Giving and Taking Away: Mapping Ethical Recommendations for Addressing Emotional Retraumatization in Bionics Research

Cleveland Clinic Lerner Com-Cwru, Cleveland OH

Investigators

Abstract

ABSTRACT As investigations into emerging bionic technologies continue, it is imperative to understand and transparently inform potential research participants and future patients about the risks and possible side effects of bionic interventions. This transdisciplinary study combines methods from empirical bioethics and cognitive bionics to achieve two overarching goals. The first will be to document potential risks of retraumatization of research participants in bionic research that restores an embodied experience, changes it, or removes it. Thus, allowing investigational bionic technology researchers to anticipate and plan for ethical approaches in the future that can be outlined in the informed consent processes. The second, will establish standards for evaluating, disclosing, and mitigating intended and unintended effects of perceptual modulation to guide informed consent for bionic research and clinical interventions. The development of standards for ethically appropriate disclosure of intended and unintended effects and psychosocial risks associated with use of cognitive bionic technologies will be informed by stakeholders in biotechnology research. Stakeholders include those with lived experience participating in bionic device research and experts in biomedical engineering, clinical translational research, bioethics, research oversight specialists, and statistics. In connection with the objective to address ethical issues pertaining to informed consent practices, the proposed project elicits participant perspectives on the informed consent process in research into emerging biotechnologies and guides risk/benefit analyses to strengthen informed consent practices for bionic device research. Ultimately, this research will provide practical guidance to biotechnology developers, sponsors, and research oversight bodies regarding ethically optimal approaches to informing prospective bionic research participants and future users of bionic technologies about implications for user well-being.