Research Integrity and Assurance

The Institutional Biosafety Committee (IBC) reviews recombinant DNA research conducted at or sponsored by the University for compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (Guidelines) and approves those research projects that comply with the Guidelines.   Additionally, the IBC reviews and approves research involving:

• microorganisms and viruses pathogenic to humans, plants or animals
• select agents
• biological material from human and non-human primates

The Dean for Research, with assistance from the Biosafety Officer and the IBC Chair, recruits and nominates IBC members. Committee members are formally appointed by the Dean for Research in writing to three-year terms. The following are voting members:

• A minimum of three faculty members with expertise in recombinant DNA technology, general issues of laboratory biosafety and use of infectious materials will serve on the Committee
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• At least two members shall not be affiliated with the University and will represent the interest of the Community with respect to health and protection of the environment. 
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• The Biosafety Officer (BSO), a University Health Services physician and the Attending Veterinarian are ex-officio voting members of the Committee. 

The IBC:

1. Ensures that Principal Investigators are aware of the responsibility to register research involving recombinant DNA and biohazards with the Committee.
2. Reviews recombinant DNA research conducted at or sponsored by the University for compliance with the Guidelines and approves those research projects that are found to conform to the Guidelines.
3. Notifies the Principal Investigator of the results of the IBC’s review.
4. In accordance with the Guidelines and after a thorough risk assessment, lowers containment levels for research that falls under Section III-D-2-a,  Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.
5. Sets containment levels that are not established by the Guidelines.
6. Adopts emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research activities.
7. Makes recommendations for medical surveillance that may be required for staff, students and faculty to the Medical Director, University Health Services.
8. Investigates potential violations of the Guidelines.
9. Reports any significant problems with or violations of the Guidelines and any significant research-related exposures, accidents or illnesses to the IO and the NIH Office of Biotechnology Activities (OBA) within 30 days.
10. Reviews and issues approvals, when appropriate, for research involving microorganisms and viruses that is pathogenic to humans, animals or plants.
11. Reviews and approves, when appropriate, of research involving biological materials from human and non-human primates.
12. Conducts the local review and approval of all University research activities involving the possession and use of Select Agents and Select Agent Toxins, to assure that these activities and the related facilities comply with applicable federal, state and local laws and regulations and University policies, regardless of the source of funding for the project.
13. Recommends to the Institutional Official sanctions on any individual whom the IBC determines has violated the terms of an approved protocol, has conducted projects subject to its authority without gaining appropriate IBC approval, or has otherwise violated any provision of applicable federal, state, and local regulations and guidelines, or institutional policies regarding subjects under its purview.
14. Submits an annual report summarizing the Committee’s activities to the IO.  The IO shall submit the annual report to the URB. 
15. Performs a biennial review of the IBC’s compliance with the Guidelines and submits the findings to the IO. The review shall be performed using assessments tools available from the NIH Office of Biotechnology Activities.
16. Periodically consults with external experts regarding the IBC’s compliance with the Guidelines and submits findings to the IO.

No member of an IBC may participate (except to provide information requested by the IBC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest.

If the IBC Chair's research is under review, the IBC Administrator will assign a Committee faculty member to facilitate review and approval of the project.

1. A minimum of five voting members constitutes a quorum and is required at the IBC meetings to conduct business.  Votes will be decided by a simple majority of those present.  A quorum must be present (in person or through telephone or video conferencing) to take action on research that is not exempt from the Guidelines or involves biosafety level 3 pathogens, select agents and toxins.
2. Committee meetings are held quarterly or at the call of the Chairperson. Meeting days and times shall be posted on a University website accessible to the general public.
3. Staff from the Office of Research Integrity and Assurance (RIA) maintain all approved Committee meeting minutes. The RIA Director and a representative from the University’s Office of Legal Counsel will respond to requests for copies of meeting minutes received from persons not associated with the University. RIA Director will redact content of meeting minutes if advised by University Legal Counsel prior to responding to requests.
4. Comments received from the public regarding the IBC’s actions are referred by the Director, RIA to the IO, the IBC Chair and the BSO. The IO is responsible for review and approval of the IBC’s response to public comments. The IBC administrator forwards all public comments and the University’s response to NIH Office of Biotechnology Activities.
5. Recombinant DNA research is reviewed as follows:
   1. Experiments that require NIH and IBC approval prior to initiation – Section IIIA and III-B.  At a convened meeting, the IBC will review the Registration Document for Biohazards and Recombinant DNA (Registration) and determine: 1) if the research requires NIH and IBC approval before initiation; and, 2) if the appropriate containment facilities are available to conduct the research.
   2. Experiments that require IBC approval before initiation – Section III-D. The IBC will review, request modifications, and approve all Registrations in this category at a convened meeting.
   3. Experiments that require IBC notice simultaneous with initiation – Section III-E. The IBC will review, request modifications, and approve all Registrations in this category at a convened meeting.
   4. Experiments that are exempt from the NIH Guidelines – Section III-F. The IBC chair and the BSO will review, request modifications, and approve of Registrations describing research that is exempt from the NIH Guidelines.  The IBC will not review rDNA research that is exempt from the Guidelines.
6. Experiments Involving Infectious Microorganisms and Viruses.
   1. Biosafety Level 2 - The IBC Chair and the BSO will review the Registration.  Research involving biosafety level 2 non-recombinant pathogens must be approved by the IBC Chair and the BSO.  Either may request that the Registration be reviewed b the full Committee via email or at a convened meeting.
   2. Biosafety Level 3 - Proposals for all research involving biosafety level 3 pathogens must be approved by the URB. The IBC will review research involving biosafety level 3 human pathogens at a convened meeting. The IBC must also approve of all Standard Operating Procedures for work with Biosafety Level 3 agents.
7. Select Agents and Toxins. Proposal for research with HHS and USDA select agents and toxins must be approved by the URB. The IBC will review and approve of all Registrations describing research with select agents and toxins at a convened meeting.
8. Human and Non-Human Primate Materials. The BSO will review and assign containment levels for research involving human and non-human primate materials.

APHIS and CDC implemented the provisions of Public Law 107-188, the "Public Health Security and Bioterrorism Preparedness Response Act of 2002" (The Act) through a series of regulations.  The regulations culminated with the publication of the final Select Agents Regulations (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) in the Federal Register on March 18, 2005.  The Final Rules were published in the Federal Register on March 18, 2005 and became effective on April 18, 2005.

NIH Guidelines for Research Involving Recombinant DNA Molecules.  Oct 22, 2011. Dept of Health and Human Services, NIH

This charter is reviewed annually by the IBC. Recommendations for modification are submitted by the IBC to the URB for review and approval.