Georgia Tech's IRBs are established pursuant to Title 45 Code of Federal Regulations Part 46 including Subparts A, B, C, and D, and Title 21 CFR Part 50, 56, 312, and 812.
The IRBs are also authorized to retain consultants when necessary.
These federal resources may be helpful in learning more about regulations that affect protocol applications:
- Health and Human Services Regulations on Protection of Human Subjects (Pre-2018 Common Rule)
- Health and Human Services Regulations on Protection of Human Subjects (Revised 2018 Common Rule) - Effective 01/21/2019
- Food & Drug Administration Regulations
- FDA Information Sheets (Guidance for Institutional Review Boards and Clinical Investigators)
- Federal Office for Human Research Protections/HHS
- Federal HIPAA regulations (Department of Health and Human Services National Standards to Protect the Privacy of Personal Health Information)
- NIH Clinical Trial Requirements (NIH Definition of clinical trial)
- NIH Single IRB Policy (Single IRB Policy for Multi-site Research)
Please see the following resources that pertain to the Revised Common Rule, which went into effect on 01/21/2019: