Organ and tissue donation and transplantation have seen remarkable advances in recent years. This valuable development has been made possible by considerable progress in medical science and the efforts of health authorities, who have facilitated these practices that are essential for saving lives and advancing medical knowledge. However, despite this progress, concerns and questions remain surrounding donation and transplantation procedures. Many of these concerns are rational, given the circumstances in which these procedures are performed. Hence the importance of recognising and respecting the autonomy and dignity of patients undergoing these interventions. These considerations explain the existence of numerous laws worldwide that regulate the procurement and clinical use of human organs, as well as territorial coordination in matters of donation and transplantation. All these regulations seek to protect the individual and their rights, governed by principles such as altruism, solidarity, gratuity, information and anonymity. In this context, a fundamental question arises: where is respect for the patient’s autonomy and dignity specified? The answer lies in informed consent, a crucial instrument. In this analysis, we will examine its definition, origin, basis, and its specific relationship to organ donation.
According to Annas and Grodin (1992), the concept of informed consent originated during the Nuremberg Trials. This development was a response to the atrocities committed in human experimentation and culminated in the creation of the first Code of Medical Ethics in 1947[1] . This code emphasised the essential nature of voluntary participation in any scientific trials and research, which translates into free consent. Informed consent is defined as “a person’s approval of the proposed action or omission, once they have received adequate information[2] “. According to this definition, consent is intrinsically linked to the autonomy and dignity of the person. Indeed, any dignified treatment of an individual must be based on respect for their freedom as a subject.
Due to its importance, informed consent has been extended to the healthcare field. This was reflected in Article 5 of the 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, which states: “An intervention in the health field may only be carried out after the person concerned has given his or her free and unambiguous consent. [3]The person must be given adequate information beforehand about the purpose and nature of the intervention, as well as its risks and consequences.”
In the same article, the Convention recognises fundamental principles such as autonomy, beneficence, non-maleficence, justice, capacity and voluntariness. These ethical and legal pillars ensure that informed consent is a valid process and, in turn, guarantee essential patient rights, such as the right to information and respect for privacy.
In the context of organ donation, the exercise of the right to information, respect for privacy and informed consent are equally fundamental. For example, anyone who freely and legally decides to donate an organ while alive has the right to receive detailed information about each stage of the process. This involves providing clear materials covering the consent process, medical and psychosocial assessment, pre- and post-operative care, and the necessary follow-up after donation[4] . It is crucial that these materials thoroughly explain the risks and benefits associated with living donation, as well as recommendations for subsequent lifestyle. The potential donor must be fully informed about the voluntary and altruistic nature of the donation; no one is obliged to donate. Given its characteristic of being a free and gratuitous act, donation cannot be linked to any financial remuneration. Therefore, receiving or requesting any type of financial compensation for a donation is considered a crime and is punishable by law.
The person must be informed of their right to revoke their consent to donation at any time. All donors have the right to refuse donation, and their decision will be respected and kept confidential. However, while the patient has the right to information, they also have the right not to be informed, which must be documented. Many specialists in this field consider this right to be complex. In any case, patients considering organ donation while alive must be fully informed about the entire process and give their written consent after receiving the relevant explanations from medical professionals. This information, provided by experts in the field, is not intended to frighten the donor, but rather reflects the responsibility of the healthcare system to adequately inform the patient so that they can make an informed and free decision. Although consent is usually verbal as a general rule, there are circumstances that require it to be in writing. For example: 1) surgical intervention, 2) invasive diagnostic and therapeutic procedures, and 3) the application of procedures that involve risks or inconveniences with a significant and foreseeable negative impact on the patient’s health. In the field of organ donation, consent must be in writing, although the donor patient has the right to revoke it if they deem it appropriate. Ultimately, what underlies all of this is the protection of the individual and their rights.
In the context of living donors, the application of informed consent does not usually present major difficulties, provided that the specific exceptions and regulations established by the laws on living donation are taken into account. However, the situation becomes considerably more complex when it comes to deceased donors. In these cases, not only are doctors and transplant personnel involved, but also the donor’s closest relatives.
For any organ removal procedure carried out by the local organ procurement organisation (OPO), the priority is to verify that the deceased did not previously object to donation, generally through informed consent or a statement of their wishes. This is because, according to the laws of various countries that regulate organ and tissue donation and transplantation, a deceased person who has not expressly stated their opposition is considered a potential donor. While these regulations are positive, as they allow for the recovery and increase in the availability of organs for transplantation, the real challenge does not lie in investigating whether the deceased person expressed their willingness to donate to their relatives or the doctors who treated them (which can be asked of the family). The main complexity lies in how healthcare professionals can determine the real and reliable wishes of the deceased.
The situation becomes less clear in organ donation, as prior informed consent can be revoked by the donor at any time, even without notification. In such circumstances, family members play a key role. When there is doubt about the wishes of the deceased, it is essential to consult the family, who become indirectly responsible for authorising or refusing the donation. It is therefore crucial to accompany and explain to the family the rationale behind the organ removal process and its vital importance in saving lives. Effective communication by healthcare personnel can mitigate the legal controversies that often arise around the involvement of the donor’s family members.
It should be noted that, in the case of deceased donation, consultation with the family is unavoidable. It is therefore strongly recommended that potential donors discuss their wishes with their families in advance. It is essential to continue educating the public about the importance of communicating their intention to donate to their loved ones, as the family’s decision is often complicated by a lack of clear information about the deceased’s wishes. In most cases, if the family is aware of the deceased’s wishes, these will be respected and fulfilled.
By Jean Rolex, C.M.
[1] Annas, G.J., Grodin, M.A. (1992). The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press. Monograph Collection (Matt – Pseudo)
[2] Ibid.,
[3] Oviedo Convention (1997). Convention on Human Rights and Biomedicine. Retrieved from https://www.bioeticayderecho.ub.edu/
[4] Clinical Transplant Services Kidney/Pancreas Transplant Programme. (2019). Informed consent for living kidney donors. Retrieved from https://www.ohsu.edu/
