Please be aware that the changes to the federal regulations that govern human subjects research go into effect on January 21st, 2019. Please see our Standard Operating Procedures for this transition to see how these changes will affect your research.
The following policies, guidance, and supporting documents ensure that research conducted at Georgia Tech protects the rights and welfare of human research subjects and complies with all applicable laws and regulations.
Georgia Tech IRB Policies and Procedures Manual (Pre-2018 Common Rule)
This document sets forth the policies required of all Georgia Tech faculty, staff, and students conducting research that involves human subjects.
Georgia Tech IRB Policies and Procedures Manual (Revised 2018 Common Rule) - Effective 01/21/2019
The revised federal policy for the protecting of human subjects will go in effect on 01/21/2019. This document sets forth the revised policies required of all Georgia Tech faculty, staff, and students conducting research that involves human subjects.
Standard Operating Procedure for the Transition to the New Common Rule (Effective January 21, 2019) at Georgia Tech
The revised federal policy for the protecting of human subjects will go in effect on 01/21/2019. This document sets forth the procedures that will be in place to officially transition from the Pre-2018 Common Rule to the 2018 Common Rule.
Investigator Agreement for a Clinical Investigation
This agreement is intended for use between Georgia Tech and a PI conducting a clinical trial. The clinical trial agreement sets forth the expectations of the Food and Drug Administration concerning the investigator’s responsibility to (1) supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) protect the rights, safety, and welfare of study subjects.
Georgia Clinical & Translational Science Institute (GCTSA) Data Use Agreement
As a GCTSA member, Georgia Tech executes data use agreements with other GCTSA partners to facilitate the sharing of de-identified data and limited data sets. GT researchers who are exchanging data with GCTSA partners, Children’s Healthcare of Atlanta, Emory University, Morehouse School of Medicine, Georgia Institute of Technology and the University of Georgia, should utilize this Data Use Agreement. Please complete Exhibit A (at the end of the agreement) and upload it to your IRBWISE protocol application.
Georgia Institute of Technology EU GDPR Privacy Notice
The European Union General Data Protection Regulation (“EU GDPR”) is a new and more stringent regulation governing the use of personal data. It imposes new obligations on entities that control or process personal data about people who are located in the European Union. This regulation applies both inside the European Union (“EU”) and outside of the EU, and applies to data about anyone in the EU, regardless of whether they are a citizen or permanent resident of an EU country.
Please refer to the following links for further details:
- EU GDPR website
- Institute GDPR Compliance Policy
- GT's Institutional Review Board EU GDPR Privacy Notice
- GT's Institutional Review Board EU GDPR Consent Form for Sensitive Personal Data
- Researcher’s EU GDPR Human Subjects Research Data Protection Regulation Privacy Notice