Incidental findings: A common law approach

Accountability in Research

Volumn 15, Issue 4, 2008, Pages 242-261

  Tovino, Stacey A ^a  

^a DRAKE UNIVERSITY   (United States)

Author keywords

Bailment; Contract law; Fiduciary duty; Incidental findings; Neuroethics; Neurolaw; Tort law

Indexed keywords

ARTICLE; BRAIN; DIAGNOSTIC IMAGING; ETHICS; HUMAN; HUMAN RELATION; INCIDENTAL FINDING; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LEGAL ASPECT; MEDICAL RESEARCH; METHODOLOGY; NEUROSCIENCE; PATHOLOGY; RESEARCH SUBJECT; UNITED STATES;

BIOMEDICAL RESEARCH; BRAIN; DIAGNOSTIC IMAGING; DISCLOSURE; HUMANS; INCIDENTAL FINDINGS; INFORMED CONSENT; NEUROSCIENCES; RESEARCH SUBJECTS; RESEARCHER-SUBJECT RELATIONS; UNITED STATES;

EID: 61449396663     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620802388705     Document Type: Article

References (34)

1. 45 C.F.R. 46.111 (2007).
2. 45 C.F.R. 46.116 (2007).
3. 45 C.F.R. 46.117 (2007).
4. Andrews, L. B. (2006). The battle over the body, Trial, 42: 22-29.
5. Belsky, L., and Richardson, H. S. (2004). Medical researchers' ancillary clinical care responsibilities, British Medical Journal, 328(7454): 1494-1496.
6. Coleman, C. H. (2005). Duties to subjects in clinical research, Vanderbilt Law Review, 58: 387-449.
7. Greenberg V. Miami Children's Hosp. Research Institute, 264 F. Supp. 2d. 1064 (S.D. Fla. 2003).
8. Grimes V. Kennedy Krieger Institute, 782 A.2d 807 (Md. 2001).
9. Heinemann, T., Hoppe, C., Listl, S., Spickhoff, A., Elger, C. E. (2007). Incidental findings in neuroimaging: Ethical problems and solutions, Deutsches Arzteblatt, 104(27): A-1982.
10. Iacangelo V. Georgetown University, 2006 U.S. Dist. LEXIS 95848 (D.D.C. Oct. 11, 2006); 2007 U.S. Dist. LEXIS 21081 (D.D.C., Mar. 26, 2007).
11. Illes, J. (2006). 'Pandora's' box of incidental findings in brain imaging research, Nature Clinical Practice Neurology, 2(2): 60-61.
12. Illes, J., Desmond, J. E., Huang, L. F., Raffin, T. A., and Atlas, S. W. (2002). Ethical and practical considerations in managing incidental neurologic findings in functional magnetic resonance imaging, Brain and Cognition, 50(3): 358-365.
13. Illes, J., Kirschen, M. P., Edwards, E., Bandettini, P., Cho, M. K., Ford, P. J., Glover, G. H., Kulynych, J., Macklin, R., Michael, D. B., and Wolf, S. M. (2006). Incidental findings in brain imaging research, Science, 311(5762): 783-784.
14. Illes, J., Kirschen, M. P., Edwards, E., Bandettini, P., Cho, M. K., Ford, P. J., Glover, G. H., Kulynych, J., Macklin, R., Michael, D. B., Wolf, S. M., and Grabowski, T. (2008). Practical approaches to incidental findings in brain imaging research, Neurology, 70(5): 384-390.
15. Illes, J., Kirschen, M. P., Karetsky, K., Kelly, M., Saha, A., Desmond, J. E., Raffin, T. A., Glover, G. H., and Atlas, S. W. (2004). Discovery and disclosure of incidental findings in neuorimaging research, Journal of Magnetic Resonance Imaging, 20(5): 743-747.
16. Illes, J., Rosen, A. C., Huang, L., Goldstein, R. A., Raffin, T. A., Swan, G., and Atlas, S. W. (2004). Ethical considerations of incidental findings on adult brain MRI in research, Neurology, 62(6): 888-890.
17. Institute for Women's Health v. Imad, No. 04-05-00555-CV (Feb. 15, 2006).
18. Jansson, R. L. (2003). Researcher liability for negligence in human subjects research: Informed consent and researcher malpractice actions, Washington Law Review, 78(1): 229-263.
19. Kirschen, M. P., Jaworska, A., and Illes, J. (2006). Subjects' expectations in neuroimaging research, Journal of Magnetic Resonance Imaging, 23(2): 205-209.
20. Lo V. Burke, 249 Va. 311 (1995).
21. Melly, A. E. (2007). Bailments, American Jurisprudence 2d., 8A:1.
22. Miller, F. G., Mello, M. M., and Joffe, S. (2008). Incidental findings in human subjects research: What do investigators owe research participants? Journal of Law, Medicine and Ethics, 36(2): 271-279.
23. Milstein, A. C. (2008). Research malpractice and the issue of incidental findings, Journal of Law, Medicine and Ethics, 36(2): 356-360.
24. Moore V. Regents, 51 Cal.3d 120, 128 (1990), cert, denied, 499 U.S. 936 (1991).
25. Morreim, E. H. (2004). Litigation in clinical research: Malpractice doctrine versus research realities, Journal of Law, Medicine and Ethics, 32(3): 474-484.
26. Richardson, H. S. (2008). Incidental findings and ancillary-care obligations, Journal of Law, Medicine and Ethics, 36(2): 256-270.
27. Richardson, H. S., and Belsky, L. (2004). The ancillary-care responsibilities of medical researchers: An ethical framework for thinking about the clinical care that researchers owe their subjects, Hastings Center Report, Jan.-Feb., at 25.
28. Suthers V. Amgen, Inc., 372 F. Supp.2d 416 (S.D.N.Y. 2005).
29. Suthers V. Amgen, Inc., 441 F.Supp.2d 478 (S.D.N.Y. 2006).
30. Symposium. (2008). Incidental findings in human subjects research: From imaging to genomics, Journal of Law, Medicine, and Ethics, 36(2): 216-383.
31. Vernooij, M. W., Ikram, M. A., Tanghe, H. L., Vincent, A. J. P. E., Hogman, A., Krestin, G. P., Niessen, W. J., Breteler, M. M. B., and van der Lugt, A. (2007). Incidental findings on brain MRI in the general population, New England Journal of Medicine, 357(18): 1821-1828.
32. Whitlock V. Duke University, 637 F. Supp. 1463 (1986).
33. Wolf, S. M. (2008a). The challenge of incidental findings, Journal of Law, Medicine and Ethics, 36(2): 216-218.
34. Wolf, S. M. (2008b). Managing incidental findings in human subjects research: Analysis and recommendations, Journal of Law, Medicine and Ethics, 36(2): 219-248.