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Deceased donor: deceased person from whom it is intended to obtain organs for subsequent transplantation and who, in accordance with the requirements established in this royal decree, had not expressly stated their opposition. Meaning that by default every citizen is an organ donor unless annulled in writing.
Organ Procurement
Article 8. Requirements for obtaining living donor organs.
1. Obtaining organs from living donors for subsequent transplantation may be carried out if the following requirements are met:
a) The donor must be of legal age, enjoy full mental faculties and be in adequate health.
b) It must be an organ, or part of it, whose procurement is compatible with life and whose function can be adequately and sufficiently safely compensated by the donor’s body.
c) The donor must be previously informed of the consequences of his decision, of the risks, for himself or for the recipient, as well as possible contraindications, and of the way of proceeding foreseen by the center in the event that once the organ had been removed, it would not be possible to transplant it into the intended recipient. The donor must grant their consent expressly, freely, consciously and disinterestedly. Information and consent must be given in appropriate formats, following the rules set by the principle of design for all, so that they are accessible and understandable to people with disabilities.
d) The donor must not suffer or present mental deficiencies, mental illness or any other condition for which they cannot grant their consent in the indicated manner. Organs from minors may not be obtained, even with the consent of the parents or guardians.
e) The destination of the organ obtained will be its transplant to a specific person with the purpose of substantially improving their vital prognosis or their living conditions.
2. Organs from living donors will not be obtained or used if sufficient chances of transplant success are not expected, if there are suspicions that the free consent of the donor referred to in this article is being altered, or when for any reason it could be considered that mediates economic, social, psychological or any other type of conditioning.
In any case, to proceed with obtaining it, it will be mandatory to have a report from the corresponding Ethics Committee.
3. Living donors will be selected based on their health and medical history. The state of physical and mental health of the donor must be accredited by a qualified doctor other than those who are going to carry out the extraction and transplant, who will report on the risks inherent in the intervention, the foreseeable consequences of a somatic or psychological nature, the repercussions that it may entail in your personal, family or professional life, as well as the expected benefits of the transplant and the potential risks for the recipient. In this sense, the importance of transmitting her personal history must be transferred to the living donor. In light of the result of this examination, any person may be excluded when obtaining it may pose an unacceptable risk to their health,
The above points will be accredited by means of a medical certificate that will necessarily refer to the state of health, the information provided and the response and motivations freely expressed by the donor and, where appropriate, to any indication of external pressure on the donor. The certificate will include the nominal list of other professionals who may have collaborated in such tasks with the certifying physician.
4. To proceed with the procurement of living donor organs, the presentation, before the Court of First Instance of the locality where the extraction or transplant is to be carried out, at the choice of the promoter, of a request from the donor or communication from the Director of the health center in which it is to be carried out, or the person to whom he delegates, in which the personal and family circumstances of the donor, the purpose of the donation, the health center in which the extraction is to be carried out, the identity of the doctor responsible for the transplant and the medical certificate on the mental and physical health of the donor will be attached.
The donor must grant their express consent before the Judge during the appearance to be held in the Voluntary Jurisdiction file being processed, after explanations from the doctor who is to carry out the extraction and in the presence of the doctor referred to in section 3 of this article, the doctor responsible for the transplant and the person who should give the approval for the intervention, according to the authorisation document for the extraction of organs granted.
5. The document of transfer of the organ where the consent of the donor is manifested will be extended by the Judge and signed by the donor, the doctor who will carry out the extraction and the other assistants. If any of the foregoing doubts that the consent to obtain it had been given expressly, freely, consciously and disinterestedly, they may effectively oppose the donation. A copy of said transfer document will be provided to the donor. Under no circumstances may organs be obtained without the prior signature of this document.
6. At least twenty-four hours must elapse between the signing of the organ transfer document and its removal, and the donor may revoke their consent at any time before the intervention without being subject to any formality. Said revocation may not give rise to any type of compensation.
7. Obtaining organs from living donors may only be carried out in health centres expressly authorised to do so, and the procedure must be reported to the responsible competent authority prior to its completion.
8. Notwithstanding the provisions of article 7, the living donor must be provided with healthcare for his recovery and his clinical follow-up in relation to obtaining the organ shall be facilitated.
Article 9. Requirements for obtaining deceased donor organs.
1. Obtaining organs from deceased donors for therapeutic purposes may be carried out if the following requirements are met:
a) That the deceased person from whom it is intended to obtain organs, has not left an express record of his opposition to obtaining organs after her death. Said opposition, as well as its agreement if you wish to express it, may refer to all types of organs or only to one of them and will be respected.
In the case of minors or incapacitated persons, the opposition may be recorded by those who had held legal representation during their lifetime, in accordance with the provisions of civil legislation.
b) Whenever it is intended to proceed to obtain organs from deceased donors in an authorised centre, the person in charge of the hospital transplant coordination, or the person delegated, must carry out the following pertinent checks on the wishes of the deceased:
1st Investigate whether the donor made his will clear to any of his relatives, or to the professionals who have treated him at the health center, through the annotations that they may have made in the clinical history, or in the means provided in current legislation.
2nd Examine the documentation and personal belongings that the deceased carried with him.
Provided that the circumstances do not prevent it, the relatives present in the health centre must be provided with information on the need, nature and circumstances of the obtaining, restoration, conservation or mortuary health practices.
2. Obtaining organs from the deceased may only be done after diagnosis and certification of death carried out in accordance with the provisions of this Royal Decree and in particular in Annex I, ethical requirements, scientific advances in the matter and medical practice. generally accepted.
The professionals who diagnose and certify the death must be doctors with the appropriate qualification for this purpose, different from those who have to intervene in the extraction or transplant and will not be subject to the instructions of the latter.
The death of the individual may be certified after confirmation of the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of brain functions. The time at which the diagnosis of death was completed will be recorded as the patient’s time of death.
3. Irreversible cessation of circulatory and respiratory functions will be recognised by appropriate clinical examination after an appropriate period of observation. The clinical diagnostic criteria, the observation periods, as well as the confirmatory tests that are required according to the medical circumstances, will be adjusted to the protocols included in Annex I.
In the case expressed in the preceding paragraph, and for the purposes of death certification and organ procurement, the existence of a death certificate issued by a doctor other than the one involved in the extraction or transplantation shall be required.
4. The irreversible cessation of brain functions, that is, the finding of non-reactive coma of known structural aetiology and irreversible nature, will be recognised by means of an adequate clinical examination after an appropriate period of observation. The clinical diagnostic criteria, the observation periods, as well as the confirmatory tests that are required according to the medical circumstances, will be adjusted to the protocols included in Annex I.
5. In cases of accidental death, as well as when there is a judicial investigation, before carrying out the harvesting of organs, authorisation must be obtained from the corresponding judge, who, following a report from the forensic doctor, must grant it provided that the process is not hindered. result of the investigation of criminal proceedings.
In cases of death diagnosed by circulatory and respiratory criteria that require judicial authorisation, in order to proceed with the manoeuvres to maintain the viability of the organs and with the preservation manoeuvres, action will be taken in accordance with the provisions of Annex I.
The request to obtain organs must be accompanied by the death certificate referred to in sections 3 or 4 of this article, depending on the case, along with a medical report explaining the personal circumstances and admission to the hospital, and an accrediting sheet, signed by the person in charge of hospital transplant coordination or the person to whom he/she delegates, that the doctor or doctors who sign the death certificate are different from the one who is going to carry out the organ extraction and/or the transplant.
6. The person in charge of hospital transplant coordination or a delegated person, as determined in the centre’s authorisation, must issue a document expressly stating:
a) That the verifications have been carried out on the will of the deceased, or of the persons who hold their legal representation.
b) That the necessary information about the obtaining process has been provided to the relatives, provided that the objective circumstances have not prevented it, stating the latter situation if it occurs.
c) That death has been verified and certified and said death certificate is attached to the authorisation document.
d) In the situations of death contemplated in section 5, that there is authorisation from the corresponding judge.
e) That the hospital center where the collection is to be carried out is authorised to do so and that said authorisation is in force.
f) The organs for which procurement is not authorised, taking into account the restrictions that the donor may have established.
g) The name, surnames and professional qualifications of the doctors who have certified the death, and that none of these doctors is part of the extraction or transplant team.
7. The deceased donors will be adequately characterised, in accordance with the provisions of article 21.
8. Once the body of the deceased donor has been restored after obtaining it, access or visits to their relatives and close friends must be allowed, if so requested.
Full Royal Decree with annexes in Spanish.
To opt in and apply for a donar card or out of donating organs, please speak with the staff at your health centre for guidance and options.
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