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Tag: IRB

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I *Heart* Paper–Technological Advances and Human Subject Research Protection Programs

(PRIM&R) Public Responsibility in Medicine and Research

While attending the 2021 Advancing Ethical Research Virtual Conference (AER21), I had the opportunity to join several breakout sessions that…

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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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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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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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Women’s Health, Research, and Sex as a Biological Variable

(PRIM&R) Public Responsibility in Medicine and Research

Ensuring that women are represented in research studies and in science fields is an important part of advancing science and…

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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.