Ethics

The LUMINOUS project raises a number of ethical issues related to experiments with human subjects that have diverse disorders of consciousness.

In the near term, the primary ethical issues raised by LUMINOUS relate to safety and privacy of the participants in the experimental campaigns. In this front, the consortium has defined an external Ethical Advisory Board (EAB from now on) that will oversight the ethical and legal aspects of all the experimental research. In particular, all experimental procedures conducted in LUMINOUS will undertake the ethical review process described in Figure 1. Shortly, the ethical review process consists of a two-step process: first, the EAB will review the documentation and to issue an ethical approval. After an EAB approval, the applicable ethics committees at the national level will have to review again and issue the final approval. The experiment will only be executed after it has been reviewed and approved by the two entities.

Figure 1: Workflow for acquiring an ethical approval for experimental campaigns conducted within Luminous

 

The members of the external EAB will work independently of the investigators in LUMINOUS. They will provide an evaluation of the code of conduct towards participants and confirm that the documentation associated to the experimental procedures is compliant to international ethical and regulatory standards.

As agreed among all consortium partners, the members of the Ethics Advisory Board are the following:

Member	Affiliation	Expertise
Wim Pinxten (president of the EAB)	Univesity of Hasselt Department Medicine and Life Sciences Diepenbeek, Belgium	Ethical aspects of biomedical research
Aldo Amantini	Azienda Ospedaliero Universitaria Careggi Department of Neuroscience Florence, Italy	Neurophysiopathology
Friedhelm Hummel	University Medical Center Hamburg-Eppendorf Department of Neurology Hamburg, Germany	Neurology
Wilhelm Vossenkuhl	Ludwig Maximilians University Faculty of Law Munich, Germany	Philosophy of science, ethics, moral identity, self-will, ethics of medical practice, philosophy

In the longer term, LUMINOUS related technologies and research could raise ethical issues concerning social interactions and concepts of personhood. Interactions with patients with disorders of consciousness, anesthesia monitoring and fetal development are based on the current understanding of what is consciousness, which crucially depends on the clinical examination by a specialist. The research in LUMINOUS touches several of these aspects, opening a discussion with profound ethical impact in terms of treatment of pain, end-of-life policies and medical management in general. These interactions will be analyzed in the WP4 through the development of LUMINOUS project.