Hostname: page-component-586b7cd67f-rcrh6 Total loading time: 0 Render date: 2024-11-28T14:59:32.208Z Has data issue: false hasContentIssue false
  • English
  • Français

Incidental Findings in Pediatric Research

Published online by Cambridge University Press:  01 January 2021

Benjamin S. Wilfond  and
Katherine J. Carpenter
Get access Rights & Permissions [Opens in a new window]

Extract

Incidental research findings, as defined in this symposium’s consensus paper, are unexpected findings discovered in the course of research but “beyond the aims of the study.” These include findings generated by research methodology, such as imaging or genetic analysis, findings related to clinical screening for inclusion or exclusion, or direct observations of physical abnormalities or behavior. Decisions about managing incidental research findings involve important ethical considerations regarding a researcher’s obligations to provide care, minimize harms, and respect research participants’ wishes. When the research participant is a child, the triadic relationship between the researcher, child participant, and parent makes these considerations more complicated. (See Figure 1.)

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 332 - 340
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.CrossRefGoogle Scholar
Freedman, B. et al., “In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children,” Hastings Center Report 23, no. 2 (1993): 13–19.CrossRefGoogle Scholar
Burke, W. et al., “Genetic Test Evaluation: Information Needs of Clinicians, Policy Makers, and the Public,” American Journal of Epidemiology 156, no. 4 (2002): 311–318.CrossRefGoogle Scholar
Diekema, D. S., “Parental Refusals of Medical Treatment: The Harm Principle as Threshold for State Intervention” Theoretical Medicine and Bioethics 24, no. 4 (2004): 243–264.CrossRefGoogle Scholar
Campbell, A. T., “Consent, Competence, and Confidentiality Related to Psychiatric Conditions in Adolescent Medicine Practice,” Adolescent Medicine Clinics 17, no. 1 (2006): 25–47.Google Scholar
Rozovsky, F. A., Consent to Treatment: A Practical Guide, 4th ed. (New York: Aspen, 2007): Chap. 5.02 [a], at 20–22.Google Scholar
Protection of Human Subjects: Subpart D — Additional Protections for Children Involved as Subjects in Research, 45 C.F.R. 46 (2007).Google Scholar
Id.Google Scholar
Miller, F. G., Wendler, D., and Wilfond, B. S. “When Do the Federal Regulations Allow Placebo-Controlled Trials in Children?” Journal of Pediatrics 142, no. 2 (2003): 102–107.CrossRefGoogle Scholar
Illes, J. et al., “Ethical Consideration of Incidental Findings on Adult Brain MRI in Research,” Neurology 62, no. 6 (2004): 888–890.CrossRefGoogle Scholar
See Wolf, et al., supra note 1; Beskow, L. M. et al., “Informed Consent for Population-Based Research Involving Genetics,” JAMA 286, no. 18 (2001): 2315–2321; Bookman, E. B. et al., “Reporting Genetic Results in Research Studies: Summary and Recommendations of an NHLBI Working Group,” American Journal of Medical Genetics Part A 140, no. 10 (2006): 1033–1040; Renegar, G. et al., “Returning Genetic Research Results to Individuals: Points-to-Consider,” Bioethics 20, no. 1 (2006): 24–36.Google Scholar
Santelli, J. S. et al., “Guidelines for Adolescent Health Research: A Position Paper of the Society for Adolescent Medicine,” Journal of Adolescent Health 33, no. 5 (2003): 396–409.Google Scholar
Sigman, G. S. et al., “Disclosure of a Diagnosis to Children and Adolescents When Parents Object: A Clinical Ethics Analysis,” American Journal of Diseases of Children 147, no. 7 (1993): 764–768; Wiener, L. et al., “Disclosure of an HIV Diagnosis to Children: History, Current Research, and Future Directions,” Journal of Developmental and Behavioral Pediatrics 28, no. 2 (2007): 155–166.CrossRefGoogle Scholar
Ford, C. et al., “Confidential Health Care for Adolescents: Position Paper for the Society for Adolescent Medicine,” Journal of Adolescent Health 35, no. 2 (2004): 160–167.CrossRefGoogle Scholar
See Campbell, , supra note 5.Google Scholar
See Protection of Human Subjects, supra note 7.Google Scholar
See Ford, et al., supra note 14.Google 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; Ravitsky, V. and Wilfond, B. S., “Disclosing Individual Genetic Results to Research Participants,” American Journal of Bioethics 6, no. 6 (2006): 8–17.CrossRefGoogle Scholar
Clayton, E. W. and Ross, L. F., “Implications of Disclosing Individual Results of Clinical Research,” JAMA 295, no. 1 (2006): 37; Shalowitz, D. I. and Miller, F. G., “Implications of Disclosing Individual Results of Clinical Research,” JAMA 295, no. 1 (2006) 37–38.Google Scholar
Wendler, D. et al., “The Ethics of Paying for Children's Participation in Research,” Journal of Pediatrics 141, no. 2 (2002): 166–171.CrossRefGoogle Scholar
Davis, D. S., “Genetic Dilemmas and the Child's Right to an Open Future,” Hastings Center Report 27, no. 2 (1997): 7–15.CrossRefGoogle ScholarPubMed
Chidiac, R. M. and Aron, D. C., “Incidentalomas: A Disease of Modern Technology,” Endocrinology and Metabolism Clinics of North America 26, no. 1 (1997): 233–253.CrossRefGoogle Scholar
American Society of Human Genetics Board of Directors, “Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents,” American Journal of Human Genetics 57, no. 5 (1995): 1233–1241; Nelson, R. M. et al., “Ethical Issues with Genetic Testing in Pediatrics,” Pediatrics 107, no. 6 (2001): 1451–1455.Google Scholar
Lucassen, A. and Parker, M., “Revealing False Paternity: Some Ethical Considerations,” The Lancet 357, no. 9261 (2001): 1033–1035; Taub, S. et al., “Managing Familial Risk in Genetic Testing” Genetic Testing 8, no. 3 (2004): 356–359; Richards, J. L. and Wolf, S., “Medical Confidentiality and Disclosure of Paternity,” South Dakota Law Review 48, no. 3 (2003): 409–442; Ross, L. F., “Disclosing Misattributed Paternity,” Bioethics 10, no. 2 (1996): 114–130.CrossRefGoogle Scholar
Gollust, S. E. et al., “Direct-to-Consumer Sales of Genetic Services on the Internet,” Genetics in Medicine 5, no. 4 (2003): 332–337.CrossRefGoogle Scholar