title: Protecting subjects' interests in genetics research.
abstract: Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. Simultaneously, a significant shift of academic biomedical science toward commercialization has occurred, spurred by U.S. federal policy changes. The concurrent rise in both the roles that subjects play and the commercial interests they have presents numerous ethical challenges. We examine the interests of different research participants, finding that these interests are not addressed by current policies and practices. We conclude that all participants should be given a voice in decisions affecting ownership, access to, and use of commercialized products and services, and that researchers and institutions should negotiate issues relating to control of research results and the sharing of benefits before the research is performed.
authors.affiliation: Center for Bioethics, University of Pennsylvania, 3401 Market Street, Suite 320, Philadelphia, PA 19104-3308, USA. merz@mail.med.upenn.edu
authors.forename: Jon F
authors.initials: JF
authors.lastname: Merz
authors.forename: David
authors.initials: D
authors.lastname: Magnus
authors.forename: Mildred K
authors.initials: MK
authors.lastname: Cho
authors.forename: Arthur L
authors.initials: AL
authors.lastname: Caplan
mesh_terms: D000533:Altruism; D002140:California; D017825:Canavan Disease / Q000235:genetics; D004992:Ethics, Medical; D005106:Exploratory Behavior; D036281:Genetic Research; D005826:Genetics, Medical / Q000191:economics* / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends*; D006805:Human Experimentation / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D010330:Patents as Topic; D028701:Patient Rights / Q000331:legislation & jurisprudence / Q000639:trends; D011561:Pseudoxanthoma Elasticum / Q000235:genetics; D035842:Research Subjects; D012649:Self Concept; D019896:alpha 1-Antitrypsin Deficiency / Q000235:genetics