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Tag: revised common rule

> revised common rule
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PRIM&R’s Advancing Ethical Research: Conference Summary (2018) & Looking Ahead

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory…

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Reflections on the Advancing Ethical Research Conference

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was very inspiring. It provided me an opportunity to be immersed in an…

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Applying the new HIPAA Exemption: Are you in or out?

(PRIM&R) Public Responsibility in Medicine and Research

For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was…

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How should a “reasonable” HRPP approach key information?

(PRIM&R) Public Responsibility in Medicine and Research

“One person’s flexibility is another person’s ambiguity.” I kept going back to this comment, articulated by Carrie Wolinetz (NIH), as…

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How to Operationalize the Revised Common Rule

(PRIM&R) Public Responsibility in Medicine and Research

After over five years of discussion—from the advance notice of proposed rulemaking and two implementation delays—the revised Common Rule finally…

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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.