TAG ARCHIVES FOR IRBs

11
Jun2019

In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients." The guidance is one of the latest moves by the agency to expand eligibility criteria, and hence the knowledge base for how drugs work in various populations, for the clinical trials they regulate. It makes recommendations not only for sponsors but also for IRBs. On May 13, PRIM&R submitted comments in response to the draft guidance. PRIM&R also has an upcoming webinar, Pediatric Risk Determination: IRB Considerations and Cases, on Thursday, September 19 that will review considerations for IRBs in assessing the risks and benefits of pediatric studies. Read more

22
Apr2019

Twenty years ago in 1999 I attended my first annual PRIM&R conference. I did so in the aftermath of then OPRR (now OHRP)’s shutdown of human subjects research that year of three federally funded institutions. At the time, there was a feeling of “there go I but for the grace of god;” if it could happen at these institutions, it could happen anywhere. Here we are in 2019, and there are once again scandals grabbing the research compliance headlines—this time involving scientific misconduct and questions of research integrity. And I cannot help but step back 20 years to that pivotal moment for IRBs and human subjects protections programs across the United States and ask again, what does a strong and robust Research Integrity program look like? Read more

12
Apr2019

Despite their significant importance in society and communities, there is a scarcity of research on the undocumented immigrant population. In addition, only a handful of studies address the social and emotional concerns of undocumented immigrants and students. At AER18, panelists Gene Gloeckner, PhD; Elizabeth Jach, MA; and Colleen Kohashi, MA, CIP, presented ways to ethically and sensitively conduct research with undocumented immigrants. Read more

12
Feb2019

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

27
Dec2018

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