How will sequencing the human genome affect human gene transfer?
Knowing the details of our genetic makeup (the human genome) will help scientists find and understand genes involved in health and disease. This knowledge is key to developing strategies for using gene transfer to correct various diseases and disorders. How is human gene transfer research regulated? Two Federal agencies provide special oversight of human gene transfer research. The Food and Drug Administration (FDA) authorizes and regulates all human gene transfer clinical trials conducted in the U.S. FDA has information about their role at http://www.fda.gov/cber/infosheets/genezn.htm. The NIH, through its Office of Biotechnology Activities, also oversees this field, requiring researchers to follow certain scientific and ethical principles and to comply with safety reporting requirements. These requirements are set forth in the NIH Guidelines for Research Involving Recombinant DNA Molecules (see http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html. All institutions that receive N
