ROWAN UNIVERSITY

Title: Biosafety and Dual Use Research Concern Policy
Subject: Research
Policy No: Res: 02/28/2018
Applies: University-Wide
Issuing Authority: President
Responsible Officers: Vice Chancellor for Research and Sr. Vice President for Facilities Planning and Operations
Adopted: 2010
Last Revision: 09/19/2025
Last Reviewed: 02/05/2026

I. PURPOSE

The purpose of this policy is to describe the University’s adherence to multiple federal requirements surrounding obligations prescribed by: 1) the Office of Science and Policy NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines, 2024) (e.g., for the safe use of potentially biohazardous, mutagenic, genotoxic, teratogenic, neurotoxic and hyper-allergenic agents), and 2) the Office of Science and Policy guidelines on research with high-consequence pathogens and toxins to determine and assess impacts to public health, agriculture, food security, economic security, or national security as established by the Unites States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. These federal guidelines mandate Rowan’s adherence triggered by the University receiving federal sponsored funds. Rowan will implement these requirements to the degree required as a recipient of federal funds.

II. ACCOUNTABILITY

Under direction of the President, Sr. Vice President for Facilities Planning and Operations and the Vice Chancellor for Research, Rowan University shall implement and ensure compliance with this policy. The Vice Chancellor for Research functions as the Institutional Official and may delegate that role as appropriate.

III. APPLICABILITY

Rowan University will apply this policy to all biohazardous agents/materials and recombinant or synthetic nucleic acid molecules research conducted at Rowan University. This policy also applies to any use of biohazardous agents/materials that may be a dual use of research concern.

Rowan University has established an Institutional Biosafety Committee (IBC) and appropriate policies and procedures for the effectiveness of the IBC. . Policies and procedures include, but are not limited to, initial and continuing review and approval of applications, proposals, and activities involving use and storage of recombinant or synthetic nucleic acid molecules and biohazardous agents/materials research conducted at Rowan University. Rowan University is not participating in or sponsoring recombinant or synthetic nucleic acid molecule research involving human subjects.

IV. DEFINITIONS

Biocontainment - the containment of pathological microorganisms within a well-defined, strictly controlled area, usually a research laboratory.
Biohazard - a biological agent, such as an infectious microorganism or a biological toxin, or a condition that constitutes a threat to humans, especially in biological research or experimentation. The potential danger, risk, or harm from exposure to such an agent or condition.
Biosafety – The application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious and recombinant materials.
Biosafety Level - The level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels.
Biosafety Officer - The designated scientific-administrative officer who assures compliance and biosafety of research involving biohazards and/or recombinant and synthetic nucleic acids.
BMBL - “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) is produced by the Centers for Disease Control and Prevention (CDC), Office of Health and Safety and the National Institutes of Health to provide national guidelines to promote the safety and health of workers in biological and medical laboratories.
Dual Use Research of Concern (DURC) – 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.
Environmental Safety and Health – A discipline and specialty that studies and implements practical aspects of environmental protection and safety at work. In simple terms it is what organizations must do to make sure that their activities do not cause harm to anyone.
Exposure Control – A plan that is important to help protect workers from exposures to blood and other body fluids also known as Bloodborne pathogen exposure control
Institutional Official – Senior Officer of Rowan University with authority to establish the Institutional Biosafety Committee (IBC) and oversight of the administration and operations of the IBC.
Institutional Biosafety Committee (IBC) - institutional body responsible for oversight of activities involving biohazardous materials as required by the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and the Centers for Disease Control and Prevention (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL).
Institutional Contact for Dual Use Research (ICDUR) - is the official designated by the research institution to serve as an internal resource for application of this Policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.
Institutional Review Entity – Subcommittee of the IBC and responsible for review of biological agents or toxins subject to U.S. Government, NIH Policy on Dual Use of Research Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
Life Sciences - pertains to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, microbiology, synthetic biology, virology, molecular biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches to understanding life at the level of ecosystems, populations, organisms, organs, tissues, cells, and molecules. Life sciences is defined in United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014 Institutional DURC Policy).
OSHA - an injury or illness is considered by the Occupational Safety and Health Administration to be work-related if an event or exposure in the work environment either caused or contributed to the resulting condition or significantly aggravated a pre-existing condition.
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.
PEOSH - Public Employees Occupational Safety and Health (PEOSH) develops and enforces occupational health standards for public employees and encourages employers and employees to improve their working environment.
Principal Investigator - (PI) The lead researcher for the project and is responsible for research compliance regulations at the laboratory level.
Recombinant DNA Technology – The process of taking a gene or a DNA fragment from one organism and inserting into the genome of another. One commonly used technology involves the insertion of a new fragment of DNA that codes for a specific protein such as a growth hormone gene transferred into and expressed by a bacterium.
Risk Group - The classification of biological agents into the four risk groups applies for both so-called natural biological agents and genetically modified organisms. This takes into consideration pathogenicity of the organism, mode of transmission and host range, and also taking into consideration effective preventive measures and availability of effective treatment.
Select Agents – Biological substances (agents) declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety".
Synthetic Nucleic Acids - Molecules that are constructed by joining naturally-occurring nucleic acid molecules and that can integrate and replicate into the genome of a living cell (i.e., recombinant nucleic acids) or nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but that are complementary to and can form base pairs with naturally occurring nucleic acid molecules , or molecules that result from the replication of recombinant or synthetic nucleic acids.
USDA/APHIS - United States Department of Agriculture, Animal and Plant Health Inspection Service, a multi-faceted Agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities.

V. REFERENCES

NIH Office of Science Policy - The NIH Office of Science Policy (OSP) promotes progress in the biomedical research enterprise through the development of sound and comprehensive policies. OSP also is the primary policy adviser to the NIH Director on matters of significance to the agency, the research community, and the public (https://osp.od.nih.gov/.)
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. (https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/.)
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition. https://www.cdc.gov/labs/bmbl/index.html.
Dual-Use Research of Concern. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. For additional information, please visit the NIH Office of Science Policy, Dual Use Research of Concern. https://aspr.hhs.gov/S3/Pages/Dual-Use-Research-of-Concern-Oversight-Policy-Framework.aspx
29 CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens Standard; Occupational Safety and Health Administration. United States Department of Labor https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.
Rowan University Laboratory Safety Policy. https://confluence.rowan.edu/display/POLICY/Laboratory+Safety+Policy.

VI. POLICY

Rowan IBC Responsibilities

The Rowan IBC is responsible for reviewing recombinant or synthetic nucleic acid molecule research conducted at or sponsored by the institution for compliance with the NIH Guidelines as specified in Section III, Experiments Covered by the NIH Guidelines, and approving those research projects that are found to conform to the NIH Guidelines. The Rowan IBC shall function according to and in compliance with NIH Guidelines, Section IV-B-2-b.

The Rowan IBC is responsible for reviewing use of biohazardous agents, including cytotoxic, genotoxic, mutagenic, and teratogenic agents used in research; including when those agents are used in the conduct of animal use activities.

The Rowan IBC is responsible for reviewing life sciences research that involves agents and toxins identified in section 6.2.1 and categories of experiments identified in section 6.2.2 of the United States Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern. The IBC subcommittee charged to review and approve life sciences dual use of research concerns will be the Rowan Institutional Review Entity (IRE). Rowan IRE will provide a final report to the Rowan IBC related to all aspects of a dual use of research concern. The Rowan IBC may hold approval of proposed work with agents and toxins until Rowan IRE final report is submitted to the IBC. Rowan University has identified and made public the institution’s Institutional Contact for Dual Use Research (ICDUR) to receive notifications and alerts of proposed use of agents and toxins and categories of experiments subject to dual use of research concerns.

Additional responsibilities of IBC include:

1. Review and approval of the research or teaching activity performed by individual researchers whose work involves the use and/or potential exposure to biohazards, on a regular and continuing basis at three-year intervals.
2. Assess the containment levels of the work using the physical parameters and work practices as part of risk assessment consistent with hazard group classification and as required by the NIH Guidelines, for all experiments, including those involving animals, cell cultures, tissues, human-derived materials, biological toxins, infectious agents, and regulated pathogens and pests.
3. Assess and lower the risks in proposed experiments in which DNA from Risk Group 2, 3, or 4 or Restricted Agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
4. Notify the Principal Investigator of the results of the IBC's protocol review including deferring approval, require modifications to secure approval and approval.
5. Review and approve plans covering accidental spills and personnel contamination resulting from research using biological hazards.
6. Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic acid molecule research.
7. Suspend or terminate approval of research that is not being conducted in accordance with the IBC's requirements.
IBC Membership
The University shall maintain an active Institutional Biosafety Committee (IBC) as described in the NIH Guidelines, Section IV-B-2. The IBC membership shall include broad representation from Rowan University; however, no fewer than five members. At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment (e.g., officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community). At least one member must be a representative of the university’s environmental health and safety program. This member can act in and be appointed as a Biological Safety Officer for any large-scale research or production ac activities involving viable organisms containing recombinant or synthetic nucleic acid molecules.

Rowan IBC members will include faculty, scientists, and staff that have expertise, knowledge, or skills in use of recombinant or synthetic nucleic acid molecules, assessing risk related to use and experimentation, biocontainment practices and procedures, assessment of physical areas, buildings, and room containment requirements, and experts in the areas of animal and plant use of recombinant or synthetic nucleic acid molecules, containment practices and procedures, and biohazardous agents and materials.
IBC Members Conflict
No member of an IBC may be involved (except to provide information requested by the IBC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest.
IRE Responsibilities
When research involves one or more of the agents or toxins listed in Group 1, it will be evaluated for DURC potential and such research must be conducted at Rowan University in accordance with the USG Policy.

Pursuant to its obligations under the USG Policy, Rowan University IRE will evaluate research that involves one or more of the agents or toxins listed in Group 1 below and produces, aims to produce, or is reasonably anticipated to produce one or more of the effects of Group 2 below. As per the USG policy, there are no Exempt quantities.
1. Group 1 - Agents and Toxins subject to DURC
  1. Avian influenza virus (highly pathogenic)
  2. Bacillus anthracis
  3. Botulinum neurotoxin
  4. Burkholderia pseudomallei
  5. Burkholderia mallei
  6. Ebola virus
  7. Foot-and-mouth disease virus
  8. Francisella tularensis
  9. Marburg virus
  10. Reconstructed 1918 influenza virus
  11. Rinderpest virus
  12. Toxin-producing strains of Clostridium botulinum
  13. Variola major virus
  14. Variola minor virus
  15. Yersinia pestis
2. Group 2 – Categories of Experimental Effects
  1. Enhances the harmful consequences of the agent or toxin
  2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification
  3. Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
  4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
  5. Alters the host range or tropism of the agent or toxin
  6. Enhances susceptibility of a host population to the agent or toxin
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above
IRE Membership
IRE membership must include three members and will be determined based upon use of agents and toxins subject to DURC (Group 1) and categories of experiments (Group 2). At least two members must be representatives from the Office of Research Compliance and Environmental Health & Safety Office. Ad-hoc members, who are individuals that have expertise, understanding, and knowledge related to bioagents/biomaterials, laboratory security and safety, facilities operations, or other aspect of the research scope of work may be included as designated by the Associate Vice-President/Chief Research Compliance Officer. Ad-hoc members can be internal faculty or staff of Rowan University, an external, unaffiliated individual, or a consultant.
IRE Members Conflict
No member of an IRE committee may be involved (except to provide information requested by the IRE) in the review of a life sciences research project in which that IRE member expects to be engaged or has a direct financial interest.
Principal Investigator’s (PI) Responsibilities:
A PI may not acquire, take possession of, transport, or introduce into any laboratory recombinant or synthetic nucleic acid molecules or biohazardous agent or toxin until required IBC approval for use and/or storage is obtained from the IBC.
Principal Investigators are responsible for:
1. Submitting for review and approval any proposed experimentation and use of recombinant or synthetic nucleic acid molecules or biohazardous agent or toxin to the Rowan IBC
2. Adhering to Rowan University’s general laboratory and biological safety practices; including any laboratory standard operating procedures required by Rowan’s Environmental Health & Safety Office
3. Informing Rowan University of laboratories and locations using recombinant or synthetic nucleic acid molecules or biohazardous agents or toxins
4. Not initiating or modifying any IBC approved use of biohazardous agents or materials or recombinant or synthetic nucleic acid molecules without obtaining Rowan IBC approval of new use (see Sections III-A, III-B, III-C, III-D, and III-E, Experiments Covered by the NIH Guidelines)
5. Communicate dual use of research concerns in a responsible, timely, and transparent manner. Notifying the IRE and IBC throughout the entire project life cycle from planning, implementation, to post-completion, when changes occur in experimental procedures, and newly founded or discovered risks related to the use of one or more of the agents listed in section 6.2.1 of USG policy
6. Disclosure to IBC and IRE of any conflicts of interest related to proposed work with biohazardous agents/materials and/or recombinant or synthetic nucleic acid molecules.
Openness of IBC meetings
To the degree required by law or federal regulation, Rowan’s IBC may share meeting informationmaterials with the public. Contact information for the IBC is available to the public to inquire about attendance at a Rowan IBC meeting.
HHS/USDA Select Agents and Toxins
The institution is engaged in conducting experiments involving select agents. Use of select agents is included in IBC registrations and identified as material in laboratory registrations. Rowan EH&S manages select agents and toxins, regardless if the select agent and toxin is in exempt quantities or not, according to CDC or USDA policy and regulations. Laboratories in possession of (whether in use or not) must meet all aspects of the rules and regulations governed by the agency they registered with (CDC or USDA).
Non-Compliance
Non-Compliance with the NIH Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) or USG Policy (DURC) or other relevant and required so called guidelines or requirements authorize Rowan to suspend the research or to take any other action to satisfy compliance (e.g., suspension, limitation). Issues and matters related to non-compliance must be reported to Rowan Environmental Health & Safety, Office of Research Compliance, any other college, school, or administrative unit at Rowan university, from an external, non-Rowan individual, or Rowan University’s anonymous reporting system/hotline.

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Biosafety and Dual Use Research Concern Policy

ROWAN UNIVERSITY