For resources and updates from the Office of Research Integrity Assurance related to the Coronavirus, visit: https://researchintegrity.gatech.edu/coronavirus.
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:
- The revised 2018 Common Rule
- List of Federal Agencies complying with the 2018 Common Rule
- Revised 2018 Common Rule OHRP Training Videos:
- Additional resources can be found on the CITI site at https://about.citiprogram.org/en/final-rule-resources/#irbimpact and https://about.citiprogram.org/en/final-rule-resources/#overview