Institutional Biosafety Committee (IBC)
Research at Ball State University (BSU) involving recombinant or synthetic nucleic acid molecules, Select Agents including “excluded attenuated Select Agent strains,” or any use of biological materials assessed as Risk Group 2, conducted or BSU sponsored by faculty, staff, and students must be conducted in a manner that does not pose a significant risk to;
- The health or safety of laboratory workers
- Non-research personnel in the BSU community
- The public
- The environment
Federal regulations on the use of recombinant or synthetic nucleic acid molecules mandates the establishment of an IBC, which reviews, approves and oversees projects involving recombinant or synthetic nucleic acid molecules.
A. All NIH-funded projects involving recombinant or synthetic nucleic acid techniques must comply with the NIH Guidelines. Non-compliance may result in (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of other unrelated NIH funds for recombinant or synthetic nucleic acid research at the Institution, or (ii) a requirement for NIH approval prior to initiation of any or all recombinant or synthetic nucleic acid projects at the Institution.
B. If statement A above applies to at least one project at BSU, then all non-NIH funded projects involving recombinant or synthetic nucleic acid techniques conducted at or sponsored by the Institution must comply with the NIH Guidelines, irrespective of the source of funding. Noncompliance may result in (i) suspension, limitation, or termination of NIH funding for recombinant or synthetic nucleic acid research at the Institution, or (ii) a requirement for NIH approval prior to initiation of any or all recombinant or synthetic nucleic acid projects at the Institution.
On 23 September 2019, the ORI received the following statement from the NIH Office of Science Policy (OSP):
Thank you for providing the NIH Office of Science Policy (OSP) with an update of the registration for the Institutional Biosafety Committee (IBC) at Ball State University. We have reviewed the updated information and found it compliant with Sections IV-B-2-a-(1) through IV-B-2-a-(3) of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
The BSU IBC is functional and comprised of BSU researchers, staff, and two non-affiliated members. Research protocols are submitted electronically for review via InfoReady.
Questions regarding the IBC and protocol submission process can be submitted to Jim Klenner.
IBC Meetings
Common Questions
The following research projects would require an InfoReady submission of an IBC protocol:
- Research that involves recombinant and synthetic nucleic acid molecules and the cells, organisms and viruses containing such molecules. This includes the purchase, creation, or use of any transgenic material.
Recombinant and synthetic nucleic acid molecules are defined as:
i. Molecules that are a) constructed by joining nucleic acid molecules and b) that can replicate in a living cell i.e., recombinant nucleic acids;
ii. Nucleic acid molecules that are chemically or by other means synthesized or amplified including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules i.e., synthetic nucleic acids, or
iii. Molecules that result from the replication of those described in i. or ii. above.
- Human or non-human primate source materials
- Includes cell lines (established or primary), tissues, blood, blood products, body fluids
- Exceptions: materials that were fixed prior to receipt (stained microscope slides)
- Naturally occurring or engineered micro-organisms or viruses capable of causing disease in humans and/or animals are Risk Group (RG) 2, 3 or 4 pathogens as defined by NIH (Note: This list is not all inclusive).
- Those agents not listed in RG 2, 3, and 4 are not automatically or implicitly classified as non-pathogens or in RG. Large doses or high concentrations could lead to illness (RG1) - V. vulnificus
- Includes any human, animal, and/or plant pathogen, and
- self-replicating (prions) and/or transactive proteins (Tat)
- Toxins (possession, use, and/or transfer)
- With an LD50 of 100 microgram/kilogram body weight or less
- Any newly discovered toxin for which the LD50 has not been determined
- Any toxin covered under the NIH Guidelines (any experiment involving the cloning of toxin molecules with an LD50 of less than 100 nanograms per kilogram body weight)
- Large scale cultures of over 10 liters in one vessel
- Environmental samples collected from areas that may contain infectious agents
If a Principal Investigator does not receive external funding, they must still register with the IBC as this is based on the biological materials used in their experiments and not on the funding source.
A risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Consult the following web site for guidance.
The Office of Research Integrity has an online Biological Safety Training module available to all BSU faculty, staff, and students. The link below will take you there.
Ball State University Biological Safety Training
- Research that involves DNA consisting of DNA from prokaryotic host when propagated only in that host or transferred to another host by well established physiological means, or rDNA consisting of DNA segments from different species that exchange DNA by known physiological processes, i.e., Natural Exchangers.
- Research using synthetic nucleic acids that:
- 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
- are not designed to integrate into DNA, and
- are nucleic acids used in vitro (i.e. PCR, DNA sequencing) and does not involve the cloning and propagation of recombinant DNA in cells, and
- do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
*If a synthetic nucleic acid is deliberately transferred into one or more human research participants, an IBC protocol will be required and must be submitted.
- Those nucleic acid oligonucleotides that are not in organisms, cells, or viruses and have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.
IBC Review
There are two types of review for IBC research submissions:
- Administrative Review for minor amendments, Continuing Reviews, and submissions not involving biological toxins or recombinant and synthetic nucleic acids.
- Full Committee Review for major amendments, New Protocols, and Renewal Submissions.
New protocols and renewals are usually assigned to Full Committee Review. Based on the nature of changes requested in an amendment, e.g., minor changes such as adding personnel, can be Administratively Reviewed and approved. Final approval for BSL2 or higher protocols may require a project-specific lab inspection is completed. The IBC Administrator completes a pre-review and determines which initial review is necessary for your research proposal.
Assuming all submissions require a Full Committee Review, we recommend researchers submit their protocols to the IBC, using InfoReady, at least two weeks before the next IBC meeting in order to be reviewed at that meeting. The IBC currently meets on the second Friday of each month.