Hostname: page-component-586b7cd67f-dlnhk Total loading time: 0 Render date: 2024-11-30T15:18:01.340Z Has data issue: false hasContentIssue false
  • English
  • Français

The Management of Incidental Findings in Neuro-Imaging Research: Framework and Recommendations

Published online by Cambridge University Press:  01 January 2021

Erica K. Rangel
Get access Rights & Permissions [Opens in a new window]

Extract

With improved diagnostic capability and accuracy, the fields of medicine, neuroscience, psychiatry, and psychology have benefitted remarkably from the dramatic advancements in neuroimaging technology. Not only can surface and subsurface structures of the brain be mapped with incredible anatomical detail (with magnetic resonance imaging), now neural activity can be imaged across time as the brain responds to different stimuli (with functional magnetic resonance imaging). These sophisticated techniques have been a vital element in the recent increase in neuroimaging-based research. This increase, while producing new diagnostic techniques and improved treatment mechanisms for neurological disease, has also led to a new dilemma for human subjects researchers: how should incidental findings be managed? An incidental finding (IF) is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of this study.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 1 , Spring 2010 , pp. 117 - 126
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Wolf, S. et al., “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law Medicine & Ethics 36, no. 2 (2008): 219–248, at 219.CrossRefGoogle Scholar
Vernooij, M. W. et al., “Incidental Findings in Brain MRI in the General Population,” New England Journal of Medicine 357, no. 18 (2007): 1821–1828; Kumra, S. et al., “Ethical and Practical Considerations in the Management of Incidental Findings in Pediatric MRI Studies,” Journal of the American Academy of Child and Adolescent Psychiatry 45, no. 8 (2006): 1000–1006; Illes, J. et al., “Ethical Consideration of Incidental Findings on Adult Brain MRI in Research,” Neurology 62, no. 6 (2004): 888–890; Weber, F. and Knopf, H., “Incidental Findings in Magnetic Resonance Imaging of the Brains of Healthy Young Men,” Journal of Neurological Sciences 240, no. 1 (2006): 81–84.CrossRefGoogle Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, U.S. Government Printing Office Washington, D.C., 1979.Google Scholar
Emanuel, E., Wendler, D., and Grady, C., “What Makes Clinical Research Ethical?” Journal of the American Medical Association 283, no. 20 (2000): 2701–2711, at 2701.CrossRefGoogle Scholar
Id.Google Scholar
Fried, C., Medical Experimentation: Personal Integrity and Social Policy (Amsterdam: North Holland Publishing Company, 1974).Google Scholar
Id., at 47.Google Scholar
Weijer, C. and Miller, P. B., “Therapeutic Obligation in Clinical Research,” The Hastings Center Report 33, no. 3 (2003): 3–4; Coleman, C. H., “Duties to Subjects in Clinical Research,” Vanderbilt Law Review 58, no. 2 (2005): 387–449; Freedman, B., Glass, K. C., and Weijer, C., “Placebo Orthodoxy in Clinical Research. II: Ethical, Legal and Regulatory Myths,” Journal of Law, Medicine & Ethics 24, no. 3 (2007): 252–259, at 253.Google Scholar
Morreim, H., “The Clinical Investigator as Fiduciary: Discarding a Misguided Idea,” Journal of Law, Medicine & Ethics 33, no. 3 (2005): 586–598.CrossRefGoogle Scholar
Illes, J. et al., “Practical Approaches to Incidental Findings in Brain Imaging Research,” Neurology 70, no. 5 (2008): 384–390; Beauchamp, T. and Childress, J., Principles of Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001): At 173–176.Google Scholar
Miller, F. G., Mello, M. M., and Joffe, S., “Incidental Findings in Human Subjects Research: What do Investigators Owe Participants?” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 271–279.CrossRefGoogle Scholar
Richardson, and Belsky, also recognize that all moral agents, not just clinicians or researchers, have the duty to rescue those in need, at least when one can provide the help without serious sacrifice or risk. For a philosophically compelling defense of a duty to rescue, see Scanlon, T. M., What We Owe to Each Other (Cambridge, MA: Harvard University Press, 1998). Richardson, and Belsky's, ancillary care duties are those that lie beyond these general duties to rescue and are specially incumbent on human subject researchers. Richardson, H. S. and Belsky, L., “Medical Researchers' Ancillary Clinical Care Responsibilities,” BMJ 328, no. 7454 (2004): 1494–1496. Richardson, H. S. and Belsky, L., “The Ancillary Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care That Researchers Owe Their Subjects,”” Hastings Center Report 34, no. 1 (2004): 25–33.Google Scholar
Id. (Richardson, and Belsky, , “Medical Researchers' Ancillary Clinical Care Responsibilities”), at 26.Google Scholar
As will be addressed later in the paper, I distinguish between anticipated and unanticipated IFs. Ancillary care will only create obligations for unanticipated IFs, while other research ethics standards will govern anticipated IFs.Google Scholar
See Richardson, and Belsky, , “Medical Researchers' Ancillary Clinical Care Responsibilities,” supra note 12, at 27.Google Scholar
Id., at 30.Google Scholar
Id.Google Scholar
See Weijer, and Miller, , supra note 8.Google Scholar
See Emanuel, et al., supra note 4.Google Scholar
Id.; Miller, F. G. and Brody, H., “A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials,” Hastings Center Report 33, no. 3 (2003): 19–28, at 26.CrossRefGoogle Scholar
Richardson, H. S., “Incidental Findings and Ancillary Care Obligations,” Journal of Law Medicine & Ethics 36, no. 2 (2008): 256–270, at 259.CrossRefGoogle Scholar
Royal, J. M. and Peterson, B. S., “The Risks and Benefits of Searching for Incidental Findings in MRI Research Scans,” Journal of Law Medicine & Ethics 36, no. 2 (2008): 305–314, at 306.CrossRefGoogle Scholar
Katzman, G., Dagher, A. P., and Patronas, N. J., “Incidental Findings on Brain Magnetic Resonance Imaging from 1000 Asymptomatic Volunteers,” JAMA 282, no. 1 (1999): 36–39, at 36.CrossRefGoogle Scholar
Illes, J., Desmond, J. E., Huang, L. F., Raffin, T. A., and Atlas, S. W., “Ethical and Practical Considerations in Managing Incidental Findings in Functional Magnetic Resonance Imaging,” Brain and Cognition 50, no. 3 (2002): 358–365; Kim, B. S., Illes, J., Kaplan, R. T., Reiss, A., and Atlas, S. W., “Neurologic Findings on Brain Magnetic Imaging from 1000 Asymptomatic Volunteers,” JAMA 282, no. 1 (2002): 36–39; see Katzman, et al., supra note 23; Illes, J., Kim, B. S., Kaplan, R. T., Reiss, A., and Atlas, S. W., “Neurologic Findings in Healthy Children on Pediatric fMRI: Incidence and Significance,” International Society for Magnetic Resonance Imaging 23, no. 1 (2002): 1–4.CrossRefGoogle Scholar
Illes, J. and Chin, V. N., “Bridging Philosophical and Practical Implications of Incidental Findings in Brain Research,” Journal of Law Medicine & Ethics 36, no. 2 (2008): 298–304, at 303.CrossRefGoogle Scholar
See Wolf, et al., supra note 1; NIH Conference Proceedings, Detection and Disclosure of Incidental Findings in Neuroimaging Research, 2005; see Royal, and Peterson, , supra note 22.Google Scholar
Parker, L., “The Future of Incidental Findings: Should They Be Viewed as Benefits?” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 341–351.CrossRefGoogle Scholar
King, N. M. P., “Defining and Describing Benefit Appropriately in Clinical Trials,” Journal of Law Medicine & Ethics 28, no. 4 (2000): 332–343, at 338.CrossRefGoogle Scholar
See Emanuel, et al., supra note 4, at 2706.Google Scholar
45 CRR 46.116, 2007; 21 CFR 50.20, 2007.Google Scholar