(Last Revised: May 2013)

Purpose of the IBC

The purpose of the Institutional Biosafety Committee (IBC) at the University of North Carolina at Chapel Hill (UNC‐CH) is to review research with recombinant or synthetic nucleic acid molecules and other hazardous biological agents being conducted at or sponsored by UNC. Institutions that receive support from the National Institutes of Health (NIH) for recombinant or synthetic nucleic research are required to establish and register an Institutional Biosafety Committee (IBC) with the NIH Office of Biotechnology Activities (OBA) in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The IBC at UNC‐CH was established in 1978.

Function of the IBC

The IBC is responsible for the oversight, administration, and review of UNC‐CH Lab policies and projects involving research with recombinant or synthetic nucleic acid molecules and hazardous biological materials that may pose safety, health, or environmental risks. To this end, the IBC assists and advises Principal Investigators and other researchers in meeting their responsibilities to ensure that the biological aspects of the research are conducted in a safe manner using established biosafety standards, principles and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and UNC‐CH Policies.

The IBC will investigate and report any significant problems with or violations of the NIH Guidelines and any significant research‐related accidents or illnesses involving recombinant genomic materials to the Principal Investigator, the Biological Safety Officer, the Department Chair, and the NIH Office of Biotechnology Activities (OBA) within 30 days, unless the IBC determines that the Principal Investigator or lead researcher has already filed a report.

Structure of the IBC

A broad array of available research and regulatory expertise is important for the IBC given the range of recombinant DNA research that the committee reviews. The NIH requires that the IBC have at least five members selected who collectively have the experience, expertise, and capability needed to assess the breadth and safety of recombinant and synthetic nucleic acid molecules as well as other biological materials, agents, and organisms as needed to identify any potential risks to workers, public health, or the environment.

Composition of Committee

Based on the types of research activities at UNC‐CH, the IBC will normally have the following minimum representation:

  • Two to five technical representatives from UNC‐CH programs that conduct research with potentially hazardous biological materials.
  • The EH&S Biological Safety Officer (BSO) and the Associate Biological Safety Officers
  • An expert in dual use research
  • An expert in animal containment principles
  • An expert in plant containment principles
  • An expert in human research protocols
  • The UNC Responsible Official
  • Two community members who work or live in the Chapel Hill/Carrboro area. These members will not directly be affiliated with the University of North
    Carolina.

Procedures for Appointing Members

The UNC‐CH Chancellor formally appoints all IBC members. IBC member nominations are managed in the following manner:

  • The IBC Chair nominations are recommended by EHS, and appointed for a three‐year period.
  • Potential IBC members are recommended by committee members to the IBC Chair. The IBC Chair, after consultation with the University Responsible Official and the Biological Safety Officer, then makes the recommendation to the UNC‐CH Chancellor on appointment of the nominee to serve on the IBC.

Terms of Membership

IBC membership is a minimum three‐year period of service. Members may be appointed for subsequent three year terms if they are willing to continue to serve. If an institutional member does not attend three meetings throughout the calendar year, the IBC Chair may consult the EHS Director to ask that a replacement be nominated.

Conflict of Interest Policy

It is the policy of this committee that no member of the IBC may be involved (except to provide information requested by the IBC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest. Each member is expected to notify the IBC chair in these circumstances and recuse themselves when such proposals are being discussed and are up for a vote. In addition, if the IBC chair is principal investigator on a project, the Biological Safety Officer or another IBC committee member present at the meeting will sign the approval form if the project is approved.

Meetings

The IBC will normally conduct meetings on the first Monday of every month. In the event of a University holiday, the meeting will be postponed to the next Monday. A proposed agenda will be developed and distributed before the meeting by the University Biological Safety Officer or his/her designee. Meeting minutes will be taken by the Biological Safety Officer or his/her designee to accurately reflect the topics of discussion. Meeting minutes will be reviewed, approved by the members, and maintained on file at EHS. All meetings will be open to the public unless otherwise posted, and minutes will be provided to the public when requested by the public and in accordance with the scope and requirements of the NIH Guidelines.

Procedures for Defining a Quorum

In the event that the IBC chair must be absent, he/she will request another committee member to serve as chair during the absence. Meetings will proceed with no less than five members present, and must contain at least two members from the UNC faculty. A quorum is declared at the beginning of each meeting and consists of the committee members in attendance. All IBC members are voting members. Decisions such as approval of research projects or policies are approved when a majority of IBC members present vote for approval.

The IBC may use consulting experts or establish working groups to execute its responsibilities or acquire needed expertise for select tasks. Consultants or working group members may include, for example, persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes, the environment, or any scientific area where the IBC members do not have expertise. Consultants or working group members are not IBC voting members unless nominated and appointed as described previously.

Member Roles and Responsibilities

The IBC is responsible for reviewing, approving, and monitoring all UNC research projects involving biological materials that may pose differing levels of safety, health, or environmental risk to plants, animals, or humans. The goal of the committee is to ensure work is conducted in a safe manner. To accomplish this task, the IBC performs initial and periodic review as well as approval of required project biosafety documentation that demonstrates that the work is conducted safely. Once the Principal Investigator has submitted a Registration of Recombinant and/or Synthetic Nucleic Acid Molecules Experiments form to the IBC, the IBC is responsible for assessment of the containment levels, facilities, procedures, practices, training, and expertise of personnel involved in the proposed research and in comparison to biosafety standards.

  • Review and approve UNC biosafety policies, and make recommendations to the Responsible Official (RO), the Director of EHS, on strategic biosafety matters. The IBC is responsible for maintaining reviews, minutes, and reports in an orderly and retrievable fashion.
  • Training of the IBC Committee is important. The IBC Chair is responsible for ensuring that the IBC members are appropriately trained in research guidelines and regulations.

Oversight of Dual Use Research

The IBC has the responsibility of oversight of dual research which falls under the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern. These duties include but are not limited to the following:

  • Notify the designated personnel on the Cross Functional BSL3 team that a dual use protocol has been reviewed by the IBC and that input is needed.
  • Notify the Principal Investigators of the Cross Functional BSL3 and IBC’s final review.
  • Based on the risk assessment, in collaboration with the IBC and EHS, develop a plan to apply any necessary and appropriate risk mitigation measures. These measures may include the following:
    • Requesting that the PI modify the design or conduct of the research.
    • Applying specific or enhanced biosecurity or biosafety measures.
    • As necessary the IBC and EHS will continue to consult with the PI in the event the research changes or deviates from the protocol.

Oversight of Non‐Exempt Research Proposals

The IBC has the responsibility of oversight of all research proposals which fall under the NIH Guidelines at UNC‐CH. These duties include but are not limited to the following actions.

  • Notify the Principal Investigator of the results of the IBC’s review or approval.
  • Serve as a forum to review, make recommendations to appropriate stakeholders, and raise awareness related to biosafety concerns, institutional needs, emerging biosafety issues, and new biosafety requirements.
  • Review recombinant and synthetic nucleic acid molecule research conducted at or sponsored by UNC-CH for compliance with the NIH Guidelines as specified in Section III, Experiments Covered by the NIH Guidelines.
  • Submit an annual report to NIH OBA that includes a roster of IBC members, member roles, and biographical sketches of each member.
  • Stipulate terms for updating and renewal of registrations and send reminders notifying Investigators when updates are required, i.e. SOPs and LSPs are reviewed annually. Schedule G, Registration of Recombinant DNA Experiments, and Schedule H, Use of Transgenic Animals or Plants, approvals are valid for five years, after which they must be renewed.
  • Support information flow between the IBC, the IRB, and the IACUC.
  • Assessment of Facilities Inspection of all facilities submitting protocols for approval will be conducted on an ongoing basis. All laboratories will be inspected on a yearly basis as will all SOPs and Laboratory Safety Plans. The Principal Investigator will be responsible for informing the IBC of any changes to facilities, personnel or practices which have occurred since the last update.
  • Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic research.
  • Training requirements as stipulated by NIH Guidelines.

IBC and Biosafety Standards

The following standards have specific requirements for IBC’s and biological work:

  • Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), Federal Register (March 2013).
  • Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, CDC and NIH.
  • Biological Safety Manual. UNC‐CH – 2012
  • Laboratory Safety Manual. UNC‐CH –2012

Additional biosafety standards related to UNC‐CH biological work are summarized below:

  • Bloodborne Pathogens Standard, Occupational Safety and Health Administration (OSHA) 29 CFR 1910,1030
  • Select Agents and Toxins, Health and Human Services (HHS) 42 CFR 121
  • Plant Pathogens and Pests, USDA 9 CFR Parts 92,94,95,96, 122 and 130
  • Importation of Human Pathogens, U.S. Public Health Service (USPHS) 42 CFR 71
  • North Carolina Medical Waste Management Rules, Sections 15A NCAC 13B

Principal Investigator

Definition

The Principal Investigator (PI) designation is given to a UNC‐CH faculty member who has primary responsibility and accountability to direct the proper conduct of a scientific research project or program. If the research is conducted by a team of researchers at a research site, the Principal Investigator is the leader responsible for that team whose name appears as Principal Investigator on the Grant Application or Award. With regard to the Institutional Biosafety Committee, the PI has overall responsibility of laboratory personnel working under the requirements of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. The PI must be listed on a Laboratory Safety Plan and multiple PIs can work under the same LSP.

IBC Charter Approval

IBC members will review proposed amendments to this charter during a regularly scheduled meeting of the committee and vote on acceptance of each amendment.