Source: https://vcfa.uark.edu/fayetteville-policies-procedures/vprs/2097.php
Timestamp: 2019-10-16 02:15:06
Document Index: 555729638

Matched Legal Cases: ['art 331', 'art 121', 'art 73', 'art 331', 'art 121', 'art 73']

Policy on Institutional Biosafety Committee (IBC) Review and Approval | VCFA | University of Arkansas
Fayetteville Policies and Procedures 209.7
Policy on Institutional Biosafety Committee (IBC) Review and Approval
The following is the policy of the University of Arkansas, Fayetteville (hereafter referred to as the University) regarding protocol review and approval by the IBC. It applies to all University research, teaching, business activities, employees and other persons acting as representative of the University, involving materials or technologies described in III-A below.
University faculty, staff and students will comply with the authority and guidance of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines); the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL); the Federal Select Agent Regulations (7 CFR Part 331; 9 CFR Part 121; and 42 CFR Part 73); and other federal, state, and local regulations; and university policies, as applicable.
In accordance with federal regulations, the University will constitute an Institutional Biosafety Committee (IBC) with members appointed by the Provost and Executive Vice Chancellor for Academic Affairs (Provost). The IBC will comprise, at a minimum, five faculty members; a graduate student with knowledge of protocols involving recombinant and synthetic nucleic acid molecules; two members unaffiliated with the university (except for their membership on the IBC) and who represent the interests of the community with respect to health and environmental protection; and a representative of the Pat Walker Health Center. Additionally, staff members holding the following positions will serve as ex officio, non-voting members: the manager of the Central Laboratory Animal Facility (CLAF); the Biological Safety Officer; and the Director of Research Compliance. The committee members will collectively have the expertise to assess research protocols subject to its review. Members are appointed for three-year terms and a Chair is appointed by the Provost.
The IBC is registered with the National Institutes of Health Office of Science Policy (NIH OSP). Registration updates are submitted on an annual basis. The annual update includes a) a roster of all members including the roles they serve as applicable (e.g. plant expert; animal expert, biosafety officer); and b) biographical sketches of all members including community members.
On behalf of the University, the IBC has the following functions:
Review and vote on approval of all protocols involving: recombinant and/or synthetic nucleic acid materials regardless of funding source; Risk Group 2 or 3 microorganisms as defined in the NIH Guidelines; biological toxins; bloodborne pathogens; human and nonhuman primate materials; mammalian tumor cell lines; transgenic plants; and transgenic animals.
Protocols involving live vertebrate animals must also be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC).
Protocols involving human materials may also require review and approval by the Institutional Review Board (IRB). Such review is required when the protocol meets the definition of Human Subjects Research per 45 CFR 46.102.
Only microorganisms that can be safely manipulated in existing university laboratories may be considered. A risk assessment must be conducted and included in the protocol.
Microorganisms, plant pathogens, and toxins subject to oversight by the Federal Select Agent Program may not be considered. Exempt quantities of select toxins and excluded strains of microorganisms may be permissible.
Protocols involving the use of tumor cell lines that are not well-characterized; were immortalized with viral agents (e.g. simian virus 40 [SV-40], Epstein-Barr virus [EBV]; human papillomavirus [HPV]; etc.); or are otherwise known to be carrying viral genomic material or human bloodborne pathogens must be reviewed and approved by the IBC. Protocols involving well-characterized cell lines known to be free from viral genomic material or human bloodborne pathogens, and that do not otherwise contain elements subject to IBC oversight, do not require IBC review, but must, for awareness, be submitted to the IBC Coordinator and the Biological Safety Officer using Form 9. Such projects may still require review by other committees.
Assess the containment levels required for proposed research involving any of the materials listed in (A) above.
Assess the adequacy of facilities; Standard Operating Procedures (SOPs); and training of the Principal Investigator and other laboratory personnel to conduct the proposed work.
At the request of University researchers, the IBC may review; provide guidance on; and vote on approval of additional protocols not involving the above-listed materials.
Keep abreast of mandated guidelines and other sources of best practices to ensure continued institutional compliance.
Serve as a resource for investigators conducting any research subject to review by the IBC.
Make recommendations to the Office of Research Compliance and/or the Office of Environmental Health and Safety regarding biosafety concerns.
Report to the Provost and to the NIH Office of Science Policy any significant problems or incidents of noncompliance with the NIH Guidelines and any significant, research-related accidents or illnesses.
The IBC meets monthly or as needed. Meeting dates are listed on the University’s Research Compliance website. When possible and consistent with the protection of privacy and proprietary interests, meetings of the IBC are open to the public. A quorum (50% + 1 of voting members) is required to conduct official IBC business.
No member of the IBC may be involved in the review or approval of a project in which s/he has or may expect to have a direct financial interest, except to provide information as needed to the committee. If any member must recuse himself or herself for review of a protocol, the committee will determine if a quorum still exists before proceeding.
Protocols may be approved for no more than three years. Projects must be resubmitted for review after three years. No work on any project subject to this policy may be conducted until approval is granted.
Meeting minutes will be made available, upon request, to the public. Public comments on committee actions and committee responses shall be forwarded to the NIH Office of Science Policy in accordance with NIH Guidelines.
The Director of Research Compliance, under the direction of the Vice Chancellor for Research and Innovation, and in collaboration with the IBC and the IBC Coordinator, shall oversee the University’s compliance with applicable laws and regulations and shall have primary responsibility for ensuring that this Policy is properly implemented and followed.
Definitions of Human Subjects Research 45 CFR 46.102
Federal Select Agent Regulations 7 CFR Part 331
Federal Select Agent Regulations 9 CFR Part 121
Federal Select Agent Regulations 42 CFR Part 73
List of Excluded Strains of Microorganisms
List of Exempt Quantities of Select Toxins
NIH Biosafety in Microbiological and Biomedical Laboratories
Registration for Research Projects: Form 9