Institutional Biosafety Committee (IBC)

Charter

Adopted 12/03/07

This charter describes the responsibilities, membership, organization, and meetings of The University of Montana (UM) Institutional Biosafety Committee (IBC).

I. Responsibilities of the UM Institutional Biosafety Committee

A. Perform the functions of an IBC as specified in NIH Guidelines for Research Involving Recombinant DNA Molecules.  Also see NIH Guidelines Explained.

B. Review applications for recombinant DNA research conducted at UM for compliance with NIH Guidelines, and approve those research projects that are found to conform.

1. The IBC grants final authorization for research projects involving recombinant DNA.

a. Written notification of IBC approval is required before research can begin.
b. All recombinant DNA research must be registered with the IBC, even if it is exempt from NIH Guidelines.

2. IBC reviews include:

a. Assessment of the biosafety level required per the NIH Guidelines for the proposed recombinant DNA research.
b. Assessment of the facilities, procedures, practices, training and expertise of personnel involved in the recombinant DNA research.

3. IBC applications have a unique tracking number and a mechanism for periodic review and updating.

a. Approved applications expire 3 years from the approval date.
b. A new application must be submitted to the IBC and approved before the previous application expires in order for research to continue without interruption.
c. The Biosafety Officer (BSO) is responsible for monitoring expiration dates and alerting Principle Investigators (PIs) ninety days before their application expires.

4. Approval by the Institutional Animal Care and Use Committee and Radiation Safety Committee must be obtained when relevant.

C. Review and approve applications for using hazardous biological agents in research projects at UM.

1. The UM IBC grants final authorization for research projects involving hazardous biological agents including:

a. Bacterial, fungal, parasitic, viral, rickettsial or chlamydial agents causing disease in humans, animals or plants.
b. Toxins.
c. Gene therapy vectors.
d. Human cell lines, tissue or blood products. 
e. Written notification of approval is required before project work can begin.

2. IBC reviews include:

a. Assessment of the biosafety level required by the NIH Guidelines for the proposed biohazard research as outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
b. Assessment of the facilities, procedures, practices, and training and expertise of personnel involved in biohazard research

3. IBC applications have a unique tracking number and a mechanism for periodic review and updating.

a. Approved applications expire 3 years from the approval date.
b. A new application must be submitted to the IBC and approved before the previous application expires in order for the research to continue without interruption.
c. The BSO is responsible for monitoring expiration dates and alerting PIs 90 days before their application expires.

4. Approval by the Institutional Animal Care and Use Committee and Radiation Safety Committee must be obtained when relevant.

D. Receive summary reports from the BSO regarding:

1. Exposures of individuals to hazardous biological agents, including management of exposures and resulting infections.

2. Medical surveillance programs.

3. Contamination of facilities with hazardous biological agents.

4. Certifications of biological safety cabinets.

5. Certifications of autoclaves.

6. Failure to comply with established policies and regulations regarding the safe conductof research involving hazardous biological agents.

7. Procedures and training requirements related to packaging and shipping of hazardous biological agents to ensure compliance with applicable guidelines, policies and regulations.

E. NIH Compliance

1. UM’s IBC is registered with the NIH Office of Biotechnology Activities (OBA).

2. UM is in full compliance with the NIH Guidelines.

3. Annual reports, including a current roster and updated biographical sketches of IBC members, are submitted to NIH OBA by the BSO.

II. Membership and Organization of the UM Institutional Biosafety Committee:

A. The following IBC members are appointed by the UM Vice President for Research and Development:

1. Four members from the UM research community representing a diversity of disciplines relevant to biomedical research, infectious diseases, and recombinant DNA technology.

2. UM Director of Environmental Health & Risk Management.

3. UM Attending Veterinarian.

4. UM Biosafety Officer (BSO).

5. UM Compliance Officer.

6. Clinical Laboratory Supervisor at Curry Student Health Center.

7. Three members of the local medical/nursing/veterinary community. 

B. The IBC Chair is selected from the Committee membership and appointed by the Vice President for Research and Development.  The IBC Chair serves a two-year term and may be reappointed for additional terms.

C. The members serve overlapping terms of three years, and may be reappointed for additional terms.

III. Meetings of the UM Institutional Biosafety Committee

A. The IBC meets at least quarterly throughout the calendar year.

B. Meetings are held on the UM campus.

C. Special meetings may be called by the BSO, the IBC Chair, or the Vice President for Research and Development.

D. The BSO serves as the Executive Secretary and maintains all records, correspondence, and meeting minutes.

E. Following each meeting, the BSO prepares a set of draft minutes for distribution to all IBC members.  Minutes are labeled “FINAL” at the next meeting after consideration and approval of suggested changes.

F. IBC business conducted electronically

1. An IBC application for all research activities involving infectious agents, toxins, gene therapy, recombinant DNA and/or human blood products and tissue is completed by the Principal Investigator (PI) and submitted electronically to the BSO.

2. IBC applications received between meetings (defined as those received by the BSO prior to 2 weeks before the next meeting date) are sent to Committee members via e-mail by the BSO unless the Chair or BSO decides to call an IBC meeting.

3. The BSO is responsible for:

a. Assigning a number to the application.
b. Archiving both electronic and hard copies of the application.
c. Corresponding with the PI.
d. Forwarding applications to other IBC members for review.
e. Corresponding with the other IBC members.
f. Summarizing IBC comments and discussion regarding the application.
g. Forwarding IBC concerns and/or recommendations to the PI.
h. Sending the approved application to the PI.

4. The IBC Chair and the BSO assign a biosafety level for the research in compliance with the Biosafety in Microbiological and Biomedical Laboratories, 5th Edition.

5. Members are given at least 10 business days to respond to the e-mail, with an e-mail reminder sent by the BSO after 7 days.  All members should respond indicating either:

a. Approval,
b. Approval with minor comments, or
c. Disapproval and request for a full committee meeting.

6. Members may contact the BSO for clarification or further information.  BSO responses are sent to the entire membership.

7. Once all responses are received, the BSO provides a summary of the decision including any comments and discussion to the full Committee.  If responses are not received from two-thirds of the membership at the end of the 10-day response period, or if any member has indicated their disapproval and request for a meeting, the IBC Chair will call a meeting of the full Committee or will table discussion until the next scheduled meeting.

8. The BSO is responsible for informing the PI of the IBC’s final decision regarding the application.