Return of Research Results: General Principles and International Perspectives

Knoppers B. M. Joly Y. Simard J. Durocher F. , “The Emergence of an Ethical Duty to Disclose Genetic Research Results: International Perspectives,” European Journal of Human Genetics 14, no. 11 (2006): 1170–1178.

A notable exception is the Statement on the Principled Conduct of Genetics Research, Human Genome Organization, 1996, available at <http://www.eubios.info/HUGO.htm> (last visited August 17, 2011).

McGuire A. L. Lupski J. R. , “Personal Genome Research: What Should the Participant Be Told?” Trends in Genetics 26, no. 5 (2010): 199–201, at 199; McGuire A. L. Caulfield T. Cho M. K. , “Research Ethics and the Challenge of Whole-Genome Sequencing,” Nature Reviews Genetics 9, no. 2 (2008): 152–156, at 152–153.

Ravitsky V. Wilfond B. S. , “Disclosing Individual Genetic Results to Research Participants,” American Journal of Bioethics 6, no. 6 (2006): 8–17, at 9–10.

International Declaration on Human Genetic Data, UNESCO, 2003, article 19, available at <http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html> (last visited August 17, 2011).

See McGuire Lupski , supra note 3, at 199; Wolf S. M. , “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; Bredenoord A. L. Kroes H. Y. Cuppen E. Parker M. van Delden J. J. M. , “Disclosure of Individual Genetic Data to Research Participants: The Debate Reconsidered,” Trends in Genetics 27, no. 2 (2011): 41–47, at 44.

Forsberg J. S. Hansson M. G. Eriksson S. , “Changing Perspectives in Biobank Research: From Individual Rights to Concerns about Public Health Regarding the Return of Results,” European Journal of Human Genetics 17, no. 12 (2009): 1544–1549.

Dressler L. G. , “Biobanking and Disclosure of Research Results: Addressing the Tension between Professional Boundaries and Moral Intuition,” in Solbakk J. H. Holm S. Hoffmann B. , eds., The Ethics of Research Biobanking (New York: Springer, 2009): 85–99, at 90.

Kristman V. L. Kreiger N. , “Information Disclosure in Population-Based Research Involving Genetics: A Framework for the Practice of Ethics in Epidemiology,” Annals of Epidemiology 18, no. 4 (2008): 335–341, at 336; see Wolf , supra note 6, at 237–238; see Bredenoord , supra note 6, at 44.

Council for International Organizations of Medical Sciences, International Ethical Guidelines for Epidemiological Studies, 2008, at Commentary on Guideline 8 [hereinafter cited as CIOMS].

World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects , 2008, at Articles 18, 20–21, available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited August 17, 2011).

See CIOMS, supra note 10, Guideline 8.

Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects , 2002, at Guideline 8, available at <http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm> (last visited August 17) [hereinafter cited as CIOMS Biomedical Research]; see CIOMS, supra note 10, at Commentary on Guideline 8.

See Ravitsky Wilfond , supra note 4, at 9.

Fernandez C. V. Kodish E. Weijer C. , “Informing Study Participants of Research Results: An Ethical Imperative,” IRB: Ethics and Human Research 25, no. 3 (2003): 12–19, at 12.

See McGuire Lupski , supra note 3, at 199; Shalowitz D. I. Miller F. G. , “Disclosing Individual Research Results of Clinical Research: Implications of Respect for Participants,” JAMA 294, no. 6 (2005): 737–740, at 738; see Fernandez , supra note 15, at 12; see Ravitsky Wilfond , supra note 4, at 9; see Wolf , supra note 6, at 237–238.

See Shalowitz Miller , supra note 16, at 738.

Id., at 738.

International Epidemiological Association, Good Epidemiological Practice – IEA Guidelines for Proper Conduct in Epidemiologic Research , 2007, available at <http://www.ieaweb.org/index.php?option=com_content&view=article&id=15&Itemid=43> (last visited August 17, 2011).

Humgen website, available at <http://www.HumGen.org> (last visited February 15, 2011).

Norms from international consortia will be analyzed in an article from this symposium issue. See Wallace S. , “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.

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 Meyer M. N. , “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).

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 <http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf> (last visited August 17, 2011).

For an analysis and recommendations on the specific topic of incidental findings, see Wolf , supra note 6.

Ries N. M. , “Research Participants' Rights to Access Information about Themselves Held by Public Research Institutions,” Health Law Review 18, no. 3 (2010): 5–14.

See World Medical Association, supra note 11, at Article 20.

Organisation for Economic Co-operation and Development, Guidelines on Human Biobanks and Genetic Research Databases , 2009, at Article 1.H, available at <http://www.oecd.org/dataoecd/41/47/44054609.pdf> (last visited August 17, 2011).

See CIOMS Biomedical Research, supra note 13, at Guideline 5; see CIOMS, supra note 10, at Guideline 5.

Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research , 2005, at Article 28, available at <http://conventions.coe.int/treaty/en/treaties/html/195.htm> (last visited August 17, 2011).

International Society for Pharmacoepidemiology, Guidelines for Good Pharmacoepidemiology Practices , 2007, at Article II, available at <http://www.pharmacoepi.org/resources/guidelines_08027.cfm> (last visited August 17, 2011).

See International Epidemiological Association, supra note 19.

World Medical Association, Statement on Genetics and Medicine , 2009, at Article 22, available at <http://www.wma.net/en/30publications/10policies/g11/index.html> (last visited August 17, 2011).

Human Genome Organisation, Statement on Benefit Sharing , 2000, available at <http://www.eubios.info/BENSHARE.htm> (last visited August 17, 2011).

See CIOMS, supra note 10, at Commentary on Guideline 8.

See World Medical Association, supra note 11, at Article 30.

See International Society for Pharmacoepidemiology, supra note 30, at Article II.

See World Medical Association, supra note 32, at Article 22.

See International Epidemiological Association, supra note 19.

See International Society for Pharmacoepidemiology, supra note 30, at Article II.

See World Medical Association, supra note 11, at Article 30.

See International Epidemiological Association, supra note 19.

See Organisation for Economic Co-operation and Development, supra note 27, at Article 9.4.

See Human Genome Organisation, supra note 33.

See Council of Europe, supra note 29, at Article 28.

See International Epidemiological Association, supra note 19.

See International Society for Pharmacoepidemiology, supra note 30, at Article II.

See in this symposium issue, Knoppers B. M. Dam A. , “Return of Results: Towards a Lexicon?” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 577–582.

See CIOMS Biomedical Research, supra note 13, at Guideline 5; CIOMS, supra note 10, at Guideline 5.

See International Epidemiological Association, supra note 19.

See Council for International Organizations of Medical Sciences, supra note 10, at Commentary on Guideline 5.

See Council of Europe, supra note 29, article 27.

World Health Organization, Genetic Databases: Assessing the Benefits and the Impact on Human and Patient Rights, 2003, at Recommendation 16.

Renagar G. (Pharmacogenetics Working Group), “Returning Genetic Research Results to Individuals: Points to Consider,” Bioethics 20, no. 1 (2006): 24–36, at 35–36.

Anderson D. C. (Pharmacogenetics Working Group), “Elements of Informed Consent for Pharmacogenetic Research,” Journal of Pharmacogenomics 2, no. 5 (2002): 284–292, at 287.

Id., at 287.

UNESCO, International Declaration on Human Genetic Data, 2003, at Article 10, available at <http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html> (last visited August 17, 2011).

See Organisation for Economic Co-operation and Development, supra note 27, at Article 4.14.

See Human Genome Organisation, supra note 33.

See Ravitsky Wilfond , supra note 4; Shalowitz , supra note 16; Beskow L. M. Burke W. , “Offering Individual Genetic Research Results: Context Matters,” Science Translational Medicine 2, no. 38 (2010): 38cm20–31; see Fernandez , supra note 15; Caulfield T. , “Research Ethics Recommendations for Whole-Genome Research: Consensus Statement,” PLOS Biology 6, no. 3 (2008): 430–435; Wolf , supra note 6; Fabsitz R. , “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants,” Circulation Cardiovascular Genetics 3, no. 6 (2011): 574–580; see Bredenoord , supra note 6.

See McGuire , supra note 3; Miller F. A. Christensen R. Giacomini M. Robert J. S. , “Duty to Disclose What? Querying the Putative Obligation to Return Research Results to Participants,” Journal of Medical Ethics 34, no. 3 (2011): 210–213; Forsberg , supra note 7; Kristman Kreiger , supra note 9; Meyer , supra note 22.

Ossorio P. N. , “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.

See Caulfield , supra note 60, at 433.

Beskow L. M. Smolek S. J. , “Prospective Biorepository Participants' Perspectives on Access to Research Results,” Journal of Empirical Research on Human Research Ethics 4, no. 3 (2009): 99–111; Madadi P. Joly Y. Avard D. Chitayat D. C. Smith M. A. Ross C. J. D. Carleton B. C. Hayden M. R. Koren G. , “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; Madadi P. Joly Y. Avard D. Chitayat D.C. Smith A. Ross C. J. D. Carleton B. C. Hayden M. R. Koren G. , “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.

Frameworks are also considered to not take into account empirical data on the return of results. See Roberts J. S. Shalowitz D. I. Christensen K. D. Everett J. N. Kim S. Y. H. Raskin L. Gruber S. B. , “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.

See Ravitsky Wilfond , supra note 4; Beskow Burke , supra note 60; Wolf , supra note 6; Fabsitz , supra note 60, at 576.

See Beskow , supra note 60; Richardson H. S. Belsky L. , “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.

See Kristman Kreiger , supra note 9, at 337.

Kohane I. S. Taylor P. L. , “Multidimensional Results Reporting to Participants in Genomics Studies: Getting it Right,” Science Translational Medicine 2, no. 37 (2010): 38cm20.

See Fernandez , supra note 15.

Some form of sub-criteria could also be considered in respect to literature developed for the application of the ACCE model. See Haddow J. E. Palomaki G. E. , “ACCE: A Model Process for Evaluating Data on Emerging Genetic Tests,” in Khoury M. Little J. Burke W. , eds., Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease (New York: Oxford University Press, 2003): At 217–233; Centers for Disease Control and Prevention, ACCE Model List of 44 Targeted Questions Aimed at a Comprehensive Review of Genetic Testing (2010), available at <http://www.cdc.gov/genomics/gtesting/ACCE/acce_proj.htm> (last visited August 17, 2011).

Ossorio P. N. , “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.

European Commission – The Independent Expert Group, The 25 Recommendations on the Ethical, Legal and Social Implications of Genetic Testing , 2004, at 22, available at <http://ec.europa.eu/research/conferences/2004/genetic/pdf/recommendations_en.pdf> (last visited August 17, 2011).

See Human Genome Organization, supra note 2; Kohane Taylor , supra note 69.

See Bredenoord , supra note 6, at 44.

See McGuire Lupski , supra note 3, at 200.

See Meyer , supra note 22, at 44; Richardson Belsky , supra note 67, at 26; Bredenoord , supra note 6, at 45.

See Beskow , supra note 60.