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Creating a new Institutional Biosafety Committee protocol
If you are using recombinant DNA (rDNA) or synthetic nucleic acid molecules, regardless of Biosafety Level, for research or teaching purposes at Indiana University, you are required to submit an Institutional Biosafety Committee protocol for review. If you are using non-recombinant biological materials at Biosafety Level 2 or higher* for research or teaching purposes at IU, you are also required to submit a protocol for review.
*To initiate BL-3 research at IUPUI, a BL-3 IBC sub-committee must first review and approve a research proposal before an IBC or IACUC BL-3 protocol can be reviewed and approved. For more information regarding the review and approval process for the use of BL-3 materials and access to the BL-3 facility at IUPUI, please email IBC@iu.edu. Please note, there is currently no BL-3 facility at IU Bloomington or any of the regional campuses.
A protocol is a detailed set of activities for the project you’re proposing, supported by evidence from other research and from preliminary investigations. A complete protocol must be submitted to, reviewed by, and, in most cases, approved by the Institutional Biosafety Committee before work can begin.
What do you need to do to prepare a new IBC submission?
Prior to submitting a new protocol to the Institutional Biosafety Committee, you should:
- [TEMPORARY CHANGE NOTICE] At this time, all new IBC submissions are on hold for the planned Kuali Protocols Implementation.
- Visit IBC Kuali Protocols Launch for more information.
- Complete required training. Ensure that you and all personnel listed on your protocol are up to date on the appropriate required training.
Who is responsible for what?
Both you, as a principal investigator, and the IBC have specific responsibilities in identifying and addressing biosafety concerns throughout the research process.
The following individuals may serve as a principal investigator on an IBC protocol:
- professor with an official faculty position
- emeritus professor
- various clinical professors
- various scholars/scientists
- additional titles if given PI status by the Office of the Vice Provost for Research for the purpose of obtaining external grant support
- 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.
Can cloth masks be worn in labs?
I would like to work with SARS-CoV-2 in the BL-3 space at IUPUI, what do I need to do?
Please email the IBC Office at email@example.com 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 IBC Office at firstname.lastname@example.org to obtain the SARS-CoV-2 BL-3 Proposal Form to have your experiments completed in the IUPUI 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 IUPUI but would like to conduct SARS-CoV-2 BL-3 work. How can I do this?
At this time only IUPUI has a BL-3 space. If you are at IUB or a regional campus, contact the IBC Office at email@example.com 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.
Need help submitting your protocol?
Contact the Institutional Biosafety Committee Office at 812-855-0656 or email IBC@iu.edu.