On January 28, 2017, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Published on January 19, the revised policy, or “Common Rule,” represents the first significant regulatory changes in human research oversight since 1991. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration. Read more
TAG ARCHIVES FOR federalwide assurance
By Anita Pascoe, MS, CIP, project coordinator at Intermountain Healthcare
"Check what box?" you may ask. Let me explain — without getting too hung up on a paraphrase of Shakespeare's famous question.
In the wake of the 2014 AER Conference last December, I have spent considerable time reflecting on the current regulatory framework governing human subjects research. (Yes, I do have a life, but I am a Certified IRB Professional [CIP®], so matters like these interest me.) In the United States, federal regulations require that all research on human subjects be reviewed and approved by an institutional review board (IRB). IRBs have the authority to approve, [...] Read more
On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.
Q: Why can't I determine if a study involves "human subjects" before I determine if it is "research"?
A: From a regulatory standpoint, the definition of a “human [...] Read more