Debate rages among bioethicists, as some seek to narrow the field to include only moral decisions over modern medicine and technology, while other want to expand the field to encompass moral decisions that could affect any organism capable of experiencing fear . One of the most major debates in bioethics involved that of human experimentation, and led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. Later, the 1979 Belmont Report, which came out of the Commission, adopted three fundamental principles—autonomy, beneficence, and justice —which have been highly influential across the scope of bioethics.
The RAC continues to explore the issues raised by the potential of in utero gene transfer clinical research. However, the RAC concludes that, at present, it is premature to undertake any in utero gene transfer clinical trial. Significant additional preclinical and clinical studies addressing vector transduction efficacy, biodistribution, and toxicity are required before a human in utero gene transfer protocol can proceed. In addition, a more thorough understanding of the development of human organ systems, such as the immune and nervous systems, is needed to better define the potential efficacy and risks of human in utero gene transfer. Prerequisites for considering any specific human in utero gene transfer procedure include an understanding of the pathophysiology of the candidate disease and a demonstrable advantage to the in utero approach. Once the above criteria are met, the RAC would be willing to consider well rationalized human in utero gene transfer clinical trials.