The Right Not to Know in the Context of Genetic Testing

Sander, Gerald G.; Božić, Mijo

doi:10.1007/978-3-030-16465-2_10

Gerald G. Sander⁹ &
Mijo Božić⁹

Part of the book series: Europeanization and Globalization ((EAG,volume 5))

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Abstract

The use of new analytical techniques in genetic testing makes it difficult to provide the test person with useful information on all relevant outcomes of the examination at issue. In cases of incurable diseases, the affected person frequently does not want to be informed about test results. Against this background, it is essential to inform him—before commencing the testing—about his right not to know. This right is now broadly recognised. However, it is not absolute, although exceptions to the rule are limited to a very few situations.

This paper examines the difficulties inherent in the right not to know from the point of view of the now broadly applied diagnostic methods based on analyses of the test person’s genetic constitution.

The authors wish to thank Professor Hans-Peter Zenner, University of Tübingen and Clinical Evaluation Services Tübingen for reviewing this chapter.

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Notes

1.
Leopoldina (2014), p. 15.
2.
Based on Council of Europe (2012), accessed March 7th 2017.
3.
The prediction of an incurable monogenetic disease is especially distressing, considering that the underlying mutation will lead, with virtual certainty, to the onset of the disease (e.g. Huntington’s chorea). The patient is here put in the situation of being a ‘healthy sick’ individual. See Leopoldina (2014), p. 61.
4.
In the context of this paper, the expression ‘test person’ is used as an umbrella term to cover patients, clients, and clinical trial study participants.
5.
For more on this issue see Leopoldina (2014), p. 61, and Chiapperino (2016), p. 78 ff.
6.
Gesetz über genetische Untersuchungen bei Menschen, hereinafter abbreviated to GenDG. The act took effect on February 1st, 2010. GenDG aims at defining the prerequisites for conducting genetic studies and analyses and for using samples and data obtained through genetic testing. The scope of application of the GenDG is laid down in Sec. 2 (1). Accordingly, the act applies to genetic studies and to genetic analysis carried out as part of genetic studies on those already born as well as on embryos and fetuses during pregnancy. It also applies to the treatment of genetic samples and genetic data obtained in the course of genetic testing for medical purposes and for research on descent. In addition, GenDG applies to genetic studies in the insurance industry and in employment.
7.
Okada (1998), accessed March 7th 2017.
8.
Ibid.
9.
Ibid.
10.
Ost (1984), accessed March 7th 2017.
11.
See the overview of the most relevant papers on these issues in English: Nijsingh (2016), p. 1. The most relevant paper in German from this era is Taupitz (1998), pp. 583–602.
12.
Andorno (2004), pp. 435–439; accessed March 7th 2017.
13.
The right to informational self-determination was first affirmed in the ruling of the German Federal Constitutional Court [Bundesverfassungsgericht, BVerfG] relating to personal information collected during the 1983 census; judgement of the German Federal Constitutional Court from December 15th 1983 - 1 BvR 209/83 et al. - BVerfGE 65, 1 (in German). The BVerfG ruled that: “[…] in the context of modern data processing, the protections of the individual against unlimited collection, storage, use and disclosure of his personal data is encompassed by the general personal rights of the German constitution. This basic right warrants in this respect the capacity of the individual to determine in principle the disclosure and use of his/her personal data.”
14.
See, for example, Di Fabio, in: Maunz/Dürig, Grundgesetz, 78th suppl, September 2016, GG Art. 2 para. 192.
15.
BMBF-Projektgruppe (2016), p. 399.
16.
See the judgment of the German Federal Court [Bundesgerichtshof, BGH] from May 20th 2014—BGH VI ZR 381/13; available on http://juris.bundesgerichtshof.de/cgi-bin/rechtsprechung/document.py?Gericht=bgh&Art=en&az=VI%20ZR%20381/13&nr=67940; accessed June 30th 2017.
17.
Schneider (2014), p. 3133.
18.
Ibid., p. 3134.
19.
BMBF-Projektgruppe (2016), p. 399.
20.
The German National Academy of Sciences “Leopoldina” in its position paper on Individualised Medicine [one of the synonyms for Personalised Medicine] explains the goals of this new model in a very clear manner: “Individualised Medicine aims to improve the efficacy and quality of treatment through targeted prevention, systematic diagnostics and tailored therapeutic procedures that are oriented to the needs of individual patients or patient groups; at the same time, Individualised Medicine aims to reduce side effects and increase the cost-effectiveness of treatment over the long term.” Leopoldina (2014), p. 15.
21.
Leopoldina (2014), p. 61 ff.
22.
See more on this issue in Na et al. (2015), p. 4; accessed March 7th 2017. See also Duttge (2016), p. 668.
23.
See German Ethics Council (2013), p. 74.
24.
BMBF-Projektgruppe (2016), pp. 401 ff.
25.
BMBF-Projektgruppe (2016), p. 402.
26.
German Ethics Council (2013), pp. 74 ff.
27.
Eckhardt et al. (2014), pp. 98 ff. (referring to an interview with Max Baumann).
28.
Ibid. See also on these issues Manyonga et al. (2014), pp. 561–562; accessed July 16th 2018.
29.
See more on this issue in Na et al. (2015), p. 4; accessed March 7th 2017.
30.
Personalized Medicine Coalition (2014) Figure 1, p. 5; accessed March 7th 2017.
31.
See https://www.genome.gov/10001177/, accessed March 7th 2017.
32.
Presidential Commission for the Study of Bioethical Issues (2013), p. 33; accessed March 7th 2017.
33.
Ibid.
34.
German Ethics Council (2013), p. 75 fn. 146.
35.
BMBF-Projektgruppe (2016), p. 402, Recommendation #5.
36.
Presidential Commission for the Study of Bioethical Issues (2013), p. 34. For the sake of completeness, it is necessary to point out that imaging is also capable of resulting in incidental and secondary findings. However, here the potential for such findings is inherent in the test. Imaging usually captures the surrounding organs or areas outside the focus of the test itself. However, this technique is irrelevant in the context of the present paper, as imaging is not a specific characteristic of genetic testing.
37.
The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) was an advisory panel of the nation’s leaders in medicine, science, ethics, religion, law, and engineering. The Bioethics Commission advised the US President Barack Obama [2009–2017] on bioethical issues arising from advances in biomedicine and related areas of science and technology.
38.
Presidential Commission for the Study of Bioethical Issues (2013), p. 27.
39.
Eckhardt et al. (2014), p. 98.
40.
The same is true for Switzerland under the Gesetz über genetische Untersuchungen beim Menschen (GUMG) Sec. 18 (1); see Eckhardt et al. (2014), p. 98.
41.
Leopoldina (2014), p. 62.
42.
Leopoldina (2014), p. 62; BMBF-Projektgruppe (2016), p. 402.
43.
BMBF-Projektgruppe (2016), p. 403, Recommendation #13; see also BGH VI ZR 381/13, judgement from May 20th 2014. The Leopoldina takes an obviously different view, based on Heyers (2009), pp. 507–512; Leopoldina (2014), p. 62.
44.
If the latter himself is not a genetic relative of the test person, of course.
45.
Eckhardt et al. (2014), p. 99.
46.
See, for example, the actor’s Angelina Jolie revelation in the online edition of The New York Times, published on May 14th 2013, available on http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html; accessed March 7th 2017.
47.
Presidential Commission for the Study of Bioethical Issues (2013), p. 17.
48.
Laestadius et al. (2016); accessed March 7th 2017.
49.
Prainsack (2013), p. 26; accessed July 16th 2018.
50.
Presidential Commission for the Study of Bioethical Issues (2013), p. 17.
51.
Ibid.
52.
German Ethics Council (2013), p. 84.
53.
Ibid.
54.
Ibid.
55.
German Ethics Council (2013), p. 84. The German Ethics Council points to one more problematic aspect of DTC testing, namely the difficulty of determining whether the genetic sample comes from the person ordering the genetic diagnosis. However, this aspect is less crucial in the context of the discussion of the right not to know.
56.
Leopoldina (2010) Recommendation #19, p. X. Leopoldina’s paper is concerned exclusively with predictive genetic tests. However, the relevant provisions of GenDG on information, consent and genetic counselling apply equally to predictive and diagnostic genetic tests. Consequently, based on this view, the prohibition should apply to all categories of genetic tests. See on this issue also Borry et al. (2012), pp. 715–721; accessed July 5th 2017.
57.
BMBF-Projektgruppe, p. 402 fn. 31.
58.
Ibid.

References

Position Papers, Statements, Documents

Council of Europe (2012) Genetic Tests for Health Purposes. Available on: http://www.coe.int/t/dg3/healthbioethic/Source/en_geneticTests_hd.pdf
German Ethics Council (2013) The future of genetic diagnosis – from research to clinical practice – Opinion. Available under http://www.ethikrat.org/files/opinion-the-future-of-genetic-diagnosis.pdf
German National Academy of Sciences Leopoldina, acatech – National Academy of Science and Engineering and Union of the German Academies of Sciences and Humanities (2014) Individualised Medicine – Prerequisites and Consequences Halle (Saale), 104 p. Available on: http://www.leopoldina.org/uploads/tx_leopublication/2014_Stellungnahme_IndividualisierteMedizin_EN.pdf
German National Academy of Sciences Leopoldina, acatech – National Academy of Science and Engineering, Berlin Brandenburg Academy of Sciences and Humanities and Union of the German Academies of Sciences and Humanities (2010) Statement on Predictive Genetic Diagnostics as an Instrument of Disease Prevention, November 2010. Available on: https://www.leopoldina.org/uploads/tx_leopublication/201011_natEmpf_praedikative-EN_01.pdf
Personalized Medicine Coalition (2014) The case for personalized medicine, 4th edn. Available on: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_case_for_personalized_medicine.pdf
Presidential Commission for the Study of Bioethical Issues, Anticipate and Communicate – Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (2013) Available on: https://upload.wikimedia.org/wikipedia/commons/6/6e/Anticipate_and_Communicate_-_Ethical_Management_of_Incidental_and_Secondary_Findings.pdf

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University of Applied Sciences Ludwigsburg, Ludwigsburg, Germany
Gerald G. Sander & Mijo Božić

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Faculty of Law, University of Rijeka, Rijeka, Croatia
Nada Bodiroga-Vukobrat
Croatian Academy of Sciences and Arts, Rijeka, Croatia
Daniel Rukavina
Juraj Dobrila University of Pula, Faculty of Medicine, Pula, Croatia
Krešimir Pavelić
Department of Biotechnology, Centre for High-Throughput Technologies, University of Rijeka, Rijeka, Croatia
Krešimir Pavelić
University of Applied Sciences, Ludwigsburg, Germany
Gerald G. Sander

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Sander, G.G., Božić, M. (2019). The Right Not to Know in the Context of Genetic Testing. In: Bodiroga-Vukobrat, N., Rukavina, D., Pavelić, K., Sander, G.G. (eds) Personalized Medicine in Healthcare Systems. Europeanization and Globalization, vol 5. Springer, Cham. https://doi.org/10.1007/978-3-030-16465-2_10

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DOI: https://doi.org/10.1007/978-3-030-16465-2_10
Published: 03 August 2019
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