PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. In this post, Sarah Luery describes her experience as a principal investigator (PI) and master’s student submitting to the IRB, and shares tips (now as an IRB Administrator) to demystify the IRB process. Read more
TAG ARCHIVES FOR exempt
by Rebecca D. Armstrong, DVM, PhD, director of research subject protection, at the University of California, Berkeley and a member of PRIM&R’s Education Committee
In early June, I was invited to attend a multiday convention, The Asilomar Convention for Learning Research in Higher Education, co-hosted by Stanford University and the Massachusetts Institute of Technology to share [...] 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
by Amy Davis, JD, MPH, Senior Director for Programs and Publications at PRIM&R
Remember the Johns Hopkins-Michigan study in which the Michigan Hospital system implemented an intensive care unit-based check-list system for inserting a catheter to reduce central line infections? The project was submitted to the Johns Hopkins Medical Institution’s (JHMI) institutional review board (IRB) in 2004, who categorized the [...] Read more