In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change described in the revised Common Rule.
The effective and compliance date for the revised rule is January 19, 2018, and with this date on the horizon, webinar attendees had many questions for the presenters about the new rule and what implementation might look like in their own human [...] Read more
Many of us have read the Common Rule revisions around informed consent and scratched our heads. What exactly does it mean that “informed consent must begin with concise and focused…key information that is most likely to assist in understanding reasons one might or might not participate”? My hope is that key information will become the vehicle that drives greater subject understanding and gives reviewers some relief. I look forward to seeing how the guidance around and the implementation of this section develops. Read more
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