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

Wolf S. , “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law Medicine & Ethics 36, no. 2 (2008): 219–248, at 219.

Vernooij M. W. , “Incidental Findings in Brain MRI in the General Population,” New England Journal of Medicine 357, no. 18 (2007): 1821–1828; Kumra S. , “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. , “Ethical Consideration of Incidental Findings on Adult Brain MRI in Research,” Neurology 62, no. 6 (2004): 888–890; Weber F. 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.

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.

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.

Id.

Fried C. , Medical Experimentation: Personal Integrity and Social Policy (Amsterdam: North Holland Publishing Company, 1974).

Id., at 47.

Weijer C. 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.

Morreim H. , “The Clinical Investigator as Fiduciary: Discarding a Misguided Idea,” Journal of Law, Medicine & Ethics 33, no. 3 (2005): 586–598.

Illes J. , “Practical Approaches to Incidental Findings in Brain Imaging Research,” Neurology 70, no. 5 (2008): 384–390; Beauchamp T. Childress J. , Principles of Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001): At 173–176.

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.

Richardson 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 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. Belsky L. , “Medical Researchers' Ancillary Clinical Care Responsibilities,” BMJ 328, no. 7454 (2004): 1494–1496. Richardson H. S. 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.

Id. ( Richardson Belsky , “Medical Researchers' Ancillary Clinical Care Responsibilities”), at 26.

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.

See Richardson Belsky , “Medical Researchers' Ancillary Clinical Care Responsibilities,” supra note 12, at 27.

Id., at 30.

Id.

See Weijer Miller , supra note 8.

See Emanuel , supra note 4.

Id.; Miller F. G. 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.

Richardson H. S. , “Incidental Findings and Ancillary Care Obligations,” Journal of Law Medicine & Ethics 36, no. 2 (2008): 256–270, at 259.

Royal J. M. 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.

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.

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 , 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.

Illes J. 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.

See Wolf , supra note 1; NIH Conference Proceedings, Detection and Disclosure of Incidental Findings in Neuroimaging Research, 2005; see Royal Peterson , supra note 22.

Parker L. , “The Future of Incidental Findings: Should They Be Viewed as Benefits?” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 341–351.

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.

See Emanuel , supra note 4, at 2706.

45 CRR 46.116, 2007; 21 CFR 50.20, 2007.