Legal and ethical issues in neuroimaging research: human subjects protection, medical privacy, and the public communication of research results
Introduction
Current efforts to delineate the field of “neuroethics” reflect an emerging view that ethical problems in the neurosciences merit a distinct domain within the broader arena of bioethics (Stanford Center for Bioethics, 2002). As evidenced by this special issue of the journal Brain and Cognition, neuroimaging techniques are a logical focus for this new “neuroethical” inquiry, given the capacity of imaging technology to animate mind–brain relationships in ways that compel us to reexamine concepts of identity, personal responsibility, and criminal culpability.
Although neuroimaging in medicine gives rise to important ethical concerns—many of which are addressed by other authors in this volume—the use of neuroimaging in clinical research merits the special attention of neuroethicists. At present, all research involving human subjects2 is the focus of intense scrutiny by regulators and policymakers, following a spate of compliance enforcement actions at major research institutions and a wave of lawsuits by aggrieved research participants. Plaintiffs’ attorneys, bioethicists, and politicians have proposed various reforms, but the credibility of clinical research must be sustained by those who conduct it. Unless busy investigators take the time to understand regulatory requirements, and, equally important, unless they participate in developing ethical standards specific to their fields of research, groundbreaking work will be impeded by the growing perception that research participation involves unmitigated conflict of interest and unreasonable risk.
This paper will consider neuroethics from the perspective of the neuroimaging investigator whose research involves human subjects. The focus will be on three issues of contemporary significance in clinical research: compliance with regulatory requirements for the protection of human subjects, safeguarding privacy and confidentiality, and ethical behavior in the public communication of research results.
Section snippets
The use of human subjects in neuroimaging research
Neuroimaging studies may involve multiple disciplines (e.g., physics, neuroanatomy, neurophysiology, neuropsychology, neuropsychiatry, and radiology). The field encompasses many different modalities (e.g., PET, SPECT, MRI, fMRI, and EEG). Neuroimaging researchers may be basic scientists who study brain anatomy and physiology or develop new imaging techniques, or they may be clinicians who seek to diagnose brain disorders and explore brain–behavior relationships. Yet, regardless of the nature of
Privacy and confidentiality
Investigators have an ethical obligation to respect the privacy and safeguard the confidentiality of research subjects. Federal research regulations charge IRBs with the formal responsibility of assessing the risks to privacy and confidentiality in research (45 C.F.R. §46.111(a)(7)). When an investigator wishes to use identifiable records, test results, or other patient data without the consent of the data subjects, an IRB must review the proposed project and determined that it constitutes
Public communications
When applied to brain imaging research, “neuroethics” involves far more than regulatory compliance. The field of neuroimaging must also concern itself with the interface between the scientist and society. As policymakers, the courts, and the public become aware of imaging techniques and intrigued by this window into the living brain, researchers must avoid inadvertently fueling misconceptions about the power and promise of neuroimaging. This task is complicated by media accounts that portray
Conclusion
This paper has explored ethical issues of significance to neuroimaging researchers, including protections for human subjects, issues of privacy and confidentiality, and a researcher’s obligation to communicate science responsibly. Evolutions in the concept of what constitutes a “human subject” and the researcher’s legal duties to human subjects are topics of current interest in bioethics, with clear implications for neuroimaging researchers. As a result of recent legal developments, particular
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Former Director and Regulatory Counsel, Division of Biomedical and Health Sciences Research, Association of American Medical Colleges, 2450 N. St., N.W., Washington, DC 200037, USA.