Home Forums General Discussion Forum IBC TMF Filing Reply To: IBC TMF Filing

Karen Williams

I would think you could still file the documents under the IRB/IEC section
because I believe IBC functions as a oversight, compliance and approval with members function in the same capacity as the major IRBs or Local IRBs (more local than central IRBs) as long as there members approval schedules You would file them as a local IRB. Below are some requirements of an IBC at UNC Hospital. I hope this helps

Function of the IBC
The IBC is responsible for the oversight, administration, and review of UNC‐CH Lab policies and projects involving research with recombinant or synthetic nucleic acid molecules and hazardous biological materials that may pose safety, health, or environmental risks. To this end, the IBC assists and advises Principal Investigators and other researchers in meeting their responsibilities to ensure that the biological aspects of the research are conducted in a safe manner using established biosafety standards, principles and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and UNC‐CH Policies.

The IBC will investigate and report any significant problems with or violations of the NIH Guidelines and any significant research‐related accidents or illnesses involving recombinant genomic materials to the Principal Investigator, the Biological Safety Officer, the Department Chair, and the NIH Office of Biotechnology Activities (OBA) within 30 days, unless the IBC determines that the Principal Investigator or lead researcher has already filed a report.
Structure of the IBC
A broad array of available research and regulatory expertise is important for the IBC given the range of recombinant DNA research that the committee reviews. The NIH requires that the IBC have at least five members selected who collectively have the experience, expertise, and capability needed to assess the breadth and safety of recombinant and synthetic nucleic acid molecules as well as other biological materials, agents, and organisms as needed to identify any potential risks to workers, public health, or the environment.

IBC Charter Approval
IBC members will review proposed amendments to this charter during a regularly scheduled meeting of the committee and vote on acceptance of each amendment.