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 NIAMSclinicaltrials@mail.nih.gov.

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 ClinicalTrials.gov.  

• NIH Human Subjects Research Policies
• NIH Listing of Select Human Subjects Policy Statement Notices
• NIH Clinical Research Policy 
• Removal of the Requirement for IRB Review of NIH Grant Applications Contract
• NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information 
• Requirements for Registering Clinical Trials into ClinicalTrials.gov 
• Steps to Compliance for NIH awardees
• NIH Grant Application and Proposal Considerations for Human Subjects Research
• Human Subjects System (HSS)
• Annotated Forms Set for NIH Grant Applications-FORMS-F-Series (Human Subjects on Page 32)
• NIH Inclusion Across the Lifespan Policy 
• NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
• Single IRB (sIRB) Policy for Multi-site Research
• Frequently Asked Questions (FAQs), General Questions about Human Subjects

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.

• NIH Data and Safety Monitoring Policies 
  • NIH Policy for Data and Safety Monitoring – June 1998
  • Further Guidance on Data and Safety Monitoring for Phase I and II Clinical Trials – June 2000
• 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 Office for Human Research Protections 
• 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 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.  

• Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
• NIH Human Subjects Protections Training & Resources
• Training Resources in the Responsible Conduct of Research (RCR) – HHS ORI 
• CITI Program Training & Resources 
• 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
• NIH Frequently Asked Questions (FAQs) on Human Subjects Education

Privacy and Confidentiality

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

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

OHRP and General Human Subjects Regulations

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

• Title 45 Code of Federal Regulations Part 46 – Protection of Human Subjects  
• 2020 Edition of International Compilation of Human Research Standards
• OHRP Policy and Guidance Index
• Belmont Report 1979 – Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Regulatory Guidance 
• ICH Guidance for Industry: E6 (R2) Good Clinical Practice

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.

• Title 21 Code of Federal Regulations – Food and Drugs
• FDA Clinical Trial Guidance Documents Directory 
• Information for Clinical Investigators-Drugs (CDER)
• Information for Clinical Investigators-Devices (CDRH)
• Information for Clinical Investigators-Biologic (CBER)
• FDA Encourages More Participation, Diversity in Clinical Trials
• Notice to NIH Grantees Regarding Letters or Notices from the FDA

Additional Resources: 

• Collection of Race and Ethnicity Data in Clinical Trials
• Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Product
• Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND
• Financial Disclosure by Clinical Investigators
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
• FDA and OHRP Final Guidance: Use of electronic Informed Consent & Questions and Answers
• Elaboration of Definitions of Responsible Party and Applicable Clinical Trial

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.

• NIH Stem Cell Research
• NIH Biosafety, Biosecurity and Emerging Biotechnology 
• New Initiatives to Protect Participants in Gene Therapy Trials
• NIH Biosafety Guidelines
• Approval Process for the Use of Human Pluripotent Stem Cells in NIH-Supported Research
• Informed Consent on Use of Human Fetal Tissue
• Changes to Requirements on Human Fetal Tissue Research 
• Research on Dried Blood Spots Obtained Through Newborn Screening