Human Subjects Research and Clinical Trials

NIAAA supports human subject research and clinical trials through grants, contracts, and the NIAAA Intramural Research Program. Policies and guidance established by the US Food and Drug Administration (FDA), NIH, and NIAAA should be reviewed by researchers prior to applying for support or initiating studies involving human subjects research or clinical trials. The below policies and links to outside resources provide the latest information and best practices established for the conduct of human subject research and clinical trials.

• NIAAA Clinical Trial Guidance and Policies
  • Risk Assessment Management and Oversight 
  • Guidelines for Establishing and Operating a Data and Safety Monitoring Board (DSMB)
  • Data and Safety Monitoring Guidelines (DSMP)
  • NIAAA Serious Adverse Event Reporting Policy
  • Adverse Event Decision Tree for Principal Investigators 

• NIH Clinical Trial Resources 
  • NIH Definition of a Clinical Trial
  • Clinical Trial Requirements for Grants and Contracts
  • Clinical Trial-Specific Review Criteria
  • Protocol Templates for Clinical Trials
  • Good Clinical Practice Training
  • Posting Clinical Trial Informed Consent Forms

• NIH Human Subjects Research Guidance and Policies
  • Human Subjects Research Homepage
  • Policy for the Inclusion of Women and Minorities
  • Inclusion of Children in Clinical Research

• FDA and HHS Human Subjects Research Guidance and Policies
  • FDA Guidance Documents
  • IRBs and Assurances
  • HHS Office of Human Research Protection (OHRP) Unanticipated Problems Reporting Requirements
  • Office for Human Subjects Research Protection (OHRP)