Research Malpractice and the Issue of Incidental Findings

Alphs H. , “Findings on Brain MRI from Research Studies of Occupational Exposure to Known Neurotoxicants,” American Journal of Rosentgenology 187, no. 4 (2006): 1043–1047.

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).

Illes J. , “Discovery and Disclosure of Incidental Findings in Neuroimaging Research,” Journal of Magnetic Resonance Imaging 20, no. 5 (2004): 743–747 (multiple citations omitted).

Illes J. , “Ethical Consideration of Incidental Findings on Adult Brain MRI in Research,” Neurology 62, no. 6 (2004): 888–890.

See Alphs , supra note 1, at 1–7.

See Illes , supra note 4.

Id., at 745.

Id., at 746.

Ross K. , “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 , 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.”).

The study exposed children to greater than minimal risk with no benefit and induced participation for money not altruism.

45 C.F.R. 46 (2007).

366 Md. 29 (2001).

Id., at 113.

Id., at 89, 91–100, 103.

Id., at 101.

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/overvol1.pdf> [last visited February 20, 2008]).

See, e.g., Lambert v. Park, 597 F.2d 2369 (10th Cir. 1979); Perna v. Pirozzi, 92 N.J. 444 (1983).

Id. (citing Faya v. Almaraz, 620 A.2d 327, 333 [Md. 1993]).

See Illes , supra note 5.

See generally, American College of Radiology, “Accreditation Programs,” available at <http://www.acr.org/accreditation.aspx> (last visited February 20, 2008).

See Ross , supra note 23, at 4 (citing Check E. , “Brain-Scan Ethics Come Under the Spotlight,” Nature 433, no. 7030 (2005): 185.

Id. (citing Illes , supra note 4).

See, e.g., Simpson v. Sisters of Charity of Providence in Oregon, 588 P.2d 4 (Or. 1978).

45 C.F.R. § 46.116 (2007).

See Ross , supra note 23.

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).