Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) was established to review recombinant DNA research conducted at or sponsored by UNC-Chapel Hill for compliance with the National Institutes of Health (NIH) guidelines and approve those research projects that are found to conform with the NIH Guidelines. The Institutional Biosafety Committee meets the requirements of the North Carolina Open Meetings Law. In general, the IBC meets on a monthly basis, and submissions are due by the 15th of the month preceding the meeting.
Please review the information under the tabs below for additional information regarding the IBC review process. If your question is not answered in the information below, e-mail email@example.com.
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.
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.
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.
- 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.
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.
|Committee Member||Committee Role or Area of Expertise||Position, Department|
|Doug Cyr, PhD||Committee Chair||Professor, Cell Biology and Physiology|
|Catherine Brennan||Responsible Official||Executive Director, Environment, Health and Safety|
|Amanda Craigen||Biosafety Officer||Biosafety Officer, Environment, Health and Safety|
|Christopher Broberg, PhD||Biosafety and Microbiology||Associate Biosafety Officer, Environement, Health and Safety|
|Rachael Turner*||Committee Coordinator||Biosafety Specialist, Environment, Health and Safety|
|Matthew Hirsch||AAV-Mediated Gene Therapy||Associate Professor, Ophthalmology|
|Rachel Graham, PhD||Virology||Assistant Professor, Epidemiology|
|Victoria Baxter, DVM, PhD, DACLAM||Animal Expert||Assistant Professor, Division of Comparative Medicine|
|Craig Fletcher, DVM, PhD, DACLAM||Animal Expert||Director, Division of Comparative Medicine|
|Ilana Galex, DVM, DACLAM||Animal Expert||Assistant Professor, Division of Comparative Medicine|
|Shawn Hingtgen||Stem Cell Therapy||Professor, Pharmacy|
|Barbara Savoldo, MD, PhD||Clinical Research||Research Professor, Pediatrics, Hematology and Oncology|
|William Bucha*||Export Compliance||Export Compliance Manager, Institutional Integrity and Risk Management|
|Keith Porterfield||Community Member||Assistant Fire Chief, Chapel Hill Fire Department|
|Wil Lawson||Community Member||Orange Water and Sewer Authority|
|Stanley M. Lemon, PhD||Ad Hoc Consultant (DURC)||Professor, Medicine, Microbiology and Immunology|
|Ann Matthysse, PhD||Ad Hoc Consultant (Plant Use)||Professor, Department of Biology|
|*indicates non-voting members on the committee.|
|Date||Time||Submission Due Date|
|January 11, 2023||1:00 p.m. – 2:30 p.m.||December 15, 2022|
|February 1, 2023||1:00 p.m. – 2:30 p.m.||January 15, 2023|
|March 1, 2023||1:00 p.m. – 2:30 p.m.||February 15, 2023|
|April 12, 2023||1:00 p.m. – 2:30 p.m.||March 15, 2023|
|May 3, 2023||1:00 p.m. – 2:30 p.m.||April 15, 2023|
|June 7, 2023||1:00 p.m. – 2:30 p.m.||May 15, 2023|
|July 12, 2023||1:00 p.m. – 2:30 p.m.||June 15, 2023|
|August 2, 2023||9:00 a.m. – 10:30 a.m.||July 15, 2023|
|September 6, 2023||1:00 p.m. – 2:30 p.m.||August 15, 2023|
|October 4, 2023||1:00 p.m. – 2:30 p.m.||September 15, 2023|
|November 1, 2023||1:00 p.m. – 2:30 p.m.||October 15, 2023|
|December 6, 2023||1:00 p.m. – 2:30 p.m.||November 15, 2023|
External Review Process for Industry/Commercially Sponsored Clinical Trials
UNC-Chapel Hill utilizes WCG’s external Institutional Biosafety Committee (IBC) services to review industry/commercially sponsored human gene transfer research covered under Section III-C of the NIH Guidelines. WCG will bill the study’s sponsor for use of its IBC services.
WCG’s IBC accepts applications on a rolling basis. Following the initial submission, WCG’s analyst for UNC-Chapel Hill will work with the study team to finalize site level documents and generate a study-specific standard operating procedure (SOP). The site analyst will schedule an IBC meeting once the submission and SOP have been finalized.
Internal Review Process for Grant/Federally Funded Clinical Trials
The University’s internal IBC will review grant/federally funded clinical trials. The IBC’s coordinator will send a copy of the Appendix 10a application to the study’s contact(s).
The University’s IBC meets on the first Wednesday of each month. To guarantee review, applications must be submitted by the 15th of the month preceding the meeting (i.e., submit by February 15 for review at the March meeting). Additionally, a representative must be available to attend the meeting to participate in a question-and-answer session and give a short presentation on the study design and safety procedures for the handling, administration and disposal of the investigational product.
Studies Subject to Review
Clinical research studies involving human gene transfer are covered under Section III-C of the NIH Guidelines. Studies subject to Section III-C involve the deliberate transfer of one of the following products into human research participants:
- Recombinant nucleic acid molecules
- DNA or RNA derived from recombinant nucleic acid molecules
- Synthetic nucleic acid molecules (or) that meet any one of the following criteria:
- Contain more than 100 nucleotides; or
- Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration);
- Have the potential to replicate in a cell; or
- Can be translated or transcribed.
- DNA or RNA derived from synthetic nucleic acid molecules described under 3.
In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
- Molecules that are constructed by joining nucleic acid molecules and can replicate in a living cell
- Nucleic acid molecules that have been synthesized or amplified
- Molecules that result from the replication of those described above
Per the NIH Guidelines, research covered under Section III-C of the Guidelines cannot be initiated until the study has received:
- Institutional Biosafety Committee approval
- All other applicable institutional and regulatory authorization(s) (e.g., approval from UNC-Chapel Hill’s Institutional Review Board)
Terms of Approval
IBC approval will be considered valid for the entire duration of the study, provided:
- No protocol amendments have been made which involve changing to the recombinant or synthetic nucleic acid product (e.g., changing target genes, promoter, vector source, manufacturing procedure)
- No protocol amendments have been made which change any handling procedures or safety considerations for University employees or study participants (e.g., waste disposal, personal protective equipment)
If any such changes are made, an amendment must be submitted for further IBC review. Protocol amendments should not be initiated until they have been approved by the IBC.
It is University policy that all PIs must comply with the NIH Guidelines regardless of their funding source, and all research involving recombinant or synthetic nucleic acids (rsNA) must be registered with the IBC. Review requirements may vary depending on the proposed research. Please refer to the rDNA categories outlined in the NIH Guidelines. If you have any question regarding the rDNA categories or review requirements, please contact firstname.lastname@example.org.
Clinical trials subject to the NIH Guidelines require IBC review. To request IBC review, you must complete the IBC Screening Form. Refer to the Clinical Trials tab for details on the application process and review requirements for human gene transfer studies.
The Schedule G is the IBC’s standard registration form for laboratory research proposals involving rsNA. This form is only available through the Laboratory Safety Plan (LSP) website. Schedule Gs are reviewed on a monthly basis at the IBCs meeting and must be received by the 15th of the month to be considered at the following month’s meeting. Additional details regarding the review procedure can be found under the Meeting Schedule and Charter tabs. Please contact email@example.com with any questions regarding a Schedule G application.
Schedule H forms are used to document the purchase or transfer of transgenic animals, which is an exempt activity under the NIH Guidelines. This form is only available through the Laboratory Safety Plan (LSP) website, and they are reviewed on a rolling basis. If a lab is purchasing or receiving a knockout strain, a Schedule H form is not required at this time. If a novel transgenic strain is being commissioned, labs should fill out a Schedule G for this type of modification. Please refer to the Animal Activities Table for additional information on classifying animal work.