The Wake Forest University (WFU) Biosafety Committee has the responsibility for the establishment and maintenance of a system for the control of biohazards within all campuses of the University. The Biosafety Committee has representation from WFU and WFU School of Medicine (WFSM) faculty, Employee Health Services, WFSM Environmental Health & Safety Office, WFU Environmental, Health and Safety Department, administration, and the public.
The purpose of the Biosafety Committee is to recommend policies, procedures, and programs for the safe access, handling, and disposal of biological and infectious materials. Regulatory compliance and protection of our personnel, facilities, and other resources are integral to this committee’s work. The policies developed by this committee are submitted to appropriate administrative offices for approval and implementation. The Environmental Health and Safety Office administers and enforces the policies of the Biosafety Committee for the Medical School and its affiliates. The WFU Environmental, Health and Safety Department enforces the policies of the Biosafety Committee for the Reynolda campus.
The scope of the Biosafety Committee includes all biological agents within, brought into and removed from Reynolda campus, The Medical School and/or their affiliates.
IV. Responsibilities and Authority:
A. The Responsibilities of the Biosafety Committee:
- Develop a comprehensive health and safety program for all areas involved in the use of biohazardous materials.
- Identify and approve all activities involving biohazardous materials.
- Assess the principal investigator’s qualifications and experience relative to biohazardous materials, the level of containment required, the containment facilities available, and work procedures for storage, handling, and manipulation of biohazardous agents. This assessment may require an inspection of the facility and the preparation of a document outlining specific recommendations for the management of biohazardous materials and the health surveillance of potentially exposed personnel.
- Provide the WFSM Office of Research and/or WFU Division of Programs and Partnerships with any certifications required for research grants and contract applications.
- Review at least every three years the biosafety policies and revise/develop appropriate procedures.
- Provide oversight and review of the Biosafety program.
- Review and approve protocols for recombinant DNA research conducted at or sponsored by The University for compliance with the NIH Guidelines as specified in NIH 97-3 Section III, experiments covered by the NIH Guidelines. This review shall include:
a) Independent assessment of the containment levels required by the NIH Guidelines for the proposed research, and
b) Assessment of the facilities, procedures, practices, training, and expertise of the personnel involved in recombinant DNA research.
c) Lowering containment levels for certain experiments as specified in NIH 97-3 Section III-C-2-a, experiments in which DNA from Human or Animal Pathogens (Class 2, Class 3, Class 4, or Class 5 Agents) is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.
d) Setting containment levels as specified in NIH 97-3 Sections III-C-4-b, experiments Involving Whole Animals, and III-C-5, Experiments Involving Whole Plants.
e) Periodically review recombinant DNA research conducted at The University to ensure compliance with NIH Guidelines.
f) Reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the appropriate university official and NIH/ORDA within 30 days, unless the Biosafety Committee determines that a report has already been filed by the Principal Investigator. Reports to NIH/ORDA shall be sent to the Office of Recombinant DNA Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838.
g) The Biosafety Committee may not authorize initiation of experiments that are not explicitly covered by the NIH Guidelines until NIH (with the advice of the Recombinant DNA Advisory Committee when required) establishes the containment requirement.
h) Performing such other functions as may be delegated to the Biosafety Committee under NIH 97-3 Section IV-B-2.
8. Review and approve protocols for research conducted at or sponsored by The University for compliance with CDC guidelines as specified in Biosafety in Microbiological and Biomedical Laboratories (CDC 93-8395). This review shall include:
a) Independent assessment of the containment levels required by the CDC Guidelines for the proposed research, and
b) Assessment of the facilities, procedures, practices, training, and expertise of personnel involved in recombinant microbiological and biomedical research.
9. Develop standard protocols for common biohazardous materials.
10. Notify the Principal Investigator of the results of the Biosafety Committee’s review and approval process.
11. Develop and adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research, microbiological and biomedical research.
12. Administer the enforcement component of the Biosafety Committee policies and waste disposal procedures.
13. Meet at least quarterly.
The Authority of the committee is to institute policies, procedures, and controls delegated as follows:
For the School of Medicine authority has been delegated by the Vice President and Dean of the School of Medicine to the Biosafety Committee, through its Chairman, to the Director of WFSM Environmental Health and Safety Office or their designee. This authority includes (but is not limited to) instituting appropriate control measures when there is a reasonable danger to personnel and/or the environment, and to make decisions concerning biosafety control in the following matters;
For the Reynolda Campus authority has been delegated by the Vice President of Finance and Administration to the Biosafety Committee, through its Chairman, to the Director of WFU Environmental, Health and Safety Department or their designee. This authority includes (but is not limited to) instituting appropriate control measures when there is a reasonable danger to personnel and/or the environment, and to make decisions concerning biosafety control in the following matters;
1. Develop and review protocols and procedures dealing with aspects of biosafety.
2. Require researchers to conduct and maintain inventories of biohazardous materials.
3. Inspection of laboratories conducting recombinant DNA research, and microbiological and biomedical research.
4. Assessment of compliance with NIH and CDC guidelines.
5. Collection of chemical and/or biological samples.
6. The restriction from job duties of faculty, staff, and students who conduct research involving recombinant DNA research, microbiological and biomedical research, and chemical usage without an approved Biosafety Application or in direct contradiction of submitted protocols and/or current regulations.
7. Recommend disciplinary action to the appropriate university administrator concerning noncompliance or any type of hazard.
8. Require corrective action concerning any noncompliance or type of hazard.