Our article with recommendations for improving the informed consent forms (ICFs) for medical devices clinical trials is now out.
The purpose of our work was to provide overview of the regulatory requirements for ICFs for the USA, UK, EU, Taiwan and Malaysia as of Dec 2024. In addition, we provide practical advice and examples of how to design the ICFs for medical device clinical trials which is something that is missing at the moment. Our publication also touches on some ethical aspects of using vulnerable participants in clinical research.
As part of our review we have created 2 checklists which could help biotech companies improve their standard operating procedures (SOPs) and have a harmonised approach in their global clinical trials ICF development.
You can find our article here.
We would like to express our gratitude to the members of Welsh Research Ethics Committees and clinical trials team from University Hospital Southampton NHS Foundation Trust for their valuable feedback and support.
