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