Biosafety

About the Institutional Biosafety Committee (IBC)

As mandated by the NIH Guidelines, the University of Notre Dame's Institutional Biosafety Committee is responsible for assessing the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules. Due to the inherent safety risks from research involving other potentially hazardous biologics, the University of Notre Dame's IBC assesses the appropriate biosafety containment level and appropriate safety precautions for those as well. Notre Dame's IBC currently oversees:

  • Recombinant DNA (rDNA) and Synthetic Nucleic Acid (SNA) molecules
  • Infectious agents (pathogenic bacteria, viruses, prions, fungi, protozoans)
  • Retroviruses and Lentiviruses
  • Biological toxins
  • Human or non-human primate derived tissues, bodily fluids, cell lines, blood, or blood products
  • Mammalian cells and cell lines
  • Creation of transgenic animals - animal's genome has been altered by the stable introduction of rDNA or SNA molecules, or nucleic acids derived therefrom, into the germ-line.
  • Maintenance of a transgenic rodent colony at BSL2 containment or higher
  • Purchase or transfer of transgenic rodents that require BSL2 containment or higher
  • Transgenic plants (use and creation)
  • Federally regulated Select Agents and Toxins
  • Other potentially infectious materials that may place research personnel, animal subjects, the public, or the environment at risk.

Information Regarding COVID-19 Research Projects

With the emergence of COVID-19, there is a significant need for research on the diagnostics, treatment, epidemiology, and basic biology of this infectious disease. As a prominent research institution with a mission to be a force for good in the world, we anticipate that many researchers will begin to plan experiments related to this field. 

If your research lab will be handling and processing specimens associated with COVID-19, please refer to the University Of Notre Dame Biosafety Information Regarding COVID-19 Research Projects memo before submitting your IBC protocol application.

IBC Application Process

Any University of Notre Dame investigator planning a research project that involves the above materials must submit an application for IBC review before initiating the work. The University of Notre Dame requires that you obtain IBC approval for this research regardless of the funding source and regardless of whether the rDNA or SNA research is considered exempt from the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

As of January 30, 2020, the IBC will only be accepting new protocol submissions completed in the eProtocol system and will no longer accept paper forms. If an investigator already had a protocol established before the transition to an electronic form, paper amendment submissions will still be accepted. Although, it is encouraged to switch to the electronic form as soon as possible.

Submitting an Application

Please review the following guides for step-by-step instructions on how to navigate the eProtocol system, create and submit an application, respond to reviewer comments, amend a protocol, and print a PDF version of the protocol:

  1. Creating an IBC Protocol
  2. Editing and Submitting a Protocol Application
  3. Respond to Reviewer Comments
  4. Amend an Approved Protocol
  5. PDF and Print a Protocol

Questions regarding the IBC review process, submissions, or any other IBC-related matters should be directed to the IBC Program Coordinator.

Lab Inspection Requirement

In order for the IBC to issue an approval for work at BSL2 or BSL3 containment, the laboratory where the work will be performed must be BSL2 certified by Risk Management and Safety (RMS). BSL2 Certifications is valid for 1 year, and the lab must remain BSL2 certified for the duration of the approved IBC protocol. See the RMS Assessment Guide for more information.

If you are proposing work for BSL2 containment, then, at the same time as you initiate your IBC application, contact the Biosafety Officer to schedule your BSL2 assessment. Although the IBC can review your application before your lab assessment is complete, it will not issue an approval until RMS has certified your lab.

Amendments

You will need to amend your approved IBC application in the eProtocol system if you are adding or changing:

  • Personnel
  • Laboratory rooms or new facilities
  • Change in hosts (microbial, in vitro or in vivo)
  • Addition of new materials (cell lines, vector constructs, infectious agents or biological toxins)
  • Strains of transgenic plants or animals
  • Genes studied or host/vector systems in your rDNA work
  • Work with substances derived from humans or non-human primates
  • Anything else that may have an impact on the biosafety level of the work being performed

Renewals

IBC approvals are valid for three years and must be renewed if the work described in the protocol is to be continued. All submissions in the eProtocol system can easily be cloned into a new protocol at the time of renewal, saving the investigator time and effort!

Upcoming IBC Meeting Dates

The IBC meets on the third Wednesday of every month. New submissions should be submitted at least five business days before the meeting for review.

Want to stay up-to-date on the IBC meeting schedule and submission deadlines? Consider adding our IBC Meeting Calendar to your Google calendar! Click on "+ Google Calendar" in the bottom right corner to add this calendar to yours

IBC Resources

IBC Committee

IBC Appointed Members

  • Eric Felde, JD, CIP, Director, Research Compliance
  • Kelly Jolliff (Local, Non-Affiliated), Infection Prevention Coordinator, Memorial Hospital of South Bend
  • Eric Kloss, MS, CSP, Senior Director, Risk Management & Safety
  • Joseph O’Tousa, Ph.D., Professor, Biological Sciences ​
  • Jason DeWispeleare, CHMM, Laboratory Safety Compliance Program Manager, Biosafety Officer, Chemical Hygiene Officer
  • Mary Prorok, Ph.D. (Chair),  Assistant Chair, Department of Chemistry and Biochemistry
  • Shahir Rizk (Local, Non-Affiliated), Assistant Professor, Chemistry & Biochemistry, Indiana University South Bend
  • Kevin Vaughan, Ph.D., Associate Professor of Cell Biology, Biological Sciences
  • Holly Goodson, Ph.D., Professor of Biological Sciences
  • Satish Adusumilli, DVM, Attending Veterinarian and Director of Freimann Life Sciences Center

IBC Frequently Asked Questions

  1. I don't receive NIH funding. Do I have to register my recombinant DNA protocol?
  2. How long will the IBC review take?
  3. What can I do in advance to ensure my IBC protocol submission is approved in a timely fashion?
  4. I am working with a chemical that is used to elicit a biological response but is not derived from an organism. Do I need an IBC protocol for this?
  5. If I have an IACUC approved protocol for my work with transgenic mice, do I still need IBC approval?
  6. Are there activities that do not require IBC review?
  7. What does the IBC look for when reviewing a research project? Does this include a scientific or ethical review?
  8. Who can be a Principal Investigator (PI) on an IBC protocol?
  9. What is the review process after the electronic submission of an IBC protocol or amendment?
  10. How long is the IBC protocol approval period?
  11. Who can I contact about other IBC-related questions?

I don't receive NIH funding. Do I have to register my recombinant DNA protocol?

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.

How long will the IBC review take?

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.

What can I do in advance to ensure my IBC protocol submission is approved in a timely fashion?

  • 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.

I am working with a chemical that is used to elicit a biological response but is not derived from an organism. Do I need an IBC protocol for this?

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.

If I have an IACUC approved protocol for my work with transgenic mice, do I still need IBC approval?

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.

Are there activities that do not require IBC review?

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.

What does the IBC look for when reviewing a research project? Does this include a scientific or ethical 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?

Who can be a Principal Investigator (PI) on an IBC protocol?

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.

What is the review process after the electronic submission of an IBC protocol or amendment?

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. 

How long is the IBC protocol approval period?

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.

Who can I contact about other IBC-related questions?

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 http://riskmanagement.nd.edu/.