IF you are engaged in research that involves the collection or analysis of any unfixed human biospecimens (blood, saliva, urine, feces, skin swabs, bodily secretions, tissue samples, etc.), this message is for you.
The Office of Research Compliance (ORC) would like to take this opportunity to remind you about the UNT Health Science Center?s Institutional Biosafety Policy.
As you may recall, per institutional policy, an Institutional Biosafety Committee (IBC) protocol and Blood Borne Pathogen (BBP) training are required for all activities involving the use of human biological material including (but not limited to): blood and its components, body fluids, unfixed tissues/cells and tissue fluids. This IBC protocol must receive review and approval by the Institutional Biosafety Committee.
Please note that the IBC is not part of the Institutional Review Board (IRB). While an IBC protocol focuses on the risk management of biological material from a biosafety perspective, an IRB protocol focuses on the risk/benefit management of research from a human subject perspective. Further, an IBC protocol is considered separate from the IRB protocol and IRB approval process. Therefore, you should not assume that obtaining IRB approval satisfies this or other institutional requirements. Recall that researchers are responsible for obtaining the appropriate approvals and clearance from all applicable offices, departments and regulatory agencies (e.g., Institutional Biosafety Committee, Office of Clinical Trials, Grants and Contracts, Research Conflict of Interest, Legal, Sponsor or funding agency and/or Marketing) before initiating a study in order to remain compliant with institutional policy, federal regulation and state law.
The Institutional BioSafety Committee (IBC) meets the 3rd Wednesday of every month. That means, the next two meetings available for you to obtain your IBC protocol approval are December 2016 and January 2017:
Submission Deadline IBC Meeting Date
November 30 December 21, 2016
December 21 January 18, 2017
IRB Procedures and Guidance for Studies that Involve Human Biospecimens
For Existing, IRB-Approved Research Projects that Involve Human Biospecimens:
If you already have such an IBC approval for your IRB-approved research project, submit a copy of the IBC approval letter to the Office of Research Compliance and indicate which IRB protocol(s) are linked to the IBC approval. It is your responsibility to provide clear and complete information indicating to which project(s) the IBC approval applies.
? During this transition period, investigators who do NOT already have IBC approval for their IRB-approved research project(s) will have until February 1, 2017 to obtain and submit to the Office of Research Compliance an IBC approval letter that is appropriately linked to the human research study.
? If, by February 1, 2017 the Office of Research Compliance does not have IBC approval affiliated with a given IRB protocol involving human biospecimens, then that IRB protocol will be placed on Administrative Hold (Suspension) until an IBC approval is obtained and verified.
When Submitting a New Research Project (that involves use of human biospecimens) for IRB Review:
? Include a copy of the IBC approval letter with the IRB protocol packet.
? If you do not yet have an IBC approval letter, the IRB application will be placed on ?hold? until the IBC approval letter is submitted and verified.
When Submitting an IRB-approved research project (that involves use of human biospecimens) for IRB Continuing Review:
? Submit a copy of the IBC approval letter to the Office of Research Compliance, along with the other documents associated with the Progress Report (or Final Report).
? If the project does not have IBC approval (or if the IBC approval period has expired), the IRB protocol will be placed on Administrative Hold (Suspended) until the IBC approval is made current. Investigators should avoid this ?lapse? at all costs.
Additional Guidance:
Proper planning and documentation submitted for IBC review will facilitate a quick and effective review and approval. Do not wait until the last minute to submit paperwork for IBC review.
Submission of an IBC protocol is done through the IDEATE system. Here is a link for the information and website regarding IBC submissions:
https://www.unthsc.edu/research/grant-and-contract-management/ideate-web-based-research-administration-system/.
This webpage contains links that will enable investigators to access an IDEATE tutorial and to enter the IDEATE portal to create an IBC protocol.
For specific guidance on developing an IBC protocol, contact the Bio Safety Officer, Maya Nair, PhD, by phone at (817)735-5431 or email the Biosafety Program Office (ibc@unthsc.edu).
Blood-Borne Pathogen (BBP) Training is available at the UNTHSC ?INSITE? Training page: https://insite.unthsc.edu/training/ Click on ?Blood-Borne Pathogens?.
For more information about the required Blood Borne Pathogen (BBP) training, please contact Dr. Janet Jowitt, Chief Nursing Officer at jan.jowitt@unthsc.edu, or by phone at (817) 735-2233.
General Biosafety guidance can be accessed via the following link:
https://www.unthsc.edu/research/protection-of-human-subjects/biosafety-for-human-subject-research/