Skip to main content
Connect with NIAAA
email-icon
Home
  • Join a Clinical Study
  • Find Alcohol Treatment
  • Donate

Primary Navigation

  • Alcohol's Effects on Health
    • Alcohol Topics
    • Getting Help
    • NIAAA Short Takes Video Series
    • ​​​​​​​Alcohol Interventions for Young Adults
    • Order Publications
  • Health Professionals & Communities
    • The Healthcare Professional's Core Resource on Alcohol
    • Resources from the NIAAA College Task Force
    • Alcohol Interventions for Young Adults
    • Alcohol Screening & Brief Intervention for Youth
    • Surveillance Reports
    • Additional Reports and Resources
  • Research
    • Major Research Initiatives
    • Extramural Research Program
    • Intramural Research Program
    • NIAAA Data Archive
    • Alcohol Research Resource (R24) Awards
    • NESARC-III
    • NIAAA SBIR/ STTR Program
  • Research Training
    • Training Grants by Eligibility
    • Training Grants by Mechanism
    • Research Training Programs
    • Centers and Training Working Group Roster
  • Grants & Funding
    • How to Apply for a Grant
    • Funding Opportunities
    • Management & Reporting
  • News & Events
    • News
    • Events
    • Press Room
    • Social Media
    • Spectrum
  • About NIAAA
    • NIAAA Advisory Council
    • Strategic Plan 2017- 2021
    • Our Work
    • Our Funding
    • Our Staff
    • Jobs & Training
    • Contact Us
    • History

Clinical Trial Regulations, Policies and Guidance

Breadcrumb

  1. Home
  2. Research
  3. Guidelines & Resources
  4. Clinical Trial Regulations, Policies and Guidance
In this Section

NIAAA follows and recommends the guidelines for clinical trials involving human subjects developed by the Department of Health and Human Services and the National Institutes of Health.

These guidelines include:

Human Research Protection

  • Data and Safety Monitoring Policy Guidelines
     
  • Procedures for Registering IRBS and Filing Federal-Wide assurances of Protection for Human Subjects (FWAs)
     
  • Certificates of Confidentiality
     
  • Guidelines for Establishing and Operating a Data and Safety Monitoring Board (NIAAA)
     

Human Research Participants Policy and Guidance

  • Guidance on including women and minorities
     
  • Policy on Including Children in Research involving human subjects
     
  • Office for Human Research Protection
     
  • Procedures for Register IRBs and Filing Federal Wide Assurances of Protection for Human Subjects (FWAs)
     
  • OHRP Federal Wide Assurance Application
     
  • Good Clinical Practice Guidelines (FDA website)
     

Links to Other important Clinical Trials Guidance

  • NIH Clinical Trial Requirements for Grants and Contracts

  • NIH Definition of a Clinical Trial

  • FDA Clinical Trials Guidance Documents (FDA website)
     
  • ClinRegs (NIAID) - an online database of country-specific clinical research regulatory information
email-icon

Other NIAAA Sites

  • Alcohol Treatment Navigator
  • Rethinking Drinking
  • NIAAA Spectrum
  • College Drinking Prevention
  • Alcohol Policy Information System
  • NIAAA Strategic Plan
  • Site Map
  • Accessibility
  • Privacy
  • FOIA
  • Contact Us
  • Disclaimer
  • Vulnerability Disclosure
  • USA.gov—Government Made Easy
  • U.S. Department of Health and Human Services
  • National Institutes of Health

NIAAA: Understanding the impact of alcohol on human health and well-being