The Belmont Report serves as the ethical basis upon which regulations on the use of human subjects in research are based. These principles do not technically govern the research process, and yet are essential to ensure that research is done ethically. At the 2014 Advancing Ethical Research Conference, Gigi McMillan interviewed Ilene Wilets, PhD, CIP, executive director of the institutional review board (IRB) at the New York State Psychiatric Institute, for People and Perspectives. During her interview, Dr. Wilets [...] Read more
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Due to PRIM&R’s unique position in the research ethics field, we are often approached by organizations and investigators who wish to tap into the PRIM&R community for their specialized skills, unique perspective, and dedication to conducting research with human subjects to the highest standards. This post is one such example of that. Nancy Shore, PhD, senior consultant at Community-Campus Partnerships for Health (CCPH) and principal investigator, and her study team would like the assistance of the PRIM&R community in furthering their research, which is co-sponsored by CCPH and the University of New England (UNE) with support from a grant from the Greenwall Foundation. Read on to see how you can help.[...] Read more
On April 18, 1979, the Belmont Report was first published in the Federal Register. Thirty-six years isn't that long in the grand scheme of things, but it is effectively the lifetime of the research ethics field, formally beginning as it did with the publication of the Belmont Report. We were curious how the application of the principles contained in the report has changed over that time, so we reached out to a few past PRIM&R Blog Squad members to get their thoughts.
We asked: How do you think people's understanding of the [...] Read more
by Amy Davis, JD, MPH
Overheard, a new series here on Ampersand, is a glimpse into conversations, discussion, and debate on PRIM&R's IRB Forum. No participants or institutions are identified to preserve the mission and openness of the Forum, though IRB Forum members are welcome and encouraged to comment on these posts. To suggest a topic for Overheard, please contact us. If you are not a member of the IRB Forum and would like to join, you can do so here.
On the IRB Forum, people are [...] Read more
by James E. Lewis, PhD, an independent consultant and formerly a columnist for the Association of American Medical Colleges blog, Wing of Zock
A little known, but intentional, loophole in the federal regulations allows activities involving human subjects to be labeled “innovative care.” In spite of all that has been done since World War II to protect human subjects in clinical research, this ambiguity offers a mechanism through which unscrupulous individuals can avoid the ethical and regulatory obligations for the protection of human research subjects and the norms of professional and scholarly behavior. Recent cases demonstrating this dilemma can be found on the internet, but my purpose here is not [...] Read more