A need for the broader concept of informed consent of prospective parents in MAR proceedings?
- Aleksandra Korać Graovac
- 2 days ago
- 7 min read
Updated: 1 hour ago
Informed consent is a fundamental principle in medicine, law and bioethics. The implementation of the informed consent principle ensures that patients have the right to make autonomous decisions regarding their health and medical treatment and that individuals are provided with adequate information about a procedure or medical treatment. This principle is founded in respect for autonomy and personal dignity, allowing individuals to make informed decisions about their own health and well-being. Informed consent is not merely a legal formality but a crucial ethical obligation as well.
Medical doctors must ensure that consent for a medical procedure is voluntary, informed, and documented to comply with the law.
The provisions on informed consent are incorporated in national legislation and international agreements. The most important legally binding international document on informed consent in Europe is the Convention on Human Rights and Biomedicine (Oviedo Convention, 1997)[1] by the Council of Europe. Key provision is Article 5:
Any medical intervention requires the patient's free and informed consent.
This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.
There are special provisions for consent when the patient is not capable to give the consent (e.g., minors, adults with mental disabilities – Art. 6). The European Court for Human Rights ruled that medical procedures performed without informed consent could constitute a violation of Article 8 (the right to private Life) of the European Convention on Human Rights (for example, Glass v. United Kingdom[2]).
The principle of informed consent should be applied to all medical interventions, including those related to healing infertility.[3]
Couples or individuals who suffer from infertility have rights as patients, and human rights as well. One of these human rights is the right to health,[4] that ensures that we live our lives with dignity.
There is no doubt that the cure of infertility is assumed to be a part of the medical health system. However, there are many discussions “whether the desire for a child should be considered as a fundamental need or as a personal wish.”[5] European Society for Human Reproduction argues that “infertility may be a serious handicap that prevents people from realizing an important life goal. This life goal is the possibility to parent a genetically related child or a child created within the current relationship.”[6]
Hence, medically assisted reproduction technologies may bring some medical, psychological, and legal risks to participants (prospective parents, children, and donors). The savior formula to these challenges is the concept and right to informed consent. As in any medical procedure, every participant in an assisted reproduction proceeding needs to give informed consent. Croatia, as many other countries, has a general provision (Art. 12, para. 2 of the Medically Assisted Reproduction Act)[7] that before carrying out all procedures of medically assisted fertilization, the doctor, masterof biology, or other authorized health worker is obliged to explain the details of the procedure, the chances of success and the possible consequences and dangers of the procedures for the woman, man and a child. This informed consent is concentrated on medical aspects.
Additionally, when a child is going to be conceived by donor’s gametes or donors’ embryo, the MAR Act requests compulsory psychological or psychotherapeutic counselling for prospective parents. The medical clinic is obliged to secure legal counseling (Art. 13 of the MAR Act). Legal counseling is important due to family law consequences of heterologous techniques. The most important consequence is that in the case of a donor-conceived child, nobody will be allowed to contest parenthood unless the person involved (a prospective parent or a donor) did not give consent in a notary form. Moreover, the MAR Act obliges the parents to tell the child the circumstances of his or her conception. The Family Act[8] regulates the origin of the child, taking into account the Medically Assisted Reproduction Act provisions on the consent, which lack enables contestation of fatherhood or motherhood.
Often a person who has a strong desire to have a child, especially a woman,[9] may be reluctant to understand all possible risks and consequences of medically assisted reproduction. Medical treatment of infertility is somehow special compared to other possible medical treatments, as it can include rights and obligations of third persons (eventually donor, child, spouses etc.).
Prospective parents, driven by a huge desire to achieve parenthood, don’t care about some challenges that they might face later, so it seems that a sensitive, holistic approach is needed by explaining not only medical, but also psychological, ethical, and legal risks and consequences of medically assisted reproduction.
In practice in Croatia, a problem has arisen when patients were not aware of the fact that medical institutions will be reluctant to destroy surplus cryopreserved embryos,[10] that some patients will have a problem getting approval for the transfer of their gametes or embryos to another clinic abroad where they would like to achieve pregnancy and birth under other, more liberal legal provisions, and that there is a ban on post mortem use of gametes.
Legal counseling in case of heterologous techniques should be focused on the general impossibility to contest parenthood and the right of the child to know his or her origin and psychological counseling should be focused on challenges when enough mature child finds out the truth about his or her origin (in legal systems when the identity of a donor has not been revealed).
Although many European legal systems do not enable the child to find out his or her origin, and identity of donor,[11] in a modern world it is almost impossible to hide the truth about origin. Commercial DNA databases are becoming more and more popular,[12] so there is a rising possibility that donor-conceived persons find out that they do not originate from their legal parents. Such findings might harm children's psychological well-being, so it would be advisable that their parents are sincere with them. As parents are holders of parental responsibility, they are primarily responsible for the well-being of their children, so they need adequate parental capacity to ensure it.
Consequently, informed consent should incorporate some preparation for prospective parents on how to deal with feelings of their donor-conceived child, similar to preparation for adoption.
In conclusion, informed consent before medically assisted reproduction should encompass medical, legal, ethical, and psychological aspects to protect the well-being of the family: parents and their children.
[1] ETS 164 – Convention on Human Rights and Biomedicine, 4.IV.1997.
[3] “Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. Primary infertility is the inability to have any pregnancy, while secondary infertility is the inability to have a pregnancy after previously successful conception.”
World Health Organization, Infertility, https://www.who.int/health-topics/infertility#tab=tab_1, accessed 29. 2. 2024.
[4] The right to health appeared first in the Constitution of the World Health Organization (WHO) (World Health Organization. 1946. Constitution of the World Health Organization). Its preamble defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” and emphasizes that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”
Universal Declaration of Human Rights (United Nations. 1948. Universal Declaration of Human Rights) connects health with the right to an adequate standard of living (Art. 25). Art. 12 of the International Covenant on Economic, Social and Cultural Rights United Nations (1966) explicitly recognizes the right to health as "the right of everyone to the enjoyment of the highest attainable standard of physical and mental health." Convention on the Rights of the Child (CRC) (1989) in Article 24 guarantees children's right to the highest attainable health standard, including access to healthcare and clean drinking water, Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW) (1979) ensures in Art. 12 equal access to healthcare services for women; Convention on the Rights of Persons with Disabilities (CRPD) (2006) in Art. 25 guarantees persons with disabilities the right to healthcare without discrimination that persons with disabilities, including children, retain their fertility on an equal basis with others (Art. 23 Para. 1 point c). European Social Charter (1961, revised in 1996) recognizes the right to protection of health (Article 11) and Article 35 of the Charter of Fundamental Rights of the European Union (2000/C 364/01): “Health care - Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities”.
[5] ESHRE Task Force on Ethics and Law, Pennings, G., de Wert, G., Shenfield, F., Cohen, J., Tarlatzis, B., & Devroey, P. (2008). ESHRE Task Force on Ethics and Law 14: equity of access to assisted reproductive technology. Human reproduction (Oxford, England), 23(4), 772–774. https://doi.org/10.1093/humrep/den037, p. 771.
[6] Ibid., p. 772.
[7] Zakon o medicinski pomognutoj oplodnji, Official Gazette No. 8/2012. Hereafter the MAR Act.
[9] Langher, Viviana & Fedele, Fabiola & Caputo, Andrea & Marchini, Francesco & Aragona, Cesare & Glăveanu, Vlad. (2019). Research Reports Extreme Desire for Motherhood: Analysis of Narratives from Women Undergoing Assisted Reproductive Technology (ART). Europe's Journal of Psychology. 15. 292-311. 10.5964/ejop.v15i2.1736.
[10] Roda, Hoćemo li napikon urediti uvjete prestanka čuvanja zametaka, https://www.roda.hr/udruga/programi/medicinski-potpomognuta-oplodnja/hocemo-li-napokon-urediti-uvjete-prestanka-cuvanja-zametaka.html, accessed 25. 3. 2025.
[11] According to European Atlas of Fertility Treatment Policies 2024, in Europe 21 countries make gamete and embryo donation strictly anonymous, 13 countries offer non-anonymous donation/ identity of the donor is revealed to children and 12 countries offer a mixed anonymous and non-anonymous donation.
Fertility Europe, https://fertilityeurope.eu/atlas2024/, accessed 22. 5. 2025.
[12] Just five years ago, by the start of 2019, more than 26 million consumers had added their DNA to four leading commercial ancestry databases, according to estimates by MIT Technology Review, which may increase to 100 million within a few years.
Regaldo, Antonio, More than 26 million people have taken an at-home ancestry test, February 11, 2019, online, https://www.technologyreview.com/2019/02/11/103446/more-than-26-million-people-have-taken-an-at-home-ancestry-test/, accessed 29. 3. 2025.