Regulations, Policies, and Guidance

Clinical Trials Stewardship

• Oversight and Management
• Good Clinical Practice Training
• Registering and Reporting Clinical Trials
• Funding Opportunity Announcements for Clinical Trials

Investigational New Drug

• Investigatonal New Drug Regulations (21 CFR 312)

Human Research Participants Policy and Guidance

• Office of Extramural Research - Protecting Human Research Participants Tutorial.
• Guidance on Including Women and Minorities
• Policy on Including Children in Research Involving Human Subjects
  • Infant, Child, & Adolescent Workgroup
• Research Involving Individuals with Questionable Capacity to Consent
• Guidance on Approving Research Involving Prisoners
• Policy On Reporting Race And Ethnicity Data: Subjects In Clinical Research
• Office for Human Research Protection

Protection of Human Participants

• Procedures for Registering IRBs and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs)
• OHRP Federal-Wide Assurance Application (FWA)
  "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions.
• Institutional Review Boards and Informed Consent (46 CFR)
  The IRB should ensure that all human subject research that is regulated by the Food and Drug Administration (FDA), and for which the IRB provides review and oversight, complies with FDA regulations at Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56).
• Certificates of Confidentiality
• Data and Safety Monitoring: Guidelines for NIDA Grantees
• Required Education in the Protection of Human Research Participants
• NACDA Guidelines for the Administration of Drugs to Human Subjects
• NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents
• NIDA Drug Supply Program (Chemistry & Physiological Systems Research Branch) provides chemicals and research probes that are either unavailable, difficult to obtain, or very expensive to buy to researchers. In addition, this program also provides analytical services for the analysis of researchers experimental samples.
• For Reporting Serious Adverse Events (SAEs) and Adverse Events (AEs)
  • Investigational New Drug Safety Reports (21 CFR 312.32)
  • E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF, 184 KB)- ICH Guidance
  • FDA Regulation 21 CFR 312.33 - Annual Reports

Clinical Conduct

• Principles And Guidelines For Recipients Of NIH Research Grants And Contracts On Obtaining And Disseminating Biomedical Research Resources: Final Notice (PDF, 149KB)
  Designed to provide recipients of NIH funding with guidance concerning appropriate terms for disseminating and acquiring unique research resources developed with federal funds and is intended to assist recipients in complying with their obligations under the Bayh-Dole Act and NIH funding policy.
• NIDA Policy On Counseling And Testing For HIV/AIDS And Other Infectious Diseases
• Office of Research Integrity - Policy On Responsible Conduct Of Research
• Good Clinical Practice Guidelines (ICH Document)
• Bioethics Resources

Other Important Links/Clinical Trials Guidance and Policy

• FDA Guidance Documents (FDA Web Site)
  • Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers - 1/15/2003 - (Text) (FDA Web Site)
• DEA Regulations (21 CFR 1300 to end) (GPO Web Site)
• Schedules of Controlled Substances (21 CFR 1308) (GPO Web Site)
• Clinical Informatics