Biosafety

Yes. Since the University of Notre Dame receives funding from NIH grants, ALL recombinant DNA and synthetic nucleic acid (r/sNA) molecule research conducted at the university must comply with NIH Guidelines and University policies.

If submissions are received before the submission deadline (5 business days before the next IBC meeting), it will be added to that meetings’ agenda. After committee review, the Principal Investigator will receive notice of the meeting results within 24 hours. Final approval will then depend on how quickly the questions from the committee are properly addressed.

If submissions are received before the submission deadline (5 business days before the next IBC meeting), it will be added to that meetings’ agenda. After committee review, the Principal Investigator will receive notice of the meeting results within 24 hours. Final approval will then depend on how quickly the questions from the committee are properly addressed.

If you are planning on renewing an existing IBC protocol, you should submit your renewal 60 days before the expiration date in case it needs to be discussed at subsequent meetings.

• Ensure all personnel listed on the protocol have completed the following complyND training modules within the last year: Lab Safety, Biosafety, and Bloodborne Pathogens
• Ensure lab space where the work is to be performed has been inspected by RMS within the last year
• Submit the application before the submission deadline to ensure a thorough pre-review
• Respond quickly to committee comments after the application has been discussed at the meeting.

No. These chemicals should be on your Chemical Hygiene Plan, but do not require an IBC protocol. Examples of chemicals that would not require an IBC include isoflurane, ketamine, and ethers. Examples of biologically-derived toxins, which DO require an IBC include diphtheria toxin, pertussis toxin, and cholera toxin.

This depends. If you are purchasing, transferring, or maintaining a transgenic rodent colony (i.e. breeding within a particular transgenic line) that can be housed at BSL1, IBC review is not needed. If you are generating a new transgenic rodent or purchasing, transferring, or maintaining an existing transgenic rodent colony contained at BSL2 or higher, IBC review is required.

Yes. Activities that involve only the in vitro use of nucleic acids (i.e. PCR, synthetic double-stranded RNA) and do not involve the cloning and propagation of r/sNA in cells or organisms do not need IBC review.

When reviewing projects involving r/sNA and biohazardous materials, the IBC is evaluating whether the activities can be conducted in a manner that will ensure the protection of personnel, the general public, and the environment. The IBC is not responsible for the scientific or ethical review of the project, except in cases where the scientific design of the study contributes to public health or environmental risks and/or requires potentially unsafe practices. In those cases, the IBC may require modifications that would reasonably mitigate the risk without impacting the research outcomes.

Specifically, the IBC considers the following items when reviewing a research project:

1. Does the PI have sufficient expertise to oversee the safe conduct of the research?
2. Is the proposed Biosafety Level appropriate for the work?
3. Does the proposed location(s) meet the requirements for the assigned Biosafety Level?
4. Will the work be conducted using appropriate biological safety practices and equipment?
5. Is there a potential for environmental release or public exposure? If so, how is this risk mitigated?
6. Are personnel properly trained, including general complyND trainings and lab-specific training?
7. Is hazard communication provided to all personnel who are at a reasonable risk of exposure to biohazardous or r/sNA materials?

When reviewing projects involving r/sNA and biohazardous materials, the IBC is evaluating whether the activities can be conducted in a manner that will ensure the protection of personnel, the general public, and the environment. The IBC is not responsible for the scientific or ethical review of the project, except in cases where the scientific design of the study contributes to public health or environmental risks and/or requires potentially unsafe practices. In those cases, the IBC may require modifications that would reasonably mitigate the risk without impacting the research outcomes.

Specifically, the IBC considers the following items when reviewing a research project:

1. Does the PI have sufficient expertise to oversee the safe conduct of the research?
2. Is the proposed Biosafety Level appropriate for the work?
3. Does the proposed location(s) meet the requirements for the assigned Biosafety Level?
4. Will the work be conducted using appropriate biological safety practices and equipment?
5. Is there a potential for environmental release or public exposure? If so, how is this risk mitigated?
6. Are personnel properly trained, including general complyND trainings and lab-specific training?
7. Is hazard communication provided to all personnel who are at a reasonable risk of exposure to biohazardous or r/sNA materials?

Principal Investigators must either meet the criteria for PI eligibility as defined in the University of Notre Dame’s policy on Principal Investigators and Project Directors or identify a Faculty Sponsor who meets the PI eligibility criteria. Certain exceptions may be made on a case-by-case basis, with approval from the IBC Chair.

When an IBC submission is submitted, the following events occur:

1. Pre-Review: The IBC Program Coordinator performs a pre-review of the application. At this point, the PI cannot edit the submission.
2. Clarification Requested: Once pre-review is complete, the PI, Co-PI(s), Lab Supervisor, and Study Coordinator will receive an email indicating that action is needed. Whoever received an email will be able to log into eProtocol and provide a response to each of the pre-review comments, as well as update the application as requested. After all the changes have been made, the application needs to be submitted to continue the review process.
3. Pre-Review: Once the pre-review comments have been satisfactorily addressed (this may take several iterations), the IBC Program Coordinator will assign the IBC protocol/amendment to the agenda for the next convened IBC meeting. At this point, the PI cannot edit the application.
4. Committee Review: At the fully convened meeting, the IBC application will be discussed and the committee can take the following actions:
   1. IBC application approved as written
   2. IBC application approved pending clarification. The application is returned to the PI for revisions and the PI’s responses will be reviewed by Designated Members of the IBC.
   3. IBC application tabled pending clarification. The application is returned to the PI for revisions and the PI’s responses will need to come back before the Full Committee for further review.
   4. IBC application disapproved. The application is not approved in its current state and may not be re-submitted to the IBC.
5. Post-Review: Following the Full Committee Review, the PI, Co-PI(s), Lab Supervisor, and Study Coordinator are notified of the IBC’s decision and advised of any necessary clarification or revisions.
6. Modifications Required: The the PI, Co-PI(s), Lab Supervisor, and Study Coordinator is instructed to log into eProtocol to modify the application. At this point, the application is editable. After all changes have been made, the application must be submitted again. The modifications will either be reviewed by the IBC Program Coordinator (if approved) or Committee Review (if tabled).
7. Review Complete: Once the requested modifications have been addressed, the final approval letter will be issued. At this point, the PI cannot edit the IBC application. The application may only be edited with an amendment submission. 

An IBC protocol is valid for a period of 3 years. In order to maintain continuity of approval, PIs must submit a renewal application for IBC review before the three-year approval lapses. At least 90 days prior to the expiration date, you will receive an automated email reminding you of the upcoming expiration date. A link to eProtocol will be provided in the email along with instructions on submitting a renewal application.

Please contact the IBC Program Coordinator with any questions. For general information on Risk Management and Safety at the University of Notre Dame, please see riskmanagement.nd.edu.