Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations
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24. See Illes, et al., “Incidental Findings in Brain Imaging Research,” supra note 5 at 784.
Kohane, 2006, “The Incidentalome: A Threat to Genomic Medicine,”, JAMA, 296, 212, 10.1001/jama.296.2.212
42. See generally Wagner, et al., supra note 35.
Verweij, 2002, “Unexpected Findings in Identifiable Stored Blood Samples After Analysis Without Consent: Moral Arguments For and Against Disclosure,”, Genetic Counseling, 13, 115
105. Illes, et al., “Incidental Findings in Brain Imaging Resarch,” supra note 5, at 784; NINDS Proceedings, supra note 23.
104. See OHRP, supra note 46.
14. Lucassen, and Parker, , supra note 6, at 1035; McEwen, , supra note 6, at 359–360; Ross, Friedman , supra note 6, at 116–117; Macintyre, and Sooman, , supra note 6.
69. See Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 843–44 (Md. 2001)
94. Lawrenz, and Sobotka, , supra note 11; Wolf, , Sobotka, , and Lawrenz, , supra note 11.
81. The CLIA regulations exempt research labs only when such labs “do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients.” Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, Laboratory Requirements, 42 C.F.R. § 493.3 (b) (2) (2008). This may mean that under current regulations, research labs may not report “research results” when these are individual-specific and may be used to assess health or trigger such assessment.
82. This broad definition of “utility” comports with Grosse and Khoury, supra note 80.
112. Lawrenz, and Sobotka, , supra note 11; Wolf, , Sobotka, , and Lawrenz, , supra note 11.
77. NHLBI Working Group, supra note 16.
26. Illes, et al., “Incidental Findings in Brain Imaging Research,” supra note 5.
127. Lawrenz, and Sobotka, , supra note 11; Wolf, , Sobotka, , and Lawrenz, , supra note 11.
96. See National Institutes of Health, Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials, June 11, 1999, available at <http://grants2.nih.gov/grants/guide/notice-files/not99–107.html> (last visited March 6, 2008) (comparing the definitions and reporting requirements for adverse events in the DHHS and the FDA regulations on human subjects research); see generally 21 C.F.R. § 312.32 (a) (2007) (defining “unexpected adverse drug experience”); 45 C.F.R. § 46.103 (b) (5) (2007) (requiring procedures for reporting “unanticipated problems involving risks to subjects”).
49. 45 C.F.R. Part 46 (2007) (“Protection of Human Subjects”).
3. National Human Research Protections Advisory Committee Working Group on Genetics, IRB Guidebook Chapter on Human Genetics Research, Draft 2, June 27, 2002: At 12, available at <http://www.hhs.gov/ohrp/nhrpac/documents/nhrpac13.pdf> (last visited March 6, 2008) [hereinafter IRB Guidebook].
126. Kohane, , Masys, , and Altman, , supra note 2.
40. See Pederson, Ginnerup , Sosenkilde, , and Christiansen, , supra note 8, at 1746–1747; Edwards, , Mendelson, , and Forbes, , supra note 8, at 3011.
Cho, 2008, “Understanding Incidental Findings in the Context of Genetics and Genomics,”, Journal of Law, Medicine and Ethics, 36, 280, 10.1111/j.1748-720X.2008.00270.x
10. 42 U.S.C. § 263a (2007) (“Certification of laboratories”).
2007, “Protection of Human Subjects: Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure,”, Federal Register, 63, 60364
93. See, e.g., IRB Guidebook, supra note 3.
2004, NHLBI Working Group on Reporting Genetic Results in Research Studies, Meeting Summary
32. See Hara, et al., supra note 8, at 354; Gluecker, et al., supra note 8, at 912.
86. Working Group on Reporting Results, supra note 47.
48. National Institutes of Health, Department of Health and Human Services, Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (January 25, 2008), available at <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html> (last visited March 27, 2008).
64. Shalowitz, and Miller, , supra note 4, at 738.
38. Siddiki, et al., supra note 31.
116. See 45 C.F.R. § 46.408 (2007) (“Requirements for permission by parents or guardians and for assent by children.”).
15. Ravitsky, and Wilfond, , “Disclosing Individual Genetic Results to Research Participants,” supra note 4, at 12.
108. Ormond, , supra note 17, at 30.
62. See Belsky, and Richardson, , supra note 61 at 1495; Richardson, and Belsky, , supra note 52, at 29–31. For ancillary care falling within the scope of entrustment, the strength of the claim to care depends on further factors: The participant's vulnerability, their uncompensated risks or burdens (i.e., the gratitude owed to them by the researchers), their dependence on the researchers, and the depth of the researcher-participant relationship. Belsky, and Richardson, , supra note 61 at 1495–1496; Richardson, and Belsky, , supra note 52, at 30–31.
107. See 42 U.S.C. § 263a(a)-(b); see also Clayton, , supra note 46, at 20 (stating that disclosure of research results from non-CLIA approved laboratories might be illegal if recipients “choose to act” on this information).
36. Zalis, et al., supra note 5, at 7–8.
120. See id., at 1453.
1998, Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity
20. See Kohane, , Masys, , and Altman, , supra note 2, at 214.
67. Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 834–35, 849–50 (Md. 2001).
45. See 45 C.F.R. § 46.101 (b) (4) (2007) (exempting “research involving the collection or study of existing data…, [or] pathological specimens…if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects”).
75. See National Bioethics Advisory Commission, supra note 46, at 72.
71. See Office of Human Research Protections, “Overview,” Compliance Oversight, available at <http://www.hhs.gov/ohrp/compliance/index.html> (last visited June 17, 2007).
2008, Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
68. Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 851 (Md. 2001); see also Blaz v. Michael Reese Hosp. Foundation, 74 F. Supp. 2d 803, 805–07 (N.D. Ill. 1999).
92. Richardson, and Belsky, , supra note 52.
Rothstein, 1996, “Statement on Informed Consent for Genetic Research,”, American Journal of Human Genetics, 59, 471
50. 21 C.F.R. Parts 50, 56 (2007) (“Protection of Human Subjects,” “Institutional Review Boards”).
Beauchamp, 2001, Principles of Biomedical Ethics
98. See National Bioethics Advisory Commission, supra note 46, at 63.
29. Hara, et al, supra note 8, at 357.
87. See National Bioethics Advisory Commission, supra note 46, at 72; NHLBI Working Group, supra note 16; Ravitsky, and Wilfond, , “Disclosing Individual Genetic Results to Research Participants,” supra note 4, at 10–11; Caulfield, et al., supra note 74.
Clayton, 2006, “Implications of Disclosing Individual Results of Clinical Research,”, JAMA, 295, 37
110. Lawrenz, and Sobotka, , supra note 11; Wolf, , Sobotka, , and Lawrenz, , supra note 11.
118. National Human Research Protections Advisory Committee Children's Workgroup, Clarifying Specific Portion of 45 CFR 46 Subpart D that Governs Children's Research, 2002: At 1, available at <http://www.hhs.gov/ohrp/nhrpac/documents/nhrpac16.pdf> (last visited March 6, 2008).
Siddiki, 2008, “Incidental Findings in CT Colonography: Literature Review and Survey of Current Research Practice,”, Journal of Law, Medicine and Ethics, 36, 320, 10.1111/j.1748-720X.2008.00276.x
99. Working Group on Reporting Results, supra note 47.
91. Cf. Rothstein, , supra note 56 (discussing “disclosure options” for receipt of research results by participants before research begins).
41. See Maschke, , supra note 19, at 539; NHGRI, supra note 19.
79. See National Institutes of Health, supra note 54; National Human Genome Research Institute, supra note 54.
25. Alphs, et al., supra note 7, at 1044; Illes, et al., supra note 7, at 888–889; Katzman, , Dagher, , and Patronas, , supra note 7, at 37; Kim, et al., supra note 7, at 1675.
53. See Clayton, , supra note 46, at 20; 45 C.F.R. § 164.524 (a) (2007) (describing the right of access of individuals to protected health information).
34. Id.
33. Siddiki, et al., supra note 31.
Facio, 2006, “One Size Does Not Fit All,”, American Journal of Bioethics, 6, 40, 10.1080/15265160600938351
Cho, 2006, “When Do Genetic Researchers Have a Duty to Recontact Study Participants?”, American Journal of Bioethics, 6, 26, 10.1080/15265160600935746
100. An example of this type of incidental finding is described by Verweij, and Hamel, , supra note 43. A sample from an unaffected person in a study on inherited limb malformation was later used in a second study as a “normal” control. However, that study found that the sample contained a sequence variance in a certain gene, mutations of which may cause a primary cardiac disorder. Id. at 116.
101. See Rothstein, , supra note 44, at 95.
27. American College of Radiology Imaging Network, ACRIN Protocol 6664 National CT Colonography Trial, available at <http://www.acrin.org/6664_protocol.html> (last visited June 15, 2007).
9. Illes, et al., “Incidental Findings in Brain Imaging Research,” supra note 5.
37. See Xiong, et al., supra note 28, at 23, 26.
22. See NHLBI Working Group, supra note 16.
111. Fernandez, , Kodish, , and Weijer, , supra note 73, at 14.
78. See Clayton, , supra note 46, at 20; 45 C.F.R. § 164.524 (a) (2007). Individuals generally have a right of access to their protected health information, with some exceptions. § 164.524 (a) (iii). These include protected health information that is maintained by a covered entity subject to CLIA, to the extent that providing access to this information would be prohibited by law, § 164.524 (a) (iii) (A); or when the covered entity is exempt from CLIA because it is a research lab that does “not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients,” 42 C.F.R. § 493.3 (b) (2).
Dinnett, 2004, “Considerations and Costs of Disclosing Study Findings to Research Participants,”, Canadian Medical Association Journal, 170, 1417, 10.1503/cmaj.1031668
84. NHLBI Working Group, supra note 16.
106. Bookman, et al., supra note 80, at 1037. In their summary of the NHLBI Working Group on reporting genetic research results, Bookman, et al. consider the costs involved in returning genetic research results to participants. They state that budgets for genetic research studies testing for mutations of known clinical significance should include the funds needed to offer results and to counsel on the meaning of such results. Id. at 1037.
13. IRB Guidebook, supra note 3.
Illes, 2006, “Subjects’ Expectations in Neuroimaging Research,”, Journal of Magnetic Resonance Imaging, 23, 205, 10.1002/jmri.20499
125. See NHRPAC Report, supra note 123.
Vernooij, 2006, “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, 1000, 10.1097/01.chi.0000222786.49477.a8
Shalowitz, 2006, “Ethical Considerations in the Communication of Unexpected Information with Clinical Implications,”, American Journal of Bioethics, 6, 46, 10.1080/15265160600938633
Hoffman, 2002, “Whose Duty Is It Anyway? The Kennedy Krieger Opinion and Its Implications for Public Health Research,”, Journal of Health Care Law and Policy, 6, 109