Question:
Why do community members need to participate in IBC review meetings?
- Submitter: Regulatory Coordinator, Clinical Research Institute
Answer:
Per the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), every Institutional Biosafety Committee (IBC) must include at least five members who collectively possess the experience and expertise to assess the safety of the research being reviewed and to identify any potential risk to public health or the environment. The NIH Guidelines also stipulate that at least two members of each IBC come from the surrounding community and be unaffiliated with the institution where the research is occurring apart from their membership on the IBC.1 This is an important requirement, as the NIH Guidelines were originally created partly in response to public concerns surrounding recombinant DNA and genetic engineering. Many of those original concerns of the 1970s and 1980s surrounding genetic engineering have lessened over time. However, newer ones continue to emerge as technologies advance, and IBCs today are tasked with reviewing some of the most complex and debated research taking place, including genome editing and the use of gene drive-modified organisms.
The NIH Guidelines do not require community members to be in attendance for IBC review meetings, only that they serve on the IBC itself, and institutions are free to determine their own meeting quorum requirements. At WCG, we believe that the community perspective in the review process is critical. Because of that, we require at least one community member to be present and participate in convened IBC review meetings. In our experience, community members play an integral part in the review process, as they can bring community attitudes toward research to the IBC and often possess knowledge about specific local or state biosafety requirements that other IBC members may not. This requirement is just one way WCG ensures research at our partner institutions is conducted safely and in compliance with relevant rules and regulations, whether local or federal.
- Section IV-B-2-a-(1) – NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules)
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