Institutions that fund or conduct neuroscience research should incorporate ethical considerations into all stages of the process, according to the Presidential Commission for the Study of Bioethical Issues’ April 2014 report, Gray Matters, Integrative Approaches for Neuroscience, Ethics, and Society.
"It recommends identifying ethical issues as studies are designed, all the way through to the end stages of research, including publication and dissemination of results," says Nada Gligorov, PhD, assistant professor of medical education at Icahn School of Medicine at Mount Sinai in New York, NY.
Institutions must fund the inte-gration of ethics into neuroscience research, she argues. "These important and reasonable recommendations imply that ethicists will participate in research design, and will make efforts to identify research ethics issues before they arise," says Gligorov.
This can be done by hiring individuals with expertise in ethics for particular research projects, and by supporting research ethics consultation services. These could be utilized by anyone doing research at a particular academic center.
"Incorporating ethics early on in a budding researcher’s education promotes the idea that ethics is an integral part of science," Gligorov adds.
Bioethicists have role to play
With appropriate sub-specialty expertise, bioethicists "can be useful throughout the process," says Paul J. Ford, PhD, director of the NeuroEthics Program and director of education in the Cleveland Clinic’s Department of Bioethics.
"The educated bioethicist can help provide guidance concerning ethical implications of early research," says Ford. Similarly, clinical ethicists can provide input into the implementation of clinical research protocols. Research-ers in ethics, such as Ethical, Legal, and Social Implications (ELSI) researchers, can provide helpful insights into choices that guide larger policy issues.
"Conceptualizing ethical issues as intrinsic to scientific research and inquiry, as recommended in the report, is beneficial for a number of reasons," says Gligorov.
This could help prevent ethical problems from arising in the first place. "It might also change how research ethics is conceived — moving it away from oversight and punishment to foresight and prevention," says Gligorov.
Lapses negatively impact research
Lack of trust in researchers and research institutions is one of the factors contributing to the underrepresentation of minority groups in research, notes Gligorov. "History teaches us that each additional research ethics scandal undermines scientific progress," she says.
Gligorov says one issue to consider is whether research in neuroscience is different in ethically relevant ways from other areas of research.
The commission acknowledges that the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative raises ethical issues, including consciousness, personal identity, and privacy. "But it is yet to be established that any of those are concerns raised in a unique way by research in neuro-science," says Gligorov.
Ford recommends that institutions use these approaches to address the unique ethical considerations involving neuroscience research:
- Ensure that ethics play a prom-inent role when setting research agendas.
"From the earliest stages, we need explicit value choices about the benefits and risks that are downstream from the research," Ford says.
- Explicitly require a section on grant applications outlining reasonably expected ethical implications of the science.
"Earmarking money for ethics components, as was done in the area of genetics, would assure work is being done on these issues that is proactive rather than reactive," says Ford.
- Incorporate stakeholders in discussions about research goals in the early stages of clinical neuroscience research.
- Consider the tendency for media coverage to promote unrealistic ex-pectations.
Currently, there is a tendency to highlight the abnormally good individual outcomes rather than attempting to show the average outcomes, argues Ford. "While celebrating the amazing advancements in the neurosciences, we should continue to acknowledge the limitations of the science," he says.
- Find ways to improve ethical analysis to determine when animal models are not similar enough to human disease.
"In designing trials, there are a number of ethical choices about the level of knowledge that is acceptable — in particular, whether the double blind placebo-controlled trial really is a necessity for how sure we need to be," Ford adds.
- Address the mortality risk posed by research involving serious diseases, such as major depression.
"Although we need to protect subjects from unnecessary harm, we also need to recognize whether the harm of the research is more or less than the risk they are at from the disease," says Ford.
There will always be competing interests between individual goals and societal interests, acknowledges Ford. Individual researchers may hesitate to put aspects of their field under scrutiny, for fear of losing support.
"We need to be careful that ethical considerations do not stop us from moving forward with helpful research," says Ford. "We do not want to create bureaucratic steps that unreasonably slow down progress."
- Paul J. Ford, PhD, Director of Education, Department of Bioethics, Cleveland (OH) Clinic. Phone: (216) 444-8723 E-mail: [email protected].
- Nada Gligorov, PhD, Assistant Professor of Medical Education, Icahn School of Medicine at Mount Sinai, New York, NY. Phone: (212) 241-8895. Fax: (212) 241-5028. E-mail: [email protected].
