An official website of the United States government
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.
Definition of Human Subjects Research
Are you planning 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. Become familiar with considerations, policies, and regulations related to human subjects research protections.
Pre-Award and Post-Award Processes
Learn about the process of applying for a grant, cooperative agreement, or R&D contract that involves human subjects research. Find useful resources on how to prepare your Protection of Human Subjects section. Check next steps after submitting your grant application or proposal.
Certificates of Confidentiality (CoC)
Learn about the NIH Certificates of Confidentiality policy. Determine if your research is eligible for a CoC and use our online system to request a certificate.
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 you are involved with conducting, managing, or overseeing clinical trials, learn about NIH policies and find resources to guide you.
Inclusion Policies for Human Subjects
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.
Single IRB for Multi-Site or Cooperative Research
Learn about the NIH single institutional review board (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.
Policies & Regulations for Human Subjects
Find information about human subjects research policies, including NIH-specific requirements for human subjects research studies.
Training & Resources for Human Subjects
Find training and tools to learn about human subjects research, exemptions, and NIH requirements for human subjects research.