core RCR topics. Gaining knowledge about RCR and research integrity can help IRB and HRPP personnel enhance and promote ethical research. On October 25, PRIM&R hosted a webinar to provide an overview of RCR and explain its importance and relevance to the human subjects research community. Read more

24
Jul2018

On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more

13
Jun2017

Over the coming months, I’m going to look more closely at a few areas of the revised rule. I won’t be giving tips on implementation, just pointing out some of what I find interesting in a few specific areas. In this post, I’m going to take a deeper dive into the changes around informed consent, an area that, as I mentioned in my preliminary reflections on the rule, I am pretty excited about. Read more

7
Oct2016

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more