“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
Over 2,500 research ethics professionals from the federal government, industry, and academia attended PRIM&R’s 2018 Advancing Ethical Research conference. The number of people attending the conference was thrilling to observe. I could not help but feel pride at seeing the many individuals tasked with maintaining ethical standards at various institutions. At the conclusion of one of the panel sessions, I was inspired to video record my day (using Hyperlapse, a time-lapse recording app). Read more
The teaching of ethical principles is included in many courses that train researchers on “responsible conduct of research”. The IRB 101sm preconference program at the 2018 Advancing Ethical Research Conference (AER18), however, was unique in describing the history of the development of modern research ethics, and then providing practical application in real research practice. Read more
I am thrilled to attend my second PRIM&R Advancing Ethical Research Conference (AER18) and to share my experiences as a Blog Squad member! With so many recent and forthcoming regulatory changes—the revised Common Rule, NIH single IRB of record mandate, and the EU General Data Protection Regulation (GDPR), just to name a few—this is an exciting time for the human research projections community, and I am delighted to explore these topics with you! Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials," which was published in the Federal Register on June 4, 2018.
We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are met. Presently, adolescents with cancer need to [...] Read more