Return of Research Results: General Principles and International Perspectives

Journal of Law, Medicine and Ethics

Volumn 39, Issue 4, 2011, Pages 583-592

  Lévesque, Emmanuelle ^a   Joly, Yann ^b   Simadr, Jacques ^c,d  

^a MCGILL UNIVERSITY   (Canada)

^b MCGILL UNIVERSITY   (Canada)

^c UNIVERSITÉ LAVAL   (Canada)

^d University Laval   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BIOETHICS; CONFERENCE PAPER; ETHICS; GENETICS; HEALTH CARE FACILITY; HUMAN; INFORMATION DISSEMINATION; INTERNATIONAL COOPERATION; INTERPERSONAL COMMUNICATION; PRACTICE GUIDELINE; RESEARCH SUBJECT;

BIOETHICAL ISSUES; BIOLOGICAL SPECIMEN BANKS; DISCLOSURE; GENETIC RESEARCH; GUIDELINES AS TOPIC; HUMANS; INFORMATION DISSEMINATION; INTERNATIONALITY; RESEARCH SUBJECTS;

EID: 81255209494     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2011.00625.x     Document Type: Conference Paper

References (86)

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2. A notable exception is the Statement on the Principled Conduct of Genetics Research, Human Genome Organization, 1996, available at <> (last visited August 17, 2011).
3. A. L. McGuire and J. R. Lupski, "Personal Genome Research: What Should the Participant Be Told?" Trends in Genetics 26, no. 5 (2010): 199-201, at 199; A. L. McGuire, T. Caulfield, and M. K. Cho, "Research Ethics and the Challenge of Whole-Genome Sequencing, " Nature Reviews Genetics 9, no. 2 (2008): 152-156, at 152-153.
4. V. Ravitsky and B. S. Wilfond, "Disclosing Individual Genetic Results to Research Participants, " American Journal of Bioethics 6, no. 6 (2006): 8-17, at 9-10.
5. International Declaration on Human Genetic Data, UNESCO, 2003, article 19, available at <> (last visited August 17, 2011).
6. See McGuire and Lupski, supra note 3, at 199; S. M. Wolf et al., "Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, " Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219-248, at 229 and 238
7. A. L. Bredenoord, H. Y. Kroes, E. Cuppen, M. Parker, and J. J. M. van Delden, "Disclosure of Individual Genetic Data to Research Participants: The Debate Reconsidered, " Trends in Genetics 27, no. 2 (2011): 41-47, at 44.
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11. Council for International Organizations of Medical Sciences, International Ethical Guidelines for Epidemiological Studies, 2008, at Commentary on Guideline 8 [hereinafter cited as CIOMS].
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13. See CIOMS, supra note 10, Guideline 8.
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15. See Ravitsky and Wilfond, supra note 4, at 9.
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17. See McGuire and Lupski, supra note 3, at 199
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19. see Fernandez et al., supra note 15, at 12;
20. See Shalowitz and Miller, supra note 16, at 738.
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22. Humgen website, available at <> (last visited February 15, 2011).
23. Norms from international consortia will be analyzed in an article from this symposium issue. See S. Wallace, "The Needle in the Haystack - International Consortia and the Return of Individual Research Results, " Journal of Law, Medicine & Ethics 39, no. 4 (2011): 631-639.
24. A clinician's duty to act in the beneficiary's (patient) interests is not the same in research contexts because research does not seek to serve individual interests (see M. N. Meyer, "The Kindness of Strangers: The Donative Contract between Subjects and Researchers and the Non-Obligation to Return Individual Results of Genetic Research, " American Journal of Bioethics 8, no. 11 (2008): 44-50, at 44).
25. The definition of a "clinical trial" in the Good Clinical Practice does not limit clinical trial to those investigations including therapeutic objectives (Good Clinical Practice, ICH E6, International Conference of Harmonisation [1996], article 1.12, available at <> (last visited August 17, 2011).
26. For an analysis and recommendations on the specific topic of incidental findings, see Wolf et al., supra note 6.
27. N. M. Ries, "Research Participants' Rights to Access Information about Themselves Held by Public Research Institutions, " Health Law Review 18, no. 3 (2010): 5-14.
28. See World Medical Association, supra note 11, at Article 20.
29. Organisation for Economic Co-operation and Development, Guidelines on Human Biobanks and Genetic Research Databases, 2009, at Article 1.H, available at <> (last visited August 17, 2011).
30. See CIOMS Biomedical Research, supra note 13, at Guideline 5; see CIOMS, supra note 10, at Guideline 5.
31. Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research, 2005, at Article 28, available at <> (last visited August 17, 2011).
32. International Society for Pharmacoepidemiology, Guidelines for Good Pharmacoepidemiology Practices, 2007, at Article II, available at <> (last visited August 17, 2011).
33. See International Epidemiological Association, supra note 19.
34. World Medical Association, Statement on Genetics and Medicine, 2009, at Article 22, available at <> (last visited August 17, 2011).
35. Human Genome Organisation, Statement on Benefit Sharing, 2000, available at <> (last visited August 17, 2011).
36. See CIOMS, supra note 10, at Commentary on Guideline 8.
37. See World Medical Association, supra note 11, at Article 30.
38. See International Society for Pharmacoepidemiology, supra note 30, at Article II.
39. See World Medical Association, supra note 32, at Article 22.
40. See International Epidemiological Association, supra note 19.
41. See International Society for Pharmacoepidemiology, supra note 30, at Article 2.
42. See World Medical Association, supra note 11, at Article 30.
43. See International Epidemiological Association, supra note 19.
44. See Organisation for Economic Co-operation and Development, supra note 27, at Article 9.4.
45. See Human Genome Organisation, supra note 33.
46. See Council of Europe, supra note 29, at Article 28.
47. See International Epidemiological Association, supra note 19.
48. See International Society for Pharmacoepidemiology, supra note 30, at Article 2.
49. See in this symposium issue, B. M. Knoppers and A. Dam, "Return of Results: Towards a Lexicon?" Journal of Law, Medicine & Ethics 39, no. 4 (2011): 577-582.
50. See CIOMS Biomedical Research, supra note 13, at Guideline 5; CIOMS, supra note 10, at Guideline 5.
51. See International Epidemiological Association, supra note 19.
52. See Council for International Organizations of Medical Sciences, supra note 10, at Commentary on Guideline 5.
53. See Council of Europe, supra note 29, article 27.
54. World Health Organization, Genetic Databases: Assessing the Benefits and the Impact on Human and Patient Rights, 2003, at Recommendation 16.
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56. D. C. Anderson et al. (Pharmacogenetics Working Group), "Elements of Informed Consent for Pharmacogenetic Research, " Journal of Pharmacogenomics 2, no. 5 (2002): 284-292, at 287.
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58. See Organisation for Economic Co-operation and Development, supra note 27, at Article 4.14.
59. See Human Genome Organisation, supra note 33.
60. L. M. Beskow and W. Burke, "Offering Individual Genetic Research Results: Context Matters, " Science Translational Medicine 2, no. 38 (2010): 38cm20-31
61. T. Caulfield et al., "Research Ethics Recommendations for Whole-Genome Research: Consensus Statement, " PLOS Biology 6, no. 3 (2008): 430-435;
62. R. Fabsitz et al., "Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants, " Circulation Cardiovascular Genetics 3, no. 6 (2011): 574-580
63. Shalowitz et al., supra note 16; L. M. Beskow and W. Burke, quot;Offering Individual Genetic Research Results: Context Matters," Science Translational Medicine 2, no. 38 (2010): 38cm20-31
64. T. Caulfield et al., quot;Research Ethics Recommendations for Whole-Genome Research: Consensus Statement," PLOS Biology 6, no. 3 (2008): 430-435;
65. R. Fabsitz et al., quot;Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants," Circulation Cardiovascular Genetics 3, no. 6 (2011): 574-580
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67. P. N. Ossorio, "Letting the Gene Out of the Bottle: A Comment on Returning Individual Research Results to Participants, " American Journal of Bioethics 6, no. 6 (2006): 24-25, at 25.
68. See Caulfield et al., supra note 60, at 433.
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70. P. Madadi, Y. Joly, D. Avard, D. C. Chitayat, M. A. Smith, C. J. D. Ross, B. C. Carleton, M. R. Hayden, and G. Koren, "Communicating Pharmacogenetic Research Results to Breastfeeding Mothers Taking Codeine: A Pilot Study of Perceptions and Benefits, " Clinical Pharmacology & Therapeutics 88, no. 6 (2010): 792-795
71. P. Madadi, Y. Joly, D. Avard, D.C. Chitayat, A. Smith, C. J. D. Ross, B. C. Carleton, M. R. Hayden, and G. Koren, "The Communication of Pharmacogenetic Research Results: Participants Weigh in on the Informational Needs in a Pilot Study, " Journal of Population Therapeutics and Clinical Pharmacology 18, no. 1 (2011): e152-e155.
72. Frameworks are also considered to not take into account empirical data on the return of results. See J. S. Roberts, D. I. Shalowitz, K. D. Christensen, J. N. Everett, S. Y. H. Kim, L. Raskin, and S. B. Gruber, "Returning Individual Research Results: Development of a Cancer Genetics Education and Risk Communication Protocol, " Journal of Empirical Research on Human Research Ethics 5, no. 3 (2010): 17-30, at 17-18.
73. See Ravitsky and Wilfond, supra note 4
74. H. S. Richardson and L. Belsky, "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.
75. See Kristman and Kreiger, supra note 9, at 337.
76. I. S. Kohane and P. L. Taylor, "Multidimensional Results Reporting to Participants in Genomics Studies: Getting it Right, " Science Translational Medicine 2, no. 37 (2010): 38cm20.
77. See Fernandez et al., supra note 15.
78. See J. E. Haddow and G. E. Palomaki, "ACCE: A Model Process for Evaluating Data on Emerging Genetic Tests, " in M. Khoury, J. Little, and W. Burke, eds., Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease (New York: Oxford University Press Some form of sub-criteria could also be considered in respect to literature developed for the application of the ACCE model. , 2003): at 217-233
79. Centers for Disease Control and Prevention, ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing (2010), available at <> (last visited August 17, 2011).
80. P. N. Ossorio, "Letting the Gene Out of the Bottle: A Comment on Returning Individual Research Results to Participants, " American Journal of Bioethics 6, no. 6 (2006): 24-25, at 25.
81. European Commission - The Independent Expert Group, The 25 Recommendations on the Ethical, Legal and Social Implications of Genetic Testing, 2004, at 22, available at <> (last visited August 17, 2011).
82. See Human Genome Organization, supra note 2; Kohane and Taylor, supra note 69.
83. See Bredenoord et al., supra note 6, at 44.
84. See McGuire and Lupski, supra note 3, at 200.
85. See Meyer, supra note 22, at 44
86. See Beskow et al., supra note 60.