Informed Consent and Sham Surgery as a Placebo in Fetal Cell Transplant Therapy Research for Parkinson’s Disease
Fetal cellular transplantation therapy research in Parkinson’s Disease has raised important ethical questions from its beginning. One of the most hotly debated aspects of the recent clinical research has been the use of sham surgery as a placebo for the control group. Ethicists and researchers have focused on the unique risk surgical placebos pose to research subjects as compared to conventional, medical placebos. This review will deal with informed consent and the use of use of sham surgery in the placebo arm of recent fetal tissue transplantation randomized, placebo controlled, double blind, clinical trials. Do current procedures for obtaining informed consent meet the challenge of adequately informing patients enrolling in experiments with significant risks not only in the experimental group but also in the placebo group?