NIH and Other Federal Guidelines, Regulations, & Policies for Clinical Research

Overview

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 [email protected].

NIH Human Subjects Policy and Guidance

View the NIH Guidance on Policies on Human Subjects Research to learn about the policies that govern the conduct of studies that involve human subjects. We encourage you to review the guidelines for human subjects research and the policies for inclusion of women, children, and individuals across the lifespan in studies.   

Policies and Guidelines for Data Safety and Monitoring

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.

• NIH Data and Safety Monitoring Policies
• NIAMS Data and Safety Monitoring Guidelines and Policies
• NIAMS Reportable Events Requirements and Guidelines for Investigators Conducting NIAMS-funded Clinical Research Studies
  • NIAMS Safety Reporting Assessment Flowchart
• Office for Human Research Protections (OHRP) Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
  • Guidance on Reporting Incidents to OHRP
• FDA Guidance for Clinical Trial Data Monitoring Committees – March 2006

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 on and maintain up to date certifications for human subjects protection education and good clinical practice (GCP). These are useful resources that investigators can refer to for help with understanding the education and training requirements and to gain knowledge of the various topics related to the safe and ethical conduct of human subjects research.  

• Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
• NIH Training & Resources for Human Subjects
• Resources on Research Misconduct and Reporting It
• National Institute of Allergy and Infectious Diseases (NIAID) GCP Learning Center
• National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) GCP Course
• Society of Behavioral Medicine GCP Training for Social and Behavioral Research
• Office of Human Research Protection - Regulations, Policy, and Guidance
• NIH Frequently Asked Questions (FAQs) on Human Subjects Education

Privacy and Confidentiality

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

• The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
• HIPAA for Professionals
• Impact of the HIPAA Privacy Rule on NIH Processes
• NIH Certificates of Confidentiality (CoC) - Human Subjects

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.

• FDA Guidance, Compliance, & Regulatory Information
• Search for FDA Guidance Documents