New eIBC system launches June 13!
What is the eIBC?
- We are pleased to introduce the new electronic Institutional Biosafety Committee (IBC) submission system which allows a direct interface between the IBC and the researchers, electronic approval information, real time access to forms and protocol information, and tracking of approval status.
- The eIBC system tracks minimal protocol information to allow for reporting and maintenance of data required annually such as biosafety cabinet information. The forms researchers are familiar with completing for IBC registration such as the Recombinant DNA Research Questionnaire (RDRQ) and the Infectious Agent Questionnaire (IAQ) will still be utilized in an abbreviated format.
When am I required to start using the eIBC system?
- Once the eIBC system goes live NEW IBC submissions must use the new electronic system
- Existing registrations will transition to eIBC with the next required modification or annual renewal
- For a limited period of time, on a case by case basis, the IBC may accept the paper annual renewal form
Will I have to create a new protocol in eIBC if I have an existing IBC protocol?
- No, you will not have to start from scratch! Approved IBC registrations will be transferred with PI, lab contact, title, and due date.
- If lab contact is not imported or needs to be changed, use the Assign Primary Contact activity on the protocol main page.
- Additional minimal information about the agents used, personnel, location, etc will need to be entered and the last approved RDRQ or IAQ must be uploaded*
- *RDRQ or IAQ forms that have a version date prior to 2013 will need to be updated to the new abbreviated RDRQ/IAQ form when submitting to the eIBC for the first time
How will I find my existing IBC protocol in eIBC?
- To find your IBC protocol click on "Submissions" on the left side of page. There will be multiple tabs, click on "All Submissions," this will show you all studies that you are associated with.
- At first only the PI and lab contact will be able to see the protocol in eIBC. Other lab staff will not be imported and will need to be entered with first modification or continuing renewal in eIBC in order to see the protocol in eIBC.
There are some new terms in the eIBC, what do they mean?
- Create Safety Submission –this is used to create a new IBC protocol
- Follow on submissions –this collectively refers to all modifications and renewals.
- Amendment –this is a modification or a combined modification/renewal
- Specialist –IBC office staff member that is coordinating the review
- Primary contact –this is the lab contact. They will receive the same notifications as PI
- Closure –this activity is used to terminate an IBC protocol
Will I still need to use the annual renewal/modification form?
- No, the eIBC has an online form for submission of BOTH renewals and modifications (amendments) similar to the combined paper form. Select the Create Amendment/Continuing Review button to initiate this process when you have a change to make to your project or your annual renewal is due.
Can I just email the IBC office to add grants or people to my eIBC protocol?
- No, the IBC office staff cannot edit the information entered into the eIBC, only researchers can edit. Researchers will need to use the Create Amendment/Continuing Review to update the protocol.
In the eIBC amendment/renewal page lists different amendment types. Which one do I check?
- When you have a new funding source or new personnel to add but no other changes needed, check only the administrative changes box.
- For an annual renewal with no changes, select only the no changes box.
- For other modifications, select the appropriate box
I used to use the initial rDNA research classification form to submit an exempt determination. How will I do that now?
- Exempt determinations will be made through an eIBC submission. The eIBC instructions and help text guides this process. Contact the IBC office with any questions.
How do I create a new eIBC protocol for my PI?
- Both the PI and research staff are able to create a new eIBC protocol using the Create Safety Submission button on the left side of the page.
- Warning: By default the system sets the person creating the protocol as the PI on the protocol Basic Information Page. Do NOT change this default setting until you too have been added to the protocol on the Protocol Team Member page. This is necessary because if you change the PI information before you too are added to the protocol, you will not have edit rights.
- Once data has been entered for protocol and PI appropriately assigned, use the Notify PI activity on the main page to send an email to the PI for protocol submission.
Will this link with other electronic systems?
- Not at this time. Related IACUC and IRB studies can be associated on the main eIBC study page by using the "manage related IACUC (or IRB)" button. At this time the IACUC or IRB protocol # will need to be typed in manually.
What if the grants admin in my department office needs to see what grants are associated with my IBC protocols?
- Researcher Snapshot in Cognos will be able to display IBC project status and associated grants.
- If there is a grants person or other individuals that need to keep tabs on the IBC registration (but are not conducting work on the protocol) can be added to the IBC protocol using the Manage Guest List activity on the main page of the study protocol. This gives this individual view, but not edit rights to the protocol.
What if I have a human gene transfer project or other human subjects project that requires IBC review?
- New studies: an abbreviated submission in the eIBC will be needed. This allows you to submit IBC-required forms for review.
- Ongoing studies: As before, modifications and continuing reviews will be submitted via eIRB. If any change is needed to your IBC-specific documentation, the IBC office will contact you to complete a modification in the eIBC, otherwise, no additional eIBC submissions will be required.
- For new or ongoing studies involving Botox or other botulinum toxin based agents that require review under the Dual Use Research of Concern regulations, please contact the IBC office at firstname.lastname@example.org for specific guidance.
It seems like there are some pages in eIBC where no activity is required, is that correct?
- Yes, there are some pages within the eIBC system that are informative and some pages that only apply to projects that require additional levels of oversight.