For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” Read more
TAG ARCHIVES FOR revised common rule
“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
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
The 2018 Advancing Ethical Research Conference (AER18) presentation titled “It’s Not as New as You Think: Understanding How to Operationalize the Revised Common Rule” provided information regarding the history of the Common Rule and the recent changes to it. It is important that IRB professionals and staff become familiar with these revisions, as they have important implications for the oversight and the conduct of medical research. Presenters Jeffrey A. Cooper, MD, MMM; Kristin Craun, MPH, CIP; Jessica Huening, JD; Heather Pierce, JD, MPH, helped to clarify much of the confusion concerning the recently revised regulations. Key changes in the revised Common Rule were emphasized. An important part of the presentation delineated what happens as these revised rules become effective. This was helpful in understanding how to transition from the “original” Common Rule to the revised Common Rule. Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. Read more