BIOLOGICAL SAFETY
IN THE EVENT OF A BIOLOGICAL EMERGENCY, CONTACT: | |
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Biological Safety Hotline: 404-413-3540 |
Acceptable biosafety practices require a cooperative effort between the Institutional Biosafety Committee (IBC), the Biosafety Officer (BSO), Principal Investigators (PI), and laboratory staff. Georgia State’s Biosafety Officers have responsibility for the daily administration of standards set by the IBC and act as the agents of the committee in their implementation. These officers oversee all Biosafety Protocol requests, conduct a preliminary screening of these requests, and manage assignments to the IBC for review. Biosafety officers conduct biohazardous risk assessments, assist PIs in developing research safety protocols and obtaining regulatory approvals, provide training on the principles and practices of biosafety, and arrange services for the appropriate medical surveillance of personnel working with biohazardous material. All of this is conducted in order to facilitate the PI’s work in a manner that is both safe and in compliance with relevant regulations.
IBC Protocol Registration
If your research or instructional activity involves the use of biohazardous materials, you will need to complete an IBC Protocol Registration Form A (see below) for new protocols or to separate projects. Project and personnel amendments can be submitted using Forms B and C, respectively. For clinical research, you will need to complete the Clinical Biosafety Protocol Registration Form D and submit it as instructed.
IBC Documents
Institutional Biosafety Committee Members
Name | Affiliation |
Richard Plemper - Chair | Center for Translational Antiviral Research |
Angela Mabb - Vice Chair | Neuroscience Institute |
Sang-Moo Kang | Center for Immunology, Immunity, and Infection |
Leszek Ignatowicz | Institute for Biomedical Sciences |
Jessica Bolton | Neuroscience Institute |
Margo Brinton | Department of Biology |
Chunying Li | Institute for Biomedical Sciences |
James Gurney | Department of Biology |
Robert Cox | Center for Transitional Antiviral Research |
Jianliang Xu | Department of Biology |
Sherrie Jean | Community Member |
James J. Miller | Community Member |
William Arndt, Ex officio member with vote | Associate Director, Biosafety |
Rex Howard, Ex officio member with vote | Director, Clinical Services, Division of Animal Resources |
Tiesha Murray, Ex officio member without vote | Associate Director, IACUC |
Danielle Danielly, Ex officio member without vote | Director, Research Safety Programs/High Containment Laboratories |
Donald Hamelberg, Ex officio member without vote | Vice President for Research and Economic Development |
Andrew Murray, invited to attend | Research Occupational Health Nurse Practitioner |
Natasha Griffith, invited to attend | Associate Director, High Containment Laboratories |
Evan Hutto, invited to attend | Assistant Director, Division of Animal Resources |
IBC Meeting Dates
Meeting Date | Protocol Application Deadline |
January 17, 2025 | December 13, 2024 |
February 21, 2025 | January 17, 2025 |
March 21, 2025 | February 21, 2025 |
April 18, 2025 | March 21, 2025 |
May 16, 2025 | April 18, 2025 |
June 20, 2025 | May 16, 2025 |
July 18, 2025 | June 20, 2025 |
August 15, 2025 | July 18, 2025 |
September 19, 2025 | August 15, 2025 |
October 17, 2025 | September 19, 2025 |
November 14, 2025 | October 17, 2025 |
December 12, 2025 | November 14, 2025 |
January 16, 2026 | December 12, 2025 |
- Georgia State University Biosafety Manual
- Animal Biosafety Level-1 Manual (ABSL-1)
- Animal Biosafety Level-2 Manual (ABSL-2)
- Transporting Biohazardous Materials Procedures
- Guidelines for Working with LPS-Exposed Animals
- Guidance on the Registration of Genetically Modified Animals
- Guidance for Work with Adenovirus and Adeno-associated Virus and Viral Vectors
- Guidelines for Working with Lentivirus and Lentiviral Vectors
- Biohazardous Waste Disposal Procedures
- Biohazardous Waste Disposal Flyer
- Guidance for Working with Human and Non-human Primate Derived Materials
- Respiratory Protection Program for Research Laboratories/Support Areas
- Guidance for Safe Handling of Sharps
- Bloodborne Pathogen Exposure Control Plan
- Complete Freund’s Adjuvant Guidance
Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
Purpose
The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Policy”) is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins. This Policy addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security. It supersedes the 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Federal DURC Policy), the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Institutional DURC Policy), and the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO Framework).
The intent of this Policy is to strengthen oversight of life sciences research with biological agents and toxins throughout the research lifecycle by:
- Expanding the Scope of Oversight: Defining an expanded scope of biological agent and toxin research subject to additional oversight by the U.S. government.
- Enhancing Risk Assessment: Providing a unified framework to support the consistent identification and oversight of research proposals subject to this policy that accounts for safety, security, and ethical considerations.
- Evaluating roles and responsibilities: Delineating the roles and responsibilities of principal investigators, research institutions, and federal departments and agencies that conduct, fund, or oversee research within the scope of this policy, with an emphasis on institutional oversight and management of this research
Scope
It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
- Dual-Use Research is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes
- Dual-Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
- Institutional Review Entity (IRE) is the entity established by the research institution to execute the institutional oversight responsibilities described in Section 5.2, with the attributes described in Section 5.2.B
- Pathogen with Enhanced Pandemic Potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility10 or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential. K. “Pathogen with pandemic potential (PPP)” is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.
- Reasonably Anticipated describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.
This policy categorizes the research into Category 1 and Category 2 research and expands the scope of research. Category 1 research is subject to oversight by research institutions and federal funding agencies, and Category 2 research is subject to oversight by research institutions, federal funding agencies, and their federal department if applicable12 due to heightened potential for biosafety and biosecurity risks. Any research that meets the definition of both Category 1 and Category 2 research is designated as Category 2 research.
- Category 1 Research: Category 1 DURC (Dual Use Research of Concern) refers to research involving biological agents and toxins that, if misused, could pose significant risks to public health, agriculture, or national security. These agents are expected to produce risky experimental outcomes, such as increasing a pathogen's transmissibility or virulence. These agents include all Select Agents & Toxins (in any quantity), all Risk Group 4 pathogens listed in Appendix B-IV of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, a subset of Risk Group 3 pathogens listed in Appendix B-III of the NIH Guidelines, and other agents that have not been assigned a Risk Group in the NIH Guidelines but are recommended to be handled in BSL-3 or BSL-4 in the Biosafety In Microbiological and Biomedical Laboratories (BMBL).
- Category 2 Research: Category 2 DURC-PEPP research involves experiments that enhance a pathogen’s transmissibility, virulence, or ability to evade detection or immunity, posing a significant threat to public health, agricultural crops, animals, the environment, or national security.
It is the responsibility of all NIH applicants and recipients, through their Principal Investigators (PD/PIs) and other Senior/Key Personnel (“researchers”) named in the application, to assess whether or not their research, for which NIH funding is received or sought, falls under the scope of Category 1 and/or Category 2 research. Applicants and recipients seeking to conduct research within the scope of this policy will be required to have an Institutional Review Entity (IRE) and an Institutional Contact for Dual Use Research (ICDUR). Composition and responsibilities of the IRE and ICDUR are outlined in the DURC/PEPP Policy. Researchers must work with their IRE to develop a risk-benefit assessment and risk mitigation plan, as needed, that must be approved by NIH before this work can begin or continue. Once awarded, recipients, through their PD/PIs, must carry out and oversee research according to the approved plan. Recipients and applicants are expected to develop necessary infrastructure and personnel to comply with the DURC/PEPP Policy. NIH strongly recommends institutions begin training relevant staff on the DURC/PEPP Policy.
PIs Should:
- Be knowledgeable about and comply with or follow all applicable institutional and U.S. government policies, requirements, and regulations for oversight of biological agent and toxin research.
- Assess their research at the proposal stage, and continuously throughout the research lifecycle, to identify whether there is research reasonably anticipated to be within scope of Category 1 or within scope of Category 2. Following identification of potential Category 1 or Category 2 research, notify the federal funding agency and research institution, refer the research to an appropriate IRE, and be prepared to develop a risk-benefit assessment and a risk mitigation plan.
- Work with the IRE to assess the risks and benefits of the proposed research and submit the risk-benefit assessments and draft risk mitigation plan for Category 1 or Category 2 research to the federal funding agency for review and approval when appropriate:
- Conduct Category 1 and Category 2 research in accordance with the provisions identified in the risk mitigation plan approved by the federal funding agency.
- Provide annual progress reports for Category 1 research and semiannual progress reports for Category 2 research, and as requested by the federal funding agency
- Ensure that laboratory personnel conducting life sciences research within the scope of this Policy (i.e., those under the supervision of laboratory leadership including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) have received and maintain education and training on all research oversight policies and processes and demonstrated competency.
- Communicate Category 1 and Category 2 research in a responsible manner.
NIH Implementation
The DURC/PEPP Policy requirements apply to all NIH-funded research, including grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions).
For competing grant and cooperative agreement applications, NIH will request applicable DURC/PEPP materials to be provided as part of Just-in-Time (JIT) materials submitted on or after May 6, 2025. DURC/PEPP materials must be submitted by the Authorized Organizational Representative (AOR).
For active grants and cooperative agreements, NIH will request applicable DURC/PEPP materials to be provided as part of any non-competing applications, including Research Performance Progress Reports (RPPRs), due on or after May 6, 2025. Non-competing applications that include DURC/PEPP materials must be submitted by an AOR.
Resources
Need more information? Please check out these resources.
Have more questions? Please contact our office.
Liz Coffee
GSU Biosafety Officer, Sr.
[email protected]
Biosafety Office
[email protected]
Find Training
Find Resources
Report Compliance Issues
For questions or to report concerns, please contact:
Sandie Wold
Biosafety Officer, High Containment Labs
404-413-3528
[email protected]
Joshua Jones
Senior Biosafety Specialist
[email protected]
Samantha Spencer
IACUC/IBC Compliance Officer
(404) 413-3515
[email protected]