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IBC Resources

Review the following content and additional resources to learn more about IBCs and their role in ensuring recombinant DNA research is conducted safely and responsibly.

An IBC is a committee that reviews safety aspects of research involving recombinant DNA (genetic engineering), including:

  • Risks associated with genetic modifications & experimental procedures
  • Occupational and environmental safety

The committee must be comprised of a minimum 5 members that collectively have the expertise to assess risks associated with the proposed recombinant DNA research. At least 2 members must be local community members not affiliated with the institution/site.

Each IBC is registered with the NIH Office of Science Policy. IBC registrations are updated annually.

The IBC is charged under the NIH Guidelines for assessing risks associated with research involving recombinant or synthetic nucleic acid molecules (r/sNA) molecules. This includes:

  • Assessing containment levels per NIH Guidelines
  • Evaluating the adequacy of facilities, equipment, personal protective equipment (PPE), SOPs, training and waste disposal practices
  • Inspecting facilities involved in conducting the research
  • Conducting post-approval monitoring, including review of safety reports and incident reports

NIH Guidelines require IBC review when research involving recombinant DNA is:

  • Funded by NIH

OR

  • Taking place at a NIH funded site

For clinical trials, IBC review takes place in addition to IRB review. Both committees focus on risk, but their purposes and mandates differ: while the IRB focuses on protecting the rights and welfare of human research participants, the IBC focuses on risks posed by recombinant DNA (genetically modified material) to study personnel, the community and the environment.

An IBC is comprised of:

  • A minimum of 5 members that collectively have the expertise to assess the risks associated with the proposed recombinant DNA research.
  • At least 2 of the members MUST be local community members that are not affiliated with the institution / site. The community members represent the interests of the community in regards to public health and protection of the environment.

The IBC must be able to provide documentation to NIH Office of Science Policy that:

  • The IBC has knowledge of local institutional characteristics – such as investigator training, laboratory conditions, and operating procedures

AND

  • An individual at the registering institution has the authority and responsibility to implement the IBC’s directives.

This is accomplished through the IBC set-up and registration process. Each IBC is registered with NIH, including member CVs. Registration is updated annually.

RAC review is the Recombinant DNA Advisory Committee (RAC) review process.

The RAC is a panel of up to 21 national experts in various fields various fields of science, medicine, genetics, ethics, and patient perspectives that considers the current state of knowledge and technology regarding recombinant DNA research.

When is RAC review required?

RAC review of human gene transfer protocols is limited to cases in which the IBC or IRB at the initial study site for Phase I clinical trials determines that a protocol would significantly benefit from RAC review or has been determined to meet one or more of the following criteria:

  1. The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk; OR
  2. The protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value; OR
  3. The proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies involved to evaluate the protocol rigorously.

This reflects the revised NIH guidelines published in April 2016.

Even if the protocol does not meet the above criteria, the NIH Director, in consultation (if necessary) with appropriate regulatory authorities, can select protocols for review that may present significant scientific, societal, or ethical concerns.

Either the IRB or the IBC at the initial study site for Phase I clinical trials involving human gene transfer can recommend RAC review.

Even if an oversight body involved in the review at an initial site does not request public RAC review, the NIH Director, after consultation (if needed) with appropriate regulatory authorities, may initiate public RAC review if

  • the protocol has one or more of the characteristics listed above (1, 2, or 3) and public RAC review and discussion would provide a clear and obvious benefit to the scientific community or public

OR

  • the protocol otherwise raises significant scientific, societal, or ethical concerns.

If a protocol is to undergo RAC public discussion, a complete human gene transfer protocol package must be submitted at least 8 weeks prior to the quarterly RAC meeting to be reviewed at that upcoming meeting. NIH publishes a list of upcoming RAC meetings online.

Join IBC Services

If you’re as passionate about biosafety as we are, let’s talk! Schulman is seeking IBC committee members, community members, site inspectors and consultants across the US to assist on a part-time basis with the IBC review process and biosafety-related projects.

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