What the IRE assesses at Georgia Tech

 

Screening Life Science Research

All Life Sciences Research proposed and/or performed at Georgia Tech must be screened for Dangerous Gain of Function (DGOF), Potential Dangerous Gain of Function (PDGOF), and International Research of Concern (IROC).

Life Sciences Research is defined as "research pertaining to the study or use of living organisms, viruses, or their products, including all disciplines, methodologies, and applications of biology (including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques). This includes funding for building research capacity and infrastructure, including but not limited to, construction or renovation of biosafety level 3 or 4 laboratory space (BSL-3 or BSL-4)."

Dangerous Gain of Function (DGOF) is defined as "Research with a biological agent that seeks, achieves, or has a substantial risk of achieving one or more of the outcomes listed below and could result in significant negative societal consequences."

  1. Enhancing the harmful consequences of the biological agent;
  2. Disrupting beneficial immunological response or the effectiveness of an immunization against the biological agent;
  3. Conferring to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that biological agent or facilitating its ability to evade detection methodologies;
  4. Increasing the stability, transmissibility, or ability to disseminate the biological agent;
  5. Altering the host range or tropism of the biological agent;
  6. Enhancing the susceptibility of a human, animal, or plant host population to the biological agent; or
  7. Generating or reconstituting an eradicated or extinct biological agent.

Potential Dangerous Gain of Function (PDGOF) is defined as "Research with a biological agent that could potentially result in one or more of the outcomes listed in the DGOF definition and could result in significant negative societal consequences."

International Research of Concern (IROC) is defined as "Life sciences research involving entities of concern, i.e., research conducted in a country of concern; or research conducted outside the United States by an institution of concern or an individual of concern.

Georgia Tech Assessments

  1. Georgia Tech investigators proposing and/or conducting Life Sciences Research answer screening questions related to the above-listed concerns when they submit grant proposals to the Office of Sponsored Projects (OSP) and when they submit protocol applications to the Biological Materials Safeguards Committee (BMSC), Institutional Biosafety Committee (IBC), Institutional Animal Care and Use Committee (IACUC), and/or Institutional Review Board (IRB).
  2. The BMSC, IBC, IACUC, and IRB notify the IRE office for parallel review when DGOF, PDGOF, or IROC has been identified during the respective review process.
  3. The IRE conducts a Risk Assessment to determine if the research truly meets the definition of DGOF, PDGOF, or IROC and may withhold approval of the submission.
  4. For PDGOF research, the IRE communicates with the appropriate funding agency and develops a Draft Risk Mitigation Plan. 
  5. Once approved, Georgia Tech implements the Risk Mitigation Plan (which is reviewed annually).