Frequently Asked Questions
Q: What research must be registered with the IBC? A: The University of Pittsburgh’s policy regarding recombinant DNA (rDNA) activities requires that all rDNA research must be registered with the Institutional Biosafety Committee (IBC).
Q: I share a lab with an investigator who is registered with the IBC. Doesn’t that registration apply to my work in the shared lab? A: No – Each investigator receiving funding is responsible for full compliance with the NIH Guidelines in the conduct of his or her rDNA research. Research collaborations may be recognized by the IBC, however Investigator’s receiving funding are fully responsible for all rDNA activities under their supervision.
Q: I am getting “x” materials from a lab with an investigator who is registered with the IBC. Doesn’t that registration apply? A: No – Each investigator handling recombinant DNA materials for research must register their work with the IBC. Please see OBA’s Investigator’s Responsibilities brochure: http://oba.od.nih.gov/oba/ibc/InvestigatorEducationalBrochureRecombinant DNA.pdf
Q: I have an active IBC approval for recombinant work in my lab. Recently I submitted a new research proposal. Do I have to submit a new registration with the IBC or can I just modify the current protocol? A: You will need to submit a modified application with the IBC if the research project involves a substantial change to the currently approved protocol. If you have any questions regarding a proposed modification, please call or email the IBC Office staff as they may be able to guide you through the application process The IBC Office staff on behalf of the IBC, reserves the right to request a full application for any proposed modifications that are deemed to be substantial in nature A: Risk Groups (RG) are a classification system for etiological agents; the lower the risk – the lower the risk group class. Biosafety level (BSL) refers to the physical and procedural barriers used to contain an etiological agent. Risk groups and biosafety containment levels are not proportional determinations The IBC website provides additional information regarding Risk Groups and Biosafety Levels. If you are unsure of the proper determinations after reviewing the information, please contact the IBC Office staff at 412-383-1768 or by email at rdna@pitt.edu
Q: How do I determine the appropriate risk group and/or Biosafety Level for my protocol application? A: Risk groups are a classification system for etiological agents; the lower the risk – the lower the risk group class. Biosafety level refers to the physical and procedural barriers used to contain an etiological agent. Risk groups and biosafety containment levels are not proportional determinations. The IBC application provides additional information regarding risk groups and biosafety levels. If you are unsure of the proper determinations after reviewing the information in the application, please contact the IBC Office staff at 412-383-1768 or by email at rdna@pitt.edu
Q: What is the IBC review process? A: The IBC review process involves the following steps: 1). All protocols are received through the IBC Office where they are initially screened to ensure that applications are complete 2). Complete protocols are entered into the IBC Database, placed on a distribution queue, and a confirmation email is returned to the sender NOTE: If a receipt confirmation is not provided within 1-2 days, the application was probably lost in transmission; please re-send the application, or call the IBC Office staff! 3). Committee members review the application, and will recommend one of the following possible actions:
4). The recommendations and/or concerns from the committee are relayed to the investigator through the IBC Office staff 5). Applications (or revised applications) are placed on the next available agenda as received by the Office Staff 6). The IBC is required by the NIH to review all applications at a convened meeting and make one of the following determinations:
7). The investigator is notified through the IBC Office of the committee’s decision
Q: What is reviewed by the committee? A: The IBC review process considers the following points:
Q: I have a human gene transfer (clinical trial) proposal. What will the IBC review? A: For clinical trials, the IBC will review the application and supporting documents for the following:
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