All DePaul faculty, staff, or students engaged in research or teaching activities at DePaul involving recombinant or synthetic nucleic acid molecules, biohazardous agents, or select agents or toxins are required to complete the appropriate training requirements. To learn more about the training requirements, click here.
Note - If your project does involve shipping/transport or receiving biohazardous agents you must complete shipping/transport training and/or receiving education training. Even if your activities do not involve materials that require IBC review and approval, you may still have to complete institutional shipping training to meet federal regulatory requirements for shipping and packaging of dry ice, etc.
- Protocol Application
- Prior to filling out the IBC protocol application form(s):
- Determine the biosafety containment level (BSL) and risk group levels (RG).
- Note – Currently at DePaul only research and teaching activities meeting the criteria for either BSL 1 or BSL 2 can be conducted at DePaul University.
- Determine when you plan to begin your work. All new protocols involving recombinant or synthetic nucleic acid molecules receive Full Committee Review, in compliance with NIH Guidelines. All protocols involving other biohazardous agents (NOT NIH exempt) require Full Committee Review. Teaching activities covered by IBC policy must be approved before they begin. Please submit your materials well in advance of the beginning of the activity in order to allow enough time to obtain IBC approval. See Meetings page for more information regarding the IBC meeting dates and deadlines.
- Completing the IBC protocol application(s)
- In order to obtain IBC approval, you should complete the appropriate protocol application form(s). The form(s) can found on the Forms and Templates page.
- Please be sure to be detailed and specific in the protocol application.
Lack of detail will result in the IBC requesting clarification,
additional information, and/or modifications to the application
- Standard Operating Procedures (SOPs)
- Develop and submit laboratory SOPs for any project that requires BSL-2 containment procedures.
- Develop and submit laboratory SOPs and a Blood borne pathogen plan for any protocol involving human blood, blood products, human fluids, human tissues, other potential blood containing materials, human cells or cultures, or tissue.
- Submit your IBC materials
|Protocol application(s) completed
|Signed protocol application(s) by either scanned PDF or electronic signature
|Grant Proposal - If the research is federally funded, submit a copy of the full grant proposal submitted to the funding agency. For research funded from other sources, copies of the proposals may be submitted to provide additional details not provided in the IBC submission form.
|Training - All individuals are required to take training unless their CITI training is already on file with the Office of Research Services.
||Required to complete but not required to forward copies of certificates|
Submit materials to email@example.com. There is no need to interoffice mail your protocol submission to ORS. If you have specific questions on your protocol application, please contact the Office of Research Services, Research Protections staff, see IBC Contact page.
New protocols involving recombinant or synthetic nucleic acid molecules, teaching activities, or other biohazardous agent that are not NIH exempt are reviewed by the full committee review. Please see Meetings page for more information.
- IBC Review Process
Once the IBC receives complete materials for your protocol, the protocol will be added to the meeting agenda or scheduled for the appropriate review process. After your application and materials are reviewed, you will receive a written notification regarding the review decision within 5 business days from the date of review. The IBC will either grant:
- Approval – You may begin your work. If you need to make changes to your protocol after initial approval, see tab section titled, After Approval.
- Request Modifications - If the IBC asks for revisions or additional information, prepare revised/additional materials and submit them to the IBC, along with a cover memo itemizing the changes/additions. Once you have appropriately addressed all the IBCs concerns, the IBC will issue an approval memo in writing after review of the revised materials. You may not begin your activity until you receive this written notice of approval.
- Tabled – Tabled means that there is substantial missing materials or information and review cannot occur. If tabled, the IBC will explain in writing why the IBC tabled your protocol and indicate what is required before IBC review can occur.
- Disapproval –Disapproval means that there are substantive issues with the protocol and that the protocol cannot be approved at this time. If disapproved, the IBC will explain in writing why the IBC disapproved your project and what changes would have to be made in order to obtain IBC approval.
*Conducting activities without IBC approval is considered noncompliance.
Once the IBC has approved a project, the project must be conducted as approved. Investigators still have responsibilities after receiving approval.
The IBC may ask for revisions to the amendment materials. You may not initiate the protocol changes until you receive written notification of approval for the revisions from the IBC.
- Changes in location, staff, changes in agents, methods, risk level or containment level, or any other substantive change must be approved by the IBC before implementing the change. In order to submit a protocol change for review and approval you should complete and submit the Amendment form. When changes are substantive the original protocol application should be revised to reflect the research or teaching activity as it will be conducted. If the change is limited to changes in personnel, you should complete and submit the Application for an Amendment Changing Personnel (not the PI) for an IBC approved Protocol. All forms can be found on the Forms and Templates page. Forms and supporting materials should be submitted via email to the IACUC at firstname.lastname@example.org
- Approved protocols MUST be reviewed annually, and if the protocol will continue past the three-year approval period expiration date, it must be resubmitted in full as a new protocol for de novo review. In order to renew the protocol for annual renewal, you must complete and submit the Annual Renewal Report Form to the IBC electronically via email at email@example.com. You must be sure to submit the application with sufficient time to allow for IBC review and re-approval of the research before the annual anniversary date or for de novo reviews, to prevent a lapse in IBC approval. The IBC cannot extend the approval period past the third-year expiration date noted in the approval memo without conducting the required review.
Adverse Biosafety Events and Noncompliance
- If any adverse events occur the PI of the protocol should report the event to the IBC using the Adverse Biosafety Event and Noncompliance Report Form. The same form should be used to self report any noncompliance.
- Once the project is completed you must notify the IBC and officially close the protocol using the Final Closure Report Form.