The future of incidental findings: Should they be viewed as benefits?

Journal of Law, Medicine and Ethics

Volumn 36, Issue 2, 2008, Pages 341-351

  Parker, Lisa S ^a,b  

^a School of Nursing and Mailman

^b UNIVERSITY OF PITTSBURGH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; ETHICS; HUMAN; INCIDENTAL FINDING; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL RESEARCH; RISK ASSESSMENT; SOCIAL PSYCHOLOGY;

BIOMEDICAL RESEARCH; DISCLOSURE; HUMANS; INCIDENTAL FINDINGS; INFORMED CONSENT; RISK ASSESSMENT; SOCIAL VALUES;

EID: 44949084673     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.00278.x     Document Type: Conference Paper

References (34)

1. J. Illes et al., "Incidental Findings in Brain Imaging Research," Science 311, no. 5762 (2006): 783-784.
2. D. Davis, "The Changing Face of 'Misattributed Paternity,'" Journal of Medicine and Philosophy 32, no. 4 (2007): 359-373;
3. L. S. Parker and R. A. Majeske, "Incidental Findings: Patients' Knowledge, Rights, and Preferences," Journal of Clinical Ethics 6, no. 2 (1995): 176-179.
4. B. Freedman, "Equipoise and the Ethics of Clinical Research," New England Journal of Medicine 317, no. 3 (1987): 141-145.
5. 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.
6. S. M. Wolf et al., "Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations," Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219-248. 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."
7. 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.
8. A. L. Lucassen and M. Parker, "Revealing False Paternity: Some Ethical Considerations," The Lancet 357, no. 9261 (2001): 1033-1035; see Davis, supra note 2.
9. L. F. Ross, "Disclosing Misattributed Paternity," Bioethics 10, no. 2 (1996): 114-130. 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.
10. See, for example, S. M. Wolf et al., "The Incidentalome," JAMA 296, no. 23 (2006): 2800-2801.
11. J. Wilson, "To Know or Not to Know? Genetic Ignorance, Autonomy and Paternalism," Bioethics 19, nos. 5-6 (2005): 492-504.
12. J. Illes et al., "Ethical and Practical Considerations in Managing Incidental Findings in Functional Magnetic Resonance Imaging," Brain and Cognition 50, no. 3 (2002): 358-365;
13. B. S. Kim et al., "Incidental Findings on Pediatric MR Images of the Brain," American Journal of Neuroradiology 23, no. 10 (2002): 1674-1677.
14. 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.
15. 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 thegood 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.
16. 45 C.F.R. § 46.111(a) (2) (2007).
17. 45 C.F.R. § 46.116(a) (3) (2007).
18. An exception is N. M. P. King, "Defining and Describing Benefit Appropriately in Clinical Trials," Journal of Law, Medicine & Ethics 28, no. 4 (2000): 332-343.
19. E. J. Emanuel et al., "What Makes Clinical Research Ehical?" JAMA 283, no. 20 (2000): 2701-2710.
20. 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.
21. See Emanuel et al., supra note 15.
22. Id., at 2705.
23. Id.
24. 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 distinguishingcausation 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.
25. See King, supra note 14, at 333.
26. Id.
27. J. Durant et al., "Public Understanding of the New Genetics," in T. Marteau and M. Richards, eds., The Troubled Helix: Social and Psychological Implications of the New Human Genetics (Cambridge, U.K.: Cambridge University Press, 1996): at 235-248.
28. See King, supra note 14; P. S. Appelbaum et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconception," Hastings Center Report 17, no. 2 (1987): 20-24.
29. 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.
30. 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.
31. See Wolf et al., supra note 5.
32. S. Gauthier and J. Touchon, "Mild Cognitive Impairment Is Not a Clinical Entity and Should Not Be Treated," Archives of Neurology 61, no. 7 (2005): 1164-1166;
33. S. Gauthier et al., "Mild Cognitive Impairment," The Lancet 367, no. 9518 (2006): 1262-1270;
34. P. Whitehouse and H. Brodaty, "Mild Cognitive Impairment," The Lancet 367, no. 9527 (2006): 1979.