Ethical and legal issues in haematopoietic stem cells (HSC) donation: the controversial and problematic aspects in minors

Ethical and legal issues in haematopoietic stem cells (HSC) donation: the controversial and problematic aspects in minors

Authors

  • Paola Delbon Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Forensic Medicine Unit, Centre of Bioethics Research, University of Brescia, Brescia, Italy https://orcid.org/0000-0002-7697-3840
  • Federica Attico Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Forensic Medicine Unit, University of Brescia, Brescia, Italy
  • Matteo De Nadai Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Forensic Medicine Unit, University of Brescia, Brescia, Italy
  • Camillo Almici Department of Transfusion Medicine, ASST Spedali Civili di Brescia, Brescia, Italy
  • Emilio Ferrari Department of Transfusion Medicine, ASST Spedali Civili di Brescia, Brescia, Italy
  • Michele Malagola BMT Unit, Department of Clinical & Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.
  • Adelaide Conti Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Forensic Medicine Unit, Centre of Bioethics Research, University of Brescia, Brescia, Italy

Keywords:

adolescents, informed consent, parental consent, conflict of interest, haematopoietic stem cells donation

Abstract

Starting from the case of a male adult patient suffering from Acute Myeloid Leukaemia for whom no HLA-compatible non-family donors were found, and for whom his adolescent daughter was then proposed as a donor, this article deals with the delicate issue of the minor’s consent, especially when the minor’s legal representative is in conflict of interest. In the case presented above as an example, this conflict arose when the parent was simultaneously the legal representative of the donor and the transplant recipient. The Authors report ethical and legal issues in the collection of haematopoietic stem cells from minors for the purpose of family donation and analyse the guidelines from some overseas scientific societies, the conventions drawn up within international organisations and the Italian legal system. Such a donation raises complex questions, with regard to the admissibility of the procedure, the ownership of the decision-making power and the criteria of the decision-making process: this process must take place in a context that guarantees the protection of the potential donor and his or her autonomy.

Author Biography

Paola Delbon, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Forensic Medicine Unit, Centre of Bioethics Research, University of Brescia, Brescia, Italy

Dipartimento di Specialità Medico Chirurgiche, Scienze Radiologiche e Sanità Pubblica - Università degli Studi di Brescia, Ricercatrice

References

Law No. 219 of 21 October 2005 (“Nuova disciplina delle attività trasfusionali e della produzione nazionale degli emoderivati”), Article 3; 2005.

Law No. 107 of 4 May 1990, (“Disciplina per le attività trasfusionali relative al sangue umano ed ai suoi componenti e per la produzione di plasmaderivati”), Article 3; 1990.

Decree No. 69 of 2 November 2015 (“Disposizioni relative ai requisiti di qualità e sicurezza del sangue ed emocomponenti”), Annex XI, A.2; 2015.

Law No. 52 of 6 March 2001 (“Riconoscimento del Registro nazionale italiano dei donatori di midollo osseo”), Article 4; 2001

Venuti MC. Gli atti di disposizione del corpo. Milano: Giuffrè Editore; 2002. pp. 172-173.

Montanari Vergallo G. Il rapporto medico-paziente. Consenso e informazione tra libertà e responsabilità. Milano: Giuffrè Editore; 2008. p. 385.

American Academy of Pediatrics – Committee on Bioethics. Policy Statement – Children as Hematopoietic Stem Cell Donors. Pediatrics. 2010; 125(2): 392-404. doi: 10.1542/peds.2009-3078.

Chan TK, Tipoe GL. The policy statement of the American Academy of Pediatrics – children as hematopoietic stem cell donors – a proposal of modifications for application in the UK. BMC Med Ethics. 2013; 14: 43. doi: 10.1186/1472-6939-14-43.

Smith TM. Asking children to donate bone marrow: 5 must-meet conditions. Available at: https://www.ama-ssn.org/delivering-care/ethics/asking-children-donate-bone-marrow-5-must-meet-conditions. Feb 4, 2019. (accessed on 03/10/2022).

Then SN, Kerridge IH, Marks M. Children as haematopoietic stem cell donors: ethically challenging and legally complex. Med J Aust. 2018; 208 (8): 334-337. doi: 10.5694/mja17.00758.

Jansen LA. Child organ donation, family autonomy, and intimate attachments. Camb Q Healthc Ethics. 2004; 13(2): 133-142. doi: 10.1017/s0963180104132040.

Fleck LM. Children and organ donation: some cautionary remarks. Camb Q Healthc Ethics. 2004; 13(2): 161-166. doi: 10.1017/s0963180104132088.

Pentz RD, Chan KW, Neumann JL, Champlin RE, Korbling M. Designing an ethical policy for bone marrow donation by minors and others lacking capacity. Camb Q Healthc Ethics. 2004; 13(2): 149-155. doi: 10.1017/s0963180104132064.

Van Assche K, Thys K, Vansweevelt T, Genicot G, Borry P, Sterckx S. Living tissue and organ donation by minors: Suggestions to improve the regulatory framework in Europe. Med Law Int. 2016; 16(1-2): 58-93. doi.org/10.1177/0968533216660877.

Conferenza Stato Regioni [State-Regions Conference]. Accordo tra Ministero della Salute, le Regioni e le Province autonome di Trento e di Bolzano sul documento recante “Linee-guida in tema di raccolta, manipolazione e impiego clinico delle cellule staminali emopoietiche (CSE)” [Agreement between the Minister of Health, the Regions and the Autonomous Provinces of Trento and Bolzano on the document entitled ‘Guidelines on the collection, handling and clinical use of haematopoietic stem cells (HSCs)’], 2003.

Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo. 4.4.1997.

Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin. Strasbourg. 24.1.2002.

Council of Europe, Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin. Strasbourg. 24.1.2002.

Montanari Vergallo G. Il rapporto medico-paziente. Consenso e informazione tra libertà e responsabilità. Milano: Giuffrè Editore; 2008. p. 387.

Ross LF. In Defense of the American Academy of Pediatrics Policy Statement – Children as Hematopoietic Stem Cell Donors. Pediatr. Blood Cancer. 2011; 56(4): 520-523. doi: 10.1002/pbc.23027.

Bitan M, van Walraven SM, Worel N, et al. Determination of Eligibility in Related Pediatric Hematopoietic Cell Donors: Ethical and Clinical Considerations. Recommendations from a Working Group of the Worldwide Network for Blood and Marrow Transplantation Association. Biol Blood Marrow Transplant. 2016; 22(1): 96-103. doi: 10.1016/j.bbmt.2015.08.017.

Then SN. Best interests: The ‘best’ way for courts to decide if young children should act as bone marrow donors? Medical Law International. 2017; 17(1-2): 3-42. doi.org/10.1177/0968533217694218.

Tribunale per i minorenni di Perugia. decr. 26 aprile 1999. Dir. Fam. 2000; 2: 644 ss. (with note of P. Di Marzio).

Di Marzio P. La condizione giuridica del figlio naturale tra discriminazioni, privilegi ed equilibrismi giurisprudenziali. Il problema del consenso al prelievo del midollo osseo da donatore minorenne. In: Ambrosini MT, Corrado I, Lojacono V, Ziino D, editors. Scritti sul minore in memoria di Francesca Laura Morvillo. Milano: Giuffrè Editore; 2001. pp. 95-131.

Venuti MC. Gli atti di disposizione del corpo. Milano: Giuffrè Editore; 2002. pp. 168 ss.

Wagner-Johnston ND, Hannum SM, Heughan JA, et al. Assessing Early Supportive Care Needs among Son or Daughter Haploidentical Transplantation Donors. Biol Blood Marrow Transplant. 2020; 26(11): 2121-2126. doi: 10.1016/j.bbmt.2020.08.005.

Zinner S, Cognitive development and pediatric consent to organ donation. Camb Q Healthc Ethics. 2004; 13(2): 125-132. doi: 10.1017/s0963180104132039.

Downloads

Published

21-06-2024

Issue

Section

PEDIATRICS AND ADOLESCENT MEDICINE

How to Cite

1.
Delbon P, Attico F, De Nadai M, Almici C, Ferrari E, Malagola M, et al. Ethical and legal issues in haematopoietic stem cells (HSC) donation: the controversial and problematic aspects in minors. Acta Biomed [Internet]. 2024 Jun. 21 [cited 2024 Jul. 20];95(3):e2024082. Available from: https://www.mattioli1885journals.com/index.php/actabiomedica/article/view/15820