title: First-in-human cell transplant trials in Parkinson's disease: The need for an improved informed consent process.
abstract: First-in-human clinical trials of innovative medical procedures, such as cell transplantation for Parkinson's disease, present a variety of ethical challenges. In an era of rapidly developing stem cell technologies likely to be translated into clinical trials over the next few years, it is critical that ethical concerns be fully considered. One important undertaking is ensuring that research participants give free and truly informed consent. This will necessitate adequate disclosure of risks and benefits at a time when these are incompletely defined; ensuring understanding of a complex research protocol when there is significant possibility of therapeutic misconception; and careful determination of capacity for informed consent in patients with a neurodegenerative disorder that is known to affect cognition. Here we call attention to the ethical issues that researchers conducting these types of trials will face when trying to obtain a genuinely informed consent, and we suggest possible solutions.
authors.affiliation: Division of Medical Ethics, Department of Medicine, Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065, USA. Electronic address: imd2001@med.cornell.edu.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: de Melo-Martín
authors.affiliation: Weill Cornell Parkinson's Disease and Movement Disorders Institute, Department of Neurology, Weill Cornell Medical College, 428 East 72nd Street, Suite 400, New York, NY 10021, USA. Electronic address: nah9011@med.cornell.edu.
authors.forename: Natalie
authors.initials: N
authors.lastname: Hellmers
authors.affiliation: Weill Cornell Parkinson's Disease and Movement Disorders Institute, Department of Neurology, Weill Cornell Medical College, 428 East 72nd Street, Suite 400, New York, NY 10021, USA. Electronic address: clh2007@med.cornell.edu.
authors.forename: Claire
authors.initials: C
authors.lastname: Henchcliffe
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D010300:Parkinson Disease / Q000601:surgery*; D033581:Stem Cell Transplantation / Q000941:ethics*
keywords: Bioethics; Informed consent; Parkinson's disease; Stem cell; Transplantation