Human Subjects Research

Find useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training and resources.  Learn about considerations for human subjects research when planning and submitting a research application or contract proposal, and throughout the extramural funding cycle.

 

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Definition of Human Subjects Research

Are you planning on conducting human subjects research? Learn more about research that meets the definition human subjects research, Federal regulation requirements, and whether your project may be considered exempt. Also, learn about NIH-specific considerations and become more familiar with NIH policies, and other regulations as it relates to human subjects research protections.

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Pre-Award and Post-Award Processes

Learn about the process of applying for a grant, cooperative agreement, or R&D contract, as it relates to the involvement of human subjects research. Find useful resources on how to prepare your Protection of Human Subjects section, and learn about next steps after submitting your grant application or proposal.

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Certificates of Confidentiality (CoC)

Learn more about the NIH Certificates of Confidentiality policy. Determine if your research is eligible for receiving a CoC and use our online system to get a certificate. 

Clinical Trials

Clinical Trial Requirements for Grants and Contracts

If you are submitting a grant application or responding to a contract proposal to NIH that includes a clinical trial, or are involved with conducting, managing, or overseeing clinical trials, learn about NIH policies, and find resources to guide you in your work.

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Inclusion Policies

NIH is committed to supporting clinical research that benefits individuals of all sexes/genders, races, ethnicities, and ages. The information provided on this website is designed to assist the extramural community in addressing inclusion, including the Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy, in NIH grant applications and progress reports.

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NIH Single IRB Policy

Learn about the NIH single IRB policy for NIH-funded domestic multi-site studies involving non-exempt human subjects studies. Find key resources to understand the policy expectations and the process for requesting exceptions. 

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Policies & Regulations

Find information about human subjects research policies, and NIH-specific requirements for humans subjects research studies.

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Training & Resources

Training and tools to learn about human subjects research, exemptions, and NIH requirements for human subjects research.