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
By the end of the post, I may call into question my own particular existence. In the meantime, though, let’s talk about research ethics (the two are related, I assure you).
As the 2015 Advancing Ethical Research (AER) Conference wound through its days, a theme of sorts began to emerge. It found its clearest statement in the conference’s final session, a discussion of the various reports and inquires that have come forth regarding the state of research ethics oversight at the University of Minnesota. The recent headlines about this—"Why the U. of Minnesota Research Scandal Threatens [...] Read more
It seems that in many cases, IRB offices are struggling with processing and turnaround time of new and revised protocols. This can lead to overloaded agendas, which may not allow all IRB members enough time to review every item on the agenda prior to the IRB meetings. Jon Newlin, assistant director in the Office of the HRPP at North Shore-LIJ, explained during his presentation at the 2015 Advancing Ethical Research Conference (AER15), "Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience," that to rectify this problem his institution consolidated their IRBs into one roster. In this process, they reduced their IRB from more than 20 voting members to nine with 60 [...] Read more
Like some feverish character of in a Dostoyevsky novel, as a culture, we are obsessed with all things crime and punishment. Going to prison, being in prison, and life after prison are the topics dozens of television shows and movies. Illegal activity as entertainment? We’re in. Prisoners and prisoner biomedical issues for thoughtful, systematic research? Maybe not so much.
The need for scientific inquiry seems obvious: millions of people flow through the prison system each year, and based on health impact and health disparities for that group alone, you would think the research and medical communities would be paying close attention. There are some Read more