How does your organization view noncompliance investigations? Are they seen as an opportunity for learning and growth? If we are honest, many of us would not volunteer to learn or grow our HRPPs through a noncompliance investigation. We want to get through it and hope it does not occur again. That is wishful thinking and is not the wisest approach to addressing and mitigating noncompliance. The AER19 session, “How to Investigate, Mitigate, Report and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement” inspired me to believe that there can be a bright side through the process of noncompliance investigations. Read more
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PRIM&R's Poster Program is a highlight of our annual conferences, giving members of our community the chance to share their work with the larger research ethics community. As we approach this year's 2017 Advancing Ethical Research Conference (AER17) and the associated Poster Program, read from past authors what they enjoyed most about presenting at past AER Poster Programs. 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
At November’s 2015 Advancing Ethical Research Conference (AER15), PRIM&R recognized the substantial achievements and contributions of longtime PRIM&R member, Karen Hale, RPh, MPH, CIP.
Karen is the recipient of the 2015 Applied Research Ethics National Association (ARENA) Legacy Award (ALA). The ALA was developed to honor not only the chosen individual, but also to honor the living legacy created by ARENA, which was the membership division of PRIM&R [...] 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