Challenges to Informed Consent in First-In-Human Trials Involving Novel Treatments: A Case Study of Parkinson’s Disease

摘要

Obtaining informed consent in clinical trials can be challenging both for researchers and for patients, albeit in different ways. The challenge concerns not only how to provide the needed information, but also what information to focus on when dealing with individual patients who have different goals, needs, histories, etc. This paper aims to contribute to a better informed consent process for Parkinson’s patients taking part in first-in-human clinical trials of cell replacement therapies. It outlines a range of problems which patients and researchers may face in this process and provides practical advice to researchers engaged in such trials.