Basics

The University is deeply committed to safety as a core institutional value, ensuring a secure environment for all faculty, staff, students, and the surrounding community. This commitment fosters an atmosphere where teaching, learning, service, outreach, discovery, and creativity can thrive without compromising safety standards. Every individual involved in potentially biohazardous activities share the responsibility for biosafety by adhering to specified procedures, completing required training, acting responsibly, and promptly reporting any incidents involving hazardous circumstances. The IBC is responsible for the safety, ethical conduct, and scientific integrity of biohazardous activities by ensuring the possession and utilization of biohazardous materials at the University comply with rigorous safeguards, guidelines, and regulations.

Adherence to NIH Guidelines Research Involving Recombinant DNA Molecules (referred to as the NIH Guidelines) is a cornerstone of the University’s commitment to safety. The NIH Guidelines regulate the construction and handling of recombinant DNA (rDNA) and synthetic nucleic acid molecules (sDNA), as well as organisms or viruses that may contain these elements. Compliance with these guidelines is mandatory for institutions receiving NIH or USDA funding for rDNA research and is outlined as required per terms and conditions. The NIH Guidelines cover specific practices for handling rDNA (e.g., safety considerations, types of experiments covered, and roles and responsibilities of the IBC and its members). The University acknowledges the evolving nature of research in this field, necessitating continual adaptation to emerging challenges. As such, the University has expanded the authority of the IBC beyond rDNA research to encompass oversight of all biohazardous materials which include biological agents, biologically derived toxins, and other materials that may pose risks to the environment and public health. This proactive expansion aligns with the best practices of research universities and reflects the University's commitment to fostering a culture of safety, ensuring that all activities—from teaching and learning to research and discovery—can thrive securely.

Acknowledging the pivotal role of the IBC in the planning and execution of the University’s biosafety program, the Chancellor and Institutional Official (IO) charge the IBC with reviewing, approving, and overseeing activities (research and teaching) involving biohazardous materials, rDNA, biological agents, and biologic-derived toxins at UMassD; regardless of the funding source.

The IBC has the authority to approve, require modifications to secure approval, disapprove, suspend, or terminate research activities to assure adherence to safety protocols and regulations, including the authority to grant exemption from IBC oversight, where appropriate. During review, the IBC assess facilities, procedures, safety practices, personnel expertise and training to ensure proper biohazards management and assure compliance with applicable guidelines and regulations. Projects involving biohazardous materials at other institutions should receive IBC approval from the cooperating institution, corresponding approvals must be documented. The IBC must grant approval prior to the acquisition, use, or transfer of biohazardous materials. The IBC is responsible for establishing and implementing guidelines to facilitate the safe conduct of research involving biohazardous materials, rDNA, biological agents, and biologic-derived toxins while monitoring federal, state, and local regulations to ensure UMassD compliance.

Given the University's receipt of NIH funding for rDNA research, adherence to NIH Guidelines is imperative to maintain funding and ensuring institutional compliance.  The University is responsible for registering the IBC with NIH’s Office of Science Policy (OSP), including filing an annual report which includes a roster of IBC members, their roles, and a biographical sketch outlining their qualifications. The registration and reporting assure the NIH of the local review and oversight, verifies IBC expertise meets NIH standards, provides contact information for the institution, and a census of where rDNA research is being conducted.

Membership is composed to ensure the acquisition of adequate subject-matter knowledge and expertise in work being reviewed. To ensure impartiality and provide external oversight, at least two members of the IBC are not affiliated with the University. These external members represent the interests of the broader community, offering an important outside perspective on biosafety issues. The diversity of expertise within the IBC ensures thorough reviews and risk assessments of the research and teaching activities under its jurisdiction.

In alignment with best practices and NIH recommendations, the IBC is committed to transparency. Whenever feasible, IBC meetings will be open to the public to foster community engagement and ensure the accountability of the committee’s decisions.

The purpose of this Charter is to outline the scope, responsibilities, and procedures of the IBC, and to ensure that all activities involving biohazardous materials at the University are conducted safely, ethically, and in compliance with applicable regulations. This document serves as a framework to promote a safe working environment, well-regulated research study areas, and protection for the local community.

The IBC is dedicated to upholding the highest standards of biosafety and ethical conduct in research involving biohazardous materials. The IBC ensures that activities utilizing these materials adhere to ethical and regulatory requirements, including their safe handling, storage, and disposal. By ensuring compliance with the NIH Guidelines, Health and Human Services, Biosafety in Microbiological and Biomedical Laboratories (BMBL; 6^th edition), and other relevant local, state, or federal regulations, the IBC strives to safeguard human health and promote responsible research practices.

In addition to its oversight responsibilities, the IBC establishes and implements policies that support the safe use and handling of biohazardous materials. This includes providing comprehensive training to faculty, staff, and students on proper handling practices and making informed recommendations to the University based on compliance reports, including adverse event reporting.

A key component of the IBC’s mission is to educate the University community on the regulatory requirements surrounding the use of biohazardous materials to minimize risks to research personnel, the community, and the environment. This educational outreach helps minimize risks to research personnel, the broader community, and the environment, thereby enhancing overall institutional safety and compliance.

The IBC also plays a coordinating role in reviewing and approving research projects that overlap with other institutional oversight bodies, such as Export Controls, Conflicts of Interest, the Institutional Animal Care and Use Committee (IACUC), and the Institutional Review Board (IRB). This collaborative approach approach ensures that research involving biohazardous materials is conducted with the highest level of integrity, safety, and ethical responsibility.

University BioSafety Officer, Ex-Officio Member: Brandon Linz, PhD, RBP

Total Number of Voting Committee Members = 11 Quorum = 7