Investigators Make Ethical Commitment for Neuroscience Research in Humans
There are “countless ethical questions and considerations with neuroscience research in humans,” according to Nader Pouratian, MD, PhD, a neurosurgeon at the University of Texas Southwestern Medical Center.
Pouratian is a member of a group of NIH-funded investigators, the Research Opportunities in Humans Consortium, working with intracranially acquired human neurophysiological data who agreed their work must be guided by foundational ethical principles.1 “We recognized that it is critical that we devote specific time, effort, and consideration to the ethical conduct of research,” Pouratian says. “While these are not entirely new concepts, it is easy to lose sight of these important concepts.”
One of Pouratian’s research colleagues, Ashley Feinsinger, PhD, says, “the field is rapidly growing and changing. This is an important time to define some shared foundational ethical commitments.”
More people will have devices implanted in their brains, and more parts of the brain will be open to research, according to Feinsinger, adjunct assistant professor at UCLA. “While researchers are taking advantage of these expanding opportunities, they are also committing to putting themselves as doctors first and to protect the rights of patients who make this research possible,” Feinsinger says.
The group identified two fundamental ethical commitments for researchers to abide by. First is ensuring the integrity of clinical care. “The primary concerns here are patient protection against abuse of power and compromising the care of the patient for research goals,” Feinsinger says.
For example, research interests may lead surgeon scientists to intentionally or unintentionally select brain implant locations that are different than what would be chosen based on clinical indications alone. “IRBs should be looking for practices that recognize that care and research are happening in the same space,” Feinsinger offers.
These practices could aim to ensure patients understand care and research are separate. “This could include explicit disclosures in consent about dual spaces and dual roles, or involving a team member who is not on the research team as a patient advocate,” Feinsinger suggests.
The second commitment is ensuring voluntariness. “Patients may trust their surgeon, the research team, and the institution, and they may defer to their surgeon in assessing the risks and benefits of participation,” Feinsinger notes.
The central ethical concern is patients will feel pressured to participate. This might be because of the patients’ misunderstanding of the separation of care and research, or because the patient feels obligated to help surgeons.
“IRBs should be looking for practices that maximize patients’ opportunities to discuss the research with team members, family members, and other clinicians not involved in the research,” Feinsinger says.
Ideally, practices promote continual consent and reconsent opportunities. For example, a protocol might include explicit opportunities to withdraw throughout the study. For intraoperative studies, patient participants could be formally asked to re-consent or reaffirm their participation just before it begins.
“We felt it was absolutely imperative that we not only accept these ethical concepts, but that as a group we share an explicit commitment to preserving and enhancing these overarching principles,” Pouratian reports.
Investigators also wanted to share their own experiences in promoting ethical conduct of research. “Many of us had evolved our practices, largely driven by ethical concerns. We had independently learned our own lessons,” Pouratian explains.
Pouratian no longer asks patients to consent to participate in research studies he leads. Instead, he introduces the concept of research and discusses medical risks with patients, but defers to a nonclinical research associate to obtain consent for research participation.
The group agreed there is not a uniform optimal way to conduct studies. “There are overarching principles of ethical conduct of human neuroscience research,” Pouratian says. “But the methods and implementations may vary across institutions.”
Practices may vary based on the research team, the study participants, institutional infrastructure, and the study goals. Researchers hope future investigators and IRBs will reference the guiding principles for ethical conduct of studies. “We anticipate that there will be further work developing on each of the concepts and principles raised,” Pouratian adds. “Specifically, we think there is much work still to be done to evaluate other stakeholder perspectives — patients, funders, and the public.”
REFERENCE
- Feinsinger A, Pouratian N, Ebadi H, et al. Ethical commitments, principles, and practices guiding intracranial neuroscientific research in humans. Neuron 2022;110:188-194.
There are overarching principles of ethical conduct of human neuroscience research, but the methods and implementations may vary across institutions.
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