Research malpractice and the issue of incidental findings

Journal of Law, Medicine and Ethics

Volumn 36, Issue 2, 2008, Pages 356-360

  Milstein, Alan C ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; BRAIN; BRAIN DISEASE; CHILD; CLINICAL TRIAL; CONFERENCE PAPER; CONGENITAL MALFORMATION; DIAGNOSTIC ERROR; ECONOMICS; ETHICS; HUMAN; INCIDENTAL FINDING; LEGAL ASPECT; MALPRACTICE; MEDICAL RESEARCH; NUCLEAR MAGNETIC RESONANCE IMAGING; PROFESSIONAL STANDARD; RESEARCH SUBJECT; STANDARD;

ADULT; BIOMEDICAL RESEARCH; BRAIN; BRAIN DISEASES; CHILD; CLINICAL TRIALS AS TOPIC; DIAGNOSTIC ERRORS; ETHICS COMMITTEES, RESEARCH; HUMANS; INCIDENTAL FINDINGS; MAGNETIC RESONANCE IMAGING; MALPRACTICE; RESEARCH SUBJECTS;

EID: 44949205618     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.00280.x     Document Type: Conference Paper

References (44)

1. H. Alphs et al., "Findings on Brain MRI from Research Studies of Occupational Exposure to Known Neurotoxicants," American Journal of Rosentgenology 187, no. 4 (2006): 1043-1047.
2. Columbia University Functional MRI Research Center, "The Future Role of Functional MRI in Medical Applications," available at 〈http://www.fmri.org/fmri.htm〉 (last visited February 20, 2008).
3. Id.
4. J. Illes et al., "Discovery and Disclosure of Incidental Findings in Neuroimaging Research," Journal of Magnetic Resonance Imaging 20, no. 5 (2004): 743-747 (multiple citations omitted).
5. J. Illes et al., "Ethical Consideration of Incidental Findings on Adult Brain MRI in Research," Neurology 62, no. 6 (2004): 888-890.
6. Id.
7. Id.
8. Id.
9. Id.
10. Id.
11. See Alphs et al., supra note 1, at 1-7.
12. Id.
13. Id.
14. Id.
15. See Illes et al., supra note 4.
16. Id.
17. Id.
18. Id., at 745.
19. Id.
20. Id.
21. Id.
22. Id., at 746.
23. K. Ross, "When Volunteers Are Not Healthy," EMBO Reports 6, no. 12 (2005): 1116-1119, at 1118, available at 〈http://www. pubmedcentral.nih.gov/articlerender.fcgi?artid=1369211〉 (last visited February 20, 2008) (quoting Alan Evans, neuroimaging researcher from McGill University, Montreal, Canada); see also Illes et al., supra note 5, at 890 ("[W]e must balance the benefit of involving medical personnel trained to read scans and interact with participants against the legal risk and financial burden of clinician assessment of all participant MRIs and the workload challenges associated with sheer volume.").
24. The study exposed children to greater than minimal risk with no benefit and induced participation for money not altruism.
25. 45 C.F.R. 46 (2007).
26. 366 Md. 29 (2001).
27. Id., at 113.
28. Id., at 89, 91-100, 103.
29. Id., at 101.
30. Id., at 101-102 (citing in part National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, 2001, available at 〈http://bioethics.georgetown. edu/nbac/human/overvoll.pdf〉 [last visited February 20, 2008]).
31. See, e.g., Lambert v. Park, 597 F.2d 2369 (10th Cir. 1979); Perna v. Pirozzi, 92 N.J. 444 (1983).
32. Id. (citing Faya v. Almaraz, 620 A.2d 327, 333 [Md. 1993]).
33. See Illes et al., supra note 5.
34. Id.
35. Id.
36. See generally, American College of Radiology, "Accreditation Programs," available at 〈http://www.acr.org/accreditation. aspx〉 (last visited February 20, 2008).
37. See Ross, supra note 23, at 4 (citing E. Check, "Brain-Scan Ethics Come Under the Spotlight," Nature 433, no. 7030 (2005): 185.
38. Id. (citing Illes et al., supra note 4).
39. Id.
40. See, e.g., Simpson v. Sisters of Charity of Providence in Oregon, 588 P.2d 4 (Or. 1978).
41. 45 C.F.R. § 46.116 (2007).
42. Id.
43. See Ross, supra note 23.
44. See, e.g., Stanley v. McCarver, 92 P.3d 849 (Ariz. 2004); Vucinich v. Ross, 893 So. 2d 690 (Fla. Dist. Ct. App. 5th Dist. 2005).