Institutional Biosafety Committee

Purpose of the IBC

The purpose of the Institutional Biosafety Committee (IBC) at the University of North Carolina at Chapel Hill (UNC‐Chapel Hill) is to review research with recombinant or synthetic nucleic acid molecules and other hazardous biological agents being conducted at or sponsored by the University. 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 Science Policy (OSP) in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The IBC at UNC‐Chapel Hill was established in 1978.

Function of the IBC

The IBC is responsible for the oversight, administration, and review of UNC‐Chapel Hill 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 (PIs) 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 University 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, and the NIH Office of Science Policy (OSP) within 30 days. Any spills or accidents in a BSL-2 laboratory resulting in an overt exposure will be reported immediately to the OSP. Any spills or accidents in a BSL-3 laboratory resulting in an overt or potential exposure will be reported immediately to the OSP.

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 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 Officer (ABSO)
• The UNC Responsible Official (RO)
• An expert in dual use research (ad hoc consultant as needed)
• An expert in animal containment principles
• An expert in plant containment principles (ad hoc consultant as needed)
• An expert in human research protocols
• Two community members who represent interest of the surrounding community with respect to health and protection of the environment. These members will not directly be affiliated with the University of North Carolina.

Procedures for Appointing Members

• IBC Chair nominations are recommended by EHS to the University Chancellor, The University Chancellor formally appoints the IBC Chair 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 Biological Safety Officer, then appoints the nominee to serve on the IBC.

Terms of Membership

IBC membership is typically a three‐year period of service. Members may be appointed for subsequent three-year terms if they are willing to continue to serve. The IBC Chair may remove a Committee member when necessary, e.g., due to resignation, excessive absence (4 or more absences in a calendar year), lack of contribution, or unavailability.

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 lead the review and approval of the project.

Confidentiality

IBC members shall not discuss or disclose the details of meetings or submitted protocols with individuals not directly affiliated with the IBC. Members contacted for information on IBC proceedings or minutes should forward requests to the IBC Chair, who will consult with the Office of University Counsel and the Office of Media Relations as appropriate.

Meetings

The IBC will normally conduct meetings on the first Wednesday of every month. In the event of a University holiday, or other scheduling conflict, the meeting will be postponed to the next Wednesday. Additional meetings may be called as required. 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.

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 University 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. If a quorum is not met, the meeting will be adjourned and rescheduled when feasible.

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. The Dual Use Research of Concern Policy is intended to ensure UNC’s compliance with the Federal DURC Policy for Institutional Oversight by outlining the roles and responsibilities of the University and its Principal Investigators when dealing with the high-consequence pathogens and toxins covered by the Federal DURC Policy for Institutional Oversight and provides a process for review of life sciences research, identification of potential DURC, and development and implementation of risk mitigation measures for DURC

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‐Chapel Hill. These duties include, but are not limited to, the following actions.

• Review recombinant and synthetic nucleic acid molecule research conducted at or sponsored by UNC-Chapel Hill for compliance with the NIH Guidelines as specified in Section III, Experiments Covered by the NIH Guidelines.
• 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.
• Submit an annual report to NIH OSP 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 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.

Sub-Committee Approvals

• Protocols involving experiments that are exempt from the NIH Guidelines (Section III-F, Appendix C) may be reviewed and approved by the Biosafety Office, and need not go to full Committee for review.
• Protocol renewals, or amendments of approved protocols with minor modifications, may be reviewed and approved by the Biosafety Office, and need not go to full Committee for review. This excludes renewals of BSL-3 protocols or certain BSL-2 protocols with identified biosafety concerns, which will go to full Committee.
• In unique time-sensitive situations, evaluated for need on a case-by-case basis by the Chair, an ad hoc review of BSL-1 and BSL-2 protocols may be performed by Sub-Committee. The Sub-Committee will consist of the Chair, Biosafety Officer (or designated individual) and an Animal or Plant Specialist (if required), and need not go to full Committee for review. The ad hoc review of BSL-3 protocols or certain BSL-2 protocols with identified biosafety concerns will go to full Committee.
• All Sub-Committee approvals will be indicated in the meeting agenda at the next meeting.

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 (April 2019).
• FAQs About IBC Meetings and Minutes
• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, CDC and NIH.
• Biological Safety Manual. UNC‐CH
• Laboratory Safety Manual. UNC‐CH

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

IBC Public Attendance and Minutes

Unless stated otherwise, IBC meetings are open to the public. Any member of the general public who wishes to attend an IBC meeting will be welcome to do so for the open portion of the meeting that involves discussion of research with recombinant and synthetic nucleic acid molecules subject to the NIH Guidelines. The Institution reserves the right to restrict access to the closed portion of the meeting which may include discussions on research activities that do not fall under the NIH Guidelines, or are closed to protect private or proprietary information. Section IV-B-2-a-(6) of the NIH Guidelines acknowledges that the protection of private or proprietary information is a legitimate basis for closing meetings to the public.

The NIH Guidelines require that IBC minutes be made available to the public on request. (Section IV-B-2-a-7). In accordance with the NIH Guidelines, the IBC shall allow for public review of its actions through the provision of meeting minutes to those that have requested such documentation. The IBC, in consultation with the Office of University Counsel, shall review and respond to all written requests for minutes in a manner that is consistent with the NIH Guidelines and applicable redaction policies and procedures.

Section IV-B-a-2-6 acknowledges that the protection of privacy and proprietary interests is sufficient to redact portions of minutes. In addition to trade secret and commercial information, the NIH Guidelines also allows for redaction of personal information of IBC members and “specific information whose disclosure would directly compromise institutional or national security.”

To ensure redaction is performed consistently, the following redaction procedure has been adopted in accordance with provisions allowed by the NIH Guidelines. Information not released to the Public under this procedure include:

• Portions of the IBC meeting conducted as a closed meeting
• Private information of IBC members
• Guests names at IBC meetings
• Information whose disclosure is likely to compromise institutional or national security, including, but not limited to:
  • Details related to Select Agent work
  • Locations of laboratories and animal facilities
  • PI Names working with animals
• Proprietary, confidential or trade secret information

NIH Guidelines require the IBC to respond to public comments received, and report such comments with the IBC’s response to the NIH. Public comments and the IBC’s response shall be forwarded in writing to the NIH Office of Science Policy by the Biosafety Officer in a timely manner.

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.