SA Forum is an invited essay from experts on topical issues in science and technology.

Our society is running into problems with brain research. To identify new treatments for stroke, for instance, clinical trials need to enroll stroke victims. But the brain damage in these patients that makes them good candidates for trials can also render them incapable of consenting, in a valid, informed manner, to participation. So how can medical science advance? 

There are other dilemmas: A 2005 U.S. Supreme Court ruling noted that juveniles lack fully matured brains and therefore cannot receive the death penalty in criminal cases that would otherwise warrant it. Should adult defendants be able to offer neuroscience evidence to persuade juries that they too should be excused? And should the drug modafinil, used to treat patients with narcolepsy, also be used to boost a healthy student’s performance in school?

Brain research is opening dazzling frontiers in health, but crossing into that territory raises a particularly thorny set of ethical concerns. President Obama has called upon bioethicists to join with neuroscientists to take up these challenges as a part of his BRAIN Initiative, a public-private collaboration to map how all neural circuits interact at the speed of thought. In response, the Presidential Commission for the Study of Bioethical Issues, which I chair, has today released a report identifying three critical areas where we need new policies and guidelines: Informed consent, neuroscience in court, and cognitive enhancements.

The capacity for consent. To realize the promise of preventing, treating, and curing human brain disorders, neuroscientists need to conduct research. While well-established ethical guidelines require that participants give fully informed consent before enrolling in research, many of the participants in brain studies have an impaired capacity to do so. Stroke is one example, and Alzheimer’s disease is another.  How do researchers ethically conduct studies with people who suffer from advanced Alzheimer’s disease, which can prevent their ability to understand and consent to the studies? 

The bioethics commission recommends that research should include persons with impaired capacity but only with appropriate ethical protections in place. Federal regulations require permission from a legally authorized representative if research participants cannot provide their voluntary informed consent. However, laws are very unclear about who can serve as such a representative, and this leaves a gap in patient protection that impedes vitally important science. Laws need to provide more clarity. In addition, we recommend more research on the factors that play a role in decision-making capacity to better assess when and whether that capacity is present. 

Neuroscience and the legal system. Defendants have offered neuroscience evidence during trials  to persuade juries that they might not be blameworthy, and should not be convicted of certain crimes. When the Supreme Court ruled that teenagers’ underdeveloped brains excuse them from the most severe criminal penalty, that reasoning could potentially excuse adults with underdeveloped or injured brains. Examples like these highlight the importance of ensuring that neuroscience is sufficiently reliable and ready for application to the legal system. Yet it is not clear what neuroscience evidence is mature enough for such use. The bioethics commission recommends funding research to elucidate both the ethical contributions and limitations of neuroscience in court. In addition, the commission recommends training modules for lawyers, judges, and jurors to help them understand what neuroscience can and cannot tell us.

Neural modification and cognitive enhancement. Our commission believes the discussion of enhancement needs to include all forms of neural modification, which is any intervention—such as medication, stimulation, or surgery--that changes the brain. There is a debate within society about the appropriateness of enhancing cognition.  Some people argue that it contributes to individual and societal benefit. Others, however, worry that using drugs to improve cognition is akin to cheating, or might diminish the value of personal achievement. The narcolepsy drug modafinil, which may also improve cognitive abilities of healthy schoolchildren, shows this debate will only escalate in the future without guidance. The bioethics commission recommends that each neural modifier needs to be assessed in detail to determine whether and why it is potentially safe and effective for a specific purpose, or whether it is problematic. Medical organizations should develop guidelines, which are now sorely lacking, about the risks and benefits of these modifiers. The commission also recommends that once a novel neural modifier is proven safe and beneficial, policymakers take steps to ensure that financial or social barriers do not prevent access to it.

The BRAIN Initiative is uniquely positioned to support multidisciplinary teams that can fill these crucial gaps with research and education. The bioethics commission’s first volume on neuroscience (Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society), released in May 2014, called for early and explicit integration of ethics into the neuroscience research endeavor. To ensure that modern brain science both serves the public good and gains the public’s support, we must thoughtfully tackle the most challenging ethical questions surrounding it. Only if we strongly support neuroscientists and bioethicists working collaboratively together can we expect them to answer these difficult questions and put the unlocked secrets of the human brain to the most ethical and beneficial use.

Amy Gutmann, president of the University of Pennsylvania, is chair of the Presidential Commission for the Study of Bioethical Issues.