“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
This month's scenario: You are on a committee tasked with advising the FDA on whether certain past actions unrelated to clinical research should disqualify a physician from conducting clinical studies. 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
After over five years of discussion—from the advance notice of proposed rulemaking and two implementation delays—the revised Common Rule finally went into effect on January 21, 2019. The delays in implementation, while frustrating at times, also gave institutions more time to plan and discuss best practices. Through all this discussion, however, many areas of ambiguity were identified including challenges on how to implement the changes. To help address these issues, PRIM&R held a panel on Operationalizing the Revised Common Rule at the 2018 Advancing Ethical Research Conference (AER18). While change can be challenging, working together to share ideas and best practices can help ensure the transition goes as smoothly as possible. Read more
It’s been suggested by some that it is time to jettison the term “research subject” from our research ethics vocabulary—including in the regulations—and exclusively use the term “research participant” to refer to those who enroll in research. While there are many compelling arguments for using "participant" instead of "subject" in the modern research context, PRIM&R's executive director, Elisa A. Hurley, PhD, argues that we need to keep both research "subject and research "participant" in our shared vocabulary. Read more
Last week, PRIM&R submitted comments in response to a request for information (RFI) on a draft report issued by the federal Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. Comments on the draft report are due February 20, 2019, and we encourage you to consider submitting your own comments. The community is welcome to cite PRIM&R’s comments or borrow any of the points we make Read more