By Stacey Kusterbeck
Technology is advancing rapidly for enhancement of brain function in healthy people, but remains ethically controversial. “While the potential of these technologies is exciting, ethical concerns and lack of comprehensive long-term data make their use for cognitive enhancement in healthy people a highly controversial subject,” says Markus Ploesser, MD, chief innovation officer at Open Mind Health.
Ethical oversight has struggled to keep pace with technological innovation. While technologies have evolved swiftly, there is a lack of ethical guidelines specific to their use for enhancement in healthy individuals. Currently, neuromodulation devices are being implanted for clinical or research purposes to improve a medical condition or to restore a function that has been lost. “We should, however, start to consider the framework by which we would evaluate concepts around surgery in healthy patients for pure cognitive enhancement, since there are currently clearly defined efforts in the industry sector who aim to accomplish this on a larger timescale,” says Sharona Ben-haim, MD, a neurosurgeon and associate program director of neurosurgery training at UC San Diego.
Ploesser, Ben-haim, and colleagues reviewed 23 articles to look at the ethical concerns related to electrical and magnetic neuromodulation technologies and brain-computer interfaces used to enhance brain function in healthy individuals.1 The review identified these as the most hotly debated, controversial ethical issues:
Lack of sufficient safety and efficacy data.
“There is little robust evidence supporting long-term cognitive gains at this point in time from these technologies, which raises questions about their justification,” says Ploesser.
The potential for long-term risks (like neural damage or psychological effects) is not fully understood. The possibility of unintended negative effects makes application in healthy individuals ethically controversial. “Brain enhancement could result in impairments in cognitive function or the emergence of unexpected risks that are not yet fully understood,” warns Ploesser.
Socioeconomic disparities that could deepen existing inequalities.
“There is significant concern that these technologies could widen the gap between those who can afford cognitive enhancements and those who cannot, deepening existing social inequities,” says Ploesser.
Cognitive enhancement technologies could exacerbate existing inequalities. The concern is that only wealthy individuals or certain populations will end up having access to them. “This could lead to social stratification based on cognitive abilities,” explains Ploesser. Additionally, enhanced cognitive abilities could give some individuals an unfair advantage in education, employment, or other areas of life. That prospect raises concerns about the fairness of these enhancements.
“The possibility of altering cognitive functions raises questions about how we define personhood and identity. Enhancement could blur the lines between what is natural and artificially created cognitive ability,” adds Ploesser.
Autonomy and freedom.
“Ethical debates arise over the potential for societal or professional pressures that might drive people to undergo enhancements to remain competitive, potentially infringing on individual autonomy,” says Ploesser.
Ploesser says that Institutional Review Boards (IRBs) reviewing protocols for studies on brain-enhancing technologies should ask these questions:
What is the evidence of safety for healthy participants?
“Since the use of these technologies is often not clinically necessary, safety data should be especially robust,” says Ploesser.
How are potential long-term effects being studied?
“It’s vital to account for the possibility of long-term side effects. Protocols should include mechanisms for follow-up over extended periods, even post-study,” says Ploesser. Since the technologies are relatively new, their long-term safety profile is not well-understood, especially in healthy individuals. “This raises concerns about introducing permanent neurological changes or cognitive deficits,” says Ploesser. Study protocols should include adequate monitoring for potential long-term cognitive, psychological, or neurological consequences.
In any study involving a novel, long-term implanted device, there is always a risk that the device may need to be explanted. It could become necessary because of lack of efficacy, or because of lack of long-term infrastructure support for the device itself, even if it is effective. “These unique risks must be clearly delineated, with a future plan outlined for possible scenarios,” says Ben-haim.
What is the risk/benefit ratio?
IRBs must scrutinize whether the potential cognitive benefits justify the risks for enhancement that is not medically necessary. Researchers should clearly define how they assess the balance between potential enhancement effects and any associated risks. “In many cases, the cognitive gains may be minimal or transient, while risks could be more enduring,” notes Ploesser.
How is informed consent structured?
Participants may not fully understand the risks or the experimental nature of the enhancement, given the relative novelty of the technologies and the unpredictability of outcomes. “The complexity and experimental nature of these technologies make it imperative that participants are fully informed, and able to consent with a clear understanding of potential risks and uncertainties,” underscores Ploesser.
What protections exist against potential coercion?
Since enhanced cognition could offer competitive advantages, there could be indirect societal or professional pressures on individuals to participate. “IRBs should address the potential for subtle coercion,” says Ploesser.
Typically, studies assess the potential risks of an intervention against the potential benefit of getting closer to “normal.” “Most of the clinical research we look at is designed to test interventions to cure or treat a disease or condition, to return someone to a normal level of function or longevity,” says Lindsay McNair, MD, MPH, principal consultant at Equipoise Consulting. That might mean decreasing pain, extending survival, or stopping vision loss. In enhancement studies, the participant already is “normal.” “It can be harder to make a determination of what potential risks would be acceptable against the potential benefit of being ‘better than normal,’” says McNair.
IRBs and research ethics committees need to ensure that risks for study participants are reasonable. “The most conservative approach would be to say that no risks are reasonable if there is nothing to treat or cure,” says McNair. However, IRBs also must consider the autonomy of persons to make decisions to undergo treatments or procedures if the risk/benefit comparison is acceptable to them.
IRBs also need to remember that they are reviewing the research study itself, not the possible downstream uses (or misuses) of the information that will result from the study. “The regulatory criteria for the approval of research that IRBs should be following makes this clear,” says McNair. According to federal regulations, possible long-range effects of applying knowledge gained in the research are not among the research risks that fall within the IRB’s purview.2 For example, it might be possible to extrapolate that enhancement research could eventually be used to create an army of super-soldiers or a society in which non-enhanced persons face discrimination. “But those hypothetical future uses and concerns should not be a consideration in review of the actual research project being proposed,” explains McNair.
REFERENCES
- Ploesser M, Abraham ME, Broekman MLD, et al. Electrical and magnetic neuromodulation technologies and brain-computer interfaces: Ethical considerations for enhancement of brain function in healthy people — a systematic scoping review. Stereotact Funct Neurosurg. 2024;102(5):308-324.
- Code of Federal Regulations. Criteria for IRB approval of research. 45 CFR § 46.111(a)(2) (2023).
