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In this Section
- Major Initiatives
- Medications Development Program
- Underage Drinking Research Initiative
- Fetal Alcohol Spectrum Disorders
- COMBINE Study
- Quetiapine Study
- Collaborative Studies on Genetics of Alcoholism (COGA) Study
- NIAAA-Funded Research Centers
- NIAAA Institutional Research Training Programs
- Other Key Extramural Research Activites
- Guidelines and Resources
- Division of Intramural Clinical and Biological Research
- NIAAA Laboratories
- Laboratory of Behavioral and Genomic Neuroscience
- Laboratory of Clinical and Translational Studies
- LCTS - Office of the Chief
- LCTS - Section of Brain Electrophysiology and Imaging (BEI)
- LCTS - Section of Clinical Assessment and Treatment Evaluation (CATE)
- LCTS - Section on Clinical Psycho-neuroendocrinology and Neuro-psychopharmacology (CPN)
- LCTS - Section on Human Psychopharmacology (HP)
- LCTS - Section of Molecular Pathophysiology (MP)
- Laboratory of Epidemiology and Biometry
- Laboratory for Integrative Neuroscience
- Laboratory of Liver Diseases
- Laboratory of Membrane Biochemistry and Biophysics
- Laboratory of Metabolic Control
- Laboratory of Molecular Physiology
- Laboratory of Molecular Signaling
- Laboratory of Neurogenetics
- Laboratory for Neuroimaging
- Laboratory of Physiologic Studies
- Chemical Biology Research Branch (joint lab with NIDA)
- Office of the Scientific Director
- Office of Laboratory Animal Science (OLAS)
- Research and Training
- Clinical Trials at NIAAA/NIH
- NIAAA Laboratories
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
- Procedures for Registering IRBS and Filing Federal-Wide assurances of Protection for Human Subjects (FWAs)
- Certificates of Confidentiality
- Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board (NIDA)
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 (ICH document)
Links to Other important Clinical Trials Guidance
- FDA Guidance Documents (FDA Website)
