Question:
Our site received Institutional Biosafety Committee (IBC) approval to conduct a clinical trial, and the protocol was just updated. Do we need to submit the updated protocol to the IBC? If so, what happens from there? – Research Manager, Oncology Clinic
Answer:
Yes, the updated protocol should be submitted to the IBC. This stems from a requirement in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) that principal investigators (PIs) may not initiate or modify research subject to the NIH Guidelines without IBC approval.1,2
It is important to let WCG’s IBC know about all changes to sponsor documents, including protocols, investigator brochures, and pharmacy manuals. Not only does the IBC need to have the most up-to-date documents for each study it oversees, but some changes may also require updates to site documents. For instance, an updated pharmacy manual may include changes to study agent preparation procedures that need to be reflected in the site-specific biosafety standard operating procedure (SOP), which describes the preparation and dosing of the study agent. At WCG, updated documents can be submitted for evaluation using our Change in Research Submission Form.
Once updated documents have been submitted, an IBC Chair will evaluate the changes and determine whether they represent a modification of the research that requires review by the IBC. If it does not, then a notification is issued to all affected sites that they may proceed with implementing the new document(s). If it does, then an IBC meeting will be scheduled to review the change(s).
If you have additional questions about your study’s protocol or any other Institutional Review Board (IRB) or IBC questions, please contact us at the form below. Our experts are always ready to assist you with your study.
References
- NIH Guidelines, Section IV-B-7-a-(1),https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf.
- NIH Guidelines, Section IV Section IV-B-7-c-(3), https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf.
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