Please note: Due to the significant increase in the number of studies you should allow up to three weeks for an initial review.
Data Use Agreements:
As a member institution of the Atlanta Clinical & Translational Science Institute (ACTSI), Georgia Institute of Technology has executed Data Use Agreements with the other ACTSI partners to facilitate the sharing of de-identified data and limited data sets. GT researchers who are exchanging data with ACTSI partners, Children’s Healthcare of Atlanta, Emory University, or Morehouse School of Medicine, should utilize the Data Use Agreement. Please complete Exhibit A (at the end of the DUA) and upload it in your IRBWISE protocol application. If you need assistance, please do not hesitate to contact the Office of Research Integrity Assurance.
The following human subjects resources may be helpful as you prepare your protocol for submission to the Georgia Tech IRB.
- Office for Human Research Protections (OHRP home page)
- Protection of Human Subjects: HHS and FDA Regulations
- The Belmont Report (Ethical principles and guidelines for the protection of human subjects of research)
- Food & Drug Administration
- FDA Information Sheets (Guidance for Institutional Review Boards and Clinical Investigators)
- NIH Office of Behavioral and Social Science Research
- Federal HIPAA regulations (Department of Health and Human Services National Standards to Protect the Privacy of Personal Health Information)
- Public Responsibility in Medicine and Research (PRIM&R)
- Regulatory Affairs Professional Society (RAPS)