If a site needs to submit to create an IBC with WCG, how long does the NIH registration process typically take? 

Question:

If a site needs to submit to create an IBC with WCG, how long does the NIH registration process typically take? 

• Submitter: Regulatory Coordinator, CRO 

Answer:

Under Section IV-Bⁱ of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), institutions must establish an IBC that includes, at a minimum: 

• At least five members who collectively have the experience, expertise, and capability to assess the safety of research covered by the NIH Guidelines; 

• At least two members who work or reside in the surrounding community and are not affiliated with the institution (apart from their membership on the IBC); 

• Plant, animal, and/or gene transfer experts as applicable for the research being reviewed. 

Once the IBC has been established in accordance with the NIH Guidelines, institutions are responsible for filing annual reports with the NIH that include a current IBC roster and biosketches for all members. The NIH encourages institutions to use their IBC Roster Management System (IBC-RMS) database to file these reports and to track the ongoing status and composition of the IBCⁱⁱ. 

At WCG, we partner with institutions to create IBCs staffed with experts from our extensive network of clinicians, scientists, and biosafety professionals around the country, enabling us to establish new IBCs in just a matter of days. Once an IBC has been established, the NIH’s IBC-RMS database is used to track its status and provide required annual updates to the NIH on behalf of the institution. Our approach includes parallel processes for IBC establishment and study review, meaning many IBCs can review and approve research as soon as the committee is established. Institutions wishing to partner with WCG and establish a new IBC are encouraged to complete and submit Submission Form – Part A or contact WCG IBC Services at [email protected] with any questions. 

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References

1. Section IV-B. Responsibilities of the Institution. https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf 
2. FAQs on Institutional Biosafety Committee (IBC) Administration – April 2024 https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy/faqs-on-institutional-biosafety-committee-ibc-administration-april-2024/