Audrey Van Scharen (Belgium)
University Hospital Brussels
Medical Ethics
Audrey Van Scharen, graduated Master in Political Sciences at the Vrije Universiteit Brussel (2008). While working at science communication department of the research department (RD)at Vrije Universiteit Brussels (VUB) from 2010 to 2018, she obtained her Master in Laws. While studying Law she got the opportunity to create the Ethics in research department at the VUB. She followed the growth and importance Belgian, European and international funding organizations and publishers gave in responsible research: legal compliance, ethics principles, scientific integrity and transparency in research. While working at the research department of the Vrije Universiteit Brussel (VUB). She noticed researchers had a lot of questions on the use of data. She decided to obtain a Data Protection Officer (DPO) certificate. The awareness on privacy legislation in research was low at that time, but she noticed the change (for the good or the bad(?)) the GDPR brought with its creation in 2016. Given her experience in data protection she started the implementation process for the GDPR at the VUB. Currently she is still a DPO for the National Belgian Council of Doctors and the National Belgian Council of Pharmacists in Belgium, where she advises on the use of health data in both professional orders. In the University Hospital Brussels, she is the Manager in Ethics and Research. She obtained that function after several years being a member of the medical ethics committee of the UZ Brussels (2015 - today). Currently vice-president of the Medical Ethics Committee University Hospital/VUB and vice-chair of the Health Ethics Committee of the University Hospital Brussels, she is still very close to the essential question researchers and healthcare professionals have in their legal and ethics compliance while preforming their professional activities. In the past years she noticed health care is confronting new challenges in ethics and legal compliance with the fast-growing technological possibilities in medical devices and data driven solutions. She chairs the Medical Device Framework Board of the University Hospital, advising on the implementation of the Medical Device Regulation, the In-Vitro Diagnostics Regulation, and the AI act. As an affiliated Professor to the Faculty of Health and Pharmacy of the Vrije Universiteit Brussel, she teaches Bioethics, Ethics in research and Ethics in Health Management and Policy where she aims to transfer her knowledge she gathers in daily practice to the students. Drawing on her practical experience in the field on ethics evaluations and the application of the CTR, GDPR, MDR, IVDR she started a PhD on the topic: “The sense and nonsense of Ethics Committees in health care" On the one side she will look at the focus of Belgian research ethics committees in an ethics review of innovative (bio)medical research and on the other side she will propose a best practice for the creation of ethics consultancy in healthcare in the University Hospital. She works on her PhD under supervision of Prof. dr. Pieter Cornu, Prof. dr. Maarten Moens, Prof. Dr. Michel Deneyer at the faculty of health of the VUB.

Presenter of 1 Presentation

 Conference Calendar

O028 - LEGAL, ETHICAL, AND DEONTOLOGICAL CHALLENGES FOR CLINICAL INVESTIGATIONS IN NEUROMODULATION FOR CHRONIC PAIN (ID 95)

Session Name
Oral Communications 6
Session Type
Oral Communications
Date
Sat, 02.09.2023
Session Time
16:15 - 17:15
Room
Hall C
Presenter
Lecture Time
16:25 - 16:35

Abstract

Introduction

During the last century, a considerable number of ethics codes have emerged, sometimes embedding legally binding instruments, sometimes encoding good clinical practice for the first time. Apart from the general ethical considerations in use of neuromodulatory devices, specific ethical standards should be applied in clinical trials using neuromodulation as treatment option for chronic pain. The specific, but sometimes debatable place of neuromodulation in the treatment algorithm in chronic, refractory pain, makes the inclusion of such vulnerable populations in trials unique, but requires a solid framework to concur the ethical concerns.

Adding to the ethics guidelines, regulators have tried to keep up in protecting the patient, user and society of possible risks related to such devices, namely in the protection of the patient's privacy and ensuring manufacturer responsibility during the whole lifecycle of the device. This area of research with medical devices has become a regulatory minefield that the suggestion has been made to create an academic discipline of ‘medical device science’.

This review aims to demonstrate the limits of ethics guidelines, the personal responsibility of the researcher and the usefulness of the legal, ethics and deontology frameworks for clinical investigations in neuromodulation.

Materials / Methods

In this narrative review, the authors take the reader thought the full research cycle for clinical investigations in neuromodulation; from the initiation of the research towards execution of the research and publication. In each topic the authors provide practical advices building on a multidisciplinary experience in clinical neuromodulation practice, social researchers and legal and ethics advisors.

Results

The article focusses on common hurdles, namely patient centered study designs, obtaining true informed consent, clear contracts between sponsors and research partners, fees to the patient and post-trial accessibility and support of the device, usefulness of standards, including placebo and sham interventions, expectations with respect to institutional review boards or ethics committees, and publication hygiene.

Discussion

This review clearly demonstrated that general ethical guidelines and legislation need an additional translation towards specific fields to be useful for clinicians and researchers with a background in medical device science.

Conclusions

Due to the increased number of guidelines with respect to medical devices, awarness of these regulations should be increased, whereby legal experts could provide valuable input in the future developments of clinical trials in the field of neuromodulation.

References

None.

Learning Objectives

1. To create awarness about the set of regulations (legal and ethical) with respect to medical devices.

2. To learn about all aspects of medical ethics, and to know how to safeguard these principles in every step in clinical research from initiating an idea, over execution a study to reporting results.

3. To be able to point out the gaps in current legislation.

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