Q. What type of research must be registered with the IBC?
A. All research involving recombinant DNA, synthetic nucleic acid molecules, biohazardous agents (e.g. bacteria, viruses, fungi, protozoa, prions) and/or human source materials (e.g. blood, body secretions and tissues, primary and established cell lines), must be registered with the IBC. Also, experiments involving some listed biological toxins are reviewed by the IBC if they pass the exempt limit established by CDC and USDA (http://www.cdc.gov/od/sap/sap/toxinamt.htm). If unclear whether or not a full IBC review is needed, the PI may submit a short research summary to the Biosafety Office via e-mail indicating what items will be used and the nature of the research. The Biosafety Office will advise the PI if further steps are necessary.
Q. Are immortal/established human cell lines covered by OSHA's Bloodborne Pathogens Standard?
A. Research involving the use of human-derived substances (e.g. blood or blood components, tissues, cells, secretions) is subject to the OSHA "Bloodborne Pathogens" (BBP) Standard. It is quite impossible to test human cells, including established cell lines, for all BBP/adventitious agents. Therefore, ALL human tissues and cell lines (including established lines) fall under the BBP standard. Research experiments involving human-derived materials, including established human cell lines, require IBC registration, and BSL2 practices and procedures must be followed while working with them. BBP training is required for all employees who can reasonably anticipate exposure to human blood or other potentially infections materials. This training is required both at the time of initial work assignment and at least every twelve months thereafter. Information about BBP training can be obtained at: http://www.ehs.uc.edu/itc/courses.asp. The letter of interpretation from OSHA can be found here: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21519
Q. I've never had to "mess" with this before. Why do I have to now?
A. There are two primary reasons. 1.) Compliance with the NIH and CDC Guidelines is mandatory for any institution which utilizes NIH funding. 2.) The federal government has regulations pertaining to the general possession, use and transfer of certain biohazardous agents classified as "Select Agents". Both the University and PIs are obligated to comply with these laws. In addition, some other granting agencies and even suppliers require proof of institutional approval to conduct research activities or procure agents.
Q. My source of funding is not the NIH. Do I still have to be registered with the IBC?
A. Yes. Research that is conducted at or sponsored by an institution that receives any support for recombinant DNA research from NIH must comply with NIH Guidelines regardless of the source of funding. Q. Can I just submit a research summary via e-mail to be reviewed and approved?
A. No. There is an electronic application form for IBC registration. Contact the Biosafety Office for assistance with access to the web-based application.
Q. How long does it take to get a review and notification of the results?
A. The committee meets monthly to review and approve protocols. Protocols that are received 2 weeks in advance of a meeting will be on the agenda, so 4 - 6 weeks, depending on when a protocol is submitted. Most protocols are completed with only one review; however, if follow-up with a PI is needed, a protocol may be deferred to the next meeting which would delay the protocol for approximately 4 more weeks. The PI is notified of the result following any IBC meeting in which the protocol is discussed.
Q. When does an IBC protocol approval expire?
A. An approved protocol expires after 3 years from its initial approval date. If changes (such as addition of agents and/or procedures) need to be made, amendments to the existing protocol must be submitted. Amendments other than authorized personnel and location updates will require review and approval by the full committee.
Q. I have a Human Gene Transfer (clinical trial) proposal. When and how do I submit the protocol for IBC review?
A. IBC registration follows the NIH/RAC review and approval. Once the approval letter is received by the PI, protocols may be submitted to the IBC. For clinical trials, the IBC has a specific form can be found at http://researchcompliance.uc.edu/Libraries/BioSafety_Documents/UC_HGTform_Jan_2012.sflb.ashx. Consult the Human Gene Transfer section of this website for more information.
Q. Will my laboratory be audited or inspected?
A. Yes. The Biosafety Office is responsible for conducting regular laboratory inspections. In addition, laboratories are subject to inspection by federal, state and local regulatory agencies, as well as funding and accrediting agencies.