Roles & Responsibilities

The Organizational Official (OO) is the leader of the Biosafety Program, and their responsibilities include:

• Ensure the allocation of sufficient resources for IBC oversight and periodically review these resources to support thorough and timely reviews, based on the volume and type of research conducted.
• Foster a culture of compliance with IBC requirements.
• Ensure complaints and allegations concerning the IBC are handled appropriately.
• Investigate and correct systemic issues within the IBC.

Appoint by the OO, the Institutional Official (IO) responsibilities include:

• Appointing an individual to serve as an Institutional Responsible Official (RO) on the IBC, typically the [DIEC].
• Appointing a BSO if research involves a BSL-3 or BSL-4 agent or large-scale research [any single culture exceeding 10 liters in volume].
• In consultation with the RO, appoint, evaluate, and remove IBC members to ensure the IBC is composed of individuals with appropriate expertise and commitment.
• Reviewing all major IBC actions, including initial registration, maintenance, annual renewal, and inactivation, as prepared by the RO.
• Limiting, disapproving, suspending, or terminating biological research subject to IBC oversight.
• Determining if incidents represent General Noncompliance, Serious Noncompliance, Continuing Noncompliance, or if they warrant Suspension or Termination of IBC approval, and taking appropriate action against employees in cases of Serious or Continuing Noncompliance. Ensuring the independence of the review process and address complaints and allegations concerning the IBC appropriately. Investigating and rectifying any allegations and findings of undue influence on the biological research review process.
• Annually evaluate allocation of resources to the IBC and make recommendations for adjusts as necessary.
• Providing and maintaining adequate facilities for biohazardous research.
• Supporting IBC policies and procedures that provide for the safe conduct of rDNA research, ensuring compliance with the NIH Guidelines, BMBL, and university policies and procedures.

The IO cannot approve research that the IBC has not approved.

Appointed by the IO, the RO oversees the IBC’s functioning and works closely with the IBC Chair(s), BSO, DEHS/EHS, IBC members, and researchers to ensure that research involving biohazardous materials is conducted in compliance with all applicable local, state, and federal regulations. The RO responsibilities include:

• Filing IBC registrations, biographical sketches, and if necessary, the annual report with NIH/OSP.
• Managing the registration intake, review process, and coordinating IBC registration reviews.
• Drafting, developing, and distribution of IBC agenda, minutes, discussion items, and determinations/approvals.
• Maintaining up to date records of registrations submitted, documentation provided for review, and actions taken.
• Notifying PIs of the outcome of a registration review.
• Providing administrative support to the IBC Members, IBC Chair, IBC Vice Chair, and BSO.
• Reporting oversight activity to the IBC when the activity does NOT require IBC oversight.
• Interfacing relevant information between the IBC, IRB, and IACUC (attends meetings of all three committees).
• Serving as a point of contact for regulatory agencies.
• Evaluating IBC membership to maintain a composition of individuals with appropriate expertise and commitment.
• Determining if IBC registrations at the University may rely on another institution for oversight.
• Providing training materials for PIs, IBC members, students, and staff in coordination with EHS or BSO, as necessary. Ensuring appropriate approved training is provided for IBC members, PIs, and laboratory staff.
• Reviewing all guidelines outlined in this charter at least once a year to allow for continued evaluation of the biosafety guidelines and ensure all regulatory requirements and community needs are met. Periodically reviewing existing policies and procedures to ensure compliance with local, state, and federal regulations. This allows for continued evaluation of the biosafety guidelines and ensures that all regulatory requirements and community needs are met. Policy change recommendations are brought to the IBC for review, discussion, and action. The University of Massachusetts System General Counsel may revise policies and procedures as necessary to comply with new statutory or regulatory requirements.

The OO and the IO charge the IBC to review, approve, and provide oversight and guidance to those research personnel who seek to use rDNA, biohazardous materials, agents, and toxins in experiments or teaching. 

The IBC has the responsibility to:

• Advise the RO, IO, and OO on policies, procedures, adequacy of the facilities, SOPs, and safety practices & training associated to the use of biohazardous materials in academic or clinical setting which may involve human subjects or animal care research activities.
• Conduct independent review of individual research registrations involving the use of biohazardous materials. At initial review, continuing review, and modification, the IBC reviews registrations to assess the facilities, study procedures, safety practices, containment practices, and training/expertise of personnel involved for the proposed research. Consult the available resources for current best practices and safe conduct of research. Review IBC registrations for compliance with the NIH Guidelines, institutional practices, surveillance, data reporting, and adverse event reporting. Notify the PI of the results of the review.
• Report any significant problems with or violations of the NIH Guidelines, and any significant research-related accidents or illnesses to the IO and NIH/OSP within 30 days, as applicable.
• Communicate and coordinate review and approval with [DIEC] of research projects with the Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), or export-controlled work.
• Provide recommendations for education and training related to biosafety for all UMassD faculty, staff, and students that may be involved in the use of such materials.
• Review policies, programs, and directives regarding the use of biohazardous materials in academic, research, clinical, and animal use/care activities for compliance with NIH Guidelines, and other applicable federal, state, and local laws/regulations.

The IBC has the authority to:

• Determine the level of review the research requires, biological safety containment level, and adequacy of containment practices, proposed facilities and Principal Investigator qualifications for individual research proposals.
• To approve, require modifications to secure approval, and disapprove all research activities overseen by the University.
• To Suspend or withdraw approval of research not being conducted in accordance with IBC requirements or that had been associated with unexpected serious harm to participants.

IBCs may not authorize initiation of rDNA experiments NOT explicitly covered by the NIH Guidelines until NIH (with the advice of the RAC when required) establishes the containment requirement.

Composition:

The IBC must be composed of at least 5 members, two who are not affiliated with the institution in any way other than serving on the IBC to represent the interest of the surrounding community with respect to health and protection of the environment. The committee should have collective knowledge of institutional commitments and policies, applicable laws, standards of professional conduct and practice, community attitudes, and the environment with the ability to assess the safety of rDNA research and identify potential risks to public health and safety.

Required Membership:

• 2 Unaffiliated Community Members
• Biosafety Officer (required if the IBC oversees a BSL3 facility or large-scale research is conducted)
• rDNA Technology Expert
• Plant, Plant Pathogen, Plant Pest Containment Expert
• Animal Containment Expert
• Human Gene Expert

Recommended Membership:

• Experts in biosafety and physical containment
• Responsible official for institutional policies and applicable laws
• Laboratory technical staff

IBC Leadership (Chair & Vice Chair)

The IBC Chair(s) are appointed by the IO to provide leadership to the IBC. In lieu of appointing a chair, the IO may delegate appointment of the chair to the IBC.  Acting under such delegation, the IBC may elect a chair.  The IBC chair serves a one-year term.

The Chair(s) have the responsibility to:

• In consultation with the RO, determine which registrations are exempt from convened meeting review.
• Develop meeting agendas and topics of discussion.
• Provide orientation and training of new members. Ensure all IBC members are properly trained. Help IBC members meet their expectations. Mentor and guide IBC members to use the criteria for approval.
• Assign designated reviewers to review an issue prior to official committee decisions made at the convened meeting.
• Lead the IBC convened meetings, ensure all IBC members participate actively and equally in discussions.
• Liaison between research personnel and IBC.
• Assess any reported or suspected biosafety misconduct, investigating any biosafety violations, and determining and recommending subsequent actions.
• Serve as one of three points of contact for regulatory agencies.
• Authorized to suspend or terminate research.

IBC members are appointed by the IO to participate in the review of IBC registrations, program policies, and procedures.

General Responsibilities:

• Undergo initial member training and participate in continuing education activities via citiprogram.org at least every 4 years.
• Treat all oral and written information obtained as part of the review process as confidential, and do not disclose or use confidential information without prior authorization.
• For each review consider if there is a Conflicting Interest. Members are expected to know the definition of Conflicting Interest and self-identify their Conflicting Interests. A conflicted member should not participate in that review (including discussion or voting), except to provide information requested by the IBC.
• Attend meetings and notify IBC Chair and RO of scheduling conflicts.
• In advance of the meeting, review materials provided as directed. Additional Review Considerations:
  • If one or more criteria are not met, consider what specific and directive changes would make the protocol approvable.
  • Notify the IBC Chair and RO if additional information is necessary to answer questions about the submitted materials, previous minutes, or other IBC documents.

Members assigned Primary Reviewer and Designated Reviewer are to:

• Conduct a biosafety review and risk assessment with preliminary judgments as to whether each criterion is met and provide preliminary study-specific findings.
• Review all submitted materials for accuracy and consistency.
• If committee review is required, prepare to lead the discussion regarding assignment at the meeting.

At meetings, Members are to:

• Members are expected to offer and accept constructive feedback, actively contribute to meetings, and uphold the integrity of the biosafety program.
• Ask questions and provide information which has not been discussed.
• Think critically and use the criteria for approval to decide whether to approve research and which are not met. Identify concerns, problems, or recommended change based on the criteria for approval.
• Make decisions by majority rule, not consensus.
  • Listen and learn from the group but think and vote independently.
  • Know that dissent is healthy and expected.
• Report Allegations of Undue Influence related to the Biosafety Program to IO.
• Report Allegations of Noncompliance or Findings of Noncompliance to IBC Chair and RO.

A Biological Safety Officer (BSO) is appointed by the IO if the institution plans to engage in large scale research, which is indicated if production activities involving viable organisms containing rDNA molecule of 10 liters or more of any one cell line or if the institution engages in rDNA research that requires use of BSL3 or BSL4 facilities. The BSO reports to the IO and DEHS has responsibility for oversight of research and other activities involving the use of biological materials at the institution. In the absence of a BSO, staff from the Environmental Health and Safety Office will fulfill this role. The BSO plays a vital role in maintaining biosafety standards across UMassD’s research programs, offering expertise, oversight, and training to ensure the safe handling of biological materials.

The BSO responsibilities include:

• Advise and train the IBC members, faculty, and staff (as necessary) in safe use and practices for working with potentially biohazardous materials.
• Pre-review registrations for the IBC and make recommendations to ensure safe practices are followed. Determine containment levels in accordance with the NIH Guidelines and Center for Disease Control and Prevention. Determine the necessity for health surveillance of personnel involved in projects that involve biohazardous substances.
• Annually inspect facilities and report to the IBC results regarding all UMassD biosafety facilities (including laboratories and satellite facilities). Review and inspect activities involving biohazardous materials in coordination with EHS personnel, the Office of Research Services Facility Manager, and the [DIEC].
• Report concerns, research-related accidents or illnesses, and violations of the NIH Guidelines and UMassD SOP to the IBC and RO. If a biosafety violation occurs, then an investigation will be initiated by the IBC Chair with assistance from the RO, BSO, and EHS staff.
• Help investigators develop protocols, biosafety hazardous management plans, and emergency response plans which address containment, handling accidental spills, and personnel contamination. Provide technical advice to PIs on laboratory containment facilities, safety equipment, security, and safety procedures. Provide training for staff and students in safe handling and accidental exposure procedures for their specific research-related activities.
• Provide assistance, input, and support required during an emergency response.
• Provide training on safe practices and handling of biohazardous materials, ensuring the entire institution understands the best practices for working with these substances.

The EHS Office ensures the safe conduct of research and laboratory activities by offering oversight, consultation, training, and technical assistance. It plays a central role in maintaining compliance with safety standards and protecting the health of personnel.

EHS responsibilities include:

• Regularly inspect laboratories to ensure compliance with safety and health guidelines and applicable regulations and to assist laboratories with remediating identified safety issues.
• Investigate laboratory incidents and accidents, recommending corrective actions to prevent recurrence and reduce safety risks.
• Coordinate and manage clean-up operations in the event of biohazardous spills, contamination, or other laboratory accidents.
• Develop and deliver training on laboratory and biological safety, ensuring personnel are knowledgeable about the safe handling of materials and emergency procedures.
• Ensure that the training covers the key policies and procedures outlined in the University’s safety guidelines.
• Collaborate with federal, state, and local officials to ensure adherence to applicable safety codes and enforcement regulations.
• Assist laboratory personnel in identifying, evaluating, preventing, and controlling potential hazards in the research environment.
• Provide expert advice to ensure the safe conduct of experiments and the proper use of equipment and materials.
• Oversee the implementation and adherence to all University health and safety policies, ensuring they are updated to reflect new safety guidelines and practices.
• Maintain and regularly update the University’s Biological Safety Manual, ensuring it reflects current safety protocols and regulatory requirements.
• Post and maintain biohazard warning cards for laboratories that store or use biohazardous materials to clearly identify risks and provide essential information for emergencies.

Principal Investigators (PIs) are responsible for ensuring compliance with the NIH Guidelines and the UMassD Institutional Biosafety Committee (IBC) Standard Operating Procedure (SOP) in all research involving biohazardous materials. PIs are expected to lead by example, enforcing regulations, providing clear directives, and ensuring the safety of their research teams.

The PI responsibilities include:

• Identify biohazardous and/or potentially infectious materials proposed for use.
• Notify the Office Research Administration (ORA) of any proposed activity using biohazards by indicating so on the Proposal Routing Form (PRF) accompanying a grant proposal. Ensure approval letters are forwarded to the funding agency or sponsor and fulfill all reporting requirements.
• Submit research registration form(s) to the IBC for review before commencing with any research activities using biohazardous substances or purchasing biohazardous substances. For legacy studies which now qualify for review under UMassD Other biohazardous materials, submit registration as soon as possible, while work continues. For BSL2 and category iii-D or greater await IBC approval before commencing research.
• To not make modifications to the research without prior IBC review and approval unless necessary to eliminate apparent immediate hazards Modifications to research which may alter the risk assessment, addition of new agents or vector systems, or modifications which alter the approval category require IBC review and approval. Submit revisions to registration to the IBC for review and approval before implementing changes to activities involving the use of rDNA, synthetic nucleic acid molecules, or biohazardous materials and any other committee approvals have been obtained, as necessary.
• Oversee co-investigators, student investigators, staff, students, and co-occupants of shared spaces, ensuring they are aware of potential hazards, safety practices, and procedures for dealing with accidents. Ensure all personnel are equipped with necessary protocols that outline biohazards and safety precautions. Train staff (and co-occupants of shared spaces) in: (i) the potential hazards of the materials they are working with; (ii) the practices and techniques required to ensure safety, (iii) the procedures for dealing with accidents and safety, (iv) and the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collections).
• Ensure adequate resources (time, space, staff expertise, equipment) are available to conduct the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, space, training, expertise, credentials, protocol requirements, and when relevant privileges. Develop biosafety protocols for staff and students in safe handling and accidental exposure procedures for their specific research-related activities.
• Conduct research in accordance with relevant current activities approved by the IBC. Ensure compliance with the regulations, UMassD IBC determinations, and provide directives and guidelines for the work they supervise.
• Submit continuing reviews 60 days prior to approval expiration, typically 3 years after initial approval. If research approval expires, stop all research activities, and immediately contact the IBC Chair(s) and RO.
• Maintain up to date study records; including: copies of registrations, training certificates, cabinet/fume hood certifications, safety sheets, shipping documents, and approval letters are stored chronologically and are available for audit review.
• If proposing to ship biohazardous materials, coordinate with EHS for proper handling and compliance with shipping requirements for biological materials, following EHS policies.
• Assist in any decontamination, follow-up investigation, or reporting that may be required.
• Personally conduct the activities to:
  • Supervise the laboratory staff and ensure the implementation of safety practices, maintain containment integrity (biological and physical), and correct any errors that could lead to biohazardous exposure.
  • Implement necessary specific control procedures within their own laboratories and ensure students and co-occupant staff working there receive proper instruction in the potential hazards of the materials they are working with.
  • Ensure the integrity of physical containment (e.g., biological safety cabinets) and the biological containment (e.g. purity and genotypic and phenotypical characteristics).
  • Correct work errors and conditions that may result in the release of biohazardous materials in the surrounding area or environment.
  • Investigate and report any significant problems or incidents pertaining to the operation, containment practices, and/or study procedures in writing to IBC and RO. Report the following to the IBC within 5 days:
    • Significant problems or research-related accidents and illnesses.
    • Significant deviations from IBC approved practices or deviation due to the action or inaction of the investigator or research staff.
    • Allegations of Noncompliance or Findings of Noncompliance with the NIH guidelines or UMassD SOP.
    • Protocol deviation made without prior IBC approval to eliminate an immediate hazard.
    • Audit, inspection, or inquiry by a federal agency.
    • State medical board or hospital medical staff actions.
    • Suspension or premature termination by the sponsor, investigator, or institution.
    • New or increased risk.
    • Loss of containment.

The faculty sponsor is selected by a student investigator and is responsible for overseeing the research activities of students and staff involved in biosafety-related research. They are responsible for guiding students through the IBC registration process, ensuring compliance with biosafety policies, federal regulations, and ethical standards.  The faculty sponsor acts as a mentor and liaison between the students and the IBC, helping to facilitate the development of the IBC registration application, ensuring that all aspects of the research protocol are thoroughly articulated. Their responsibilities include:

• Ensuring all students and staff involved in the research have completed the required biosafety training and verifying all personnel are adequately educated on safe handling practices for biohazardous materials.
• Actively monitor ongoing research activities to ensure compliance and be vigilant for any changes in research practices that may require amendments to the IBC registration and promptly report any deviations or incidents.
• Submitting necessary documentation, responding to IBC inquiries, and ensuring that all required reports and renewals are completed on time.
• Conducting continuous risk assessments and evaluating potential hazards associated with biohazardous materials to ensure the appropriate containment and decontamination procedures are in place.
• Maintaining accurate records of training certifications, safety inspections, and any incidents related to biosafety.

Lab personnel are appointed by PIs and are responsible for adhering to safety protocols, completing mandatory training, and promptly reporting any incidents involving biohazardous materials. Their role is vital in maintaining a safe laboratory environment through continuous awareness, risk assessment, and thoughtful experimental planning. Responsibilities of lab personnel include:

• Following all specified safety procedures and protocols as outlined by the PI and the Institutional Biosafety Committee (IBC).
• Completing all required safety training relevant to working with biohazardous materials.
• Maintaining constant awareness of surroundings and actively assess risks in the lab.
• Incorporating safety considerations into all experimental designs and activities.
• Informing supervisors of any health conditions that may increase risks when working with or being exposed to biohazardous substances.
• Promptly reporting any safety incidents, accidents, or hazardous situations to the PI and appropriate personnel.
• Engaging with PIs in safety discussions, particularly during experimental planning.
• Continuously address and integrate safety measures throughout the research process.

Departments should provide PIs the necessary support to encourage attention to important safety considerations. PIs are encouraged to engage their laboratory personnel in the discussion of safety consideration, when appropriate everyone is committed to safety, a strong sense of community identity invested in safety will emerge and benefit all.