ASU’s Institutional Biosafety Committee has developed a FAQ document to assist researchers with commonly asked IBC ERA-related questions. Researchers are encouraged to review this document and may contact [email protected] if additional clarification is needed.
The Institutional Biosafety Committee meets monthly throughout the year. Upcoming meeting dates and submission deadlines are listed below. Meeting location will be provided about 1 week prior to the meeting. IBC disclosures submitted after the submission deadline will be reviewed at the next month’s meeting.
| Meeting date | Submission deadline |
|---|---|
| November 14, 2024 | October 10, 2024 |
| December 12, 2024 | November 14, 2024 |
| January 9, 2025 | December 12. 2024 |
| February 13, 2025 | January 9, 2025 |
| March 20, 2025 | February 13, 2025 |
| April 10, 2025 | March 13, 2025 |
| May 8, 2025 | April 10, 2025 |
The next fiscal year meeting dates and submission deadlines will be planned and posted by the end of April.
What requires IBC review?
Research that requires IBC review includes, but is not limited to, the possession, storage, or use of the following materials:
- Human or nonhuman primate cell lines, tissues, blood (or blood products), feces, saliva or bodily fluids.
- Biological toxins, bioactive derivatives or subunits of toxins.
- Human etiologic agents.
- Select agents or toxins.
- Transgenic animals or plants.
- Animal or plant etiologic agents.
- Biohazards.
- Recombinant or synthetic nucleic acid molecules.
NOTE: Services offered by ASU Core Facilities do not fall under the purview of the IBC. Examples of these services include sample collection/receipt and sample processing in Core Facilities labs. By way of example:
- The activity of a Core Facilities staff person to collect the sample (i.e., draw blood), process it/provide results from the Core Facilities lab for the principal investigator would be a service and not under IBC purview.
- If the Core Facilities staff person collects the sample and gives it to the PI for their evaluation and research activities in their own lab, the service to collect the sample would not be under IBC purview. The PI’s evaluation of the sample in their lab would be reflected in the PI’s IBC disclosure.
- If the Core Facilities staff person collects the sample and performs research activities such as evaluation and interpretation of the sample as part of the PI’s research project, the Core Facilities staff person would be added to the PI’s IBC disclosure as a research team member.
Institutional resources to ensure Core Facilities service activities meet regulatory and university requirements (e.g., OSHA Bloodborne pathogen standard, lab registrations, required trainings, standard operating procedures, etc.) are available through ASU Environmental Health and Safety.
What must be submitted to the IBC?
You must complete a disclosure through the ERA system. Additional forms and templates that may be needed based on the work being completed can be found on the Forms page.
Is there help available to assist me in preparing my submission?
Templates to aid in the completion of the safety sections and a sample disclosure are available on the Forms page. For assistance with preparing SOPs or questions on laboratory safety procedures, contact [email protected]. For assistance with the disclosure submission process, contact the IBC Coordinator at [email protected].
What happens when a disclosure has been submitted?
Upon submission, the disclosure will receive pre-reviews by the IBC Coordinator and Biosafety Officer. Principal investigators will receive comments from the pre-review as applicable. You must promptly return a revised version of the disclosure that addresses all of the comments to the reviewers. Since the reviewers may require multiple revisions by the PI, prompt responses back to the reviewers are necessary to keep the process moving.
What happens when the pre-review is complete?
When the pre-review is complete, the IBC will determine the committee review process for the disclosure. The IBC requires most disclosures to be reviewed at a fully-convened IBC meeting. You can find more information on review processes in the IBC Policies and Procedures Manual. If the disclosure is assigned for full committee review, the IBC will assign the disclosure a primary reviewer from the IBC and placed on the next IBC meeting agenda. The primary reviewer will review the disclosure and, if necessary, submit any questions or comments to the investigator to address before the IBC meets. As with the pre-review process, you must promptly respond to the primary reviewer comments.
Does the PI need to attend the IBC meeting?
Yes, the PI, or an approved representative thoroughly familiar with the disclosure submission, must attend the IBC meeting to participate in the review process. Meetings are held virtually. When the disclosure is placed on the IBC agenda, the IBC Coordinator will send an Outlook calendar invite to the PI with the meeting details and agenda order.
Is there anything else that must be done prior to disclosure approval?
Depending on the research and the biosafety level, we may require training and laboratory inspection. For more information on training requirements, see Biosafety Training Information. If training is required for the disclosure, you must complete the training prior to approval. Laboratory inspections must be performed prior to approval for initial submissions. After initial submission, biosafety level 1 laboratories must be inspected every 3 years and biosafety level 2 or 3 laboratories must be inspected at least every year.
What happens after the disclosure is approved?
Once the IBC has approved the disclosure, the IBC Coordinator will process the formal approval letter and send it to the PI within 3 business days. The approval letter will also indicate the length of the approval period and any additional requirements such as training frequency or committee stipulations.
What if there are changes to the research after the disclosure is approved?
Changes to any aspect of the project require submission of a modification through the ERA system. The IBC must approve the modification request before you can implement the changes. The type and level of the change will determine the level of review required for the change.
How do I close my disclosure?
Disclosures may not be closed until all materials have been disposed of properly and a close out inspection is performed by Environmental Health and Safety. In the ERA system, select the “Request Closure” action for a given disclosure to start the process. Once the inspection is complete, the IBC Coordinator will be able to process the closure request.
What if I want to save the material for a future project?
If you do not wish to dispose of the materials, but will not be actively working with them, you will need to have a disclosure for storing the materials. This can be either a new disclosure, or a modification to an existing disclosure. The material may not be used in research or teaching until a new disclosure or modification is submitted and approved by the IBC.