IBC Contact: Jim Klenner, Associate Director

Ball State University is actively committed to preserving the health and safety of its students, staff, and faculty, and to protecting the environment and the community. It is recognized that oversight of the use of potentially pathogenic microorganisms, other biological materials, and organisms containing recombinant or synthetic nucleic acid molecules is necessary in University research and teaching laboratories. To ensure the safe handling of these organisms, the University requires compliance with the NIH Guidelines and with the recommendations in BMBL. Compliance with other applicable federal, state, and local regulations is also required.

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 IRBNet, 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.


Common Questions

The following research projects would require an IRBNet.org 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:
  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. 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
  4. 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.

Our Responsibilities

BSU Office of Research Integrity (ORI Biosafety) will be responsible for:

  • Preparing the Biosafety Manual and reviewing as needed or at least annually;
  • Making known the availability of the Biosafety Manual to each faculty member who works with biological materials;
  • Investigating accidents involving biological materials and toxins, infectious agents, and recombinant or synthetic nucleic acid molecules;
  • Tracking the certification of Biological Safety Cabinets (BSC’s);
  • Assisting and advising on the collection and disposal of biological waste when appropriate;
  • Providing online Bloodborne Pathogen annual refresher training as required by the Occupational Safety and Health Administration (OSHA), 29 CFR 1910.1030;
  • Providing online training modules in biosafety and NIH Guidelines;
  • Conducting laboratory inspections;
  • Assisting investigators with risk assessments and risk mitigation including recommending or requiring safety equipment and PPE as necessary;
  • Administering all elements of the biosafety program;
  • Assist faculty with protocol submissions to the IBC and review IBC submissions; and
  • Reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illness to the appropriate institutional official and to the NIH Office of Science Policy (OSP) immediately and within 30 days, as required.

Questions regarding the Biosafety Program can be submitted to Jim Klenner at View Email or 765-285-5106.