The challenges of obtaining ethics approval for a randomized, double-blind, placebo-controlled research study in Jersey.

Abstract

Background and objective: A PhD project involving designing and implementing a small-scale clinical trial at Jersey General Hospital encountered a variety of difficulties in obtaining ethics approval due to Jersey's unique legal and constitutional position. Clarification of the necessary route of application took some 28 months. It was established that only local ethics approval is required for clinical trials taking place in the Channel Islands and that there is no need for Medicines and Healthcare products Regulatory Agency (MHRA) approval in the form of Clinical Trials Authorization (CTA), because Jersey falls outside the existing legal and regulatory framework. The experiences and findings gained from this project would prove of use to other researchers planning to conduct clinical trials in the Channel Islands.