NIH Policies & Guidelines and Other Federal Regulations for Clinical Research

The NIH and other federal agencies have developed policies, regulations, and guidelines for investigators to follow for conducting safe, ethical, and high-quality clinical research. This page provides information that includes but is not limited to federal and NIH human subjects research policies and guidelines for monitoring clinical research, education and training for investigators, and privacy and protecting confidentiality. For further guidance or questions, reach out to the NIAMS Clinical Management Team at

  1. NIH Human Subjects Policy and Guidance
  2. Policies and Guidelines for Monitoring Clinical Research
  3. Education and Training for Investigators Conducting Clinical Research
  4. Protecting Confidentiality
  5. Office for Human Research Protections and General Human Subjects Guidelines
  6. U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials
  7. Gene Therapy, Stem Cells and Fetal Tissue

NIH Human Subjects Policy and Guidance

The NIH has policies that govern the conduct of studies that involve human subjects. We encourage you to review the following guidelines for human subjects research and policies for inclusion of women, children, and individuals across the lifespan in studies. Additionally, this section contains information about single Institutional Review Board (sIRB) and requirements for registering clinical trials on  

Policies and Guidelines for Monitoring Clinical Research

Review the NIH and other federal agency policies for data and safety monitoring in the conduct of clinical trials to ensure the safety of research participants and the appropriate and ethical conduct of the study. Learn the NIAMS requirements and guidelines for reportable events as well as reviewing and reporting unanticipated problems involving risks to human subjects or others and adverse events.

Human Subjects Education, Training and Resources for Investigators Conducting Clinical Research 

NIH investigators and those involved with conducting NIH supported clinical research are expected to be trained and maintain up to date certification on human subjects protection education and good clinical practice (GCP). Here are some useful resources that investigators can refer to which will help them understand the education and training requirements and offer resources to gain knowledge in the various topics related to the safe and ethical conduct of human subjects research.  

Privacy and Confidentiality

Learn more about the policies and guidance for ensuring the confidentiality of individuals who participant in clinical research studies.

OHRP and General Human Subjects Regulations

Learn the procedures investigators must follow in order to protect human subjects who participate in clinical research studies. 

U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials

Understand the FDA’s policies and guidance for the conduct of clinical trials as they relate to drugs, devices, and biologics.

Additional Resources: 

Gene Therapy, Stem Cells, and Fetal Tissue

Learn the policies and guidelines for conducting clinical research studies that involve gene therapy, stem cells, or fetal tissue.

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