At the end of the day—or at least the end of this day, one spent considering contemporary issues in biobanking—I can’t help but ask. Let me give some perspective, though, on how I got here.
On one side, there is a concern about subjecting others (subjecting ourselves?) to some less or more tolerable "regime of governance" in the biobanking process. Those regimes, though, take on greater and [...] Read more
At last year’s PRIM&R Advancing Ethical Research (AER) Conference, John Wilbanks, chief Commons Officer at Sage Bionetworks, enlightened us all with his talk "Informed Consent in the Mobile Era" on the possibilities of technology utilization in research. At the 2015 AER Conference’s "Moving Targets: The Challenges of Responsible Mobile Health (mHealth) Research" session, we got to see some examples of this mobile era that have built on and expanded the use of technology. [...] Read more
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
Exempting, expediting, and generally reviewing categories in social, behavioral, and educational research
Like three wise owls perched on the speakers platform, Kristina Borror, PhD, Jeffrey M. Cohen, PhD, and Dean R. Gallant, AB rolled out multiple vignettes in an interactive teaching format to review some bread and butter topics on IRB guidance at AER15. “What about this example makes it outside the exempt category?” asked Borror, director of Division of Compliance Oversight of the Office of Human Research Protections, of a skeptical audience member.
This triumvirate of veteran educators was simultaneously kind but persistent and demanding of precision in reinforcing one of the teaching points: [...] Read more