Jul09

What Your Site Needs for Gene Therapy Research

Techniques for the manipulation of DNA are advancing and expanding rapidly. Currently, more than 2,500+ clinical trials have been initiated involving human gene transfer. If your site has yet to engage in any gene transfer research, it likely will soon—and your research organization needs to be prepared.

When performing this type of research, a research organization has a responsibility to ensure its divisions secure the appropriate reviews and protect all involved parties. That means if you don’t already have an Institutional Biosafety Committee (IBC), you probably need one.

Why You’d Need an IBC

Any research involving recombinant DNA (rDNA) performed with federal funds—or done at sites receiving any National Institutes of Health (NIH) funding—must be reviewed by an IBC. This self-policing requirement comes from the NIH itself, which oversees gene therapy regulations in concert with the Recombinant DNA Advisory Committee (RAC).

Because most large organizations receive NIH funding, they will likely already have an IBC in place. However, if your organization operates at a private research site, that may not be the case. If you’re unsure whether your site receives NIH funding (and thus requires an IBC), you can see if it’s registered on the Office for Human Resource Protections website.

What Does an IBC Do?

You’re likely familiar with an Institutional Review Board (IRB), which protects the rights of human subjects in research. An IBC essentially monitors the safety and health risks for everything else—like site staff, the surrounding community, and the environment.

Because manipulated recombinant DNA (rDNA) can be dangerous to more than just the patient if mishandled, the NIH requires additional oversight for studies involving it. An IBC provides this in a number of ways, including inspecting a site’s facilities, equipment, and waste disposal practices, as well as conducting post-approval monitoring.

Creating an IRB

If you do not have an IBC at your location, but you’re looking to create one for future gene therapy studies, you can administer the IBC internally or externally. About 80% of all IBCs are administered internally. This gives the institution greater control over the IBC and allows them to tailor its processes to their own culture.

However, internal IBCs can be expensive, and your institution may lack experts in the field of human gene transfer research—or knowledge of NIH guidelines—to staff one. In these cases, opting for an independently administered IBC could be the right decision for your research organization. These can offer more flexibility and gather experts quickly as needed.

Whether you use an internal or external IBC, you can easily manage studies using rDNA in a Clinical Trial Management System (CTMS). Checklists within a CTMS can help ensure you meet all requirements, and IBC documentation can be tracked in the CTMS from initial submission to review and approval.

Interested in learning more about gene therapy and IBCs? Check out our webinars, Introduction to Recombinant DNA and IBCs, and Prepare Your Site for Challenges in Gene Therapy Research to learn more!

Does your site conduct gene transfer studies? See how Clinical Conductor CTMS can help your organization run the world’s best research.

 


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