Rebecca N. Lenzi, B. Altevogt, L. Gostin
Mar 27, 2014
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Abstract
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. This research sparked discussion and controversy over scientific, research participant safety, ethical, and other societal concerns. In response to these concerns, the National Institutes of Health (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—detailed plans of procedures—for human gene transfer trials, known as individual clinical trial protocols, to the RAC. The RAC then determines which of these require further review and public discussion by the RAC. Human gene transfer research remains one of the most heavily regulated areas of clinical research. In addition to review by the RAC, before human subjects can be enrolled in a study, individual clinical trial protocols are subject to review by the U.S. Food and Drug Administration (FDA) at the federal level and by institutional review boards (IRBs) and institutional biosafety committees (IBCs). 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. Responding to a request from the Director of the NIH, the Institute of Medicine (IOM) convened 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 With the accumulation of safety data and increased experience with its applications, gene transfer research's associated risks are now better understood.