I. INTRODUCTION
The Iowa State Institutional Biosafety Committee (IBC) is a University Standing Committee appointed by the Vice President for Research. The Committee reviews and sets conditions for conducting studies involving recombinant or synthetic nucleic acid molecules and transgenic/gene edited animals or plants as required by the Federal Register and amendments. It has the authority to require changes in operations that do not comply with the required conditions.
The IBC has the responsibility for reviewing the biological and public health safety of research and laboratory teaching conducted at Iowa State University and sets policies that comply with federal, state, and local regulations and recommendations.
II. COMMITTEE REQUIREMENTS
A. Committee Composition
The IBC shall be comprised of no fewer than five members, so selected for their collective expertise, experience, and ability to assess the safety of recombinant or synthetic nucleic acid molecule projects as well as potential biological and public health risks.
At least two members shall not be affiliated with the University except for their membership on the Committee. These two members will represent the surrounding community regarding public health and environmental protection. Eligible individuals for these two positions should be public health or environmental officials; or from other local government agencies; or active in local community, medical, health, or environmental concerns.
The ISU Biological Safety Officer (BSO) shall be a member of the Committee.
It is recommended that the IBC appoint as members, or use as consultants, individuals familiar with University commitments and policies, applicable law, standards of professional conduct, and community attitudes and environment. At least one member should be from a university laboratory technical staff.
B. Government Notification
The IBC shall identify each Committee member by a name in a report to the Federal Office of Science Policy (OSP) and shall include relevant background information on members as required by OSP.
C. General Procedures
No Committee member may be involved (except to provide information) in the review or approval of a project that the member expects to be engaged in or has a direct financial interest in.
Committee meetings are open to the public except when the protection of personnel privacy and proprietary interests are of overriding concern.
The University may establish additional Committee procedures as needed.
III. COMMITTEE FUNCTIONS
A. Recombinant or Synthetic Nucleic Acid Molecules Compliance Review
The Committee will review all recombinant and synthetic nucleic acid molecules and other genetic modification project requests and will approve those which comply with the federal, state, and local regulations and guidelines.
Included in the above review will be an assessment of the following:
- Required containment levels
- Facilities, procedures, and practices
- The training and expertise of proposed project personnel
1. Required Actions
The Committee will authorize only those genetic modification experiments that are explicitly covered by the NIH guidelines, unless approval and containment requirements have been obtained from NIH. Containment levels will be set for each project reviewed.
Each Principal Investigator requesting a project review will be notified of the results of that review.
Any significant problems, violations, accidents, or illness that involve NIH guidelines will be reported promptly to OSP. Significant accidents and illness that appear to be a hazard to public health will also be reported to the state and local public health departments.
B. Transgenic Animal and Plant Compliance Review
The Committee will review all research proposals involving transgenic/gene edited animal and/or plant work.
The IBC will determine:
- Compliance with the National Institutes of Health and the Animal and Plant Health Inspection Service guidelines
- Adequacy of designated laboratory facilities
- Adequacy of specified containment and/or confinement procedures
- The containment and/or confinement biosafety level under which the project must be conducted
C. Other Functions
When the committee, Principal Investigators, or ORE staff seek clarification from the NIH regarding the interpretation of the NIH Guidelines, the IBC Chair and the BSO will be consulted on the communication prior to it being submitted to the NIH. The IBC Chair and BSO will be copied on all communication from the ORE office with NIH.
Other functions and actions may be performed as delegated by the Vice President for Research.
D. Relationship of the BSO and the Department of Environmental Health and Safety (EH&S) with the IBC
The BSO will have the responsibility of following the directives of the IBC. The BSO also operates under the direction of EH&S, which is responsible for a wide spectrum of safety and health programs at the University.
EH&S will maintain a comprehensive safety program and will implement the periodic surveys required for the IBC to carry out its responsibilities. Included are safety surveys of laboratories, buildings, and other areas where there may be biological and public health concerns.
EH&S has the authority to require changes in unsafe operations to assure compliance with applicable regulations and recommendations and to maintain reasonable standards of health and biological safety. Any significant problems, violations, accidents, or illnesses will be reported promptly to the appropriate university official and to the IBC.
EH&S also coordinates employee participation in the Occupational Medicine Program, which provides medical surveillance for ISU personnel working with materials or under conditions with recognized risks.
IV. COMMITTEE ACTIONS
A. Meeting Frequency
The Committee shall meet as needed to conduct its required functions.
B. Quorum
The presence of a quorum shall be required for any action requiring a Committee vote.
A quorum shall consist of any number of members over 50 percent of the current Committee membership and shall include the Chair. In the absence of the Chair, the Vice-Chair will lead the meeting.
C. Meeting Minutes
Copies of all meeting minutes shall be kept in the Office of Research Ethics, and the IBC Chair maintains an electronic copy. Minutes shall be available for membership review at any time.
The University shall, upon request, make available to the public all minutes of meetings except when the protection of personnel privacy and proprietary interests are of overriding concern. If members of the public make comments on IBC actions, these comments shall be forwarded to the National Institutes of Health (NIH) along with any response from the IBC.
D. Committee Reports
Following the review of research requests or reported hazardous conditions, reports of approval or disapproval, comments, questions, or requests will be sent to the responsible person or the department executive officer as appropriate.
E. Appeals
Actions by the Committee may be appealed, in writing, to the Committee. An individual may also appeal through the Vice President for Research (VPR), after first appealing to the Committee. Grounds for appeal to the VPR are limited to 1) a violation of University rules, regulations, policies; or 2) a specific act by the University that was arbitrary or capricious.
UPDATED and APPROVED: November 14, 2023