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.
IRB Policies and Procedures
- 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 went into 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.
IRB Standard Operating Procedures
- IRB Authorization Agreements - Georgia Tech IRB of Record
- This document sets forth the procedures that are in place for how the Office of Research Integrity Assurance handles IRB Authorization Agreements when the Georgia Tech IRB is the IRB of record. Please CLICK HERE to see a flowchart of this process.
- IRB Authorization Agreements - External Institution IRB of Record
- This document sets forth the procedures that are in place for how the Office of Research Integrity Assurance handles IRB Authorization Agreements when an external institution's IRB is the IRB of record. Please CLICK HERE to see a flowchart of this process.
- Request for Student Data for Research Purposes SOP
- This document sets forth the procedures that are to be followed when a researcher is requesting the use of Georgia Tech FERPA protected data to be used for research purposes.
Other Agreements and Policies
- 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 European Union (EU) General Data Protection Regulation (GDPR) Privacy Notice
- The European Union General Data Protection Regulation (“EU GDPR”) is a 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
- Georgia Institute of Technology People's Republic of China (PRC) Personal Information Protection Law Privacy Notice
- The People's Republic of China (PRC) Personal Information Protection Law (PIPL) 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 China. This regulation applies both inside China and outside of China, and applies to data about anyone in China, regardless of whether they are a citizen or permanent resident of China.
- Please refer to the following links for further details:
- PRC PIPL Privacy Notice
- GT's Institutional Review Board PRC PIPL Consent Form
- 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.