PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was very inspiring. It provided me an opportunity to be immersed in an interesting learning opportunity, wherein I noted a common theme of this conference was to highlight the changes in the revised Common Rule and its practical implementation. 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
Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust in the research enterprise. Responsible Conduct of Research (RCR) principles are broad, and provide scientists and scholars from every discipline with a guiding framework of professional responsibilities. Many IRB professionals and members may not realize that “protection of human subjects” is one of the core RCR topics. Gaining knowledge about RCR and research integrity can help IRB and HRPP personnel enhance and promote ethical research. On October 25, PRIM&R hosted a webinar to provide an overview of RCR and explain its importance and relevance to the human subjects research community. Read more
On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more
At the 2017 AER conference, I caught the plenary session, “New Frontiers: The Changing Landscape of Research Regulations.” One of the presenters, John R. Baumann, PhD, the Associate Vice President for Research Compliance at Indiana University, shared with us how his institution was approaching the upcoming changes to the Common Rule, including the elimination of continuing review. Read more
