Rewriting the "points to consider": The ethical impact of guidance document language

Human gene transfer research has been under way for nearly 10 years, with f ew clinically significant results to date; yet public and professional expe ctations still run high, Exaggerated expectations and misconceptions about gene transfer research are attributable in part to the terminology used to describe this research, which is misleading but, in the absence of more pre cise language, is commonly used, In particular, use of the term "gene thera py" to describe gene transfer research and use of the term "patient" in pla ce of "subject" tend to cause both professionals and the public to confuse research with proven effective treatment. Investigators preparing to engage in human gene transfer research must use the NIH guidance document, "The P oints to Consider in the Design and Submission of Protocols for the Transfe r of Recombinant DNA Molecules into the Genome of One or More Human Subject s," written by the Recombinant DNA Advisory Committee, to prepare for the s ubmission of a research protocol. Several corrections in the terminology em ployed by this guidance document could help to avoid misconceptions about g ene transfer research and clarify both the promise and the limits of the re search enterprise for investigators and subjects.