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Establishing a Clear Pathway for IRB Review of Artificial Intelligence/Machine Learning in AI Human Subject Research That Involves Software as a Medical Device

(PRIM&R) Public Responsibility in Medicine and Research

In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning (AI/ML) protocols were quick to give not-human subject research…

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Race, Ethnicity, and Genomic Research: Crafting a more ethical scientific framework

(PRIM&R) Public Responsibility in Medicine and Research

The National Academies of Sciences, Engineering, and Medicine (NASEM), at the behest of the NIH, has impaneled an impressive committee…

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Findings from our Survey on the Ethical, Regulatory, and Practical Barriers to COVID-19 Research

(PRIM&R) Public Responsibility in Medicine and Research

In April of 2020, I posted on Ampersand announcing a survey. We aimed to understand the ethical, regulatory, and practical…

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Should animal research programs continue annual review as part of post-approval monitoring?

(PRIM&R) Public Responsibility in Medicine and Research

Recently, on the IACUC Channel in PRIM&R’s Online Community, there was a discussion about whether to continue annual reviews of…

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A stack of books titled Rules and Regulations
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No fear, just proper preparation–IRB Professionals and the FDA

(PRIM&R) Public Responsibility in Medicine and Research

Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.