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February 12, 2025

Rules for clinical trials with humans

Perhaps you have seen ads on social media seeking people to participate in clinical trials for medical reasons. Or maybe you know someone who volunteered for a clinical trial.

Clinical trials are vital for measuring the safety and efficacy of potential new drugs and procedures, but you should avoid any that don’t follow the rules of the National Institutes for Health, a federal agency which conducts and funds many research projects.

It insists that researchers take precautions and follow ethical and medical guidelines when using people to study the effects of new procedures and medicines.

NIH standards set “main principles” to guide the conduct of ethical research: Social and clinical value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects.

In addition, the NIH spells out the researcher’s obligations to volunteers:

“Respecting their privacy and keeping their private information confidential; respecting their right to change their mind; to decide that the research does not match their interests, and to withdraw without a penalty.

“Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating.

“Monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study.

“Informing them about what was learned from the research.”

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