III. THE INSTITUTIONAL BIOSAFETY COMMITTEE

A. COMPOSITION

1. The IBC shall comprise no fewer than five members so selected that they collectively have experience and expertise in: recombinant DNA and infectious agents technology ; the capability to assess the safety of the research experiments; and , the capability to assess any potential risk to public health or the environment. The committee shall include two individuals whose only affiliation with MUSC is membership on the IBC and who shall represent the interest of the surrounding community with respect to health and the protection of the environment. The Biological Safety Officer shall be a member of the Committee.

2. Members are to be appointed by the designated university official for a term of three years. Members may succeed themselves.

3. A quorum is 51% of the Committee membership.

4. 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, is, or expects to be engaged or in which he/she has a financial interest.

B. IBC FUNCTION

The Chairperson or his/her designee may use his/her expertise in assigning the review of the Registration Document to a subcommittee selected from the duly-appointed IBC. If the study is reviewed by the subcommittee without reservations, the Chairperson may sign the Approval Notice. In addition, should the study be approved unanimously by the subcommittee, the Chairperson has the prerogative to subject this study to review by the full committee. If the subcommittee has comments which require changes, these requested changes are transmitted to the Principal Investigator or the Principal Investigator is invited to appear before the full Committee at their regular meeting to justify his/her position. In case of a potential disagreement between the Committee and the Principal Investigator, the Chair has the prerogative to consult an independent (ad hoc) advisory source of peers. Additionally, in the case of potential conflicts of interest, an independent (ad hoc) advisory members may be appointed, as deemed necessary by the Chair to provide expertise in the subcommittee review.

The IBC review shall include but not be limited to:

1. Assessment of the containment levels for the proposed project;
2. Assessment of the facilities, procedures, and practices, and the training and expertise of the personnel performing the research;
3. Notification of the Principal Investigator of the results of the review;
4. Determination of appropriate containment as specified by the Guidelines, or as deemed necessary;
5. Annual review of the research being conducted;
6. Adopt emergency plans covering accidental spills and personnel contamination resulting from such research; and
7. Report within a reasonable time frame to the appropriate institutional official and to the NIH Office of Recombinant DNA Activities (RAG) (if applicable) any significant problems with or violations of the Guidelines, and any significant research related accidents or illnesses, unless it has been determined that the Principal Investigator has done so.

C. FACILITY INSPECTIONS

The BioSafety Officer or his/her designee will conduct initial inspections in order to assist Principal Investigators and their coworkers to maintain and use safe conditions and procedures in recombinant DNA research. Additional persons not from the IBC may be included in the inspection as advisors as necessary.

The results of the inspection shall be brought to the immediate attention of the Principal Investigator and reported to the Chair of the IBC, and deficiencies must be corrected as specified by the BSO. In addition, the BSO will arrange any further unscheduled facility inspections he/she deems necessary to determine compliance with the MUSC regulations. If the deficiencies are not corrected by subsequent inspections, the matter shall be brought to the attention of the IBC for further action.

Serious infractions which result in a reduced level of containment or present a serious hazard require immediate suspension of the experiments in progress and a report to the IBC. Experiments may continue only after the discrepancy has been corrected by the Principal Investigator, a written report to that effect has been received by the Chair of the IBC, and a follow-up inspection of the facility has taken place to assure that correction of the identified infraction(s) has been made. Furthermore, a statement of assurance must be included in the written report by the Principal Investigator on how to prevent the infraction from recurring. Any continuation of the experiments at non-permissible levels of containment will be reported concurrently to the Department Chair and the designated Institutional Official for further action.

Reinspections will be conducted every two years by Occupational Safety and Health.