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Tag: clinical trials

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Research Ethics

FDA Draft Guidance Explained: “Use of Data Monitoring Committees in Clinical Trials”

(PRIM&R) Public Responsibility in Medicine and Research

The FDA issued draft guidance for industry, titled “Use of Data Monitoring Committees in Clinical Trials,” to assist sponsors of…

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IRB

Guidance Document Summary: Unpacking FDA’s Guidance Document on Informed Consent

(PRIM&R) Public Responsibility in Medicine and Research

The FDA issued guidance in August 2023 to provide more clarity to IRBs, clinical investigators, and sponsors in complying with FDA’s informed…

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Research Ethics

Guest Blog: Ethical Considerations for Conducting Research During Times of Disruption 

(PRIM&R) Public Responsibility in Medicine and Research

By Lindsay McNair, MD, MPH, MSB  Several important ethical topics are currently relevant to the scientific and drug development communities.…

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Uncategorized

Research Ethics Roundup: ethics of insect research, patient engagement in clinical trials, and more

(PRIM&R) Public Responsibility in Medicine and Research

This month’s Research Ethics Roundup covers the reportage of the PHS Study of Untreated Syphilis, considering the ethics of research…

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Uncategorized

Research Ethics Roundup: “publish or perish” incentives, lagging trial representation for older cancer patients, and more

(PRIM&R) Public Responsibility in Medicine and Research

This month’s Research Ethics Roundup covers enduring "publish or perish" incentives, a new grant program to increase the number of…

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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.