The purpose of this Institutional Biosafety Committee (IBC) policy is to provide information on University of Wisconsin-Madison Biosafety Protocol review process.
The University of Wisconsin-Madison Institutional Biosafety Committee (IBC) policy on Biosafety protocol review is as follows.
The UW-Madison Institutional Biosafety Committee (IBC) is composed of faculty, a laboratorian, 2 public members, ex officio members, and consultants as per NIH Guidelines section IV. The committee shall at all times be composed of at least five members, including the UW-Madison Biosafety Officer (BSO) (NIH Section IV-B-2-a-(1)], and typically has 18 voting members; consultants are not voting members. With the exception of ex officio members and the Associate Vice Chancellor for Research and Graduate Education in Biological Sciences, there is no provision for designation of alternates to serve when a member cannot attend. Members and consultants sign confidentiality agreements. Regular members are selected for their expertise in subjects for which the committee will review protocols, as follows:
In accordance with NIH Section IV-B-2-a-(1), at least two members of the committee shall not be affiliated with the institution. They shall represent the interest of the community including health and protection of the environment.
Note: An ex officio member is a member of a body (a board, committee, council, etc.) who is part of it by virtue of holding another office.
Ex officio members may designate an alternate to attend committee meetings and vote in their stead in the event that they are unavailable. The designation of an individual as alternate for an ex officio voting member must be approved by the Office of the Vice Chancellor for Research and Graduate Education (OVCRGE).
The IBC members are appointed by the Vice Chancellor for Research and Graduate Education on behalf of the Chancellor at UW-Madison. The BSO provides an annual update of the roster and recommendations to the Associate Vice Chancellor for Research and Graduate Education in Biological Sciences in the OVCRGE. Regular members serve a 3-year term. At the conclusion of the 3-year term, they may elect to continue for an additional 3-year term or rotate off the committee. The length of service for public members is indeterminate. Ex officio members serve as long as they are in their respective positions. The committee chairperson, a faculty member, usually serves in this capacity for at least 1 year.
Reviews of biosafety protocols focus on the risks of the materials and measure to mitigate them, and are very different from grant proposal reviews. The IBC does not judge the merits of the scientific inquiry, traditional ethical considerations (unless it pertains to elements of public safety under the IBC review purview as per NIH guidelines), or review the scientific approach of the research itself. The IBC reviews for the purpose of risk assessment in accordance with the NIH Guidelines.
Actions by the IBC on a protocol typically involve one or a combination of the following decisions:
The following criteria generally are used for selection of full protocols to be reviewed by the IBC:
A brief summary of all III-E protocols are reviewed. Any IBC member can call for the full IBC review of an III-E protocol prior to the next meeting. During the meeting, the committee will vote for approval of all posted III-E protocols.
Protocols submitted to OBS that do not require full IBC review (e.g., personnel amendments, non-recombinant DNA protocols, protocols that are exempt from the NIH Guidelines, and grant changes) are processed, reviewed, and approved by OBS staff.
Previously approved protocols will be submitted to OBS for review at least every three years. (Note: the entire protocol will be reviewed by the OBS and by the IBC, as applicable). In addition, any changes to an experiment to which the NIH Guidelines apply will be reviewed by the IBC. Finally, protocol changes that require significant changes in safety precautions (e.g., changes in PPE, administrative controls, engineering controls) will be reviewed by the IBC. OBS has the discretion to withhold a protocol from the agenda if the protocol is deemed not ready for review.
Principal Investigators (PIs) or laboratory research staff can request to attend the IBC meeting when their protocols are discussed. The IBC may ask the PI or representative to attend the meeting in order to help clarify points and answer questions when their protocol is being reviewed.
Meetings are conducted according to Robert’s Rules of Order. Thus, the IBC cannot act on a protocol without a quorum present, which is defined as one more than half of the voting members. Attendance of meetings by voting members is critical. Committee members will be polled in advance of the meeting to ensure that the IBC will have a quorum; otherwise, the meeting will be rescheduled if possible or cancelled. It is recognized, however, that members will not be able to make every meeting.
Meetings may be digitally recorded by OBS staff for the purpose of having an accurate record of the deliberations to assist in preparation of minutes. There is no requirement that the meetings are recorded.
The UW-Madison Researchers’ Biosafety Manual, UW-Madison, Office of Biological Safety, current version
U.S Department of Health and Human Services, National Institutes of Health (NIH) - NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, current version
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) - Biosafety in Microbiological and Biomedical Laboratories (BMBL), current version