Clinical research may involve risk to participants. To ensure that human subject participation is voluntary and does not pose undue risk, the U.S. Department of Health and Human Services (HHS) issues regulations and guidelines governing HHS-supported human subjects research. In general, human subjects in NIH-funded clinical research, whether healthy volunteers or patient volunteers, are protected under the Federal Policy for the Protection of Human Subjects at 45 CFR 46, also called the Common Rule.

Human subjects protections are designed to give potential participants the information they need when deciding whether to participate in clinical research. This process of informed consent (or assent, if someone else gives permission for an individual to participate, such as for a child) assumes that the potential risks and benefits of research are balanced and that no coercion is involved in a person’s decision to participate in the study.

All applications to NIH for research involving human subjects or additions to existing awards must include a Protection of Human Subjects section according to instructions for NIH applications. More information about NIH policies is available in the Human Subjects section of the NIH Grants Policy Statement. The Office of Extramural Research website provides up-to-date information and guidance on human subjects policies and regulations. The Human Subjects Research Infographic provides a quick overview of NIH policy.

Read more about the following topics:

Informed Consent

Data Safety and Monitoring

Human Subjects Education