Frequently Asked Questions

Click the link below for an explanation of which studies require IBC approval. Recombinant DNA work (some exceptions), use of a risk group 2 or higher biological agents or toxins, and Duel-use research of concern (DURC).
https://ibc.byu.edu/training-education

Biological Safety Program:
https://brightspotcdn.byu.edu/4d/52/78dd379a4a6e964ec2f3ecb0e491/biologicalsafetyprogram-5.pdf

Dual Use Safety Program:
https://brightspotcdn.byu.edu/4c/34/0a301c5f4de5b8ba85ab7defcf23/dualusesafetyprogram-3.pdf

An IBC protocol is approved for three years. After that, it can be removed.

• Experiments using CRISPR, zinc-finger, TALEN, or similar targeted gene editing in RG 1, 2, 3, or restricted organisms or cells.
• Experiments using adenovirus, adeno-associated virus, or lentiviral vectors.
• Use of RG2 microorganisms or toxins.
• All cell and organ cultures of human origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives.
• Any experiment using RG3 or 4 organisms.
• Any experiment using a select agent or toxin.
• Any human gene transfer research.
• Deliberate formation of recombinant or synthetic nucleic acid molecules containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin).
• Whole plants regenerated from plant cells and tissues cultures that do not remain axenic cultures.
• Large scale microorganism or toxin experiments (more than 10 liters of volume in a single culture vessel).
• Deliberate introduction of genes coding for the biosynthesis of molecules that are toxic for vertebrates with an LD50 greater than 100 nanograms/kg but less than or equal to 100 micrograms/kg.

• Synthetic nucleic acid molecules that: (1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
• Escherichia coli K-12 host-vector systems, with some exceptions:
  
  • the E. coli host does not contain conjugation proficient plasmids or generalized transducing phages; or lambda or lambdoid or Ff bacteriophages or non-conjugative plasmids are used as vectors.
• Kluyveromyces lactis host-vector Systems.
• Bacillus subtilis or Bacillus licheniformis host-vector systems.
• The purchase or transfer of transgenic rodents.
• Generation of certain biosafety level 1 transgenic rodents via breeding.
• BSL1 organisms or cells that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles)

For more information please contact Rebecca Scholl in the College of Life Science at rebecca_scholl@byu.edu

Yes. Modifications can be submitted through iRIS

For further questions, contact Regina McCarthy at 801-422-3022 or at ibc@byu.edu

Yes. The NIH requires all relevant projects to be reviewed by the IBC regardless of their funding source.

There is no requirement for the order in which IACUC and IBC applications are submitted. However, IACUC final approval will not be granted until IBC approval has been received. It is advisable to submit your IBC proposal either before or at the same time as when you submit your IACUC proposal to avoid delays.

If registration forms are received before a submission deadline, it will be reviewed at the next IBC meeting. After committee review, the Principal Investigator will receive notice of the meeting results approximately 2-7 days after the meeting. This notice will be in the form of an approval letter or a memo, with additional questions from the committee. Final approval will then depend on how quickly the questions are resolved.

If this is a renewal, you should submit your protocol 60 days before the expiration date.

Whatever happens in the lab is the responsibility of the PI and therefore, those who are in the space should be made aware of any risks that are present and be trained to work safely in that lab. For help understanding and addressing possible risks in the lab, please contact Don Hunt in Risk Management at don_hunt@byu.edu

The following is a list of common toxins that are required to be registered with the IBC. However, the list is incomplete, and principal investigators can confirm that the toxins they propose to work with do or do not require IBC registration by contacting the BYU Biosafety committee at (801) 422-3022 or at ibc@byu.edu. For a complete list of CDC select agents and toxins, please refer to this list: https://www.selectagents.gov/sat/list.htm.

- Abrin
- Aflatoxin
- Bacillus anthracis edema factor
- Bacillus anthracis lethal toxin
- Botulinum neurotoxins
- Brevetoxin
- Cholera toxin
- Clostridium difficile toxin
- Clostridium perfringens toxins
- Conotoxins
- Dendrotoxin (DTX)
- Diacetoxyscirpenol (DAS)
- Diphtheria toxin
- Domoic acid
- Pertussis toxin
- Pfeisteria spp. toxin(s)
- Ricin
- SARS-associated coronavirus (SARS-CoV)
- SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors
- Saxitoxin
- Shiga-like ribosome inactivating proteins
- Shigatoxin
- Staphylococcal enterotoxins
- T-2 toxin
- Tetanus toxin
- Tetrodotoxin (TTX)

According to Section IV-B-2-a-(1) of the NIH Guidelines, the IBC must have at least 5 members that collectively have experience and expertise to assess the safety and identify potential risk to public health or the environment.

To ensure experience and expertise, IBC membership should have, at a minimum, the following:

1. At least one practicing scientist with experience in microbiology, molecular biology, or virology.
2. At least one practicing scientist with expertise in recombinant or synthetic nucleic acid molecule technology, biological safety, and physical containment.
3. At least one practicing scientist with expertise in human gene transfer experiments.
4. At least one member representing laboratory technical staff.
5. At least two community members, not affiliated with BYU in any way other than as a member of the IBC, and who do not have an immediate family member who is affiliated with BYU. At least one community member has primary experience in a nonscientific area (for example, an ethicist, lawyer, or member of the clergy).

Committee members serve at least one 3-year term. Members each have a personal commitment to laboratory safety and biosafety in particular.

Meetings are held on the second Thursday in January, March, May, July, September, and November. Primary investigators must complete and submit applications by the 25th of the month prior to when they would like their protocol reviewed. For example, to be on the March agenda, protocols must be submitted by February 25th.

Yes, PIs can review each page of the protocol to ensure it is up to date; review personnel listings, procedure relationships, and attachments before submitting.

No. If a three year review has not been processed and approved by the expiration date, the protocol will expire.

No, completion of an IBC registration form is required to validate if the work is indeed exempt.

Those wishing to attend IBC review of research involving recombinant or synthetic DNA are welcome to attend. Meetings are held on the second Thursday of January, March, May, July, September, and November from from 12pm-2pm. Information about upcoming meetings can be obtained by calling the IBC Administrator at 801-422-3629.

Bradley Geary
David Erickson
Don Hunt- Biosafety Officer
Eric Edwards- Community Member
Jason Jay- Administrator
Jeremy Headman- Community Member
Paul Savage
Richard Robison- Chair
Rebecca Scholl