The research world, and inevitably PRIM&R’s 2015 Advancing Ethical Research Conference (AER15), is abuzz with the proposed changes to the common rule. As most people are wondering what exactly these potential changes could mean for their research organizations, the question becomes "Are we ready?"
There is much to be said about single IRB review, but as P. Pearl O'Rourke, MD, pointed out during the pre-conference presentation "Single IRBs Are Here: Are You Ready?", up to this point it has been voluntary to participate in a reliance agreement with another institution or organization. What the new rule will force is a relationship that many institutions lack the infrastructure [...] Read more
When we interact with colleagues at the 2015 Social, Behavioral, and Educational Research Conference (SBER15), an extremely helpful insight can arrive at any time, and from any source. But it’s difficult to know in advance when we will perceive it, and how it will affect the way we address our own research responsibilities.
For instance, I had no idea that an insight from a morning presentation would affect the way that I approach a challenge that I occasionally face as IRB Chair at Providence College. From time to time, we receive applications for projects in which advance processes of informed consent are not appropriate because they would “tip off” participants and [...] Read more
Welcome to the latest installment in our series of featured member interviews. This series highlights individuals within our membership who are making an impact on the research ethics field through their work. This month, we hear from Heather Kim, a senior regulatory compliance auditor in Quality Management for Copernicus Group IRB.
Elise Davis (ED): When and why did you join the field?
Heather Kim (HK): I had just begun my Masters in Regulatory Affairs when we covered the IRB in a basic Part 50 and 56 overview. Around that time, I was looking for [...] Read more
By any chance, do you remember me? I was a new blogger for Ampersand at last year’s AER Conference in Baltimore. I was also a new member of PRIM&R, having joined because of my recent appointment as Chair of the Institutional Review Board of Providence College.
So it’s one year later, and how do I feel? My goodness, what a difference a year makes! I now feel like a grizzled veteran, enlightened by a year’s worth of research experience.
The most important lesson I learned from last year’[...] Read more
Welcome to another installment of our featured member interviews where we introduce you to our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about Jackie Blundon, MS, CIP, director of the Human Research Protection Program at Wheaton Franciscan Healthcare. Read more