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The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent

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Brain Organoids in Research and Therapy

Part of the book series: Advances in Neuroethics ((AIN))

Abstract

Research with and on brain organoids implicates well-known problems of consent: under which circumstances is consent required, when is it valid, and how far does it reach? In some cases, these problems are exacerbated by the applicability and complex interplay of specific statutes such as the Transplantation Act, the Transfusion Act, and the regulations on medicinal products. For that reason, this article seeks to provide an overview of the problems of consent within the various contexts of brain organoid use.

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Notes

  1. 1.

    Lancaster et al. (2013), p. 374; Bartfeld and Clevers (2018), p. 91; Taupitz (2020a), p. 805.

  2. 2.

    On the rights regarding severed bodily substances, see below, Sect. 7.2.2.2. See also Halàsz (2004), p. 216; Central Ethics Committee (2003), pp. 5-6, both also arguing that the removal interferes with bodily integrity, whereas the further use of seperated body substances can violate (only) the right of personality; and Parliamentary Document 16/5374 (2007), p. 72, which also differentiates between removal and further use.

  3. 3.

    In the opinion of the German legislature, it sets too low requirements in some areas and provides too little protection for certain groups of persons. For that reason, some argue that the Convention should be taken into account to the extent it sets higher, not lower, requirements than the German legal system. See, e.g., Breithaupt (2012), p. 243.

  4. 4.

    Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research (2005).

  5. 5.

    Recommendation Rec(2016)6 of the Committee of Ministers to member states on research on biological materials of human origin.

  6. 6.

    This can be deduced from Art. 2 no. 2 of the Recommendation CM/Rec(2016)6: “This recommendation does not apply to (...) the use in a specific research project of biological materials of human origin removed for the sole purpose of that project. This is within the scope of the Additional Protocol concerning Biomedical Research (CETS No. 195).”

  7. 7.

    See Sect. 7.2.2.3.

  8. 8.

    Which is why, within the German legal system, the declaration is not only a recommendation. See Kern (2019a), § 4 III.6. para. 36.

  9. 9.

    See in particular Sect. 7.3.1.3.

  10. 10.

    Spickhoff (2008), p. 385; Taupitz (2000), p. A12. On the problem of which specific article provides the basis for the right to self-determination, see Müller (2013), p. 175 et seq. Müller argues that the right to consent to physical interventions follows from Art. 2 para. 2 p. 1 GG, and that the right to be informed follows from Art. 2 para. 1 in conjunction with Art. 1 para. 1 GG.

  11. 11.

    Schroth (2009), p. 722; Halàsz (2004), p. 19.

  12. 12.

    On possible uses of collected somatic cells, Dettmeyer and Madea (2004), p. 86.

  13. 13.

    Wagner (2020a), sec. 630d BGB para. 21; for more details, see Taupitz (2012), p. 585; Taupitz (2000), pp. A58 et seq.

  14. 14.

    Schreiber (2019), p. 223.

  15. 15.

    On this issue, Katzenmeier (2020), sec. 630d BGB para. 13 et seq; Fink (2005), pp. 78–79; Schreiber (2019), p. 154 et seq.

  16. 16.

    Fink (2005), p. 79; on the consent with regard to the right of personality, Schreiber (2019), p. 223 et seq.

  17. 17.

    Spickhoff (2018a), sec. 107 BGB para. 15; Wagner (2020a), sec. 630d para. 43.

  18. 18.

    Katzenmeier (2020), sec. 630d BGB para. 14; Lipp (2021c), XIII. D. para. 38; limited to cases of risk of death or considerable damage to health: Taupitz (2000), p. A63 et seq.; on the minor’s right of veto, Federal Court of Justice (2007), p. 218. The right to veto differs from co-consent in that the minor does not have to actively exercise his or her right of self-determination. Schreiber (2019), p. 166.

  19. 19.

    Fink (2005), pp. 79–80; Schreiber (2019), pp. 212, 223–224, likewise argues in favor of a right of co-decision.

  20. 20.

    Kern (1994), p. 755.

  21. 21.

    Spickhoff (2018b), sec. 630d para. 8.

  22. 22.

    Spickhoff (2018a), sec. 107 para. 15; Spickhoff (2008), pp. 389–390; see also Wagner (2020a), sec. 630d para. 43–44.

  23. 23.

    Thus, in the case of abortion, Higher Regional Court Hamm (2020), p. 1374. Generally, Spickhoff (2018a), sec. 107 para. 15.

  24. 24.

    Katzenmeier (2020), sec. 630d para. 18 et seq.; Taupitz (2000), pp. A67–A68.

  25. 25.

    Lipp (2021c), XIII. B. para. 13.

  26. 26.

    Lipp (2021c), XIII. E. I. para. 50; see above, Sect. 7.1.2.

  27. 27.

    Lipp (2021c), XIII. E. I. para. 50; see also, National Ethics Council (2004), pp. 16–17, 64–65.

  28. 28.

    Lipp (2021c), XIII. E. I. para. 51.

  29. 29.

    National Ethics Council (2004), p. 65; see also Baston-Vogt (1997), p. 274 et seq.

  30. 30.

    See, e.g., para. 12 of the WMA Declaration of Taipei on Ethical considerations regarding Health Databases and Biobanks (2016); for revocation and its consequences, see National Ethics Council (2004), pp. 69–70.

  31. 31.

    Kern and Rehborn (2019), sec. 42 para. 79.

  32. 32.

    For this interpretation, see Stock (2009), p. 155; Suhr (2016), p. 172; Sternberg-Lieben (2019), sec. 228 StGB para. 17–18; Federal Court of Justice (2004), p. 2459.

  33. 33.

    On the irrelevance, in principle, of ulterior objectives, Sternberg-Lieben (2019), sec. 228 StGB para. 19; Federal Court of Justice (2004), p. 2459; Förster (2020), sec. 823 BGB para. 34; and, as regards the result, Ohly (2002), p. 421.

  34. 34.

    Hardtung (2017), sec. 228 StGB para. 47; see also Ohly (2002), pp. 421 et seq.

  35. 35.

    Förster (2020), sec. 823 BGB para. 35; but see Ohly (2002), p. 408.

  36. 36.

    Spindler (2020), sec. 823 BGB para. 84; Förster (2020), sec. 823 para. 34; Deutsch and Spickhoff (2014), para. 419.

  37. 37.

    Halàsz (2004), p. 216; Wenzel (2019), chapter 4 para. 158; Prütting and Merrem (2019), sec. 630d BGB para. 11.; diese Uneinheitlichkeit auch feststellend: Ohly (2002), pp. 397–398.

  38. 38.

    Federal Court of Justice (2017), p. 2686.

  39. 39.

    Federal Court of Justice (1976), p. 1790.

  40. 40.

    Federal Court of Justice (1953), p. 701.

  41. 41.

    Sec. 138 BGB has a much broader scope of application than sec. 228 StGB. Cf. Stock (2009), p. 158. See the rulings of the Federal Court of Justice (1976), p. 1790; Federal Court of Justice (1953), p. 701), which measured the immorality of consent in private law against sec. 138 BGB (applied analogously) and did not focus on a danger to life. Instead, they asked whether the interventions in the body generally violate “what moral conduct is required of the individual within the social community according to the prevailing views of our legal and cultural society” (see Federal Court of Justice (1976), p. 1790, on the case of sterilization). On the application of criminal law restrictions to private law, Ohly (2002), pp. 400 et seq. According to Ohly (2002), we should ask whether the restriction seeks to protect the person consenting, in which case the invalidity of the consent extends to private law (pp. 405–407).

  42. 42.

    Stock (2009), p. 156, Suhr (2016), p. 172, and Schroth (2009), p. 726, also argue that societal aspects should be left out of the equation when applying sec. 228 StGB, as they would render moot the right to self-determination.

  43. 43.

    Lipp (2021b), VII. E. I. para. 41; Ohly (2002), p. 426.

  44. 44.

    See Sect. 7.2.2.2.

  45. 45.

    Dederer (2009), p. 109.

  46. 46.

    Dederer (2009), p. 107 with reference to John Locke, Giovanni Pico de la Mirandolla and Marcus Aurelius; Lackermair (2017), p. 293. In the field of ethics, the moral status of human beings is often justified with reference to Kant or to the autonomy of human beings as well: Chen et al. (2019), p. 466; Karpowicz et al. (2004), p. 334.

  47. 47.

    Dederer (2009), p. 108.

  48. 48.

    Dederer (2009), pp. 107–108; Lackermair (2017), p. 290.

  49. 49.

    Lackermair (2017), pp. 293–294.

  50. 50.

    Thus also, Dederer (2009), p. 108.

  51. 51.

    Federal Constitutional Court (1970), p. 26.

  52. 52.

    Dederer (2009), p. 108; Lackermair (2017), pp. 296–270.

  53. 53.

    Federal Constitutional Court (1977), p. 227; cf. Dederer (2009), p. 108.

  54. 54.

    Federal Constitutional Court (1970), p. 26. For criticism of the “wilfulness” personhood criteria, see Lackermair (2017), pp. 269–270.

  55. 55.

    For more details: Dederer (2009), p. 118 et seq.

  56. 56.

    Lackermair (2017), p. 297.

  57. 57.

    Chen et al. (2019), p. 463.

  58. 58.

    Chen et al. (2019), p. 463.

  59. 59.

    Qian et al. (2016), pp. 1238 et seq.; Qian et al. (2018), pp. 565 et seq.

  60. 60.

    Chen et al. (2019), p. 465. See also Farahany et al. (2018), p. 430, who note that it is unclear whether brain organoids will attain consciousness in the future, and Lavazza and Massimini (2018), p. 608, who compare the challenge of detecting brain activity in cerebral organoids with the efforts to assess consciousness in brain-injured non-communicating patients. Incidentally, researchers have already managed to produce neural activity on a region where cells of the retina had formed together with cells of the brain. See Farahany et al. (2018), p. 430; Quadrato et al. (2017), pp. 48–53.

  61. 61.

    Thus, in the context of human–animal hybrids, Lackermair (2017), p. 299.

  62. 62.

    Cf. Lavazza and Pizzetti (2020), p. 11, who emphasize that brain organoids are not human beings who are genetically identical to the cloned “original.”

  63. 63.

    Lackermair (2017), p. 301.

  64. 64.

    Kersten (2004), p. 491; Lackermair (2017), p. 301.

  65. 65.

    Lackermair (2017), p. 299.

  66. 66.

    As regards human cloning Frankenberg (2000), p. 330; as regards human–animal hybrids: Lackermair (2017), p. 288.

  67. 67.

    See Lackermair (2017), p. 301, who asks that question with regard to hybrids and chimeras.

  68. 68.

    Lackermair (2017), pp. 301–302.

  69. 69.

    For arguments in favor, see German Ethics Council (2011), pp. 61–62. For objections, see Lackermair (2017), p. 350 et seq.

  70. 70.

    Listed by Daviaud et al. (2018), p. 2.

  71. 71.

    Lancaster et al. (2013), p. 373 et seq.; Li et al. (2017), p. 823 et seq.

  72. 72.

    Forsberg et al. (2018), p. 1 et seq.

  73. 73.

    Qian et al. (2016), p. 1238 et seq.; Watanabe et al. (2017), p. 517 et seq.

  74. 74.

    Kersten (2004), p. 509 et seq.; Buchanan et al. (2012), p. 199; Dreier (2013), Art. 1 sec. 1 para. 109; Lackermair (2017), p. 302 et seq.; Spranger (2001), p. 242; and Schroth (2009), p. 722, all reject the idea of human dignity as a constraint on that person’s own rights. For a more cautious approach, see Ohly (2002), p. 414. On Ohly’s view, whether one has the right to dispose of one’s own rights depends on whether this disposition would cause irrevocable loss of liberty, personal self-determination, or the essential factual prerequisites of a life lived autonomously. There is no such risk in our case, however.

  75. 75.

    Spranger (2001), pp. 242–243 (see p. 242 for the permissibility of therapeutic research); see also Taupitz (2012), pp. 585–586, and the references cited therein.

  76. 76.

    Taupitz (2012), p. 586. On the permissibility of research on minors that does not benefit them directly but involves only minor physical interventions, Lipp (2021c), XIII E. I. para. 107.

  77. 77.

    Taupitz (2012), p. 586.

  78. 78.

    Taupitz (2012), p. 586.

  79. 79.

    On the relevance of the incapacitated person’s wish to participate in the research, Lipp (2021c), XIII. E. I. para. 104. But see Spranger (2001), p. 243, who, to protect the person under custodianship from self-harm, argues that his or her wish is irrelevant if it involves any form of research.

  80. 80.

    For the right to object, see below.

  81. 81.

    See Sect. 7.1.2.1.

  82. 82.

    On this controversial point, cf. Spranger (2001), p. 243.

  83. 83.

    As regards minors, Schreiber (2019), p. 278 et seq, in particular p. 284-285. See Sect. 7.4, on the data protection requirements, pursuant to which the further use of data without the data subject’s consent is only permissible if there is an appropriate legal basis and particular protective requirements are met; on the view I advocate, the further use of genetic data is unlawful if the data subject does not consent. Violations may incur onerous financial sanctions; see sect. 41 of the Federal Data Protection Law and Art. 83 para. 5 lit. (a) Reg. (EU) No 2016/679.

  84. 84.

    Taupitz (1998), p. 597 et seq.

  85. 85.

    See Federal Court of Justice (2014), p. 2192, which in this case denied a violation.

  86. 86.

    On the applicability of the GenDG—whose sec. 2 para. 2 no. 1 states the Act does not apply to “research”—Schreiber (2019), p. 94.

  87. 87.

    Schreiber (2019), p. 286.

  88. 88.

    See Sect. 7.2.2.3.

  89. 89.

    See Schreiber (2019), p. 293, and the references cited therein; Taupitz (2000), p. A79.

  90. 90.

    For adults, cf. Lipp (2021c), XIII. E. I. para. 104; for the general context, National Ethics Council (2004), p. 21; Taupitz (2000), p. A75 et seq.

  91. 91.

    Schreiber (2019), p. 154; Spickhoff (2018b), sec. 630d para. 7; Taupitz (2000), p. A75 et seq.

  92. 92.

    Schreiber (2019), p. 154.

  93. 93.

    Such as in Art. 31 para. 1 lit. (c) and Art. 32 para. 1 lit. (c) of the Reg. (EU) No 536/2014.

  94. 94.

    See Art. 31 para. 1 lit. (b), para. 3 and Art. 32 para. 1 lit. (b), para. 2 of the Reg. (EU) No 536/2014.

  95. 95.

    Lipp (2021c), XIII. E. I. para. 108.

  96. 96.

    See Sect. 7.2.2.2.

  97. 97.

    Fink (2005), p. 80.

  98. 98.

    As just discussed in the case of research on incapacitated persons.

  99. 99.

    See Sect. 7.2.2.2, on rights over severed bodily substances.

  100. 100.

    For the legal consequences of altering a thing by processing it, see secs. 947 BGB et seq.

  101. 101.

    Cf. Faltus (2021), p. 131.

  102. 102.

    See generally Klumpp (2017), preliminary remarks to §§ 104 ff., para. 100, and the references cited therein; Fink (2005), p. 77; c.f. Schreiber (2019), p. 319 et seq.

  103. 103.

    Mansour et al. (2018), p. 432 et seq.; Daviaud et al. (2018), p. 1 et seq.

  104. 104.

    Mansour et al. (2018), p. 440; Daviaud et al. (2018), pp. 2 and 3, also report positive findings.

  105. 105.

    Daviaud et al. (2018), pp. 1 and 2.

  106. 106.

    The German Transplantation Act does not apply to the transfer of human tissue or organs to animals, which means that no specific requirements for the informed consent of the cell donor arise from more specific legislation.

  107. 107.

    See also Farahany et al. (2018), p. 431.

  108. 108.

    Generally on the creation of chimeras, Lackermair (2017), p. 299.

  109. 109.

    Lackermair (2017), p. 299.

  110. 110.

    Muotri et al. (2005), p. 18644 et seq.; Lackermair (2017), p. 68 et seq., 299–300, refers to this experiment to argue against “humanizing” animals through human neuronal cells.

  111. 111.

    On the possibility of generating not only whole-brain organoids but also region-specific brain organoids, Chen et al. (2019), pp. 463–464, and Daviaud et al. (2018), p. 17 (and the references cited therein). Karpowicz et al. (2004), p. 334, presume there might be a transfer of functional behavior when entire brain regions are transplanted between closely related, functionally and morphologically similar beings, such as chimpanzees and humans.

  112. 112.

    Chen et al. (2019), pp. 465, 467.

  113. 113.

    Chen et al. (2019), p. 466.

  114. 114.

    Chen et al. (2019), p. 467.

  115. 115.

    Balaban et al. (1988), p. 1339 et seq.

  116. 116.

    Greely et al. (2007), p. 35; Chen et al. (2019), p. 468; cf. Lackermair (2017), p. 70.

  117. 117.

    Chen et al. (2019), p. 469, do not answer that question.

  118. 118.

    Lackermair (2017), p. 299.

  119. 119.

    Lackermair (2017), p. 300.

  120. 120.

    See Chen et al. (2019), p. 469. Farahany et al. (2018), p. 431, suggest a case-by-case evaluation. For Greely et al. (2007), p. 38, a mouse with human language capacities and self-consciousness would at least be “troubling.”

  121. 121.

    Bartfeld and Clevers (2018), p. 93.

  122. 122.

    Bartfeld and Clevers (2018), p. 93.

  123. 123.

    Based on Art. 5 Directive 2001/20/EU.

  124. 124.

    Based on Art. 4 Directive 2001/20/EU.

  125. 125.

    Wachenhausen (2016a), sec. 4 AMG para. 184.

  126. 126.

    The French version of the Directive referred to “chez l’homme,” while the Regulation refers to “en rapport avec l’homme.”

  127. 127.

    There does not seem to be any scholarship as yet regarding the changed wording. Neither this term nor the term “in humans” used in the Directive appear anywhere else in the Regulation itself, nor is there any reference to this amendment.

  128. 128.

    Lipp (2021c), XIII.E.IV.1. para. 71; Wachenhausen (2016b), sec. 40 AMG para. 7.

  129. 129.

    See, e.g., Art. 31 and 32 (clinical trials on incapacitated subjects and minors), as such a trial can only be carried out if either the subject has a direct benefit or there is at least a benefit for the population represented by the subject, provided it imposes only a minimal burden on the subject in comparison with the standard treatment. However, neither can the procedure examined here yield a direct benefit nor can the prerequisite be fulfilled that only a minimal burden may exist in comparison with the standard treatment. The latter means that no further burdensome interventions may be carried out compared to the standard therapy, such as the collection of samples to test the drug’s mode of operation. See Schreiber (2019), p. 248.

  130. 130.

    Winnands (2016), sec. 22 para. 54; Rehmann (2020), sec. 22 para. 20; Franken (2020), sec. 12 A. para 2 and A.IV. para. 9.

  131. 131.

    A so-called individual healing attempt. See Lipp (2021c), XIII.E.III. paras. 59 et seq.; Kern (2019b), § 131 I.3. para. 20.

  132. 132.

    Kern (2019b), § 131 I.3. para. 20; Bender (2005), p. 512.

  133. 133.

    Lipp (2021c), XIII.E.III. para. 59–61. On the healing attempt as a therapeutic study, if the results are evaluated systematically, Schreiber (2019), p. 8. Bender (2005), p. 515, considers a healing attempt a therapeutic study and therefore research if it comprises at least 10 persons, as this number suggests a certain degree of standardization.

  134. 134.

    Halàsz (2004), p. 231.

  135. 135.

    See Schreiber (2019), pp. 294–295; Central Ethics Committee (2003), p. 9, which allows for consent that covers “all possible studies”; National Ethics Council (2004), pp. 14, 58–59.

  136. 136.

    Taupitz and Schreiber (2016), p. 307.

  137. 137.

    Schreiber (2019), pp. 294–295; Taupitz and Schreiber (2016), p. 307.

  138. 138.

    Taupitz and Schreiber (2016), p. 307; Schreiber (2019), p. 295.

  139. 139.

    Halàsz (2004), p. 232.

  140. 140.

    Schreiber (2019), p. 295, refers to this Declaration in the context of broad consent.

  141. 141.

    Lippert (2001), p. 407.

  142. 142.

    On this now outdated opinion, see Halàsz (2004), p. 15 et seq.

  143. 143.

    Halàsz (2004), p. 19. According to the so-called superposition thesis, the living body is also a thing, but the property over it is subsumed by the right of personality until a part of the body is separated. See Schünemann (1985), p. 86 et seq.

  144. 144.

    At least if they contain genetic material, Taupitz (1991), p. 210.

  145. 145.

    However, it is unclear how separated substances become a thing. For the different approaches, see Halàsz (2004), p. 31 et seq.; Lippert (2001), p. 407.

  146. 146.

    The opinions on how the right of personality continues to cover the substances after their removal differ. Taupitz (1991), p. 209 et seq., proposes two different solutions: either the right of personality continues to exist, by analogy to sec. 953 BGB, in the substance or the use of the substance affects the donor’s right of personality; Halàsz (2004), p. 36 et seq., emphasizes the connection that remains between the substance and the donor.

  147. 147.

    On this approach, which combines both rights, Schröder and Taupitz (1991), p. 40 et seq.; Taupitz (1991), p. 209 et seq.; Halàsz (2004), p. 26 et seq.; Lippert (2001), p. 407; Baston-Vogt (1997), p. 285 et seq. On the approach that emphasizes the right of personality, Schröder and Taupitz (1991), p. 38 et seq.; Halàsz (2004), p. 20 et seq. On the approach that emphasizes property rights, Schröder and Taupitz (1991), p. 35 et seq.; Halàsz (2004), p. 22 et seq.

  148. 148.

    Federal Court of Justice (1994), pp. 127–128.

  149. 149.

    Laufs and Reiling (1994), p. 775.

  150. 150.

    See Laufs and Reiling (1994), p. 775, who fail to appreciate, however, that this aspect of the right of personality is not about “family planning” as an activity but about the bond that connects the person concerned with his or her body part even though it is separated from him or her.

  151. 151.

    Taupitz (1991), p. 210.

  152. 152.

    Schröder and Taupitz (1991), pp. 44, 54; Taupitz (1991), p. 210-211; Taupitz and Schreiber (2016), p. 305; Fink (2005), p. 56.

  153. 153.

    See, e.g., Halàsz (2004), p. 195, who argues that the self-determination of the rights holder and the physician’s right to free research must limit each other. Why should that be so?

  154. 154.

    See also von Freier (2005), pp. 325–326.

  155. 155.

    Baston-Vogt (1997), p. 289 et seq.

  156. 156.

    Schröder and Taupitz (1991), p. 67.

  157. 157.

    On dereliction and the transfer of ownership, Halàsz (2004), pp. 258–259; Breithaupt (2012), p. 215 et seq.; Schreiber (2019), pp. 320–321.

  158. 158.

    Thus Lippert (2001), p. 407, according to whom a separate informed consent is required “in normal cases,” but who later limits this statement to research projects in which genetic dispositions are examined (p. 409). See also Dettmeyer and Madea (2004), pp. 85–86. I set to the side other ways—other than giving consent—to allow the use of separated body substances. On this matter, Fink (2005), p. 154 et seq.; Halàsz (2004), p. 233 et seq.

  159. 159.

    For persuasive arguments against assuming implied consent, Schröder and Taupitz (1991), p. 62; Taupitz (1991), pp. 218–219; Breithaupt (2012), pp. 254–255; von Freier (2005), p. 326.

  160. 160.

    Thus, e.g., in copyright law, or when a person uses a thing that its owner threw away in the expectation that it would be destroyed. See Taupitz (1991), p. 219.

  161. 161.

    Based on the principle that research always requires prior consent. See Art. 21 para. 1, para. 2 lit. (a) Recommendation CM/Rec(2016)6, and Art. 22 Oviedo Convention.

  162. 162.

    Contrary to non-coding material, coding material, which codes for the synthesis of certain proteins, allows drawing conclusions about personal characteristics. See Halàsz (2004), pp. 201–202.

  163. 163.

    See Halàsz (2004), p. 202, who assigns this data to the core area protected by the right of personality. For a less extensive view, see Fink (2005), p. 66. Generally on research with genetic data, Schröder and Taupitz (1991), p. 64. Schreiber (2019), p. 124 et seq., suggests differentiating, especially with regard to the purpose of the data collection.

  164. 164.

    Schröder and Taupitz (1991), p. 64.

  165. 165.

    Halàsz (2004), p. 197–199; Schreiber (2019), p. 309; National Ethics Council (2004), pp. 13, 57–58

  166. 166.

    See Halàsz (2004), p. 196.

  167. 167.

    See also von Freier (2005), p. 326.

  168. 168.

    “(...) evidence is provided that reasonable efforts have been made to contact the person concerned (i.); the research addresses an important scientific interest and is in accordance with the principle of proportionality (ii); the aims of the research could not reasonably be achieved using biological materials for which consent or authorisation can be obtained (iii); and there is no evidence that the person concerned has expressly opposed such research use (iv).”

  169. 169.

    Central Ethics Committee (2003), p. 6; Taupitz (2020a), p. 808; Schröder and Taupitz (1991), pp. 82–83; Schreiber (2019), pp. 309–310.

  170. 170.

    This is also the case in Art. 21 para. 4 Recommendation CM/Rec(2016)6. See Breithaupt (2012), pp. 209, 262; Dettmeyer and Madea (2004), pp. 92–93; National Ethics Council (2004), pp. 12–13, 52, 56–57. Halàsz (2004), p. 203, for whom the right of personaltiy protects only “genetically relevant” substances (pp. 56–57), argues that this holds true at least for non-coding bodily materials. Nitz and Dierks (2002), pp. 402-403, also seem to argue that consent is not “normally” required for research on anonymized material. See also Taupitz and Schreiber (2016), p. 306, who argue, however, that the waivability of consent also depends on the type of use. von Freier (2005), p. 323, finally, refers to the statement of the National Ethics Council (2004).

  171. 171.

    See, e.g., Central Ethics Committee (2003), p. 6, which emphasizes the criterion of anonymization. See also Taupitz (2020a), p. 808; Schreiber (2019), pp. 307–308 and 311.

  172. 172.

    Cf. von Freier (2005), p. 323

  173. 173.

    Halàsz (2004), p. 200; Fink (2005), p. 62.

  174. 174.

    Halàsz (2004), p. 203.

  175. 175.

    von Freier (2005), p. 324 et seq.; also Halàsz (2004), p. 87 et seq.; Fink (2005), p. 56.

  176. 176.

    Thus also Freund and Weiss (2004), p. 317; Schreiber (2019), pp. 310 et seq.; von Freier (2005), p. 327; Fink (2005), p. 75, also does not consider consent per se indispensable. Taupitz (2020a), p. 808, focuses on the degree of anonymization but also emphasizes additional aspects.

  177. 177.

    Explicitly Fink (2005), p. 75.

  178. 178.

    For this stance, see Breithaupt (2012), pp. 208–209, and Nitz and Dierks (2002), p. 402.

  179. 179.

    Baston-Vogt (1997), pp. 291–292.

  180. 180.

    See also von Freier (2005), p. 326.

  181. 181.

    For minors, see also Schreiber (2019), p. 312.

  182. 182.

    See Lavazza and Pizzetti (2020), p. 13 et seq.; Farahany et al. (2018), p. 432.

  183. 183.

    Dreier (2013), Art. 1 sec. 1 para. 109.

  184. 184.

    Lavazza and Pizzetti (2020), p. 11.

  185. 185.

    See, e.g., the contributions of Greely et al. (2007); Karpowicz et al. (2004) ; Lackermair (2017) ; German Ethics Council (2011).

  186. 186.

    Schröder and Taupitz (1991), pp. 69–70; Taupitz (1991), p. 210; Taupitz (2020a), p. 808; but see, Fink (2005), p. 70 et seq.

  187. 187.

    Schröder and Taupitz (1991), p. 66.

  188. 188.

    See Taupitz (2020a), p. 809; Wernscheid (2012), p. 229.

  189. 189.

    See Taupitz (1991), p. 217, and Fink (2005), p. 74 and the references cited therein. But see Halàsz (2004), pp. 203–204.

  190. 190.

    Thus Halàsz (2004), pp. 123–124.

  191. 191.

    Schröder and Taupitz (1991), pp. 71–72.

  192. 192.

    Schröder and Taupitz (1991), p. 77.

  193. 193.

    On the abandonment of property and the implied transfer of ownership, Halàsz 2004, pp. 258–259; Breithaupt (2012), p. 215 et seq.

  194. 194.

    Halàsz (2004), p. 39, pp. 65–68.

  195. 195.

    Taupitz (1991), p. 218, argues that a violation of the right of personality becomes likely if the remuneration is especially high, and that there may only be a breach of contract between the doctor and his or her patient in other cases. See also Schröder and Taupitz (1991), pp. 78–79. But see Halàsz (2004), pp. 260–261, according to whom the donor transferred the right to economic exploitation of the materials to the physician or researcher, at least in cases in which he or she transfers his or her ownership to the latter.

  196. 196.

    For greater detail, see Schröder and Taupitz (1991), p. 77 et seq.

  197. 197.

    Taupitz and Schreiber (2016), p. 306.

  198. 198.

    Wagner (2020b), sec. 630d para. 53.

  199. 199.

    von Freier (2005), p. 327.

  200. 200.

    See Freund and Weiss (2004), p. 317 and the references cited therein.

  201. 201.

    Freund and Weiss (2004), p. 317.

  202. 202.

    Freund and Weiss (2004), p. 317; Wagner (2020b), sec. 630d para. 52.

  203. 203.

    The Tissue Directive 2004/23/EC likewise applies to cells. See Art. 2 para. 1, according to which the Directive applies to tissues and cells, and Art. 3 lit. a and b, which defines tissues and cells, respectively. The German legislature then decided, for the sake of simplicity, to use the term “tissue” for both cells and tissues. See Parliamentary Document 16/3146 (2006), p. 24.

  204. 204.

    Wernscheid (2012), p. 112; Taupitz (2020a), p. 809; Faltus (2021), p. 131.

  205. 205.

    Parliamentary Document 16/3146 (2006), p. 21; Wernscheid (2012), p. 112; Taupitz (2020a), p. 809.

  206. 206.

    Gerke (2020), pp. 291, 295; Taupitz (2020a), pp. 809, 811.

  207. 207.

    Thus, explicitly, Gerke (2020), p. 295.

  208. 208.

    König (2005), sec. 1 TPG para. 17; Rixen (2013), sec. 1 TPG para. 3 and footnote 8.

  209. 209.

    See also Faltus (2021), p. 131.

  210. 210.

    Gerke (2020), p. 295

  211. 211.

    Taupitz (2020a), p. 811.

  212. 212.

    Gerke (2020), p. 291; Taupitz (2020a), p. 811.

  213. 213.

    But see Taupitz (2020a), p. 811.

  214. 214.

    Pühler et al. (2010), p. 25.

  215. 215.

    In this context, sec. 17 para. 1 p. 2 no. 2 TPG is very misleading: It refers to medicinal products that are “manufactured from or using organs,” which seems to suggest that organs within the meaning of the Transplantation Act can constitute medicinal products in some form after all. To avoid contradicting sec. 2 para. 3 no. 8 of the Medicinal Products Act, sec. 17 para. 2 no. 2 TPG must be read to cover only medicinal products that stem from processed organs which themselves are no longer organs within the meaning of the Transplantation Act—because they no longer form a “functional unit”—and which are also no longer tissues as parts of organs within the meaning of sec. 1a no. 1 TPG.

  216. 216.

    Parlamentary Document 16/12256 (2009), p. 58 and p. 26; Document of the Federal Council 171/09 (2009), p. 50; Parlamentary Document 16/13428 (2009), pp. 46–47 and p. 75; Federal Law Gazette (2009), p. 2009.

  217. 217.

    Parliamentary Document 17/7376 (2011), p. 17.

  218. 218.

    For the medicinal properties of brain organoids, see below, Sect. 7.3.1.3.1.

  219. 219.

    Faltus (2021), p. 131.

  220. 220.

    Faltus (2021), p. 131.

  221. 221.

    Thus for the removal of pancreata Pühler et al. (2010), p. 25.

  222. 222.

    Gerke does not address tissue property and concludes that the transfer of artificial organs does not fall under the Transplantation Act: Gerke (2020), p. 295.

  223. 223.

    König (2005), sec. 1 TPG para. 17; Rixen (2013), sec. 1 TPG para. 3, also fn 8.

  224. 224.

    König (2005), sec. 1 TPG para. 17.

  225. 225.

    See Sects. 7.3.1.3.2 and 7.3.1.3.3, for autologous transplantation, and Sect. 7.3.2.3 for allogeneic transplantation.

  226. 226.

    Federal Law Gazette (2007), p. 1580.

  227. 227.

    Thus generally for hiPS cell therapies, Gerke (2020), p. 296. For the requirements under sec. 1 para. 3 no. 1 TPG, see Rixen (2013), sec. 1 TPG para. 10.

  228. 228.

    Gerke (2020), p. 298. See Sect. 7.3.3.

  229. 229.

    Schmidt-Recla (2013), sec. 8c TPG para. 3.

  230. 230.

    On the duty to inform about the prospects of success of an organ transplantation, see Müller (2013), p. 167, and below, Sect. 7.3.2.3.

  231. 231.

    König (2005), sec. 1 TPG para. 17, mentions the possibility of a curative attempt in the context of transplantations (albeit before sec. 8c was adopted).

  232. 232.

    Schmidt-Recla (2013), sec. 8c TPG para. 6.

  233. 233.

    See Sects. 7.3.1.3.2 and 7.3.1.3.3, for autologous transplantations.

  234. 234.

    For incapacitated minors, see sec. 1627 BGB. For incapacitated adults under custodianship, see sec. 1901 para. 2 and 3 BGB.

  235. 235.

    Schmidt-Recla (2013), sec. 8c TPG para. 12.

  236. 236.

    Schneider (2020), sec. 1901 BGB para. 11.

  237. 237.

    Schneider (2020), sec. 1901 BGB para. 15.

  238. 238.

    Lipp (2021c), XIII.D. para. 36, 38; Deutsch and Spickhoff (2014), para. 1138-139, 1334.

  239. 239.

    Gerke (2020), p. 254; Taupitz (2020a), p. 811.

  240. 240.

    For greater detail, see Gerke (2020), pp. 254 et seq.; Taupitz (2020a), pp. 811–812.

  241. 241.

    For hiPS cell-based therapeutics in general, see Gerke (2020), pp. 254–255. For organoids, see Taupitz (2020a), pp. 811–812.

  242. 242.

    It is doubtful, for instance, whether the CRISPR/Cas method, which can change the genetic information of a cell through self-repair mechanisms, creates a gene-therapeutical medicinal product. For an analysis under the German Gene Technology Act, see Deuring (2020), pp. 379 et seq.

  243. 243.

    Schmidt-Recla (2013), sec. 8c TPG para. 6.

  244. 244.

    Ulsenheimer (2019), chapter 24 § 152 IV.2. para. 31; Lipp (2021a), VI.A.I.6.a) para. 30.

  245. 245.

    In contrast to the Transplantation Act, sec. 6 para. 1 sent. 3 TFG does provide for separate consent.

  246. 246.

    On the scope of the information, see Sect. 7.3.1.2.

  247. 247.

    See Art. 14 sec. 2, also with regard to further conditions.

  248. 248.

    That is, the legal representative of minors, sec. 1626 et seq. BGB, the custodian of incapacitated adults, sec. 1896 et seq. BGB, or the authorized representative, sec. 1901c BGB.

  249. 249.

    Müller (2013), p. 166. Generally on the scope of the obligation to provide information in the case of novel medical methods, Lipp (2021c), XIII.D. para. 32; Deutsch and Spickhoff (2014), para. 1333.

  250. 250.

    See Sects. 7.3.1.3.2 and 7.3.1.3.3, for the admissibility of clinical trials.

  251. 251.

    Faltus (2016), p. 643; Gerke (2020), p. 298 ; Tag (2017), sec. 28 TFG para. 1.

  252. 252.

    Thus for hiPS cells Gerke (2020), p. 299. For a definition of blood and blood components, see Gerke (2020), p. 297.

  253. 253.

    See also Rixen (2013), sec. 1 para. 3 footnote 8.

  254. 254.

    Thus for autologous blood transfer Tag (2017), sec. 6 TFG para. 10.

  255. 255.

    Tag (2017), sec. 6 TGG para. 6.

  256. 256.

    See recital 26 for the criteria that determine whether a person is “identifiable.” It remains disputed whether a pseudonymization (Art. 4 no. 5 Reg. (EU) No 2016/769) qualifies, at least from the perspective of the data processing agents, as anonymization. See Spindler and Dalby (2019a), Art. 4 Reg. (EU) No 2016/769 paras. 14 et seq.; Taupitz (2020b), pp. 606 et seq.

  257. 257.

    See Schreiber (2019), p. 105, and the references cited therein. Breyer (2004), p. 660, Breithaupt (2012), p. 240, and Fink (2005), p. 60, also reject classifying body substances as data.

  258. 258.

    von Freier (2005), p. 324; Schreiber (2019), p. 105.

  259. 259.

    Schreiber (2019), pp. 130–131; for greater detail on the meaning of anonymization and de facto anonymization, especially in the context of genetic data, see Taupitz (2020b), p. 605 et seq.

  260. 260.

    Art. 4 no. 1; Schreiber (2019), p. 106; Fink (2005), p. 61.

  261. 261.

    Schreiber (2019), p. 109; Albers and Veit (2020), Art. 9 Regulation (EU) No 2016/679 para. 50-51.

  262. 262.

    Schreiber (2019), p. 109.

  263. 263.

    Schaar (2017), p. 215.

  264. 264.

    The BDSG applies to public bodies of the federal level as well as to private persons. The data protection laws of the Länder will not be dealt with separately in this chapter.

  265. 265.

    Spindler and Dalby (2019b), Art. 9 Regulation (EU) No 2016/679 para. 25; Schreiber (2019), p. 116. For greater detail regarding the balancing of interests, especially the possibility of obtaining consent, see Taupitz (2020b), p. 621 et seq. For criticism, see Fleischer (2018), p. 302.

  266. 266.

    Schreiber (2019), p. 116; Fleischer (2018), p. 302.

  267. 267.

    Schreiber (2019), p. 117.

  268. 268.

    Schreiber (2019), p. 117.

  269. 269.

    Schreiber (2019), pp. 119–120.

  270. 270.

    See, e.g., Goerdeler and Laubach (2002), p. 117; Keller (1989), p. 2292. Fink (2005), p. 66, argues that the core of the right of personality is not affected if the research merely aims to uncover the (not yet established) connection between genetic predispositions and the development of a disease (i.e., a personality-related characteristic). Taupitz (2020b), p. 613 et seq., argues that the “research clauses” apply to genetic data, as neither Art. 9 nor sec. 27 differentiate between genetic data and other sensitive data. Yet, Art. 9 para. 4 allows the member states to introduce further conditions, including limitations, with regard to the processing of genetic data. This allows narrowing the scope of sec. 27, if the consideration of fundamental rights requires it, without coming into conflict with EU law. See Schreiber (2019), p. 122.

  271. 271.

    Federal Constitutional Court (2000), p. 32.

  272. 272.

    Fink (2005), p. 66. But see Schreiber (2019), p. 123 et seq., who argues the purpose of the use should also be relevant. The objection to this argument, however, is that it eviscerates the notion of a fundamental right’s core protection. In particular, it does not follow from the Federal Constitutional Court’s “Diary Decision” that the purpose of use alters the personal and intimate nature of the data concerned. Rather, the Court argued (in a questionable manner) that the diary entries could be used for criminal investigations because they “inherently affect”—by providing information about the cause and background of the criminal offense—“the sphere of others or the interests of the community” (Federal Constitutional Court 1989, p. 379). Crucially, the information embodied in one’s genes does not “inherently affect” the interests of others or the community.

  273. 273.

    See Taupitz (2020b), p. 609.

  274. 274.

    Schreiber (2019), p. 280; Taupitz (2020b), p. 619.

  275. 275.

    Schreiber (2019), p. 281.

  276. 276.

    Schreiber (2019), p. 281.

  277. 277.

    Schreiber (2019), p. 281.

  278. 278.

    Schantz (2016), p. 1844. See also Schantz (2020), Art. 5 Regulation (EU) No 2016/679 para. 22; Spindler and Dalby (2019b), Art. 9 Regulation (EU) No 2016/679 para. 23; Schreiber (2019), pp. 282–283; Fleischer (2018), p. 294 et seq. For a contrasting opinion, see Schlösser-Rost (2020), sec. 27 BDSG para. 13.

  279. 279.

    Weichert (2017), p. 540; Schreiber (2019), p. 283.

  280. 280.

    Fleischer (2018), p. 301; Greve (2020), sec. 27 BDSG para. 15.

  281. 281.

    Albers and Veit (2020), Art. 9 Regulation (EU) No 2016/679 para. 88; also in favor of disclosure being a form of processing, Taupitz (2020b), p. 618 et seq.

  282. 282.

    On this provision, Fleischer (2018), pp. 308–309.

  283. 283.

    Schreiber (2019), p. 111; Fleischer (2018), p. 296.

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  1. Faculty of Law, Ludwig Maximilian University, Munich, Germany

    Silvia Deuring

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    David Hamburger

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Deuring, S. (2022). The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent. In: Dederer, HG., Hamburger, D. (eds) Brain Organoids in Research and Therapy. Advances in Neuroethics. Springer, Cham. https://doi.org/10.1007/978-3-030-97641-5_7

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