Institutional Biosafety Committee Charter

Mission

The charge of the Institutional Biosafety Committee (IBC) is to assure the safe acquisition, use and disposal of all biological agents at the University of New Hampshire (UNH). It is the responsibility of the Committee to establish appropriate health and safety policies in accordance with federal regulations and guidelines that cover biological safety and evaluate research being conducted at UNH for biological safety considerations.

Definition of Biohazards

Biohazards are defined as biological agents and materials which are potentially hazardous to humans, animals and other forms of life. They include known pathogens and infectious agents including bacteria and their plasmids and phages, viruses, fungi, mycoplasmas, and parasites; cell lines, animal remains, and laboratory animals including insects which might harbor such infectious agents; and primate body fluids. Also included are potentially biohazardous organisms used in procedures such as recombinant DNA and genetic manipulations. Biohazards will be classified according to risk levels requiring appropriate containment.

Purpose and Scope

UNH acknowledges its responsibility to provide a program for the handling, storage and disposal of biological agents, to provide emergency response to incidents involving biological agents, and to educate the UNH community about the safe use of biological agents in research, teaching, and public service activities. The IBC reports to the Vice President for Research on matters related to the use of biological agents in research, teaching, and public service activities at UNH. Specific tasks include:

Recommending to the UNH Environmental Health and Safety Committee (EHSC) policies and procedures to ensure the health and safety of all faculty, staff, students, patients, and visitors at UNH.

Ensuring UNH compliance with:
- All federal, state and local regulations;
- Procedures and principles relating to the prevention and/or control of infectious diseases; and,
- The procurement, storage, use and disposal of biological agents used in UNH research, teaching, and outreach facilities.
Certifying investigators, their laboratories and/or their practices for work at appropriate biological safety levels. Activities identified as Biological Safety Level 2 (BSL-2) and greater may not proceed without the written consent of the IBC prior to initiation of work.
Overseeing the development and maintenance of written biohazard safety/infectious disease control plans that minimize exposures for all affected personnel through the use of proper engineering controls and work practices; to make the plan available to the institutional community; to recommend updates to the plan, as necessary. Additionally, overseeing the development and implementation of educational programs related to infectious diseases and biohazard safety.
Overseeing the monitoring follow-up of those persons testing positive for identified pathogens.
Identifying tasks that carry the risk for transmission and the occupational groups involved.
Reviewing instances of TB, HBV, HIV, or other potentially infectious diseases, to identify exposure-prone procedures, and to determine those circumstances, if any, under which an infected health care worker may perform such procedures.
The Office of Environmental Health & Safety (OEHS) implements IBC-approved programs.

IBC Responsibilities

Review IBC procedures at least annually.
Assume the responsibility for ensuring biological safety at UNH.
Review the use of biological agents at UNH and evaluate them in terms of the criteria for approval. IBC approval is necessary before initiating any work with these biological agents.
Review all infectious agent or recombinant DNA registration forms. A quorum must be present and a majority vote of those in attendance is required for approval.
Review and prescribe special conditions, requirements, and restrictions that may be necessary for safe handling of biological agents. For example, the IBC may require students, staff and researchers to pass an oral or written examination, worker physical examinations (e.g. blood test, urine test, PPD, respiratory protection, required vaccinations, etc.), upgrading of facilities (biological safety cabinets, hoods, autoclaves, etc.), special designation of areas of use within the laboratory, posting of additional caution signs, use of special disposal methods, use of special handling procedures, and special procedures to be followed after contamination events or incidents.
Set containment levels as specified in CDC and NIH guidelines.
Withhold authorization of any studies not explicitly covered by CDC/NIH guidelines until CDC/NIH establishes the containment requirements.
Receive and review periodic and/or urgent reports from the Biological Safety Officer (BSO) regarding:
- Exposures of individuals to biological agents;
- Loss or theft of biological agents;
- Status of certifications of biological safety cabinets;
- Status of certifications of autoclaves;
- Records of infectious waste disposal; and
- Records of Select Agent purchase/transfer.
Report any problems, violations, accidents, or illnesses to the EHSC, CDC, NIH, and other appropriate entities.
Recommend and/or initiate remedial actions when safe procedures are not followed under an authorized project or when procedures are not in compliance with government regulations or the UNH Laboratory Safety Plan. If necessary, this may involve the termination of authorizations or confiscation of biological agents. The IBC will re-authorize operations when activities are performed in a manner acceptable to the IBC and the Office of Environmental Health and Safety (OEHS).
Conduct periodic review of UNH activities involving biological agents to ensure compliance with all appropriate laws, regulations, policies, and program requirements. Reviews will be done on an annual basis.
Keep department chairpersons, principal investigators and other academic and administrative officers advised of changes in rules and recommendations of various government agencies concerned with biological safety.
Maintain records of meeting minutes, protocol reviews, and other documents related to use of biological agents at UNH and the IBC's work.
Serve as a liaison with the NIH for IBC duties.
Serve as a liaison with CDC, State of New Hampshire Department of Health and Human Services, and other regulatory agencies in matters of registration, licensing and biohazard safety.

IBC Membership

Full Members: The committee shall consist of no fewer than five full members, of whom;

At least one member from each department with appropriate infectious diseases expertise;
A biological safety officer;
Three or more faculty members with experience in rDNA technology and/or biological safety and containment; and
Two community members.

Ex Officio Voting Members: In addition, the following are designated as voting members:

Director, OEHS

Ex Officio Non-Voting Members: in addition, the following are designated as members without vote:

Regulatory Compliance Manager, Office of Sponsored Research

Members are to be appointed by the Vice President of Research for a term of two years. Members may succeed themselves.

Removal of a member from the IBC requires documented and substantiated "just cause" that demonstrates the member to be unfit or unable to serve on the IBC. "Just cause" for removal may include, but is not limited to, lack of regular attendance at meetings, a finding of misconduct, or an unresolved conflict of interest. The decision to remove a member is made by the Vice President of Research and a majority vote of the IBC membership

Individuals that cannot attend an IBC meeting due to a sabbatical should appoint replacement to serve during their absence. If a replacement cannot be found, the member will be temporarily removed from the IBC (during their absence) and will not be considered a member of the IBC when determining if a quorum is present. The individual is expected to return to the IBC upon their return to the University.

The Committee shall meet no less than four times per year. A quorum is greater than 50% of the Committee membership. All matters requiring a vote by the IBC requires a simple majority of the quorum.

No member of the IBC may be involved in the review or approval of a project in which he/she has been, is, or expects to be engaged or in which he/she has professional or financial interest, except to provide information requested by the IBC.

IBC Procedures for Registering Work Involving Infectious Agents or Recombinant DNA

Registration

Registration forms are available at http://www.unh.edu/ehs/biological-safety.htm and from OEHS. Once a form is completed, it is signed by the principal investigator and forwarded to the Biological Safety Officer for assessment and forwarding to the IBC Chair for discussion and approval. The IBC returns the signed application (with conditions of approval, if necessary) to OEHS where a letter of approval is generated and sent to the principal investigator. Approval will be granted for a program and the associated facility. Approval for use of biological agent will only be issued to faculty members. Biohazardous material may not be used for any purpose or in any other location, other than that originally approved by the IBC. Project changes will require an amendment to the application.
Amendments to Approved Applications

In order to initiate new work under an existing approval, the investigator should contact OEHS to determine if an amendment to the application is necessary. Amendment requests must be received in writing to OEHS who will arrange for IBC review. Personnel changes are to be reported to OEHS as they occur. Once a year OEHS will generate a list of certified protocols and request that the principal investigator verify it is current.
Renewal of Previously Approved Applications

Approval to work with a biological agent is for a maximum period of four years. Two months prior to expiration, OEHS will issue a reminder of the expiry date. At that time, the principal investigator must specify whether the program is to continue and whether any changes are planned. Major changes to an application will require referral to the IBC.
Certification of Granting Agency Forms

All sponsor assurances related to biological safety are to be completed by the applicant and forwarded to the Office of Sponsored Research (OSR) with the grant. OSR will obtain the authorized signature for these forms upon verification by the OEHS of IBC approval.
Facilities and Equipment Assessment

Facilities and equipment are assessed as part of the registration approval. Assessments are conducted by OEHS. Biological safety cabinets and all HEPA filtered equipment must have a valid performance certificate attached on a conspicuous location to verify current testing. Testing is required:
- Prior to use;
- Annually thereafter;
- After relocation;
- After HEPA filter replacement; and
- After servicing such as a fan motor replacement.
The IBC reserves the right to periodically repeat the assessment to verify current status or implementation of guideline and regulation amendments.
Biohazard Signs

All appropriate signs should be posted for facilities approved for biological research or storage rated at BSL-1, BSL-2 and BSL-3. The sign signifies the presence of a biohazard, identifies the principal investigator, and displays emergency telephone numbers.
Orientation and Training

Principal investigators are responsible for being cognizant of all hazards associated with their research projects and for ensuring that personnel reporting to them are trained in safe laboratory practices and understand the hazards. Training and understanding cannot be assumed for employees or students transferring from another laboratory or institution. Contact OEHS for training requirements and scheduling.
Emergency Response

Emergency response procedures must be developed and posted for all facilities approved for biological research or storage rated at BSL-1, BSL-2 and BSL-3. Every person using the containment facility must be made aware of its contents. For practical purposes, procedures should be simple, and a copy filed with OEHS.
Interpretation

Questions of interpretation or application of these procedures should be directed to the Biological Safety Officer in OEHS or the IBC Chair.