Hostname: page-component-cd9895bd7-7cvxr Total loading time: 0 Render date: 2024-12-25T20:36:42.873Z Has data issue: false hasContentIssue false
  • English
  • Français

Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?

Published online by Cambridge University Press:  01 January 2021

Franklin G. Miller ,
Michelle M. Mello  and
Steven Joffe
Get access Rights & Permissions [Opens in a new window]

Extract

A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation?

Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that 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 the study.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 271 - 279
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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. M. et al, “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219–248; see also Illes, J. et al, “Incidental Findings in Brain Imaging Research,” Science 311, no. 5762 (2006): 783–784.CrossRefGoogle Scholar
Id. (Illes, et al)Google Scholar
Illes, J. et al, “Discovery and Disclosure of Incidental Findings in Neuroimaging Research,” Journal of Magnetic Resonance Imaging 20, no. 5 (2004): 743–747; Mamourian, A., “Incidental Findings on Research Functional MR Images: Should We Look?” American Journal of Neuroradiology 25, no. 4 (2004): 520–522.CrossRefGoogle Scholar
See Illes, et al, supra note 1; id. (Illes, et al); Illes, J. et al, “Ethical and Practical Considerations in Managing Incidental Findings in Functional Magnetic Resonance Imaging,” Brain & Cognition 50, no. 3 (2002): 358–365.CrossRefGoogle Scholar
Belsky, L. and Richardson, H. S., “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.CrossRefGoogle Scholar
Bovio, S. et al, “Prevalence of Adrenal Incidentaloma in a Contemporary Computerized Tomography Series,” Journal of Endocrinological Investigation 29, no. 4 (2006): 298–302.CrossRefGoogle Scholar
Beauchamp, T. L. and Childress, J. F., Principles of Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001).Google Scholar
Morreim, E. H., “The Clinical Investigator as Fiduciary: Discarding a Misguided Idea,” Journal of Law, Medicine & Ethics 33, no. 3 (2005): 586–598.CrossRefGoogle Scholar
See Beauchamp, and Childress, , supra note 7, at 168–170.Google Scholar
Scanlon, T. M., What We Owe to Each Other (Cambridge: Harvard University Press, 1980).Google Scholar
Id., at 224.Google Scholar
Id.Google Scholar
Zwitter, M. et al, “Professional and Public Attitudes towards Unsolicited Medical Intervention,” BMJ 318, no. 7178 (1999): 251–253.CrossRefGoogle Scholar
See Beauchamp, and Childress, , supra note 7, at 5–7.Google Scholar
Spaulding v. Zimmerman, 116 N.W.2d 704 (Minn. 1962).Google Scholar
See Belsky, and Richardson, (“Medical Researchers’ Ancillary Clinical Care Responsibilities”), supra note 5; Richardson, and Belsky, (“The Ancillary-Care Responsibilities of Medical Researchers”), supra note 5.Google Scholar
See Belsky, and Richardson, (“Medical Researchers’ Ancillary Clinical Care Responsibilities”), supra note 5.Google Scholar
See Richardson, and Belsky, (“The Ancillary-Care Responsibilities of Medical Researchers”), supra note 5.Google Scholar
Id., at 32.Google Scholar
Grossman, R. I. and Bernat, J. L., “Incidental Research Imaging Findings: Pandora's Costly Box,” Neurology 62, no. 6 (2004): 849–850.CrossRefGoogle Scholar
Kleinschmidt, A., “Incidental Neuroimaging Findings: Lessons from Brain Research in Volunteers,” Current Opinion in Neurology 20, no. 4 (2007): 387–389.CrossRefGoogle Scholar
Id.Google Scholar
Kirschen, M. P. et al, “Subjects’ Expectations in Neuroimaging Research,” Journal of Magnetic Resonance Imaging 23, no. 2 (2006): 205–209.CrossRefGoogle Scholar
Shalowitz, D. I. and Miller, F. G., “Disclosing Individual Results of Clinical Research: Implications of Respect for Participants,” JAMA 294, no. 6 (2005): 737–740.CrossRefGoogle Scholar
See Illes, et al, supra note 1.Google Scholar
Appelbaum, P. S. et al, “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” HastingsGoogle Scholar