This is a Shannon award providing partial support for the research projects that fall short of the assigned Institute's funding range but are in the margin of excellence. The Shannon award is intended to provide support to test the feasibility of the approach; develop further tests and refine research techniques; perform secondary analysis of available data sets; or conduct discrete projects that can demonstrate the PI's research capabilities or lend additional weight to an already meritorious application. The abstract below is taken from the original document submitted by the principal investigator. DESCRIPTION (Adapted from Investigator's Abstract): Within the last decade, a variety of gene therapies have been envisioned for an ever- widening spectrum of diseases. By "gene therapies: they mean the modification, with therapeutic intent, of human genes within somatic cells. How can physicians and patients, researchers and subjects, institutions and policy makers make informed decisions about the use of the wide variety of emerging gene therapies? Dr. Churchill's thesis is that gene therapies raise new and nontrivial ethical concerns that cannot be accounted for by the current legal and ethical framework for informed consent. More specifically, he will challenge and test the Belmont Report's distinction between research and treatment as a basis for informed consent policy. This project aims: 1) to produce an interdisciplinary evaluation of informed decision-making about gene therapies; and 2) to develop new policies to guide decisions about the presentation and use of these new therapies. To achieve these aims, Dr. Churchill and colleagues will study the legal and ethical development of informed consent doctrine for research and therapy over the past half century. They will undertake a comparative social and historical analysis of two disease-treatment pairs: the genetic modification of autologous hematopoietic stem cells including autologous bone marrow transplantation for the therapy of sickle 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 them 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. The products of the project will be: 1) legal, ethical, social, and historical analyses, published in the scholarly literature, and 2) the formation of new policy for informed decision making about gene therapy, in collaboration with a panel of consultants.