Bioethics and Informed Consent in Prenatal Diagnostics

Autor

DOI:

https://doi.org/10.15633/pch.13107

Słowa kluczowe:

Informed consent, bioethics, chromosomal anomalies, prenatal diagnostics

Abstrakt

Innovative methods of prenatal diagnosis allow us to see the development of the fetus and to detect early disorders of fetal development, which may lead to an early diagnosis and possible treatment, or to a woman’s decision to terminate the pregnancy. Therefore, it is very important to accurately inform a woman about the risks and consequences of this life-related issue, even before deciding to perform prenatal tests; and after the results, when a misinterpreted diagnosis may lead a woman to terminate her pregnancy. The obligation of doctors to inform patients is inseparable from the requirement to receive informed consent. The two parts are mandatory for any medical procedure and intervention. The main requirements for the informed consent include rationality, sufficient and clear information, free will, and the form of consent conforming to the legal acts. However, informed consent is not an absolute requirement, as the patient has a right to remain uninformed. Additionally, under certain circumstances, it might be impossible to inform patients, or to receive consent from patients or their duly authorized representatives. Prenatal testing is an integral part of ante-natal care that aims to verify the proper development of the fetus, or to identify potential hereditary or chromosomal diseases at the earliest possible stage. Prenatal testing can be classified as non-invasive or invasive measures, according to the types of procedures In addition to this, according to the aim of the procedure, into diagnostic prenatal testing with the aim of prenatal therapy, and purely diagnostic prenatal testing. Purely diagnostic prenatal testing is closely connected with the problem of selective abortion.

Part of this article covers the main problems of informed consent in prenatal diagnostics, by outlining two stages of the process: conveyance before prenatal testing, and interpretation of the results alongside presentation of the possible choices. The legal implications we consider are based on information from other European countries: we name the main questions analyzed by courts, including cases of “wrongful birth” and “wrongful life”; inappropriate information regarding possibilities of abortion; the right of a woman to use all available diagnostic methods; and the allocation of damages to the claimants.

Bibliografia

Alberry M. S., Aziz E, Ahmed S. R., Abdel-Fattah S., Non invasive prenatal testing (NIPT) for common aneuploidies and beyond, “Eur J Obstet Gynecol Reprod Biol.“ (2021) Mar; 258, pp. 424–429.

Baker J., Shuman C., Chitayat D., Wasim S., Okun N., Keunen J., Hofstedter R., Silver R., Informed Decision-Making in the Context of Prenatal Chromosomal Microarray, “J Genet Couns.“ (2018) Sep; 27 (5), pp. 1130–1147.

Bar V. C., Non-Contractual Liability Arising out of Damage Caused to Another (2009), pp. 352.

Berlin L., Wrongful life. Malpractice issues in radiology, “American journal of roentgenology“ (2003) 181, pp. 1181–1188.

Brown M.T., The Moral Status of the Human Embryo, “J Med Philos.“ (2018) Mar 13; 43 (2), pp. 132–158.

Brüggemeier G., Ciacchi A. C., O’Callaghan P., Personality Rights in European Tort Law, (2010), pp. 525–526.

Case 27617/04, R.R. v. Poland [2011] ECR.

Chervenak F. A., McCullough L.B., Professionally Responsible Counseling About Fetal Analysis, “Obstet Gynecol Clin North Am.“ (2021) Dec; 48 (4), pp. 777–785.

Dahl K., Kesmodel U., Hvidman L., Olesen F., Informed consent: attitudes, knowledge and information concerning prenatal examinations, “Acta Obstetricia et Gynecologica“ (2006) Nr. 85, pp. 1414–1419.

Dukhovny S., Norton M.E., What are the goals of prenatal genetic testing?, “Semin Perinatol.“ (2018) Aug; 42 (5), pp. 270–274.

Dundar M., Uzak A. S., Erdogan M., Akbarova Y., Prediction, prevention and personalisation of medication for the prenatal period: genetic prenatal tests for both rare and common diseases, “EPMA Journal“ (2011) Nr. 2, pp. 181–195.

Fry J., Antiel R. M., Michelson K., Rowell E., Ethics in prenatal consultation for surgically correctable anomalies and fetal intervention, “Semin Pediatr Surg.“ (2021) Oct; 30 (5), pp. 151102.

Geissler K. H., Pearlman J., Attanasio L.B., Physician Referrals During Prenatal Care, “Matern Child Health J.“ (2021) Dec; 25 (12), pp. 1820–1828.

Giesen I., Of wrongful birth, wrongful life, comparative law ant the politics of tort law system, “Tydskrif vir Heedendaagse Romeins-Hollandse Reg (THRHR)“ (2009) Nr. 72, pp. 257.

Huster S., Non-invasive prenatal diagnostics (NIPD) in the system of medical care. Ethical and legal issues, “J Perinat Med.“ (2021) May 31; 49 (8), pp. 972–978.

Jong D. A., Dondorp J. W., Die-Smulders C. E. D., Frints G. M. S., Wert D. M. W. R. G., Non-invasive prenatal testing: ethical issues explored., “European Journal of Human Genetics“ (2010) Nr. 18, pp. 272–277.

Kater-Kuipers A., de Beaufort I. D., Galjaard R. H., Bunnik E. M., Rethinking counselling in prenatal screening: An ethical analysis of informed consent in the context of noninvasive prenatal testing (NIPT), “Bioethics“ (2020) Sep; 34 (7), pp. 671–678.

Kiani A. K., Paolacci S., Scanzano P., Michelini S., Capodicasa N., D’Agruma L., Notarangelo A., Tonini G., Piccinelli D., Farshid K. R. Petralia P., Fulcheri E., Buffelli F., Chiurazzi P., Terranova C., Plotti F., Angioli R., Castori M., Pös O., Szemes T., Bertelli M., Prenatal genetic diagnosis: Fetal therapy as a possible solution to a positive test, “Acta Biomed.“ (2020) Nov 9; 91 (13-S): e2020021.

Milinković N., Ignjatović S., Šumarac Z., Majkić-Singh N., Uncertainty of Measurement in Laboratory Medicine, “J Med Biochem.“ (2018) Jul 1; 37 (3), pp. 279–288.

National Conference of a Catholic Bishops Science and Human Values Committee, Critical Decisions: Genetic Testing and its Implications, “Origins“ 25: no 45 (May 2, 1996), pp. 770.

Pope John Paul II., The Gospel of Life, (Mar. 25, 1995), no. 63, Origins 24: no. 42, Apr. 6, 1995, pp. 711.

Potter K. B., Reilly O. R. et. al., Exploring informed choice in the context of prenatal testing: findings from a qualitative study, “Health Expectations“ (2008) Nr. 11, pp. 355–365.

Rowe H. J., Fisher W. R. J., Quinlivan A. J., Are pregnant Australian women well informed about prenatal genetic screening? A systematic investigation using the Multidimensional Measure of Informed Choice, “Australian and New Zealand Journal of Obstetrics and Gynaecology“ (2006) Nr. 46, pp. 433–439.

Schmitz D., Henn W., The fetus in the age of the genome, “Hum Genet.“ (2021) Aug 23. Epub ahead of print.

Sivanadarajah N., El-Daly I., Mamarelis G., Sohail M. Z., Bates P., Informed consent and the readability of the written consent form, “Ann R Coll Surg Engl.“ (2017) Nov; 99 (8), pp. 645–649.

Suter S. M., The routinization of prenatal testing, “American journal of law and medicine“ (2002) Nr. 28, pp. 233–270.

Tan C. M. J., Lewandowski A. J., The Transitional Heart: From Early Embryonic and Fetal Development to Neonatal Life, “Fetal Diagn Ther.“ (2020) 47 (5), pp. 373–386.

Tobola-Wrobel K., Wysocka E., Pietryga M., The clinical usefulness of biochemical (free β-hCg, PaPP-a) and ultrasound (nuchal translucency) parameters in prenatal screening of trisomy 21 in the first trimester of pregnancy, “Ginekol Pol.“ (2019) 90 (3), pp. 161–166.

Vikas H., Kini A., Sharma N., Gowda N. R., Gupta A., How informed is the informed consent?, “J Family Med Prim Care“ (2021) Jun; 10 (6), pp. 2299–2303.

Zerres K., Rudnik-Schöneborn S., Holzgreve W., Do non-invasive prenatal tests promote discrimination against people with Down syndrome? What should be done? “J Perinat Med.“ (2021) May 31; 49 (8), pp. 965–971.

Pobrania

Opublikowane

2023-04-28

Numer

Tom 13 Nr 1 (2023)

Dział

Articles

Licencja

Creative Commons License

Utwór dostępny jest na licencji Creative Commons Uznanie autorstwa 4.0 Międzynarodowe.

Twórca oświadcza, że służą mu prawa autorskie do utworu i że nie są ograniczone w zakresie objętym niniejszym oświadczeniem oraz że utwór jest dziełem oryginalnym i nie narusza praw autorskich innych osób.

Twórca zezwala Uniwersytetowi Papieskiemu Jana Pawła II w Krakowie na nieodpłatne, niewyłączne i nieograniczone w czasie korzystanie z utworu, to jest:

  • utrwalanie i zwielokrotnianie: wytwarzanie egzemplarzy utworu techniką drukarską, reprograficzną, zapisu magnetycznego oraz techniką cyfrową;
  • obrotu oryginałem albo egzemplarzami, na których utwór utrwalono (wprowadzanie do obrotu, użyczenie lub najem oryginału albo egzemplarzy, publiczne wystawienie, wyświetlenie, a także publiczne udostępnianie utworu w taki sposób, aby każdy mógł mieć do niego dostęp w miejscu i w czasie przez siebie wybranym);
  • włączenie utworu w skład utworu zbiorowego;
  • udzielanie przez Uniwersytet Papieski Jana Pawła II w Krakowie sublicencji Creative Commons Uznanie autorstwa 4.0 Międzynarodowe (CC BY 4.0)

Uniwersytet Papieski Jana Pawła II w Krakowie udostępnia utwór na Platformie Czasopism należącej do uczelni, na licencji Creative Commons Uznanie autorstwa 4.0 Międzynarodowe (CC BY 4.0). Tym samym uprawnia wszystkich zainteresowanych do korzystania z utworu pod następującymi warunkami:

  • zostanie podany autor i tytuł utworu,
  • zostanie podane miejsce publikacji (tytuł czasopisma i adres internetowy do oryginalnie opublikowanego utworu).