title: Gene therapy and informed consent decision making: nursing research directions.
abstract: Recent gene therapy clinical trials have demonstrated significant promise for treating a number of genetic neuromuscular disorders. Although nurses are experienced in educating patients and families about the benefits and risks of conventional therapeutics, there are significant challenges for guiding patients through the decision-making phase of gene therapy clinical trial participation. The first part of this review provides an overview and update on neuromuscular gene therapy, including viral delivery principles and historical progress. The second part discusses risk/benefit perception of gene therapy and factors affecting the decision making for patients interested in participating in a trial. Future challenges for gene therapy are targeted high-efficiency delivery, and additional research on developing patient-centered decision support interventions.
authors.affiliation: College of Nursing, Department of Pediatrics, The Ohio State University, and Center for Gene Therapy, The Research Institute, Nationwide Children's Hospital, Columbus, OH 43210, USA.
authors.forename: Rita W
authors.initials: RW
authors.lastname: Kaspar
authors.forename: Celia E
authors.initials: CE
authors.lastname: Wills
authors.forename: Brian K
authors.initials: BK
authors.lastname: Kaspar
mesh_terms: D002986:Clinical Trials as Topic / Q000451:nursing / Q000523:psychology; D003657:Decision Making; D003661:Decision Support Techniques; D000229:Dependovirus / Q000235:genetics; D005544:Forecasting; D015316:Genetic Therapy / Q000379:methods / Q000451:nursing / Q000523:psychology; D005822:Genetic Vectors / Q000627:therapeutic use; D006301:Health Services Needs and Demand; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D009468:Neuromuscular Diseases / Q000235:genetics / Q000523:psychology / Q000628:therapy; D024802:Nurse's Role; D015399:Nursing Research / Q000458:organization & administration*; D010353:Patient Education as Topic; D010358:Patient Participation; D035842:Research Subjects; D012307:Risk Factors