By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services
While both committees focus on risk, they have contrasting responsibilities. IRBs are tasked with protecting the rights and welfare of research subjects. IBCs, however, seek to protect study personnel, the community and the environment from exposure to engineered genetic material and other biohazardous agents. An IBC may also advise the IRB in assessing potential risks to the study subjects.
While one IRB can oversee research protections for multiple sites, IBCs are locally based at the research site, include the involvement of community members and can only oversee research at that location. For the sake of efficiency, local IBC meetings can be centrally coordinated and synchronized, but each IBC remains responsible for local review.
Because of the risks involved, gene therapy research requires additional safety measures to ensure that research subjects and study staff as well as the community and the environment surrounding the research site are not harmed by the modified genetic material or the infectious agents that may be utilized to deliver them. These safety measures go beyond the human subject protection requirements that IRBs enforce and always require a site inspection as part of the approval process.