Claire Henchcliffe
Weill Cornell Medical College, USA
Title: How can we improve the informed consent process for first-in-human stem cell trials in Parkinson’s disease?
Biography
Biography: Claire Henchcliffe
Abstract
Neurorestorative approaches in Parkinson’s disease (PD) based upon new stemcell technologies are imminent. As clinicaltrials are starting, it is critical to consider how to best ensure a genuinely informed consent.We therefore focused upon current barriers to such a goal and identified the following themes:
(1)Barriers to adequate disclosure of risks and benefits(investigator-dependent): In first-in-human trials, risks and benefits are incompletely defined. A substantial literature in fetal tissue transplant in PD is only partially applicable, and the possibility of serious risks remains, including tumor formation, graft rejection, and risks of immunosuppressive agents if administered.
(2)Barriers to understanding clinical research methodology(participant-dependent):Research participants may have difficulties understanding concepts integral to clinical research, such as equipoise. There is also strong evidence that the therapeutic misconception influenced participant’s consent in previous surgical trials in PD. Cognitive dysfunction, common in PD, may or may not impair understanding of informed consent information, thus complicating evaluation of capacity to consent.
(3) Need for extended consent process (investigator and participant-dependent): The traditional model of a single limited visit to address informed consent appears to be insufficient in upcoming clinical trials that involve complex scientific underpinnings, uncertainty in risks and benefits, and recruitment of participants with a neurodegenerative disorder that commonly affects cognition. Extended informed consent processes to consider include the use of multimedia educational materials, assignation of a “research partner”, and multiple disclosure sessions.