Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting

• DOI: 10.1371/journal.pone.0128209
• Publication Date: 2015-05-26T18:19:20Z
• Authors: Laurent Cleret de...; Sophie Sudraud; Christophe Verny; Pierre Krystkowiak; Clémence Simonin; Philippe Damier; Jean-François Dem...; Frédéric Supiot; Amandine Rialland; David Schmitz; Patrick Maison; Katia Youssov; Anne-Catherine Ba...
• Keywords: Adult; Male; Science; Psychologie appliquée; 03 medical and health sciences; 0302 clinical medicine; Belgium; Neural Stem Cells; Surveys and Questionnaires; Humans; Informed Consent; Q; R; Sciences bio-médicales et agricoles; Middle Aged; Allografts; 3. Good health; Adult; Allografts; Belgium; Female; Follow-Up Studies; France; Humans; Huntington Disease/therapy; Informed Consent; Male; Middle Aged; Neural Stem Cells/transplantation; Stem Cell Transplantation; Surveys and Questionnaires; Huntington Disease; Medicine; Female; France; Biologie; Research Article; Follow-Up Studies; Stem Cell Transplantation

Background There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders. Methods We performed a longitudinal study Huntington's disease patients during Multicenter Fetal Cell Intracerebral Grafting Trial Disease (MIG-HD) France Belgium. Patients their proxies completed questionnaire at inclusion, before signing form after one year follow-up, randomization transplantation. The explored understanding protocol, satisfaction with information delivered, reasons participating trial expectations regarding transplant. Forty-six 27 16 later. Results comprehension score was high similar inclusion (72.6% vs 77.8%; P > 0.1) but only decreased HD year. (73.5% 66.5%; correlated both proxies. motivation expectation profiles were remained unchanged Conclusions Cognitively impaired capable consenting participation this trial. This procedure has presumably strengthened should be proposed future gene or cell therapy Because potential cognitive decline, designated as provisional surrogate decision-makers, even competent patients.