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, or
- 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 IRBNet.
Questions regarding the IBC and protocol submission process can be submitted to Jim Klenner at View Email or 765-285-5106.