Human clinical trials are becoming an increasingly important part of the fast-changing field of implantable brain-computer interface (BCI) research. Testing to help determine safety and efficacy in the human body is the next step in the development of clinical BCI devices for treatment of neurologic conditions like stroke, spinal cord injury and amyotrophic lateral sclerosis (ALS). Because testing implantable BCIs in humans can sometimes have serious and/or unexpected impacts, developing a better understanding of risks and establishing best practices in this area of research is an ethical imperative.
A new paper released this month by CSNE members, Dr. Eran Klein and Dr. Jeffrey Ojemann, "Informed Consent in Implantable BCI Research: Identification of Research Risks and Recommendations for Development of Best Practices", aims to address these issues.
"The purpose of this paper is to stimulate discussion within the field of BCI research about informed consent practices. While everyone engaged in BCI research recognizes that informed consent is needed, not everyone may have thought about special challenges that BCI research may present and how to address them," said Klein, a leader of the CSNE's Neuroethics Research Thrust.
As described in Klein and Ojemann's paper, informed consent is an ethical and legal requirement for conduct of clinical research. Information about a test subject's medical condition, therapeutic options, and potential risks and benefits of research participation must be disclosed. Subjects must also have the capacity to understand, appreciate and make a reasoned decision to enroll in a research study, and the decision to participate in a research study must be voluntary and free of undue influence.
Though some early investigators in implantable BCI research have begun to develop and share informed consent processes, best practices for informed consent in implantable BCI research do not yet exist. As implantable BCI research increasingly moves into clinical trials, Klein and Ojemann believe that now is an opportune time to think broadly and systematically about informed consent in BCI research.
In their paper, Klein and Ojemann focus on identifying research risks associated with an implantable BCI, arguing that understanding safety and other research-related risks is a critical part of ensuring meaningful and informed consent processes. The preliminary framework of safety and other research-related risks articulated in the paper serves as a starting point to stimulate discussion about developing best practices.
The paper also offers a framework of recommended guidelines for informed consent in implantable BCI research. Recommendations include:
- having multidisciplinary teams work together to develop a communal understanding of BCI research risks and ways to communicate these risks effectively to subjects.
- noting that consent practices in BCI can benefit from systematic collection and sharing of risk data.
- thinking of informed consent in research as a process, rather than a discrete event.
- taking social and familial relationships into account. Participation in BCI research can make substantial demands on caregivers, sometimes causing undue burdens or affecting their relationship with the test subject in unexpected ways.
- pointing out that understanding BCI research risks will involve exploration of preferences, values and meaning with potential test subjects.
- noting that subjects may need help to engage in the kind of imaginative exercises needed to consider the personal ramifications of participating in BCI research, particularly if subjects possess only a rudimentary understanding of the range of BCI capabilities.
"There are two important contributions that this paper makes. The first is to move people beyond thinking that disclosing safety risks is all that matters to informed consent. We argue that there are a number of other considerations — such as privacy, identity, unrealistic expectations — that are important for BCI research consent," said Klein. "The second contribution is to move the field toward best practices for research informed consent. We outline some ways that the discussion about best practices can move forward."
Development of ethical frameworks for neural engineering research, like the one this paper outlines, is an important part of the work at the CSNE. The CSNE's Neuroethics Research Thrust, which is co-led by Klein and Dr. Sara Goering, studies how ethical issues such as identity, privacy, authority and moral or legal responsibility are intertwined with neural technologies.