Institutional BioSafety Committee, Forms and Instructions

The following activities require IBC approval:

• All forms of research utilizing recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing such molecules.
• Use of certain human and non-human primate source material (e.g. blood, body secretions and tissues, primary and established cell lines). SEE ALSO FAQ #2 BELOW
• Use of biohazardous agents (e.g. bacteria, viruses, fungi, protozoa, prions).
• Use of Select Agents and Toxins as defined by the S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) (www.selectagents.gov/sat/list.htm).
• Any material (for example, animal pathogens) requiring a CDC import license or a USDA permit.

Two questions to consider:

1. Are the samples known or suspected to contain infectious agents (e.g., SARS-CoV-2 / COVID-19, GI pathogens, etc.) that pose a risk of transmission?
2. Does the research involve amplification or culturing of any infectious agent?

If the answer to either of the above questions is “Yes,” the protocol requires IBC review. However, an exemption form (see link below) can be submitted in place of a full IBC protocol if the protocol involves routine work with human biospecimens and is covered by standard lab SOPS, universal precautions, etc.

Finally, all research involving human materials requires Biosafety Level 2 (BSL-2) containment procedures and would likely benefit from IBC review.  Therefore, the IBC is always willing to accept an application for review based on a PI’s risk assessment of their project.

Contact the IBC chair Andy Harris (harr0547@umn.edu; 612-250-0863), who will be happy to discuss whether your research / teaching activity requires IBC approval.

Please see the IBC flowchart at the bottom of the Home page under Resources.

Most applications complete the full review process in approximately 4-6 weeks, although this can vary depending on several factors including the availability of IBC committee members to meet, the extent of revisions to the protocol required by the committee, and the speed at which the investigator responds to the request for revisions.

The fundamental consideration for the IBC in reviewing projects is that the activities meet standards of good biological safety practice emphasizing protection of personnel, the general public, and the environment.  The IBC is not responsible for the scientific review of the project, except in those cases where the scientific design of the studies contributes to or requires potentially unsafe practices. In those cases, the IBC may require modifications that would reasonably mitigate the risk without impacting the research outcomes. Specifically, the IBC reviews the following aspects of the study:

• Appropriate Biosafety level for proposed research
• Use of appropriate biosafety practices
• Vectors and host systems used in the proposal
• Potential for environmental release
• Suitable facilities, procedures, practices and training of personnel