Institutional Biosafety Committee (IBC)

Medical College of Wisconsin
Institutional Biosafety Committee

Statement of Principles

Mission

The Institutional Biosafety Committee (IBC) at the Medical College of Wisconsin (MCW) has the responsibility to assure the safe use of recombinant DNA as outlined by NIH, to assure the safety of MCW personnel and others, and to limit the environmental impact of biological agents, including pathogens, utilized by researchers at MCW.

Definitions

Recombinant DNA:  (1) Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell OR (2) molecules that result from the replication of those described in (1).

Pathogen:  Any biological agents including bacteria, viruses, fungi, toxins, tissues and human serum that represent a known or pose a theoretical risk to humans.

Purpose and Scope

Currently the IBC falls under and reports to the Safety Committee at the Medical College of Wisconsin.  While the Safety Committee has general responsibilities towards safe use of hazardous materials in research programs of the college, the IBC has special concerns regarding the use of recombinant DNA as outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules.   Therefore, the IBC has certain responsibilities involving the conducting of recombinant DNA research at MCW that concerns approval, safety, environment and oversight.  The IBC reports to the Safety Committee that resides in the office of the Senior Associate Dean for Research.  The IBC also has a duty to maintain effective communication with the public and accomplishes this by having two members of the IBC who are non-affiliated with the College.  Additionally, an IBC Web site exists for the dissemination of information and to serve as a resource for Principal Investigators who are currently using or planning to use recombinant DNA molecules in their research. 

IBC Responsibilities

The IBC will:

1. Amend IBC Policy and Procedures as needed, and review on an annual basis.
    
2. Assume responsibility for ensuring the safe use of recombinant DNA at MCW.
    
3. Review all uses of recombinant DNA at MCW and evaluate such use in terms of criteria for approval.  In all cases IBC approval is necessary before initiating work.  A quorum of the IBC must be present and a majority vote of those in attendance is required for approval.
    
4. Review and prescribe special conditions, requirements, and restrictions that may be necessary for the safe handling of biological agents.  The IBC may require students, staff and researchers to pass an oral or written examination, worker physical examination (e.g. blood test, urine test, PPD, required vaccinations, etc.), use of special facilities, upgrading of facilities, special designation of areas of use within the laboratory, posting of additional caution signs, use of special disposal methods, use of special handling procedures, and special procedures to be followed after contamination events or incidents.
    
5. Review all recombinant DNA and pathogens registration forms on an annual basis.  
    
6. Set containment levels as specified in CDC and NIH Guidelines.
    
7. Withhold authorization of any studies not explicitly covered by CDC/NIH Guidelines until CDC/NIH establishes the containment requirements.
    
8. Receive and review periodic and/or urgent reports from the Biological Safety Officer (BSO) regarding:
   
   a. Exposures of individuals to biological agents;
   b. Loss or theft of biological agents;
   c. Status of certification of biological safety cabinets;
   d. Status of certification of autoclaves;
   e. Records of infectious waste disposal; and
   f. Records of Select Agent purchase/transfer
    
9. Report any problems, violations, accidents or illnesses to the Safety Committee, NIH as outlined in Section IV-B-2-b-(7), and other appropriate agencies.
    
10. Recommend and/or initiate remedial actions when safe procedures are not followed under an authorized project or when procedures are not in compliance with government regulations or the MCW Safety Plan.  This may involve termination of authorizations or confiscation of biological agents.  The IBC will re-authorize operations when activities are performed in a manner acceptable to the IBC and the Safety Committee.
     
11. Conduct periodic review of MCW activities involving biological agents to ensure compliance with all appropriate laws, regulations, policies and program requirements.  Reviews will be done on an annual basis.
     
12. Post changes to rules and regulations from various government agencies as needed to the IBC Web site.  These changes will also be e-mailed to Chairpersons, Principal Investigators and administrative officers of MCW.
     
13. Maintain records of meeting minutes, protocol reviews, and other documents related to the use of recombinant DNA molecules in research conducted at MCW.
     
14. Serve as a liaison with NIH for IBC duties.
     
15. Serve as a liaison with CDC, State of Wisconsin Department of Health and other regulatory agencies in matters of registration, licensing and biohazard safety.

 Membership

The IBC committee shall consist of no fewer than five voting members, as specified in Section IV-B-2-a-(1) of the NIH Guidelines. These members shall be selected based on their experience in the following areas:

1. At least one member with infectious disease experience
2. At least one member with experience using rDNA in animals;
3. At least three members with experience in rDNA technology and/or biological safety and containment;
4. A biological safety officer; and
5. Two, non-affiliated members that represent community interest in health safety and environment.

The IBC committee shall also have an Ex Officio voting member;

       Chairman of the Safety Committee

Members are appointed by the Senior Associate Dean of Research for renewable terms of 3 years.

Removal of a member from the IBC requires documentation and substantiated "just cause" that demonstrates the member to be unfit or unable to serve on the IBC.  "Just cause" for removal may include, but is not limited to, lack of regular attendance at meetings, a finding of misconduct, or an unresolved conflict of interest.  The decision to remove a member is made by the Senior Associate Dean of Research upon a majority vote of the IBC membership.  Individuals that cannot attend an IBC meeting, due to a lengthy absence (e.g. sabbatical leave) should notify the Senior Associate Dean of Research so that a replacement may serve during their absence.

The IBC will meet monthly and a quorum is defined as greater than 50% attendance of voting members of the committee.  All matters requiring a vote by the IBC require simple majority of the quorum.

No member of the IBC may be involved in the review or approval of a project in which he/she is conflicted or potentially conflicted, (e.g has been, is or expects to be directly engaged in the project or has professional or financial interest, except to provide information requested by the IBC.)

IBC Procedures

1. Review of recombinant DNA research begins with registration of research through the Office of Research.  Recombinant DNA summary forms and all other safety forms are submitted online by the Principal Investigator.
    
2. Recombinant DNA summary forms are forwarded to Dr. Phillip Pratt (Co-Chair for IBC) and if necessary, Pathogens forms forwarded to Dr. Thomas Zahrt (Co-Chair for IBC).
    
3. The rDNA summary forms are reviewed by the Co-Chair to determine if any applications fall into the Exempt Classification as outlined in the NIH Guidelines.  rDNA research falling into the Exempt Classification will receive an approval form and summary (performed by the Co-Chair) indicating that the research falls into the Exempt category.  This form is then returned to the Office of Research.
    
4. All "non-Exempt" rDNA research will be reviewed and voted on by the IBC at regular monthly meetings.  The Co-Chair will assign two members from the IBC to review each summary.  These reviewers will present their summarized reports at the monthly meeting where the summary will be approved, disapproved or sent back to the investigator if additional information is required to determine approval status.  If clarification is needed regarding the rDNA research being proposed, the two reviewers will forward their request(s) to one of the Co-Chairs who will then collate and forward this information to the PI prior to the monthly meeting. 
    
5. All approved rDNA summaries will then be forwarded to the Office of Research by the Co-Chair.  Each approval will have a three year lifespan and will have to be renewed annually by the PI.
    
6. Minutes of every IBC meeting will be recorded, distributed to members and approved by the committee during the subsequent meeting.
    
7. No member may vote on an rDNA summary for which he/she has been, is or expects to be directly engaged in or in which he/she has professional or financial interest, except to provide information requested by the IBC.
    
8. IBC Co-Chairs will summarize the monthly activities of the IBC at the Monthly Safety Committee Meeting.

Adapted and modified from the University of New Hampshire IBC web site.