TAG ARCHIVES FOR key information

25
Mar2019

“One person’s flexibility is another person’s ambiguity.”

I kept going back to this comment, articulated by Carrie Wolinetz (NIH), as I helped my HRPP prepare for the revised Common Rule implementation in January.  Although Dr. Wolinetz was referring to the NIH’s Genomic Data Sharing Policy, the phrase is a perfect expression of my thoughts on the “concise and focused presentation of the key information” that now must appear at the beginning of consent forms.

This topic was addressed at the AER18 plenary session “To Participate or Not to Participate, that Is the Question.” Moderated by Ivor Pritchard (OHRP), panelists Celia Fisher (Fordham University), Jonathan [...] Read more

7
Jul2017

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