Hostname: page-component-586b7cd67f-t8hqh Total loading time: 0 Render date: 2024-11-28T14:57:46.002Z Has data issue: false hasContentIssue false

The Future of Incidental Findings: Should They be Viewed as Benefits?

Published online by Cambridge University Press:  01 January 2021

Extract

The possibility of generating incidental findings — in both research and clinical contexts — has long been regarded as a risk of these enterprises. Should incidental findings (IFs) in research also be regarded as potential benefits? At first glance, it would seem they ought to be. After all, in particular circumstances or given a particular set of values, any piece of information can be beneficial. Therefore, it may seem incoherent or unduly paternalistic to regard IFs only as risks. Moreover, developments in science and technology increasingly transform what was once of uncertain meaning and dubious value into information that is likely to have clear meaning and potential personal value, if not obvious clinical utility. For these reasons, it would seem that in the future, IFs should be treated as potential benefits in the design and regulation of research.

Type
Symposium
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

Illes, J. et al., “Incidental Findings in Brain Imaging Research,” Science 311, no. 5762 (2006): 783784.CrossRefGoogle Scholar
Davis, D., “The Changing Face of ‘Misattributed Paternity,’” Journal of Medicine and Philosophy 32, no. 4 (2007): 359373; Parker, L. S. and Majeske, R. A., “Incidental Findings: Patients’ Knowledge, Rights, and Preferences,” Journal of Clinical Ethics 6, no. 2 (1995): 176–179.CrossRefGoogle Scholar
Freedman, B., “Equipoise and the Ethics of Clinical Research,” New England Journal of Medicine 317, no. 3 (1987): 141145.CrossRefGoogle Scholar
Of course, sometimes IFs are managed according to a one-size-must-suit-all policy established at the institutional or clinic level. Nevertheless, such policies — like all clinical practice guidelines — should be developed with the welfare of the typical patient or majority of patients in mind.Google Scholar
Wolf, S. M. et al., “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219248. In 1993, the Office of Protection from Research Risks (OPRR) came close to this definition in its IRB Guidebook section on human genetic research, which described IFs as “genetic information that is learned during the course of the study that does not directly relate to the research.” U.S. Department of Health and Human Services, Office of Protection from Research Risks, Protecting Human Research Subjects: IRB Guidebook (Washington, D.C.: U.S. Government Printing Office, 1993): At 5–54.CrossRefGoogle Scholar
Lucassen, A. L. and Parker, M., “Revealing False Paternity: Some Ethical Considerations,” The Lancet 357, no. 9261 (2001): 10331035; see Davis, , supra note 2.CrossRefGoogle Scholar
Ross, L. F., “Disclosing Misattributed Paternity,” Bioethics 10, no. 2 (1996): 114130. Ross's argument would apply equally well to any finding of misattributed parentage or ancestry, although she focuses her argument on the most commonly discussed finding of paternity. Davis describes the range of harms and benefits associated with learning one's ancestry is different from what one had previously believed. See Davis, , supra note 2. Note that Ross makes her argument in support of disclosing misattributed paternity with regard to the context of clinical care, not research, where she generally finds a higher degree of paternalism appropriate. See Ross, , supra. Although there are points of similarity between them, clinical care and research contexts are importantly different. See, for example, Wolf, S. M. et al., “The Incidentalome,” JAMA 296, no. 23 (2006): 2800–2801.CrossRefGoogle Scholar
Wilson, J., “To Know or Not to Know? Genetic Ignorance, Autonomy and Paternalism,” Bioethics 19, nos. 5–6 (2005): 492504.CrossRefGoogle Scholar
Illes, J. et al., “Ethical and Practical Considerations in Managing Incidental Findings in Functional Magnetic Resonance Imaging,” Brain and Cognition 50, no. 3 (2002): 358365; Kim, B. S. et al., “Incidental Findings on Pediatric MR Images of the Brain,” American Journal of Neuroradiology 23, no. 10 (2002): 1674–1677.CrossRefGoogle Scholar
Indeed, it is because of the personal nature of the value of information, its subjective value, that Ross argues it is epistemically incoherent and inappropriately paternalistic not to disclose a finding like misattributed paternity in the clinical context.Google Scholar
In most cases, interventions that preserve or restore health are objectively ascribable goods because they are good for an individual no matter what her particular conception of the good is. On the other hand, when such interventions involve costs and thus trade-offs with other goods, it is reasonable for individuals to reject such interventions in favor of goods they value more.Google Scholar
45 C.F.R. § 46.111(a) (2) (2007).CrossRefGoogle Scholar
45 C.F.R. § 46.116(a) (3) (2007).CrossRefGoogle Scholar
An exception is King, N. M. P., “Defining and Describing Benefit Appropriately in Clinical Trials,” Journal of Law, Medicine & Ethics 28, no. 4 (2000): 332343.CrossRefGoogle Scholar
Emanuel, E. J. et al., “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 27012710.CrossRefGoogle Scholar
Public health interventions are obviously an exception to this individual focus of health care. Nevertheless, the contrast between research and (public) health care stands. The difference between public health research and public health practice is more obviously temporal: Current populations are the subject of research so that future populations may benefit.Google Scholar
See Emanuel, et al., supra note 15.Google Scholar
Id., at 2705.Google Scholar
Distinguishing between direct and indirect benefit in terms of its causal relationship to the research intervention — whether it “arises from” or “is derived from” the intervention — may suit research in which an intervention's efficacy is being tested. However, identifying the relevant causal relation (between research intervention and positive effect) or distinguishing causation from mere association is challenging and perhaps impossible for many studies, especially those whose goal is to characterize a condition, track physiological changes, or examine quality of care or adequacy of health services. Even in clinical research it would be preferable to focus on the study aims, not solely on causal pathways, in determining whether a study presents a reasonable prospect of (direct) benefit.Google Scholar
See King, , supra note 14, at 333.Google Scholar
Durant, J. et al., “Public Understanding of the New Genetics,” in Marteau, T. and Richards, M., eds., The Troubled Helix: Social and Psychological Implications of the New Human Genetics (Cambridge, U.K.: Cambridge University Press, 1996): At 235–248.Google Scholar
See King, , supra note 14; Appelbaum, P. S. et al., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report 17, no. 2 (1987): 2024.Google Scholar
The definition of harm utilized here is one of being made worse off; the failure to afford a benefit — that is, failure to take an opportunity to make someone better off — is not a harm in this view.Google Scholar
The risk would be that of (1) the confidentiality of the recorded IF being breached; (2) the information being identifiable as pertaining to a particular subject; and (3) it being used to that person's detriment.Google Scholar
See Wolf, et al., supra note 5.Google Scholar
Gauthier, S. and Touchon, J., “Mild Cognitive Impairment Is Not a Clinical Entity and Should Not Be Treated,” Archives of Neurology 62, no. 7 (2005): 11641166; Gauthier, S. et al., “Mild Cognitive Impairment,” The Lancet 367, no. 9518 (2006): 1262–1270; Whitehouse, P. and Brodaty, H., “Mild Cognitive Impairment,” The Lancet 367, no. 9527 (2006): 1979.CrossRefGoogle Scholar