Institutional Biosafety Committee (IBC) Charter

Purpose

This document establishes the Marine Biological Laboratory (MBL) Institutional Biosafety Committee (IBC) mandate, responsibilities and authority, and administrative rules to ensure compliance and safe practices for biological material use throughout the ǧƵ.

Policy

1. Institutions that receive any research funding from the National Institutes of Health (NIH) are required to adhere to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
2. The ǧƵ is required by the NIH Guidelines to establish an IBC to review research projects involving recombinant or synthetic nucleic acid molecules.
3. The ǧƵ has created the IBC to develop policies and procedures to ensure the health and safety of all faculty, staff, students, and visitors at MBL, and to ensure compliance with all pertinent federal, state and local regulations.

Authority

The Committee reports to the ǧƵ Director & President on matters related to the use of biohazardous materials at MBL. The Committee Chair shall meet annually with the ǧƵ Compliance Committee to give a 10 minute presentation and submit a 2-page report.

The Committee shall be responsible for:

1. Developing biosafety policies appropriate to MBL activities, including work practices, biohazardous waste management, and medical surveillance of personnel, if necessary.
2. Reviewing and approving research and educational course projects involving the use of recombinant DNA; synthetic nucleic acids; viral pathogens; bacterial pathogens; prions and biological toxins according to CDC/NIH guidelines.
3. Investigating significant violations of MBL biosafety procedures or policies, and significant accidents or illnesses involving biological agents. If appropriate, the I BC will recommend disciplinary action to the ǧƵ senior officials.
4. Certifying to the NIH annually, that facilities, procedures and practices, and training and expertise of personnel meet the NIH standards.

A. THE CHARGE
1. The IBC is a Standing Committee established by the ǧƵ Director & President to:
(a) Ensure that all activities involving biohazardous materials are conducted in compliance with federal, state and local regulations and applicable ǧƵ policies.
(b) Assist and advise the ǧƵ research and teaching community on incorporating good biosafety practices into all research activities involving biohazardous materials.
(c) Reduce the risk of potential biohazardous threats to the ǧƵ Community,the public and the environment.

2. The IBC is granted with the authority to:
(a) Review and approve practices and procedures regarding research and other activities involving biohazardous materials.
(b) Direct the Biological Safety Officer (BSO) and the Safety Department to inspect facilities where biohazardous materials are used and/or stored.
(c) Take appropriate action, including suspending research projects, in situations that present a risk of harm to life or health and in cases of serious, repeated or continued non-compliance with federal and state regulations or IBC biosafety guidelines.

B. RESPONSIBILITIES
1. Assumes full responsibility for ensuring biological safety at MBL.
2. Develops and implements policies, procedures and guidelines related to the use of biohazardous materials in research and teaching activities at MBL.
3. Reviews and monitors all research and teaching activities conducted at the ǧƵ that involve the use of infectious agents, biological toxins, recombinant DNA and other biohazardous materials.
4. Assists Principal Investigators, Course Directors/faculty members and affiliated scientists in MBL Community in meeting their responsibilities for assessing risks, establishing policies and procedures, training personnel and maintaining facilities and equipment.
5. Provides guidance and support to the BSO in carrying out the requirements of the ǧƵ's Biosafety Program.
6. Advises the ǧƵ Director and President and other members of the ǧƵ administration on all matters related to the use of biohazardous materials in conducting of research and teaching activities at the ǧƵ.

Membership

1. The ǧƵ Director & President shall appoint the IBC members.
2. The IBC shall be composed of at least five members who collectively represent experience and expertise in a wide range of biosafety areas applicable to MBL's research and teaching activities.
3. At least two members of the IBC members must be from outside the ǧƵ community (not affiliated with the ǧƵ apart from their membership on the IBC) and who represent the interest of the surrounding community with respect to health and protection of the environment.
4. Faculty or staff with special expertise who are not members of the IBC may be asked to advise the IBC, as appropriate.

Responsibilities of IBC Chair

1. Manage the meetings of the IBC.
2. Ensure the BSO has the support to implement the directives of the IBC.
3. Ensure IBC members are appropriately trained.
4. Provide administrative approval for projects that require IBC approval prior to the next scheduled IBC meeting, if necessary.
5. Review the use of biological materials at MBL registrations that do not require full lBC approval, and evaluate them based on the criteria for approval.

Meeting Frequency, Quorum
1. The Committee shall meet at least once every 6 months, or as often as necessary to fulfill its institutional responsibilities.
2. A quorum shall be a majority (greater than 50%) the voting members of IBC, of which at least one member present must be a community representative. All matters requiring a vote by the IBC will be determined by a simple majority
(greater than 50%) of the quorum.
3. Minutes of the Committee meetings shall be kept and made available for public inspection, upon request.

Conflict of Interest
No member of the lBC may participate in the review or approval of a research project in which he/she has been, is, or expects to be involved in or in which he/she has professional or financial interest, except to provide information requested by the IBC. The IBC member must abstain from voting and remove him/herself from the room when the vote takes place.