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.