Research, Treatment and Informed Consent in Gene Therapy

This project is designed to analyze the adequacy of the Belmont Report's distinction between research and treatment as a basis for informed consent policy especially as it pertains to gene therapies. The project will produce an interdisciplinary evaluation of informed decision making about gene therapies and will develop new policies to guide decisions about the presentation and use of these new therapies. A comparative social and historical analysis will be undertaken of two disease-treatment pairs: the genetic modification of autologous hematopoietic stem cells including autologous bone marrow transplantation (ABMT), for the therapy of sickly cell disease; and the use of an inhaled modified adenovirus as gene vector for the pulmonary manifestation of cystic fibrosis. Close examination and comparison of these two cases - one prospective and one in clinical trials - will help us illuminate the broad social as well as scientific context that must be appreciated by individuals and institutions before sound policies can be devised and informed decisions made.