Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee


Report at a Glance

In the 1970s, scientists first developed methods for manipulating DNA – resulting in what is called recombinant DNA. One of the applications of these methods, known as gene transfer, is an experimental technique involving the insertion of new genetic material into a human subject. In response to concerns about gene transfer, NIH established in 1974 the Recombinant DNA Advisory Committee (RAC) to provide oversight and a public forum for discussion. Today, NIH-supported researchers are still required to submit all research protocols to the RAC. The RAC then determines which of these require further review and public discussion by the RAC.


With the accumulation of safety data and increased experience with its applications, gene transfer research’s associated risks are now better understood. Therefore many have argued that today RAC review is redundant and unnecessary in its current form. NIH asked the IOM to form a committee to determine whether gene transfer research continues to raise concerns that warrant extra oversight by the RAC of individual clinical trial protocols involving gene transfer. The committee was also asked to recommend criteria to guide when the RAC should, if deemed necessary, review individual protocols.

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