Institutional Biosafety Committee

Wake Forest University (WFU) Institutional Biosafety Committee (IBC) provides local review and oversight of nearly all research involving recombinant or synthetic nucleic acid molecules (r/sNA) conducted at or sponsored by the University.  The Committee approves the research projects that comply with the National Institute of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nuclei Acid Molecules.  Furthermore, the IBC is typically assigned to review and approve research involving:

• Select agents and toxins
• Microorganisms and viruses pathogenic to humans, plant or animals
• Xenotransplantation
• Biological material from human and non-human primates
• Stem cell research and nanotechnology
• “Dual Use” research
• Animal tissues that present zoonotic disease concerns

The IBC reports to the Provost.

IBC – “Institutional Biosafety Committee” is a committee that meets the requirements for membership, reviews, approves and oversees projects in accordance with the responsibilities specified in Section IV-B-2 of NIH Guidelines

BSO – Biosafety Officer

r/sNA – Recombinant or synthetic nucleic acid molecules research

PIs – Principal Investigators

Guidelines – National Institute of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nuclei Acid Molecules.

EHS – Environmental, Health and Safety Department

NIH OBA – National Institute of Health Office of Biotechnology Activities

NIH OSP – National Institute of Health Office of Science Policy

 A) IBC Membership

The Provost, with assistance from the BSO and the IBC chair, recruits and nominates IBC members. IBC members are formally appointed by the Provost in writing to three-year terms. The NIH requirement for IBC membership includes:

• A minimum of five.
• At least two members shall not be affiliated with the University and will represent the interest of the community with respect to health and protection of the environment.
• At least one individual with expertise in animal containment principles.
• At least one individual with expertise in plant containment principles.
• The EHS Biosafety Officer (BSO).
• The Provost or  his/her  designee also may appoint  additional  persons  from any component  or  discipline  in the University  to serve  in an ex-officio capacity.
• The BSO will serve as Executive Secretary to the Committee.
• The Chairperson of the Committee will be appointed by the Provost or his/her  designee from among the Committee.
• The Chairperson and members may be reappointed for additional terms whether consecutive or  non-consecutive, at the pleasure of the Provost or his/her designee.
• If an IBC member does not attend three meetings throughout the calendar year, the IBC Chair will consult the EHS Director to ask that a replacement be nominated.

   B) The Responsibilities of IBC are as follows:

• Performs the function of an Institutional Biosafety Committee as specified in the NIH Guidelines.
• Ensures that Principal Investigators (PI) are aware of the responsibility to register research involving r/sNA and biohazards with the IBC.
• Assists and advises PIs and other researchers in meeting their responsibilities to ensure that the biological aspect of the research are conducted in a safe manner utilizing biosafety standards, principles and work authorization.
• Reviews all research involving r/sNA conducted at or sponsored by the University for compliance with Guidelines and approves those research projects that are found to conform to the Guidelines.
• Reviews and issues approvals, when appropriate, research involving microorganisms and viruses that are pathogenic to humans, animals or plants.
• Reviews and approves, when appropriate, research involving biological materials from human and non- human primates.
• Conducts the local review and approval of all University research activities involving the possession and use of Select Agents and Select Agent Toxins, to assure that these activities and the related facilities comply with applicable federal, state and local laws and regulations and University policies, regardless of the source of funding for the project.
• Notifies the PI of the results of the IBC’s review.
• IBC will not authorize initiation of experiments which are not explicitly covered by the Guidelines until NIH (with the advice of the Recombinant Advisory Committee (RAC) when required) establishes the containment requirement.
• Sets containment levels as specified in the Guidelines (Sections III-D-4-b, Experiments Involving Whole Animals, and III-D-5, Experiments Involving Whole Plants).
• The IBC periodically reviews r/sNA research conducted at the institution to ensure compliance with the Guidelines.
• Adopts emergency plans covering accidental spills and personnel contamination resulting from r/sNA research activities.
• Enforces the NIH Guidelines to ensure that IBC approved conditions are adhered to, fully investigating potential violations or compliance problems.
• Reviews reports  of  accidents  or  other  incidents resulting  in the exposure of faculty, staff, students or  the environment to r/sNA Molecules as well as reports of noncompliance with  established University policies or regulatory requirements regarding the safe conduct of research.
• Reports any significant problems with, or violations of the Guidelines and any significant research-related exposures, accidents or illnesses involving recombinant genomic materials to the PI, the BSO, The Department Chair, The Provost and the NIH Office of Biotechnology Activities (OBA) within 30 days. Incidents occurring in Biosafety Level (BL) 2 laboratories resulting in an overt exposure will be reported to NIH OBA, the IBC Chair and the Provost by the Biosafety Officer within 48 hours.
• Informs the Provost of any individual whom the IBC determines has violated the terms of an approved protocol, has conducted projects subject to its authority without gaining appropriate IBC approval, or has otherwise violated any provision of applicable federal, state, and local regulations and guidelines, or institutional policies regarding subjects under its purview.
• Performs a biennial review of the IBC’s compliance with the Guidelines and submits the findings to the Provost. The review shall be performed using assessment tools available from the NIH OBA.
• The IBC shall file an annual report with NIH OSP which includes: (i) a roster of all Institutional Biosafety Committee members clearly indicating the Chair, contact person, Biological Safety Officer (if applicable), plant expert (if applicable), animal expert (if applicable), human gene therapy expertise or ad hoc consultant (if applicable); and (ii) biographical sketches of all Institutional Biosafety Committee members (including community members)

    C) Principal Investigator Responsibilities

Principal Investigators (PIs) are responsible for full compliance with the Guidelines during the conduct of r/sNA research. As part of this general responsibility, the PI should:

• PI’s must register all r/sNA research with the IBC.
• Be adequately trained in good microbiological techniques.
• Provide laboratory research staff with protocols describing potential biohazards and necessary precautions.
• Conduct laboratory-specific training for staff.
• Supervise laboratory staff to ensure that the required safety practices and techniques are employed.
• Correct work errors and conditions that may result in the release of r/sNA molecules.
• Ensure integrity of physical containment and biological containment.
• Comply with permit and shipping requirements for r/sNA molecules.
• Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination.

• A quorum shall consist of greater than one-half of the voting members and is required at the IBC meetings to conduct business. Votes will be decided by a simple majority of those present. A quorum must be present (in person or through telephone or video conferencing) to take action on research that is not exempt from the Guidelines or involves biosafety level 3 pathogens, select agents and toxins.
• IBC meetings are held at least quarterly or at the call of the Chairperson. Meeting days and times shall be posted on the EHS website, which is accessible to the general public.
• A proposed agenda will be developed and distributed before the meeting by the BSO or his/her designee. Meeting minutes will be taken by BSO or his/her designee.
• Meeting minutes will be reviewed, approved by the members. EHS staff maintain all approved IBC meeting minutes. And all meetings will be open to the public unless otherwise posted.
• Upon request, the IBC shall make available to the public all meeting minutes and any documents submitted to or received from funding agencies.
• Comments received from the public regarding the IBC’s actions are referred by the Director of EHS to the Provost, the IBC Chair and the BSO. The Provost will review and approve the IBC’s response to public comments. The IBC administrator forwards all public comments and the University’s response to NIH OBA
• The IBC chair and the BSO will review, request modifications and approve of registrations describing research that is exempt from the Guidelines.
• All r/sNA research that is not exempt from the Guidelines will be reviewed and approved, if appropriate, by the IBC at a fully convened meeting prior to initiation of the research.
• The IBC will notify the Principal Investigator if the research described on the IBC Registration form requires review and approval by NIH Office of Biotechnology Activities (OBA) and/or the Recombinant Advisory Committee (RAC).
• The BSO will review and assign containment levels for research involving human and non-human primate materials.

It is the policy of the IBC that no member of the IBC may be involved (except to provide the 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 must notify the IBC chair in these circumstances and recuse themselves when such projects are being discussed and are up for a vote. Furthermore, if the IBC Chair’s research is under review, the BSO or another IBC member will facilitate the review and sign the approval form if the project is approved.

Name	Affiliation/Department	Title
Dr. Lindsay R. Comstock Chair, Biological Chemistry Expert	Wake Forest University, Department of Chemistry	Associate Professor
Dr. Katy Lack Animal Expert	Wake Forest University, Department of Biology,	Assistant Professor
Dr. Zhang Ke Epigenetics, Cell & Molecular Biology Expert	Wake Forest University, Department of Biology,	Associate Professor
Ms. Pamela C. Moser Human Research Protection Expert	Wake Forest University, Research & Sponsored Programs	Associate Director
Dr. Brian W. Tague Plant Expert	Wake Forest University, Department of Biology	Associate Professor
Mr. Paul Hysell Biosafety Officer	Wake Forest University, Environmental Health and Safety	Associate Director, EHS
Mr. Stephen W. Fisenne Environmental, Health and Safety Expert	Wake Forest University, Environmental Health and Safety	Director, EHS
Ms. Michelle Brock Emergency Management Expert	Community Member	Emergency Management Coordinator/Planning Officer, Winston-Salem/Forsyth County Emergency Management
Mr. Gus Porter Environmental Safety & Preparedness Expert	Community Member	Environmental Safety & Preparedness Manager, High Point University

Meeting Date	Submission Deadline
TBA	14 Days prior to meeting

The IBC application form must be received by the Biosafety Officer no later than 5pm on the deadline in order to be reviewed at that month’s IBC meeting. Submissions received after the deadline will be reviewed during the next IBC meeting date.

1. Principal Investigators (PIs) must submit registration form for all protocols requiring IBC review to the Biosafety Officer in accordance with this meeting schedule
2. After initial review of the protocols by the Biosafety Officer, PIs may be asked to modify or correct protocols. All modifications and corrections must be submitted to the Biosafety Officer prior to the IBC meeting.
3. Experiments involving any animal work must also be approved by the WFU IACUC. IACUC protocols will not receive final approval until IBC approval is obtained. Biological Safety Office staff advise the IACUC staff of approved, denied, or tabled projects.
4. Experiments involving any Select Agents as defined by the USDA or CDC must be registered by the CDC or USDA. These protocols must be submitted to the Biosafety Officer to begin the CDC/USDA registration process and have approval from the IBC.

• NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), Federal Register (April 2016).
• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, CDC and NIH.