Talk about a quick dividend! The dust hasn’t even settled on the travel bags that I carried to the 2015 SBER and AER Conferences, and yet I’m already applying the lessons learned to my responsibilities as IRB Chair at Providence College.
As you may recall from my previous Ampersand postings, my learning experiences at this year’s conferences focused on the difficult choices that are faced by researchers who are engaged in “big data” projects. These researchers find it impracticable to engage in routine [...] Read more
This session at the 2015 Advancing Ethical Research (AER) Conference was a follow up to the 2014 AER Conference session "Using Empirical Evidence to Reduce Consent Form Length" presented by Amy Corneli, PhD, MPH, and Jeremy Sugarman, MD, MPH, MA. In last year’s talk, they shared preliminary data about their effective delivery of informed consent (EDICT) study based on interviews questioning what participants thought must be in the informed consent form (ICF) and what could be removed. This year’s follow-up session by Amy Corneli shared the study findings submitted for publication. What was learned can be put to use by [...] Read more
How was it listening to Dr. Massie’s plenary session at the 2015 AER Conference (AER15)? It was like sitting in a cozy room, warmed by a glowing fire, catching up with a too-long-out-of-touch dear friend. Bob Massie is a magical storyteller. Describing in measured tones, touched with a tinge of irony a life challenged by health issues both genetic (hemophilia) and manmade (infection with HIV and Hepatitis C from a tainted blood supply), he painted dozens of tender, amusing, frightening pictures of a life lived, delayed [...] Read more
Before we get too far into the new year, I wanted to take an opportunity to sneak in a few last reflections on the recent Advancing Ethical Research conference. As I prepared to leave Tennessee for Boston and AER15, I projected two goals: first and most basically, a renewal of knowledge; and second, the more lofty aspiration, to gain insight into the pragmatic relationships formed during the research process. Given the amorphous nature of both, I could argue I either achieved everything I could have hoped for, or, that [...] Read more
Many thanks to my Blog Squad colleague Courtney Zweig for exploring the proposed changes to the Common Rule involving single IRB review processes. That particular proposal is Issue #6 of 19 of the Office of Human Research Protections’ (OHRP) summary of the proposed regulatory changes in ANPRM.
If you’re reviewing the other proposed changes as well, don’t miss Issue #5 of 19 involving informed consent. According to the OHRP, modifications may be necessary because consent documents are currently "too long and hard to understand." Under the proposed regulations, these documents would be "shorter, more readily understood [and] less [...] Read more