Schulman IRB

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream.

Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring the capability to produce potentially therapeutic substances, or eliciting immune responses to fight disease.

While genetic engineering brings hope for new medical breakthroughs, the technology is not without risks. Prior to conducting research with genetic engineering, NIH Guidelines require a thorough assessment be performed to ensure the risks are identified and adequately mitigated. When conducting gene therapy studies, NIH Guidelines require review by both an institutional review board (IRB) and an institutional biosafety committee (IBC). These Guidelines apply to clinical trials involving human gene transfer that have been funded by the NIH or take place at sites that receive NIH funding.

While the IRB and IBC both focus on risk, the committees have different responsibilities and should work together to ensure gene therapy research is conducted ethically and safely. IRBs are tasked with protecting the rights and welfare of research participants, and IBCs seek to protect study personnel, the community and the environment from exposure to engineered genetic material and genetically modified biohazards. An IBC may also advise the IRB to aid in assessing risks to study subjects.

IBCs are locally based at the research site, and their membership includes individuals with expertise in genetic engineering, biological safety, infectious diseases and environmental protection. Each IBC must have at least two community members who are unaffiliated with the institution or research site and who represent the interests of the community and the local environment.

In reviewing a study, IBC members assess the facilities, procedures, safety practices, training and expertise of personnel involved in the research. The committee also assesses the research itself, including the characteristics of the proposed genetic modifications, microorganisms that may be utilized and the target cells, tissues or organs which will ultimately be affected. Facility inspections are required as part of the approval process as well as periodic reviews to ensure appropriate safety measures remain in place.

If you find your study requires IBC review, be proactive in checking with your institution. Some sites, such as universities and academic medical centers, may already have IBCs in place to monitor basic science or pre-clinical studies; however, these IBCs may or may not be prepared to review clinical research. The latter may result in unnecessary frustration and costly delays.

If your institution does not have an IBC or requires additional expertise, there are a few commercial IBC services available. Keep in mind, however, that an IBC must include a local component. NIH Guidelines do not permit IBC review to be centralized in the same manner as IRB review. Commercial IBC services may create and externally administer an IBC for the site and provide efficiencies over purely local oversight.

IBC review is a new concept to many clinical researchers, but it shouldn’t be an obstacle to research. Include IBC review in your study planning to ensure your research is conducted safely, responsibly and without start-up delays.

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