Considerations

The experimental design of the research should be scientifically sound and justifiable. PIs must clearly define the research objectives and articulate why the use of biohazardous materials is essential for achieving these goals. Defining specific research questions and hypotheses serves to justify the proposed use of these materials to the IBC. Conduct preliminary studies to test hypotheses or methodologies before committing to larger-scale research to enhance the validity of the findings and help identify potential issues early in the process. Evaluate the feasibility of replicating studies to ensure robustness and reliability in the experimental design and consider the availability of resources, personnel, funding, equipment, expertise, and time necessary for successful replication. Perform a thorough risk-benefit analysis to ensure that the potential benefits of the research outweigh the associated risks. The analysis should encompass risks to researchers and subjects, as well as broader implications for public health and safety, and must be documented for the IBC's review. PIs should address the ethical justification for using specific biohazardous materials, highlighting how the research contributes to scientific knowledge or public health. Request feedback from colleagues, mentors, or biosafety professionals to strengthen the experimental design. Constructive input can help identify potential weaknesses or overlooked considerations in the research proposal and/or help identify potential weaknesses or overlooked considerations within the research proposal. Provide any relevant feedback as references for the IBC to review, this transparency aids in the review process.

Laboratory directors, laboratory supervisors, and PIs share the responsibility of providing a comprehensive initial risk assessment to determine the risk levels associated with proposed research activities. PIs must identify potential hazards linked to the biological agents they intend to use, taking into account factors such as pathogenicity, virulence, transmission routes, and the agents' effects on human health and the environment. Examine existing literature or historical data on similar research to gain insights into potential risks, including analyzing past incidents or outcomes related to the biological agents under study, as this information can inform risk mitigation strategies. Collaborate with stakeholders, such as facility managers, safety personnel, BSO, and EHS, to gather insights on risk mitigation strategies and unique risks related to the specific laboratory environment and procedures. A dynamic risk assessment system should be implemented to adapt throughout the research lifecycle, allowing for adjustments based on evolving conditions, new information, or emerging risks, ensuring that safety measures remain effective and relevant. PIs are encouraged to document their risk assessment processes and decisions and provide any relevant publications or data as references to facilitate and inform the IBC review. 

Ensuring biosecurity is a shared responsibility, which is accomplished only by having protocols to regularly review and update security measures based on evolving risks and emerging threats. PIs should assess the risk associated with each biological material (e.g., low, medium, or high) and conduct a vulnerability assessment to identify security gaps in the use, storage, and handling of the material. The security measures should be proportional to the assessed risk level and involve a vigilant staff which restricts access to biological materials to authorized personnel to prevent potential misuse. Key biosecurity considerations include:

• Physical Security: Additional locks, such as padlocks or electronic access cards, should be installed on laboratories, freezers, and other storage locations where biological agents are housed. Controlled access areas should be clearly designated, with enhanced security for high-risk materials.
• Chain-of-Custody: Use of chain-of-custody forms within the laboratory to track the movement, transfer, and usage of biological materials to reduce the possibility of mishandling.
• Inventory Management: A complete and up-to-date inventory of biological materials should be maintained. Inventories should track not only the presence of the material but also any usage or transfer, ensuring clear oversight.
• Access Logs: Maintain logs of all individuals who have accessed laboratories or storage areas containing biological materials to track access and identify any unauthorized entry.
• Threat and Vulnerability Assessment: Conduct a formal assessment of potential threats or vulnerabilities related to the use and storage of biological materials to inform security enhancements, personnel access, and emergency response planning.

PIs are responsible for ensuring their protocols reflect an understanding of the appropriate biosafety level (BSL) required for their research. Clearly detail the use of personal protective equipment (PPE), safety cabinets, and sterilization procedures in the protocol. Work with the BSO to develop biohazardous management standard operating procedures (BHMSOPs) for the handling, storage, and disposal of biohazardous materials tailored to the lab environment and outline both routine procedures and protocols for emergency situations. Schedule regular inspections of containment facilities to ensure compliance with biosafety standards and to promptly address any deficiencies. Document inspection findings and follow up on corrective actions to maintain a safe research environment. Ensure all emergency equipment (e.g., eyewash stations, safety showers) is easily accessible and regularly tested. Maintain records of inspections and any maintenance performed on emergency equipment.

The PI is responsible for implementing a comprehensive Personal Protective Equipment (PPE) program tailored to the specific hazards associated with the research being conducted and aligns with UMassD biosafety policies and relevant regulations. The PI should establish protocols for the proper maintenance, regular inspections of PPE to identify wear and tear, procedures for cleaning and decontaminating reusable PPE, and safe disposal methods for single-use or contaminated PPE. The PI must ensure all laboratory personnel receive thorough training on the proper selection, use, and maintenance of PPE for different tasks and understand its importance in minimizing exposure risks. Regular audits and inspections should be conducted to ensure compliance with PPE requirement to be readily available and accessible in the laboratory. The PI should conduct a risk assessment to determine the appropriate PPE based on the type of biological, chemical, or radiological agents being used, the nature of the procedures involved (e.g., handling, mixing, transporting materials), and the potential routes of exposure (inhalation, dermal contact, ingestion). The PI should regularly replenish PPE supplies to ensure that all personnel always have access to appropriate protective gear. Noncompliance must be addressed promptly through retraining or disciplinary measures as necessary.

Refer to the UMassD Biosafety Manual, for detailed guidelines and best practices for PPE in laboratory settings.

Effective decontamination and disposal practices are essential for maintaining a safe laboratory environment, particularly when working with biohazardous materials. Develop proper decontamination protocols to mitigate risks associated with these materials, ensuring compliance with institutional and federal regulations. Begin with a thorough assessment of all hazardous materials involved in the research project, considering the nature and classification of these materials, including their biological, chemical, and radiological properties. Understand the characteristics of the agents being used to evaluate the specific risks associated with each material and inform the selection of appropriate and effective decontamination methods and agents. Choose agents based on the types of contaminants present, ensuring they are capable of inactivating or removing the specific pathogens or hazardous materials involved. Common options include chemical disinfectants, such as bleach solutions, ethanol, and hydrogen peroxide, as well as sterilization methods like autoclaving. It is essential to verify the selected agents are compatible with the surfaces, equipment, and materials found within the laboratory setting to avoid damage or adverse reactions. Develop clear and comprehensive procedures for decontaminating laboratory surfaces, equipment, and PPE after use. Ensure procedures include step-by-step instructions for cleaning and disinfecting work surfaces, instruments, and personal items, such as lab coats. Additionally, procedures should outline specific guidelines for handling and disposing of contaminated materials safely, including biohazard waste disposal protocols. Train all laboratory personnel on proper decontamination practices is critical to ensuring consistency and safety across the research team. The PI should emphasize the importance of adhering to these practices to prevent contamination and exposure, conducting practical demonstrations to enhance understanding and compliance. To ensure decontamination activities are effective, a systematic monitoring program should be implemented to include regular checks to verify adherence to decontamination procedures and identify any areas for improvement. Personnel should be encouraged to document their decontamination activities, noting any incidents, challenges, or deviations from established protocols, which can be critical for continuous improvement.  In the event of spills or exposure incidents, clear and well-documented response protocols must be established to outline immediate decontamination steps, such as isolating the affected area and using appropriate agents, as well as procedures for notifying the necessary authorities, including the EHS Office. All personnel should be trained to recognize situations requiring immediate action and be familiar with the procedures to follow in such events. 

PIs must create comprehensive emergency response plans that address specific scenarios, including spills, exposure incidents, and equipment failures. Each plan must detail the precise actions to be taken in response to these situations, providing a clear roadmap for all personnel. Establish protocols for notifying relevant authorities and stakeholders, ensuring that every team member knows these procedures and their specific roles during an emergency. Regular training drills help reinforce these protocols and ensure that team members can act swiftly and confidently in a crisis. Implement an incident reporting system that promotes reporting to facilitate incident documentation, incident analysis, and improve future emergency responses.

Implement an inventory management system to document and track the receipt, storage, handling, use, and disposal biohazardous materials throughout their lifecycle. Schedule periodic reviews to assess storage conditions and establish whether materials are stored securely and whether the storage environment meets biosafety requirements to ensure compliance with regulations regarding long-term storage. Documentation should be readily accessible for inspections and audits to demonstrate adherence to biosafety protocols.

While only required for studies employing BSL-2 materials, all PIs are encouraged develop a comprehensive lab-specific biohazardous management plan. This plan should address all aspects of handling, storage, and disposal of biohazardous agents in compliance with regulatory requirements and institutional policies. Below are key components that should be included in the management plan:

1. Identification of Biohazardous Materials: Clearly identify all materials to be used in the laboratory. This includes cataloging the specific agents, their characteristics, and potential risks. It is crucial to maintain an updated inventory that outlines the biological agents' names, strains, and quantities being handled.
2. Laboratory Design and Access Control: Ensure the laboratory is designed and equipped to meet required BSL standards. This includes having a restricted access area to prevent unauthorized entry, ensuring all laboratory doors are self-closing, and installing handwashing facilities. Signage indicating the biohazard status of the lab should be prominently displayed.
3. Personal Protective Equipment (PPE): Establish specific PPE requirements for all personnel working with materials. This typically includes gloves, lab coats, face shields or goggles, and respiratory protection when necessary. PIs should ensure that all personnel are trained in the correct use of PPE and that appropriate PPE is available and maintained.
4. Work Practices: Develop step by step work practices for handling the materials. These SOPs should include instructions for safe handling, decontamination procedures, and emergency protocols for spills and exposures. Regularly review and update SOPs to incorporate the latest safety guidelines and best practices.
5. Decontamination Procedures: Outline effective decontamination procedures for surfaces, equipment, and waste generated during the research process. This should include the use of appropriate disinfectants for the specific agents being handled, as well as the proper methods for cleaning and disinfecting work areas. Establish a routine schedule for decontamination to ensure ongoing safety.
6. Waste Management: Develop a comprehensive waste management plan for disposing of biohazardous waste generated during research. This plan should outline procedures for segregating, collecting, and disposing of waste in accordance with local, state, and federal regulations. Ensure that biohazardous waste is labeled appropriately and stored in designated containers until it is treated or disposed of.
7. Emergency Response Plan: Create a detailed emergency response plan specific to the laboratory. This plan should outline procedures for responding to spills, exposures, and accidents involving the materials. It should also include contact information for emergency response teams and the BSO. Regular training drills should be conducted to ensure that all personnel are familiar with the emergency procedures.
8. Training and Recordkeeping: Document training sessions for all personnel working with the materials. Training should cover safe work practices, emergency procedures, and the proper use of PPE. Maintain records of training completion, as well as any incidents or accidents that occur in the lab, to identify areas for improvement and enhance safety culture.
9. Incident Reporting and Review: Establish procedures for reporting and reviewing incidents involving materials. Encourage a culture of transparency where all personnel feel comfortable reporting near misses, spills, or exposure incidents without fear of reprisal. Conduct regular reviews of reported incidents to identify trends and implement corrective actions.
10. Regular Review and Updates: The biohazardous management plan should be reviewed and updated regularly to reflect changes in research protocols, personnel, and regulations. PIs should seek feedback from the IBC and incorporate new safety measures and best practices as they become available.

Please contact the IBC for template BHMSOP.

Involvement of external collaborators requires careful consideration and planning. Identify and address any potential conflicts of interest that may arise from the collaboration. Establish clear guidelines for transparency in decision-making processes. Ensure external collaborators receive proper orientation regarding institutional policies, safety protocols, and specific procedures related to biohazardous materials. Engage external collaborators in the risk assessment process to identify and evaluate potential hazards associated with the research. Establish mechanisms for evaluating the contributions of external collaborators, including assessing their performance and the impact of their work on the overall project objectives. Maintain open lines of communication among all collaborators to facilitate information sharing, progress updates, and collaborative problem-solving. PIs should develop clear agreements to outline role, responsibilities, and expectations among collaborators to prevent overlaps or gaps in accountability and address any potential conflicts of interest and transparency in decision-making processes. Appliable agreements include:

• Memorandums of Understanding (MOUs): Develop clear MOUs to outline the goals, responsibilities, and expectations of all parties involved in the research project. This document serves as a foundation for collaboration and clarifies each collaborator's roles.
• Material Transfer Agreements (MTAs): MTAs govern the transfer of biohazardous materials between institutions, ensuring compliance with regulations regarding the handling and use of these materials.
• Statements of Work (SOWs): SOWs detail the specific tasks, deliverables, timelines, and responsibilities of each collaborator. This helps establish accountability and aligns expectations.
• Nondisclosure Agreements (NDAs): Implement NDAs to protect sensitive information and intellectual property shared between collaborators. This agreement ensures confidentiality regarding proprietary information.
• Collaborative Research Agreement (CRA): Implement a CRA to formalize terms of collaboration, including funding, intellectual property rights, and data management.
• Data Use Agreement (DUA) or Data Transfer Agreement (DTA): Implement a DUA/DTA to outline terms for using shared data, particularly for sensitive information.

PIs should carefully assess whether the research has the potential for dual-use concerns, meaning the knowledge, tools, or techniques developed could be misused for harmful purposes, such as bioweapons or other malicious applications. In the protocol background ensure to address the following:

• Intent and Application:Clearly define the intended purpose of the research and identify any potential misuse scenarios. Evaluate how the results could be applied outside of the original research context and whether those applications could pose risks to public safety or national security.
• Oversight and Review:Implement appropriate oversight mechanisms, such as internal and external ethical reviews, to ensure that dual-use concerns are systematically identified and addressed. PIs may benefit from consulting with ethics or legal advisors specializing in dual-use research.
• Public Communication:Consider how to communicate the findings of the research to the public and other stakeholders. PIs should be prepared to discuss the benefits of the research while addressing potential concerns about misuse.
• Education and Training:Incorporate training for all research team members on the ethical implications of dual-use research. This includes developing a clear understanding of the ethical responsibilities associated with the research and the importance of considering potential misuse during all stages of the research process.

Biological toxins include naturally occurring or synthetic substances that can cause harm to living organisms. PIs must identify the biological toxins to be used in research and understand the specific hazards associated with each toxin, including toxicity levels, routes of exposure, and potential health effects.  Before initiating any work with biological toxins, PIs must obtain the necessary approvals and permits.  When conducting experiments with biological toxins, PIs should implement appropriate containment measures which designated biosafety cabinets, secure storage areas, and restricted access to laboratories where toxins are handled. Ensure all workspaces are properly labeled and equipped with necessary safety equipment, such as eyewash stations and emergency showers. Develop a waste management plan that outlines the appropriate methods for disposing of toxin contaminated materials.

For Select Agents registration, the EHS staff and BSO collaborates with the PI to ensure compliance with UMassD policies and federal regulations, including CDC, Homeland Security, the Patriot Act, and others. The registration process involves:

• Determining whether the Select Agents require registration with the CDC or are exempt.
• Justifying the scientific need for using the biological agent, toxin, or delivery system.
• Conducting detailed risk assessments for the agent, procedures, and environment.
• Registering Select Agent(s) with the appropriate federal, state, or municipal agencies.
• Identifying and securing the storage and usage locations for Select Agents.
• Developing security protocols for control of the Select Agents when not in use.
• Ensuring only authorized personnel have access to the Select Agents.
• Defining methods for disinfection, decontamination, and disposal.
• Establishing comprehensive emergency response procedures.
• Providing training recommendations and oversight for PI and research personnel.

Considerations for Toxin and Select Agents Protocol

• Conduct an initial risk assessment to determine the appropriate biosafety level (BSL) for handling the toxin or Select Agent, including toxicity, routes of exposure, risks of transmission, environmental contamination, and unauthorized access.
• Collaborate with theBSO to develop a Biohazardous Management Standard Operating Procedure (BHMSOP), specifically addressing:
• Physical and personnel security plans.
• Control measures to prevent unauthorized access to Select Agents.
• Guidelines on handling, transport, and storage of Select Agents.
• Emergency response protocols and incident reporting mechanisms.
• Ensure all necessary documents are prepared and submitted with the permit application, including:
• Justification for the Slect Agent use.
• Security measures as outlined in the BHMSOP.
• Risk assessments, training plans, and biosafety protocols.
• The PI should apply for necessary permits (e.g., CDC, USDA, or DHS)6-12 months before initiating the research to accommodate long processing times and required agency approvals. This includes:
• CDC Select Agent Program registration.
• USDA APHIS permits, if applicable.
• Any required state or local permits.

Note: All required approvals must be in place before starting any work with a toxin or Select Agent.

The creation, generation, breeding, and propagation of transgenic animals are covered under Section III-D-4 of the NIH Guidelines. These activities are not exempt from the NIH Guidelines and must be reviewed by the IBC. This includes models that involve the introduction of DNA into the germ line. Knock-out (gene silencing, gene ablation, etc.) models may be exempt from IBC review if the method used to generate the model does not leave any "new" genetic material or any markers in the animal. If the recombinant or synthetic nucleic acid molecules used to create the knock-out are permanently inserted into the genome, the experiment must be reviewed by the IBC. Models that have mutations or genetic modifications resulting from natural variation, chemical mutagenesis, or radiation exposure, but have not undergone molecular manipulation, are also reviewed by the IBC. Experiments involving the generation of transgenic animals that require BL1 containment are described under Section III-E-3 of the Guidelines, Experiments Involving Transgenic Animals, and thus require IBC Committee notification simultaneously with initiation. Transgenic and knockout animals produced in core facilities must also be registered.

Experiments involving the breeding of certain BL1 transgenic animals are exempt if the requirements described in Appendix C-VIII of the NIH Guidelines are met. The breeding of two different transgenic animals or the breeding of a transgenic animal and a non-transgenic animal with the intent of creating a new strain of transgenic animal that can be housed at BL1 containment are exempt if: (1) Both parental animals can be housed under BL1 containment; and (2) Neither parental transgenic animal contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gamma-retroviral long terminal repeat (LTR); and (3) The transgenic animal resulting from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.

PIs should assess the biological materials being transported and classify them according to the applicable regulations, including those from the Centers for Disease Control and Prevention (CDC), the Department of Transportation (DOT), and the International Air Transport Association (IATA). Contact the BSO and EHS to ensure the proper classification and determine the required packaging, labeling, and documentation. Develop an emergency response plan in case there is a spill or incident during transportation, outlining the steps to take, containment measures, and reporting procedures. When preparing biological materials for transportation, ensure all materials are securely packaged according to the regulations. Packaging must be designed to prevent leakage or contamination during transport. The outer package should be clearly labeled with the appropriate hazard symbols and handling instructions. Additionally, PIs must provide complete and accurate documentation accompanying the shipment, which includes a description of the biological material, its classification, and any necessary permits or approvals. Documentation should also include emergency contact information in case of an incident during transportation.  PIs should be aware of the specific transportation requirements for different modes of transport (ground, air, or sea) and comply with the respective regulations. Consider the destination's regulations as well, as they may impose additional restrictions or requirements for receiving biological materials.

Establish a system for monitoring and reporting adverse events incident during biohazardous research. PIs should consider:

• Incident Definition: Clearly define what constitutes an adverse event in the context of the research. This includes not only spills or exposures but also any unexpected outcomes related to biohazardous materials, such as adverse reactions in a human or animal.
• Documentation Protocol: Develop detailed procedures for documenting adverse events, ensuring all incidents are recorded accurately and promptly. This documentation should include the nature of the event, contributing factors, immediate responses taken, and any follow-up actions required.
• Reporting Channels: Outline clear reporting channels for adverse events, specifying who should be notified, including BSO, IBC, RO, and any potentially affected parties. PIs must ensure all research personnel are aware of these channels and understand their responsibility to report incidents immediately.
• Follow-up and Mitigation: Create a plan for assessing the impact of adverse events and determining necessary corrective actions. This includes analyzing root causes, implementing changes to protocols to prevent recurrence, and ensuring all team members are informed of any modifications to safety procedures.
• Regular Reviews and Drills: Incorporate regular reviews of adverse event reports and conduct drills to ensure all personnel are familiar with the reporting process.

Conduct a thorough risk-benefit analysis to ensure the potential benefits of the research outweigh the risks to human and animal subjects. For human subject’s research, the informed consent process should inform participants of potential risks and benefits associated with their participation. Outline any measures taken to minimize risks, such as monitoring protocols and post-exposure follow-ups. Measures should aim to protect participants and address any concerns related to their safety. Projects requiring the use of biohazardous materials must undergo dual committee review, involving both the IRB for human subjects and the IACUC for animal subjects. The Director of Institutional & Compliance (DIEC) serves on each oversight committee to coordinate projects that require oversight from more than one committee. For research involving human subjects, an IRB application must be completed and submitted for review. Similarly, for projects involving vertebrate animals, an Animal Care and Use Protocol Review Form must be completed and submitted to the IACUC for review. If IRB or IACUC approval has not been obtained prior to the review of the IRB application, the proposal approval will be contingent upon the approval of the dual committee review. For projects that involve the use of human and nonhuman primate source materials, the PI must comply with the UMassD Bloodborne Pathogen Program and Exposure Control Plan. The transfer of these types of materials between institutions must also follow specific packaging and shipping requirements.

Evaluate the risks of an accidental release or contamination of biohazardous materials, considering both immediate and long-term effects on local ecosystems and public health. Conduct assessments of local ecosystems to comprehend the potential impacts of the research on wildlife, natural resources, and identify vulnerable species and habitats that may be affected. Develop strategies to mitigate environmental risks, including containment measures and protocols for responding to spills to prevent environmental contamination. Engage with the BSO during the protocol development phase can provide additional insights into minimizing ecological risks.

A conflict of interest must be disclosed at the beginning of any meeting or before the review of any documents to the Committee Chair or to the Responsible Official (RO). This ensures the following:

• The responsible conduct and integrity of decisions made by the Committee.
• Protection of the Committee membership and the University from unnecessary and avoidable litigation.
• Compliance with agreements entered into with third-party funding organizations for whom the committee approves facilities, protocols, activities, or research projects.

A conflict of interest is defined as any situation in which a committee member has any of the following:

• An affiliation with any organization, company, venture, or other entity that involves a direct financial interest or benefit, either directly or through relatives by blood or marriage, in the subject matter or materials of a protocol or registration under review by the committee.
• Direct involvement in the research subject matter being reviewed by the committee.
• A familial relationship, by blood or marriage, or a business partnership with a researcher undertaking a protocol or registration considered by the committee.
• Being a research competitor or having a personal conflict with the project or the investigators, which could lead to a perceived bias.

The meeting agenda will include the item "Identification of Conflicts of Interest." Each committee member is obliged to disclose any conflict of interest or potential conflict of interest as soon as it comes to their attention. If a committee member is unaware of any conflict of interest at the time they attend a meeting and later discovers that they are in a conflict situation, they should immediately inform the Chair of the Committee or the Responsible Official (RO) once the conflict becomes apparent.

Members assigned to review a registration for which they are conflicted will be reassigned. Members are to notify the IBC Chair and the RO of any potential conflict for reassignment.

If a committee member has any doubt about whether they are in a potential conflict situation, they must raise this concern with the committee members at the commencement of the meeting. Faculty members residing in the same Department may review protocols and registrations originating from that Department as long as the Committee member does not have a personal interest or stake in the research being proposed.

If a conflict is identified, the member may be present during the discussion to answer questions but must recuse themselves from the discussion related to voting and approval. Members with a declared conflict of interest cannot be present during the IBC vote on the conflicted item.

The Environmental Health and Safety (EHS) Department is responsible for overseeing the procurement, use, and inventory of hazardous materials, as well as providing various safety training programs related to the handling of these materials. EHS has its own set of policies that can be accessed at UMassD EHS Policies. The IBC reviews proposed experiments, evaluates facility capabilities, and assesses institutional procedures, as well as PI training and expertise, to ensure that projects involving biohazardous materials are conducted safely and in compliance with NIH guidelines. While the IBC focuses on research proposals, the EHS staff oversee facility operations and the safe use of materials within each research environment. If the project is to be conducted in a UMassD laboratory, EHS staff (or BSO) may inspect the site(s) where the research will be conducted. Access to hazardous agents shall be limited to authorized personnel, in accordance with the safe handling, storage, and disposal practices established by UMassD. The use of appropriate ventilation systems, such as chemical fume hoods or biological safety cabinets, is mandatory to minimize exposure risks and ensure the safety of personnel working with hazardous agents. Hazardous agents include biological, radiological, and chemical materials that may be utilized during research projects. Facilities used for animal experimentation involving hazardous agents must be physically separated from animal housing and support areas to prevent cross-contamination and ensure the safety of both personnel and animals.

All biohazardous materials must be purchased and inventoried through the UMassD EHS Hazardous Materials PeopleSoft purchasing program. All Material Safety Data Sheets (MSDS) and product safety information sheets are accessible through the EHS Office. The disposal of hazardous materials—including biological, chemical, and physical agents—will be conducted in accordance with the UMassD EHS Office program and applicable federal, state, and municipal regulations.

In the event of accidents, injuries (including animal bites and needle sticks), or exposure incidents, immediate reporting to the supervisor, the Environmental Health and Safety Office, and the Human Resources Office is mandatory. For immediate medical emergencies, an emergency phone (ext. 9191) has been established and is staffed 24 hours a day by the UMassD Public Safety Office. All exposure incidents must be reported, investigated, and documented using an Incident Report Form.

Deviations from the policies and procedures, or biosafety/biosecurity-related incidents, must be reported the BSO, RO, and IBC Chair to be communicated to the IBC members. Individuals with biosafety and/or biosecurity-related concerns can contact the RO directly via email or phone. The IBC is responsible for reviewing and investigating concerns involving biohazardous materials. While all complaints will be reviewed, not every complaint may require a formal investigation.

When registration violations are identified, the IBC will work to ensure compliance or take immediate action to halt or suspend research activities posing a hazard to personnel. The IBC Chair (or BSO) has the authority to suspend any research or teaching activity if

• Violations pose substantive threat or harm to the health or safety of personnel, students, the public, or the environment;
• Action deviates from the approved research protocol or from the practices that are commonly accepted by the scientific community or could result in an adverse biosafety event; or
• A PI demonstrates misconduct or other serious or continued noncompliance with federal, state, or local laws, regulations or policies.

Depending on the severity of the violation, enforcement or disciplinary actions may also include but not be limited to termination of privileges, suspension of privileges, probation, a letter of reprimand, mandatory training, or other actions deemed necessary by the IBC or IO.

PI Reporting

The PI and study personnel must report any significant incident, violation of the NIH Guidelines, or any significant, research-related accidents and illnesses immediately by contacting the BSO. Examples of incidents and violations include:

• Overt exposures are defined as exposures that result in direct personnel exposure to biohazardous materials such as injection, spills, splashes or aerosol inhalation.
• Potential exposures are defined as exposures that have a high risk of exposing personnel to biohazardous materials such as spills, containment failure while working with the agent or equipment failure that may produce aerosols.
• Any exposure (overt or potential) in a BSL-3 lab.
• Overt exposure in BSL-1 or BSL-2 labs
• Any illness that may be caused by the agents used in the laboratory incidents involving the improper disposal of recombinant or synthetic nucleic acid molecules.

PIs must report other information to the IBC as soon as they become aware of the information (must also be reported to OSP):

• Information to support a new host-vector system.
• Petitions for proposed exemptions to the NIH Guidelines.
• Petitions for approval to conduct experiments specified in Sections III-A-1 and III-B.
• Petition for determination of containment for experiments not covered by the NIH Guidelines.

BSO Reporting

The BSO is required, by the NIH Guidelines, to report to the IBC:

• All violations of the NIH Guidelines and significant incidents.
• Any significant research-related accidents or illnesses.

IBC Reporting

The IBC, through the IO, will file an annual report with OSP that includes:

• A roster of all IBC members clearly indicating the Chair, contact person, BSO, plant expert, and animal expert.
• Biographical sketches of all IBC members.

The IBC is required, by the NIH Guidelines, to report to the appropriate University official and to the NIH/OSP within 30 days any significant incidents, violations of the NIH Guidelines, or any significant research-related accidents and illnesses. The IBC will be responsible to determine what actions, if any, are necessary. For example, the IBC may choose to change the frequency of lab inspections, or change the Biosafety Level of the protocol, based on results of the incident. The IBC is required to complete a final copy of the Biological Incident Reporting Form which it will be signed and dated by the IO, IBC Chair and the BSO.

Other IBC reporting requirements (to OSP and other agencies) include but are not limited to:

• Research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins without prior IBC approval.
• Lax security, unsafe procedures used in a laboratory setting, improper disposal of recombinant waste.
• Significant changes to proposed research risk without prior notification and approval by IBC.

Certain types of incidents must be reported to OSP on an expedited basis. Spills or accidents in BL2 laboratories (involving recombinant or synthetic nucleic acid molecules) resulting in an overt exposure must be immediately reported to OSP. In addition, spills or accidents involving recombinant or synthetic nucleic acid molecules occurring in high containment (BL3 or higher) laboratories resulting in an overt or potential exposure must be immediately reported to OSP. The IBC will report to the appropriate institutional official, who, in turn will report to OSP, any of the above-described incidents.

Institutional violations that will be reported to the appropriate College or department head may include but are not limited to:

• Lapses in protocol approval.
• Failure to comply with institutional and federal regulations, guidelines, and policies.

As per Section IV-B-2-a-(7) of the NIH Guidelines, if public comments are made on IBC actions, the IBC, through the IO, will forward both the public comments and the IBC’s response to the Office of Science Policy.

RO Reporting

Upon receiving a report from the IBC, the RO will report:

• In writing any problems with or violations (noncompliance) of the NIH Guidelines any significant incident, accidents, or illnesses related to recombinant or synthetic nucleic acid molecules to the NIH/OSP within 30 days or immediately for overt exposure to a BSL-2 agent or potential/overt exposure to a BSL-3 agent.
• For incidents involving Select Agents and/or Select Toxins the RO must notify the CDC/USDA.
• Any significant research-related illness or accident that may be hazardous to the public health and cooperate with state and local public health departments.

Reporting for External Requests of Information

Minutes are not for general distribution or public access but may, upon request, the institution will make available to the public all IBC meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. Information released to the public must be balanced with the need for security. Information vital to institutional or national security, or personnel or employee protection, may be redacted from IBC minutes. Redaction of proprietary and private information is allowed but “must be done so judiciously and consistently for all requested documents.” Information about the location of Select Agents and Toxins may not be released. Reasonable charges for photocopying of documents may be passed on to the organization or person requesting such information.

Reporting Undue Influence and Coercion

In cases where an IBC member or OIEC staff person experiences undue influence or coercion, they should document the issues in writing to both the RO and the IO to initiate a formal report. The IO will review the information and may convene a meeting or gather additional information as necessary. The findings will then be communicated to the IBC, which, alongside the IO, has the authority to take corrective actions as needed.

Reporting a Complaint or Request a Dispute Resolution

Individuals wishing to file a complaint regarding IBC activities or dispute resolution should provide a detailed description of the issue, including:

• The name of the study.
• The Principal Investigator (PI).
• A clear account of the complaint or dispute, including any specific deviations from approved protocols or IBC policies.
• Any relevant documents supporting the complaint.

Review and Evaluation

Upon receipt of a complaint or dispute, the IBC will:

• Acknowledge receipt within [specific time frame, e.g., 5 business days].
• Review the complaint or dispute to assess its validity and relevance.
• Gather additional information if necessary to understand the context and impact.

Compliant Resolution

The IBC will determine appropriate actions based on the complaint review, which may include:

• Discussing the issue with the PI and/or relevant parties.
• Requesting corrective actions or modifications to the research protocol.
• Implementing additional monitoring or oversight measures.
• If the complaint involves serious violations/concerns or remains unresolved at the IBC level, it will be escalated to the IO for further review and action.

Dispute Resolution

For disputes regarding IBC decisions, the Chief Research Officer and the IBC Chair may be petitioned for reconsideration if the PI disagrees with the IBC's findings. At the time of submission, the petitioner may request full committee review.  All disapproval decisions of the IBC are final and cannot be overridden by the IO. However, other decisions may be appealed to the IO. Requests for reconsideration must be submitted in writing within 30 days of receipt of the IBC’s decision and must include relevant materials and new evidence, if applicable.

Follow-Up

The IBC will document all complaints, disputes, and actions taken to resolve each.

Notice:

UMassD takes steps to protect employees and agents who report in good faith from retaliation and harassment. Every effort will be made to protect the complainant’s confidentiality, but UMassD is an agency of the Commonwealth of Massachusetts and is therefore subject to the Massachusetts Public Records law, G.L. c.66, § 10; any record made or received by an officer of the Commonwealth is presumed to be a public record and must be released to “any person” who requests it. If appropriate, concerns may fall under the purview of the UMassD Policy on Misconduct in Science.