RESEARCH REQUIRING IBC REVIEW
With the exception noted below, all research activities must be submitted for review and approval by the IBC prior to implementation.
Purview of the IBC
The IBC typically reviews research activities involving the use of:
- Recombinant or synthetic nucleic acid molecules (r/sNAs) or genetically modified organisms
- Pathogens, potentially infectious materials, parasitic agents and other biohazards
- Select biological agents and toxins under the oversight of the Federal Select Agents Program
- Dual use research of concern (DURC) agents
All research activities must be reviewed and approved by the Institutional Review Board (IRB), the Institutional Animal Care and Use Commitee (IACUC) and/ or the IBC prior to initiation. Activities that don't fall under the purview of any of these regulatory committees must be registered with the IBC using the standard IBC protocol application in the Kuali electronic submission system.
Human subject research that does not involve IBC-regulated agents but does involve the collection of biospecimens (blood, urine, saliva, etc.) does not require submission of an IBC application ONLY IF the biospecimens:
Will not be stored long-term in the researcher's laboratory for future research;
Will not be processed, extracted, assayed or otherwise manipulated in the researcher’s laboratory to answer a research question as part of the study; and
Will be delivered or shipped, without or with minimal processing, to a testing laboratory (e.g., UMC clinical lab, sponsor-designated central lab) for analysis.
Examples of minimal processing are centrifugation and transferring supernatant to new tubes; aliquoting liquids; or dissecting tissues into multiple samples.
Requirements for handling and shipping of biospecimens in these studies will be evaluated by the IRB as part of its overall review of the research.