Establishment of the International Biosafety Committee, Procedures, and Guidelines

Executive Memorandum 00-002

January 11, 2001

From: Manuel A. Esteban, President

Subject: Establishment of the International Biosafety Committee, Procedures, and Guidelines

ESTABLISHMENT OF THE INTERNATIONAL BIOSAFETY COMMITTEE, PROCEDURES, AND GUIDELINES

California State University, Chico, hereinafter University, hereby provides implementation procedures to govern the safety of all recombinant DNA research conducted at or under the auspices of the University. The University recognizes its obligation to provide research protocols that conform at a minimum to current National Institutes of Health (NIH) Guidelines.

Applicability

This policy is applicable to all research involving the use of recombinant DNA that is conducted under the authority of the University and includes research conducted by individuals who are not members of the campus community but who use University facilities. Further, this policy is applicable to all recombinant DNA research, whether funded or not by an agency of the federal government.

This policy is applicable to research activities as defined by federal regulations: "a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. "

University Procedures

The University will comply with all applicable federal laws and regulations governing the conduct of research using recombinant DNA. State and local laws will be taken into account in this process as applicable.

The Institutional Biosafety Committee (IBC) will further define university implementation procedures. On behalf of the University, the IBC is responsible for reviewing proposed recombinant DNA research for compliance with NIH Guidelines as specified in Section III, Experiments Covered by the NIH Guidelines, and approving those research projects that are found to conform at a minimum with the NIH Guidelines.

The dean of the School of Graduate, International, and Sponsored Programs will appoint the IBC chair. The IBC chair will be responsible for filing an annual report with the NIH/ Office of Biotechnology Activities per NIH Guidelines. The School will have administrative responsibility for convening the IBC and providing staff support for it to conduct its duties.

The IBC will be comprised of nine members: six appointed by the dean of the School of Graduate, International, and Sponsored Programs; one appointed by the dean of Agriculture; and two appointed by the dean of the College of Natural Sciences. Appointments will be for three years and can be renewed. The initial set of appointments will be staggered. Collectively the IBC will have expertise in recombinant DNA technology and the capability to assess recombinant DNA research and to identify potential risks to public health. Membership will include a representative of the Research and Sponsored Programs Committee, a student with a relevant academic interest, and the University's Health and Safety Officer. The IBC will also include at least one member representing laboratory technical staff. At least two members will not be affiliated with the University and will represent the interests of the surrounding community with respect to public health and the environment. The IBC will include or have available consultants knowledgeable in university commitments and policies; applicable law; standards of professional conduct and practice; community attitudes; and the environment.

The IBC is charged with proving safe practices in research involving recombinant DNA. To fulfill this mandate, the IBC will follow current NIH Guidelines as a minimum set of standards in defining and determining what constitutes covered research, what research is exempt from coverage, what safeguards and restrictions to enforce, and what procedures and guidelines to use in regulating such research.

No research involving recombinant DNA will be started until a review of the project has been carried out and written approval given. No member of the IBC may be involved in the approval of a project in which he/she has been or expects to be engaged or has a direct financial interest.

The IBC will report each September to the dean of Graduate, International, and Sponsored Programs on activities involving covered recombinant DNA research. This report, which will be forwarded to the Provost, will include a listing of all protocols reviewed during the preceding year (July 1 - June 30). Also listed in the report will be projects monitored as required periodically by federal regulations due to project length for those continuing beyond one year or those which may experience problems or pose significant risks to warrant monitoring.

When possible and consistent with protection of privacy and proprietary interests, the IBC meetings will be open to the public. Upon request, the institution shall make available to the public all IBC meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. If public comments are made on IBC actions, the University shall forward both the public comments and the IBC's response to the Office of Biotechnology Activities of the NIH.

University policy recognizes that federal and other governing regulations may change over time. Thus, the IBC is empowered to change or make new implementation procedures and guidelines in response to changing regulations and circumstances to ensure university compliance with federal and other pertinent regulations. These changes will be brought as recommendations to the Research and Sponsored Programs Committee for approval. To begin, this policy recognizes as current federal policy the NIH Guidelines for Recombinant DNA Molecules (October 2000). Issues that may arise concerning the interpretation and implementation of federal regulations in implementing this policy will be subject to final determination and interpretation by the IBC.

Guidelines for Research Approval and Monitoring

The IBC will approve research involving recombinant DNA based on the determination that federal and applicable state and local requirements related to biosafety are satisfied. Further, for nonexempt categories of research, protocols that conform at a minimum to federal regulations (NIH Guidelines) will be approved on a case-by-case basis by the IBC. As appropriate to the circumstances, the protocol will provide for monitoring the research to ensure safety. The IBC will set monitoring provisions for each project as deemed necessary and appropriate by a majority of the IBC membership.

The IBC will exercise the authority, as necessary, to withhold or suspend approval of research not meeting established regulations and procedures, not conducted in accordance with IBC decisions and conditions, or associated with bringing harm or undue risk. The IBC will report within five working days to the dean of the School of Graduate, International, and Sponsored Programs any incidents involving withholding or suspending a research project. Any member of the campus community or public at large may report suspected problems or violations of regulations of approved protocols. Reports may be made to any member of the IBC, the dean of the School of Graduate, International, and Sponsored Programs, or referred thereto by university officials. The IBC in cooperation with the dean of the School of Graduate, International, and Sponsored Programs will investigate such reports and act appropriately. The IBC will report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the appropriate official and NIH/ Office of Biotechnology Activities within thirty days, unless the IBC determines that a report has already been filed by the Principal Investigator. Principal Investigators are charged with the responsibility for reporting any unanticipated problems or risks and securing IBC approval for any significant changes in the protocol as originally approved by the IBC. In cases where research projects have been suspended, it is the responsibility of the Principal Investigator and the IBC to ensure adherence to agreed-upon protocols or if necessary to establish new protocols that minimize risk and ensure public health in accordance with NIH Guidelines.

The University Provost, who serves as University Research Officer, has final authority in all matters governed by the IBC.

Expansion of the scope of duties of the IBC beyond oversight of recombinant DNA research will require full consultation with the University's Academic Senate.