Clinical Trial Regulations, Policies and Guidance

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