Frequently Aksed Questions
Information for Researchers Using Biological Materials
- What is Ohio University’s Biosafety Policy?
- What materials are covered under Ohio University’s Biosafety Policy?
- When does use of biological materials require approval from the Institutional Biosafety Committee (IBC)?
- What safety policies does Ohio University require for biohazardous materials?
- What is the IBC and how does it work?
- How do I apply for IBC approval?
- Which form do I use for IBC approval?
- What is the IBC’s schedule?
The materials covered in the Biosafety Policy are listed and described in the Biosafety Manual. In the manual a "biohazardous agent" is defined as one that is capable or potentially capable of producing an undesirable effect upon man or the environment. The agent may be a biological or their metabolic product. These biohazardous agents include the following, for a complete list and explanations, see the manual
- Microorganisms pathogenic to man
- Harmful metabolic products of microorganisms
- Oncogenic viruses
- Recombinant DNA molecules
- Unicellular and multicellular parasitic agents
- Infectious materials of human, animal, plant origin
- Invertebrate vectors of human diseases
- Human Blood, Tissue, Body Fluids, Human cell lines and other potentially infectious materials
- Direct primary research focus on a carcinogen or family of carcinogens
- Antineoplastic or cytotoxic drugs
- Biological toxins
3. When does use of biological materials require approval from the Institutional Biosafety Committee (IBC)?
From the Policy: “All persons intending to use the listed materials (as defined in the Ohio University Biosafety manual) for research, teaching or related purposes on or off campus, must register their material with the Biosafety Officer. They must also receive the approval of the IBC prior to beginning the work, if the proposed work involves materials at or above Biosafety Level 2 (BSL2).” Additionally, all work involving recombinant DNA must be reviewed by the IBC to ensure that NIH Guidelines are being followed. If you have questions about whether or not your proposed work requires registration or approval, please contact the Biosafety Officer , 593-1662.
Safety procedures for biohazardous work are laid out in the Biosafety Manual. These include General Lab Rules, guidelines for bloodborne pathogens work, guidelines for work with animal subjects, and information about: lab signage, decontamination, disposal of waste, biosafety cabinets, and shipment of biohazardous materials.
The Institutional Biosafety Committee (IBC) is compromised for five university members (faculty and staff with knowledge of biohazardous agents) and two community members. The committee is responsible for monitoring and oversight of the use of biohazardous agents to safeguard the health and safety of Ohio University personnel, students, the community, and the environment. The IBC must also insure compliance with applicable federal regulations and guidelines, granting agency guidelines, as well as Ohio University policies and procedures. The IBC meets at least three times each year to discuss and approve new researcher proposals. They also review the status of biosafety policies, procedures and manuals.
Complete the IBC Biosafety Review Form and submit the form to the Biosafety Officer (BSO). The BSO will review your form, and may request clarification or completion of additional sections. The BSO will forward your review form to the IBC. The IBC members will review the form and may ask additional questions about your work, which you will have an opportunity to answer. At their next meeting, the IBC will further discuss your review form and take a vote on the form. The committee can vote to approve your form, to send your form to designated review, to table your form until the next meeting or to deny approval. When the committee votes for approval you will receive an approval letter and approval number from the BSO, the approval number may be requested when applying for grants. If the committee sends your form to designated review, it means that the committee has some outstanding concerns. Two designated reviewers from the committee will work with you to resolve those concerns and the reviewers can grant approval for the committee. If the form is tabled, the committee has major concerns or did not have enough advance notice to review your form. The BSO and committee will work with you to resolve any outstanding concerns before the next meeting. In the rare cases when the committee denies approval, researchers have the opportunity to appeal to the Vice President for Research. Details about the IBC’s procedures can be found here.
If you have any questions about the form, please contact the BSO , 593-1662.