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Policies & Regulations - Human Subjects

For research involving human subjects, NIH has specific requirements for research staff, and policies regarding research conduct, safety monitoring, and reporting of information about research progress. Funded research must also comply with federal regulations. Navigate through the topics below to learn more about the human subjects policies and regulations, and the related requirements for staff on NIH-funded projects.

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Policies and Policy Notices

Guide notices and policy links related to human subjects research at NIH.

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Vulnerable and Other Populations Requiring Additional Protections

Research with some groups require additional steps and safeguards for potential participants. Click on the link above to find out more about research with vulnerable populations and groups requiring additional protections.

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Data and Safety Monitoring

Find out about the Data and Safety monitoring requirements for NIH-supported human subjects research.