New Protocols

• Making the initial determination of the required levels of physical and biological containment in accordance with the NIH Guidelines and the Biosafety in Microbiological and Biomedical Laboratories
• Selecting the appropriate microbiological practices and laboratory techniques to be used for your research
• Ensuring that all personnel listed have access to the currently approved protocol and have read your protocol before beginning work
• Ensuring that the personnel listed on your protocol have sufficient knowledge and are sufficiently trained to safely perform the responsibilities for which they have been assigned
• Ensuring that all personnel fully understand the steps necessary following any spills or potential exposures with the biological agents described in your protocol
• Immediately reporting any suspected Biosafety Level 3 or confirmed Biosafety Level2 research-related illness as well as reporting any accidents, significant problems with, or violation of the NIH Guidelines, for any biosafety level, to the IU Environmental Health and Safety - Biological Safety
• Reporting to the Environmental Health and Safety Office Biological Safety Office any spills or accidents that fall under the “IBC Policy and Procedures on Reporting Laboratory Incidents.”

• Reviewing research and teaching involving biological materials or recombinant DNA or synthetic nucleic acid molecules for compliance with NIH Guidelines, the Biosafety in Microbiological and Biomedical Laboratories, and the policies of the IBC
• Notifying you, as principal investigator, of the results of the IBC’s review and approval
• Lowering containment levels for certain experiments as specified in the NIH Guidelines Section III-D-2-a: Experiments in which DNA from Risk Group 2 or Risk Group 3 agents is transferred into nonpathogenic prokaryotic or lower eukaryotic host-vector systems
• Setting containment levels as specified in the NIH Guidelines Sections III-D-4-b, Experiments Involving Whole Animals, and III-D-5, Experiments Involving Whole Plants
• Periodically reviewing recombinant DNA or synthetic nucleic acid molecule research conducted at the institution to ensure compliance with the NIH Guidelines
• Reporting any significant problems with or violation of the NIH Guidelines, and any significant research-related accidents or illnesses to the appropriate institutional official and NIH’s Office of Science Policy within 30 days, unless the IBC determines that a report has already been filed by you, the PI
• Immediately reporting any suspected Biosafety Level 3 or confirmed Biosafety Level 2 research-related illnesses, and any accidents or significant problems with or violations of the NIH Guidelines, to the appropriate institutional officials and NIH’s Office of Science Policy
• Reviewing any reports of spills or accidents that fall under the “IBC Policy and Procedures on Reporting Laboratory Accidents.” View the Institutional Biosafety Committee policies

The IBC may not authorize initiation of experiments that are not explicitly covered by the NIH Guidelines until the NIH establishes the containment requirements.

I would like to work with SARS-CoV-2 in the BL-3 space at IUI, what do I need to do?

Please email the Research Safety Office at ibc@iu.edu to obtain:

• A list of alternate risk group 2 viruses, to assess if any of these can be used in place of the SARS-CoV-2 risk group 3 virus and;
• The SARS-CoV-2 BL-3 request form for review by the BL-3 subcommittee.
  • Be sure to include on the request form why the risk group 2 alternatives could not work for your experiments.

I am interested in applying for funding or have applied for funding to conduct SARS-CoV-2 BL-3 work. Does this affect the review process?

Please email the Research Safety Office at ibc@iu.edu to obtain the SARS-CoV-2 BL-3 Proposal Form to have your experiments completed in the IUI BL-3 facility.

• At the top of the request form, be sure to include funding which is already secured as well as proposals you have submitted to request additional funding.
• At the bottom of the form be sure to state when you would like to start the experiments (i.e., September 2021) and how long you expect those experiments to run (e.g., four months).

I am located at a campus other than IUI but would like to conduct SARS-CoV-2 BL-3 work. How can I do this?

At this time only IUI has a BL-3 space. If you are at IUB or a regional campus, contact the Research Safety Office at ibc@iu.edu to discuss what alternatives may be available.

I would like to collect COVID-19 patient samples. What do I need to do?

Your IBC protocol will need to be updated to include this work. The samples can be handled at BL-2, but you cannot culture these samples unless the work is done in a BL-3 space.

• See CDC Guidance on Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) for more information.