The Institutional Biosafety Committee (IBC) is responsible for monitoring and ensuring the compliance of Wright State University laboratories with the NIH Guidelines.
The purpose of the NIH guidelines is to specify appropriate risk-based safety practices and containment measures are employed for:
- recombinant nucleic acid molecules,
- synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and
- cells, organisms, and viruses containing such molecules.
The IBC provides oversight of these recombinant/synthetic nucleic acid molecule research projects, including reviewing and approving of all research projects involving recombinant/synthetic nucleic acid molecules. The IBC responsibilities include:
- conducting comprehensive risk assessments,
- approving IBC Protocols,
- institutes appropriate corrective measures,
- develops policies and procedures, and
- reports to and communicates with NIH
The Biosafety Officer responsibilities include:
- voting member of the IBC,
- reviews all IBC protocols,
- performs laboratory inspections,
- provides emergency and incident response,
- coordinates with regulatory agencies,
- provides biosafety training, and
- consults with campus staff
The Principal Investigator (PI) is responsible for full compliance with the NIH Guidelines in the conduct of recombinant or synthetic nucleic acid molecule research. The NIH Office of Biotechnology Activities (OBA) provides a brochure for PIs to review. The information should be posted in the laboratory.
The Department of Environmental Heath and Safety (EHS) recognizes that manipulation and insertion of recombinant/synthetic nucleic acids into various organisms is an integral part of many of research and teaching laboratories.
For more information, please click on the links below.
Definition of Recombinant and Synthetic Nucleic Acid Molecules
- molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
- 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
- molecules that result from the replication of those described in (i) or (ii) above.
IBC Protocol Applications for Recombinant or Synthetic Nucleic Acids Research
Anyone intending to perform activities involving recombinant DNA or biohazardous agents must submit a protocol to the IBC for consideration, including those activities which are exempt from the NIH Guidelines.
The following steps summarize the procedure for a new IBC protocol submission:
- Complete the New IBC Protocol Application Form
- Submit the completed application to the IBSO for review
- IBSO returns reviewed application to IBC applicant
- Applicant prepares copies for Research and Sponsored Programs (RSP)
- 2 copies for Biosafety Level 1 (BSL1)
- 18 copies for Biosafety Level 2 (BSL2) or higher activities
- Applicant submits original IBC application and copies to RSP
- Copies are distributed to IBC members for review
- Protocol is reviewed at monthly meeting
- Applicant is notified of IBC protocol determination
In addition to the Institutional Biosafety Committee (IBC),
- any human subject MUST be reviewed by the Institutional Review Board (IRB);
- any animal use MUST be reviewed by the Institutional Animal Care and Use Committee (IACUC); and
- any use of radioactive materials or radiation generating equipment MUST be reviewed by the Radiation Safety Committee (RSC).
- Marjorie Markopoulos, Institutional Biological Safety Officer (IBSO) 937-775-2797
- Greg Merkle, Environmental Health and Safety Specialist 937-775-2217
- Mandy Karper, IBC Facilitator 937-775-3332