We are part of a research group at Columbia University Irving Medical Center that is participating in the NIH-sponsored Electronic Medical Records and Genomics (eMERGE) Network study. As part of our site’s exploration of the ethical, legal, and social issues involved in research using polygenic risk scores (PRS), we are conducting a series of focus groups with stakeholders to explore views on these issues. We are interested in IRB members’ perspectives on the ethical and regulatory challenges that can arise from a study like this. Read more


Before I joined the IRB administration team, I thought IRB reviewers were members of a secret society whose sole purpose was to strike down research. Like others before me, I believed my research would be put on the IRB butcher’s block and be chopped into little bits. However, IRB administrators want to see quality research out in the field and will work tirelessly to help guide researchers towards compliance to reach that goal. Read more


The review criteria utilized by IRBs possess an inherent flexibility that has allowed them to adapt to a wide range of research over the past several decades Over that time span, many questions have arisen as to whether the IRB regulations can adequately apply to such innovations as organ transplants, Car-T cell therapies, and research using digital technology.  In the face of such rapid change, in all cases, however, we have seen the wisdom of those who drafted the regulations vindicated, as the IRB review criteria have continued to protect participants in all types, styles, and manner of research. Read more


In Memoriam: Jeffrey Cohen, PhD

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The research oversight community recently suffered a huge loss with the passing of Jeffrey Cohen, PhD. Jeff was a beloved member of the PRIM&R community, known for the depth and breadth of his knowledge, his warmth and sense of humor, and his generosity as a teacher and mentor to so many in the field. Jeff was a true founding father of the field of human subjects protections, and exemplified the commitment to ethics, to doing right, that is at its core. He made us all better for knowing him. Here, we have gathered words from a few members of the PRIM&R community who knew Jeff well. We encourage you to leave your own memories and kind words about Jeff in the comments below. Read more


Are you an institutional official who works in research compliance, research integrity, human research subjects protection, animal care and use, or conflicts of interest compliance? You are invited to complete a short survey being conducted by researchers at Washington University School of Medicine. The Addressing Violations of Research Integrity and Compliance (AVRIC) study aims to understand institutional experiences and approaches to remediating research noncompliance or integrity violations. Read more


Human research rules have become a compliance bureaucracy, argues sociologist Sarah Babb in her 2020 book Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy, but that's not an inherently bad thing. The social and political climate the first research regulations were made in, and the enforcement mechanisms that would eventually take hold, have rationally led to the large and sophisticated bureaucracy that human research protections is today. Read more