TY - JOUR
AU - Neethu, Rajam
AB - Abstract ‘Informed consent’ is essentially an ethical and legal practice and has long been the central theme in the discussions over tissue research. This commentary discusses the case of Elberte v Latvia (Application no 61243/08, January 2015) which is a new direction in consent for use of tissues in health research. However it has offered lesser clarity in different ways. The case considers the importance of consent and also requires that the close relatives be given a right to consent under certain circumstances. This poses two important questions which will be dealt with under this commentary, one the factual right of the relatives to offer consent for another and secondly the impact such consent may have on tissue research. Consent, Opt-out consent, Right of relatives, Tissue research, Human rights, Biobanks Introduction People, relationships, actions, and things are often the foundation of legal jurisprudence. The principle of ‘informed consent’ is a theory based on ethical foundations given shape by the law to govern a complex set of relationships pertaining to the collection, storage, and use of human biological materials.1 It offers the right of self-determination for the patient or donor over one’s own body or its parts. On the other hand, it offers itself to be an ethically acceptable practice giving physicians, clinical practitioners, and biomedical researchers a justification to proceed with the processing of the treatment or research as the case may be. In this sense ‘consent’ also implies a duty of care on the part of medical researchers while interfering with the bodily integrity of a person.2 This value of the ethical principle of consent is also reflected more specifically in other international instruments, in particular, Article 5 of the European Convention on Human Rights and Biomedicine,3 which states that ‘an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it’.4 The Declaration on the Promotion of Patients’ Rights in Europe5 adopted by World Health Organization (WHO, Europe) offers to elaborate on the main principles of patients’ rights in Europe. This Declaration covers three basic types of patients’ rights namely: right to privacy and confidentiality, right to dignity (in terms of consent to or refuse treatment), and right to be informed (or choose not to be informed). Thus ‘consent’ and protection of ‘dignity’ of an individual has always found a strong voice in Medical Law. Most of the Member States within the European Union have adopted these main principles of the patients’ rights as outlined above in various legal forms. The Oviedo Convention6 also calls for free informed consent and respect for the wishes of the relatives in the context of those patients who are unable to offer consent owing to some form of disability. These key ethical principles have also been followed in relation to the donation of tissue and organs as well in the context of informed treatments both as a part of law and policy.7 However, the regulation with respect to living donors/patients who contribute biological materials or body parts has been more clarified in practice than in the context of dead donors. The closest document with a reference to this is the Resolution (78) 29 on harmonization of legislations of Member States relating to removal, grafting, and transplantation of human substances adopted by the committee of Ministers of the Council of Europe, which recommends that the governments of the Member States must ensure that their laws conform to the rules annexed to the resolution or adopt provisions conforming to these rules when introducing new legislation.8 Article 10 of this Resolution provides: 1. No removal must take place when there is an open or presumed objection on the part of the deceased, in particular, taking into account his religious and philosophical convictions. 2. In the absence of the explicit or implicit wish of the deceased the removal may be effected. However, a state may decide that the removal must not be effected if, after such reasonable inquiry as may be practicable has been made into the views of the family of the deceased and in the case of a surviving legally incapacitated person those of his legal representative, an objection is apparent; when the deceased was a legally incapacitated person the consent of his legal representative may also be required. Under English common law, there are many instances of tortious liability involving dead bodies requiring proof of negligence or emotional injury,9 nervous shock10 or malicious intent.11 This requirement of proof for various tortious elements often created issues for plaintiffs bringing action for recovery for interference with the dead body of their relatives as they themselves were not the primary victims.12 Even in cases where they were regarded primary victims there were many limitations imposed for claiming on behalf of the deceased. For instance in AB and others v Leeds Teaching Hospital NHS Trust, Cardiff and Vale NHS Trust,13 the representatives were parents of deceased children who claimed against the respondents14 with regard to the removal of organs from those children without the informed consent of the parents. Some of the tissues from these organs were made into wax blocks and sample slides which were later on returned but some others were retained.15 However, the parents were not informed as to such removal or retention of parts though consent was given for autopsy. Hence they claimed damages under the tort of wrongful interference with the body of their deceased children. It was held ‘that the claimants have no right of burial and possession of organs lawfully removed at post-mortem and retained … there can be no action for wrongful interference with the body of the child. If, on the other hand, a parent or parents when consenting to a post-mortem specifically asked for the return of an organ … in certain circumstances it might be arguable that a cause of action based on conversion exists, if conversion is what is being alleged by the claimants in this group action. But in the absence of such a cause of action in respect of the body of a deceased person being recognised by an English court I am not prepared to hold that one does exist’. In the above mentioned case, the court meticulously examined the question of tortious liability for conversion; nonetheless the difficulties for relatives to bring an action on behalf of the deceased as illustrated in the above case only meant an increase in the instances of tissue and organ theft.16 The legal approach to human body parts has, however, begun to find stronger ground from a Human Rights perspective particularly with Article 8 of the European Convention on Human Rights.17 The Elberte case deals with this human rights approach examining the privacy of the individual not just in terms of herself but also in terms of near or dear one. Facts of the Case The case of Elberte18 began with her husband’s death in May 2001 in a car accident. He was first taken to the hospital and then to the State Centre for Forensic Medical Examination in Riga. The experts at the Forensic Centre found that there was no stamp on Mr Elberte’s passport stating any objections to the use of his tissues and organs. This being considered as a presumed consent by the experts, a 10 by 10 centimetre of dura mater was removed from the body of the deceased. The applicant did not know anything about this removal of tissue until she was informed about a criminal investigation on illegal tissue and organ removal by the police 2 years later. Under an agreement entered into by the Latvian Government with a pharmaceutical company, the tissues and organs removed from a corpse were sent to the pharmaceutical company for creation of bio implants. Under the agreement and as per the two Latvian laws (namely the Law on the Protection of the body of a deceased person and the Use of Human Organs and Tissues), medical experts were allowed to remove tissues from a deceased body at the State Forensic Centres. However, it was their duty to verify whether a potential donor had objected to such removal by checking their passport to see if they had such a stamp. Apart from this, the Latvian law also required the experts to inform the relatives about their intention to remove the tissues or organs, and their rights to object by refusing their consent in case they objected. Under section 4 of the Latvian law,19 which is entitled ‘The Rights of the Closest Relatives’, the organs and tissues of a deceased person may not be removed against his or her wishes as expressed during his or her lifetime. However, ‘in the absence of express wishes, removal may be carried out if none of the closest relatives (children, parents, siblings or spouse) objects’.20 Transplantation may be carried out after the biological or brain death of the potential donor (S. 10).21 As the tissue had to be removed within 24 hours of the biological death of a person, the experts at the Forensic Centre only checked the wishes of the deceased from their passport and did not contact the relatives to establish their wishes. Thus presumed or ‘opt-out’ consent by the scientific experts in Latvia meant that ‘everything which wasn’t forbidden was simply allowed’. Mrs Elberte had filed thirteen complaints and four decisions were revoked before the time it moved to the Court of Human Rights.22 The instant case was in fact supplementary to the decision in Petrova vLatvia,23 in which the European Court of Human Rights found a violation of Article 8 of the European Convention on Human Rights. It was pointed out by the ECtHR that the Latvian law in the area of organ transplantation as applied at the time of the case had not been sufficiently clear and had resulted in the circumstances of that case in which the applicant had discovered that the kidneys and spleen of her deceased son were missing in the body handed over to her by the hospital, and no consent had been requested from the applicant. Though the Latvian law required the consent of a relative, the Government argued that when close relatives were not present at the hospital, national law did not impose an obligation to make specific inquiries to ascertain whether there was any objection to organ removal and that, in such cases, consent to removal could be presumed.24 While both the Petrova25 and Elberte26 cases unequivocally pointed out the disparities in the Latvian law as to the consent procedures, the specific question considered in the present case was whether the medical experts had an obligation to inform the relatives of the deceased of the intention to remove the tissue and offer them an opportunity to oppose such removal.27 This question was examined in two fronts with respect to the applicant under both Article 8 (the right to respect for his private and family life and right against arbitrary interference by public authorities) and Article 3 (No one shall be subjected to torture or to inhuman or degrading treatment or punishment) of the European Convention on Human Rights. The applicant submitted that the removal of her husband’s tissue without her consent had constituted an interference with her private life. This interference was brought about by preventing her from expressing her wishes about the removal and by not providing information as required by law. Further, the requirement of verifying the stamp in the passport could not have been done as claimed by the authorities as the passport of her husband was at their home and unavailable to the experts. Mrs Elberte also pointed out the lack of clarity of the Latvian law, which was amended in 2004 to shift from a position of ‘explicit’ to a ‘presumed’ consent system by a change in the wording of the law which was thus not only unclear but also not foreseeable in its application because it provided for no possibility for the relatives to object to tissue removal.28 The Latvian government on the other hand held that the mere absence of any objection was enough to proceed with the tissue removal. In January 2015, the European Court of Human Rights (Fourth section) held that the interference with the applicant’s right to her private life was not in accordance with the law. In reaching this conclusion, the court did not consider it relevant to assess the national law in relation to the nature of consent, but instead considered whether the applicant's right to express wishes in connection with the removal of her husband's tissue was adhered to and whether the authorities had ensured the legal and practical conditions for the exercise of the applicant's rights. In this analysis, the court found that the removal of tissue was carried out under a state-approved agreement with a pharmaceutical company abroad and it was not just an isolated case but was carried out on many other people as well. Under such circumstances, it was essential to have a mechanism in place to counterbalance the wide amount of discretion conferred upon the forensic/medical experts handling the dead bodies. However that was not the case, and hence the court concluded that ‘although Latvian law set out the legal framework allowing the closest relatives to express consent or refusal in relation to tissue removal, it did not clearly define the scope of the corresponding obligation or the margin of discretion conferred on experts or other authorities in this respect’.29 With Reference to the Additional Protocol on Transplantation of Organs and Tissues of Human Origin adopted by the Council of Europe30 and the Explanatory Report to the Additional Protocol,31 the Court noted that the relevant European and international documents on the point accorded particular importance to the principle that the relatives’ views must be established by means of reasonable enquiries. Although Latvia has neither signed nor ratified this Protocol the Court observed that, ‘whichever system a State chooses to put in place – be it that of “explicit consent” or that of “presumed consent” – appropriate procedures and registers should also be established. If the wishes of the deceased are not sufficiently clearly established, relatives should be contacted to obtain testimony prior to tissue removal32 … . Consequently, there has been a violation of Article 8’.33 Further, the Human Rights Court also held that Article 3 of the Convention34 not only includes physical ill-treatment but also psychological distress, which was in this case caused due to the un-informed removal of the tissue from the body of applicant’s Husband. The ‘To be or Not to be Question’ The foundation of the Elberte case rests on the question of ‘informed consent’ which enfolds the principles of self-determination with respect to excised body parts. Not only did the Court find a violation of human rights with respect to Mrs Elbert's right to privacy, but it also found a violation of the prohibition of degrading treatment that was caused due to the removal of Mr Elbert’s tissues.35 This essentially implies a right of self-determination not only in one’s own body but also that of a close relative as in the instant case. In essence, this substantially magnifies the perspective of both the right of self-determination and privacy. At the same time, it gives rise to two important questions namely (A) whether the extended dimensions of self-determination extend the right of privacy? and (B) how does this affect tissue research? A. The ‘Extended Consent’ For a competent person of the age of majority, the making of her own decision with respect to her own body is the legal expression of the principle of autonomy and the right of self-determination. This right exists regardless of the consequences.36 This however also implies measures to prohibit invasion of the right. This legal protection of personal autonomy is achieved by allowing individuals a personal sphere of control mediated by consent.37 Thus, given the ethical importance of consent, it is pertinent that any legal system should ensure that people are fully informed about the consent policy in whichever context they are applied and are provided with an easy means to express or reject such consent. At times this right can also be exercised by proxy in the case of patients who cannot exercise this right on account of inability of age or other disability. This is the standard measure both as per international instruments and national medical practise of various member states.38 However in the case of dead, the position is neither clearly defined nor uniformly followed. In the context of organ donations the type of consent determines the use of the organ. One strategy adopted by many countries is the opt-out model.39 It is also seen by many countries as a way to increase the supply of organs for the needy.40 In opt-in consent systems, people are required to consent to organ donation before they die in order for their organs to be donated. This usually involves registering as an organ donor or carrying a donor card. In contrast, in opt-out consent systems people must state that they object to donation before they die to prevent their organs from being transplanted.41 While opt-out consent essentially relies on the inertia of the donor, efforts must be taken to educate the citizens about this. Shepard and Carroll demonstrated this lack of awareness and argue for a more informed version of the opt-out consent.42 Thus the dangers of undervaluing consent in an opt-out system may require additional consideration of the wishes of the deceased. However it offers only an additional tool to ensure the wishes of the deceased. Studies have shown that in about two thirds of cases organs are not able to be donated, and the single largest group of such losses consists of cases where the relatives are not aware of the deceased person's wishes or are negatively predisposed towards donation.43 Under such circumstances the question of enquiry becomes blurred as to who’s right of privacy and self-determination is in fact violated. The law considers ‘privacy’ a personal right available to the living rather than to the dead. On this account, the relational right of privacy has never been accorded to the dead,44 though it was still possible for the relatives to make a claim as to the violation of their own privacy rights in relation the deceased.45 For instance in Gudmundsdóttir vthe State of Iceland,46 the Icelandic Supreme Court held that the daughter of a deceased man could prevent his tissue and health information from being entered into the Health Sector Database as a genetic analysis of her father’s samples may reveal information regarding herself ergo violating her own privacy .Thus, while an extension of privacy is not protected, offering the same in relation to autonomy of self-determination seem to be paradoxical given the increasing instances of refusal by relatives as pointed out in the organ donation studies. B. Research involving Human Tissues While the Elberte decision offered to solidify the approach to consent by relatives, it has wider ramifications in tissue research as well. As the functioning of genes is better understood, new diagnostic methods and tools are increasingly made from slices of DNA that are embedded in tissue, which enables researchers to study what an individual is predisposed to. This is essential to cure disease at the earliest opportunity or at times offer preventive care like, for instance, the BRCA1 and BRCA2 in preventing breast and ovarian cancers. Thus, the scientific and commercial value of the samples has given rise to the creation of biorepositories often also referred to as ‘biobanks’. These repositories store tissues and other human biological materials and associated data based on the purpose of the collection. Often in such cases the donors are invited to contribute in a sense of public commitment to biomedical research or taken from left out medical wastes from hospitals based on the nature of consent. The Elberte decision has opened up new frontiers of informed consent. As per the judgment, whichever consent system a state chooses to put in place (i.e. ‘explicit consent’ or ‘presumed consent’), appropriate procedures and registers should also be established. And where the wishes of the deceased are not sufficiently clearly established, relatives should be contacted so that their views can be ascertained prior to tissue removal.47 In tissue-related research for instance within biorepositories, the fact that an informed consent was taken at the time of collection may not be sufficient post the donor’s death. There would be a need to give adequate regard to the wishes of the relatives of such donor. Another possible and related issue is with respect to ‘opt-out’ consent systems which as a matter of fact are being widely employed in tissue research. It has been argued that presuming the consent of donors in such cases may amount to fraud.48 Brownsword49 gives the example of DeCode genetics databank project undertaken with the aim to map the Icelandic population, wherein an easy approach to opt-out consent in drawing the samples gave rise to great opposition. However, he states that a claim in such cases would have a footing only if a relevant right existed.50 Hence if the State may legitimately require participation in its data bank project by a certain mode of consent which exists as a justifying ethical procedure, subjects have a duty to participate. Such participation cannot be re-determined based on the wishes of a relative after the individual's death. For example, if a country has an opt-out model of consent for their population biobank, and a dutiful citizen having once offered consent by opt-out, it would be hard for anyone to accurately assess her wishes after her death, including a relative. Thus redetermining participation based on the views of relatives might lead to an over-valuation of consent which tends to endanger the true wishes of donors as well that of medical research which could potentially benefit the society at large. Conclusion The European Court of Human Rights in Elberte vLatvia, brought out clarity in the manner in which the relatives’ right to express their wishes was to be exercised and the scope of the obligation to obtain consent from a human rights jurisprudence. It has also sought to expand the concept of personal autonomy in determining the ‘use’ or ‘disposal’ of body parts of a deceased person, which was previously unclear. By its ruling that the removal of tissue from a deceased man’s body, without the knowledge or consent of his wife, amounted to degrading treatment it has widened the scope of ‘mental torture’ and ‘bodily integrity’ of the relative of the deceased. The judgment has thus offered an overtly broader definition of ‘private life’51, by offering the right to give consent on behalf of a deceased person to her relatives. Another insight offered by the judgment is that the margin of discretion to be exercised by scientific researchers using human biological materials, particularly in public funded research activities, must not be arbitrary. This calls for a greater amount of standardisation of procedures involved in such research. While these are in fact laudable, the case also has an important legal impact on research using human biological materials. The effect of this decision is that States may have to formulate special procedures to assess such wishes on a case to case basis. Many questions are also left unanswered as to the applicability of the decision, such as whether it applies only in cases of organ donation or in other instances of donation of bodily materials? While the case may seem easier in the context of organ donation cases, it may pose greater difficulties in the context of tissue repositories. Needless to say the decision in Elberte is also significant in relation to the nature of consent in such cases. Conflict of interest statement. None declared. Footnotes 1 Jessica W Berg and others, Informed Consent: Legal Theory and Clinical Practice (2nd edn, OUP 2001). 2 See Montgomery v Lanarkshire Health Board [2015] UKSC 11, Glass v United Kingdom (2004) EHRR 341 and Tysiac v Poland (2007) 45 EHRR 947. 3 Full title: 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, Concluded by the member states of the Council of Europe and the European Community at Oviedo on 4 April 1997. 4 Art 5, Oviedo Convention 1997. 5 Amsterdam 1994, <http://www.who.int/genomics/public/eu_declaration1994.pdf> accessed 14 June 2016, see for more discussions in LH Fallberg, ‘Patients’ Rights in Europe: Where Do We Stand and Where Do We Go?’ (2000) 7 Eur J Health L 1–3. Kluwer Law International. 6 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, 1997. 7 MB Kapp, ‘Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me?’ (2006) 59(4) J Clin Pathol 335–39. 8 Adopted by the Committee of Ministers on 11 May 1978 <http://www.coe.int/t/dg3/healthbioethic/texts_and_documents/Res(78)29E.pdf> accessed 14 June 2016. 9 Mcloughlin v O'Brian [1983] 1 AC 410. 10 See for instance Alcock v Chief Constable of South Yorkshire Police [1991] UKHL 5 and Frost v Chief Constable of South Yorkshire Police [1998] 3 WLR 1509. 11 For instance, desecration of the grave of Gladys Hammond <https://www.theguardian.com/uk/2006/may/12/animalwelfare.topstories3> accessed June 14 2016. For more discussions on the point see text to n 12, p 200. 12 RN Nwabueze and AM Sheila McLean, Biotechnology and the Challenge of Property: Property Rights in Dead Bodies, Body Parts, and Genetic Information (Ashgate Publishers 2007) 202. 13 [2004] EWHC 644 (QB). 14 The respondents in the case were the hospital authorities, pathologists, etc. 15 Paras 8–11, of judgment, see text to n 13. 16 For instance, the Alder Hey organs scandal involved the unauthorized removal, retention, and disposal of human tissue, including children’s organs, during the period 1988–1995 leading to the creation of the Tissue Act 2004 in UK. 17 4 November 1950. 18 Elberte v Latvia, Application no 61243/08, 13 January 2015. 19 Law on Protection of the Body of a Deceased Person and Use of Human Organs and Tissues, November 1995. 20 Text to n 19. 21 Paras 42–50 of the Judgement. 22 Para 129 of the Judgement. 23 Application no 4605/05. 24 See <http://www.echr.coe.int/Documents/CLIN_2014_06_175_ENG.pdf> accessed 14 June 2016. 25 Text to n 23. 26 Text to n 18. 27 Both the cases actually had a common discussion as to this lack of clarity in the Latvian law and consequently its confused application by the Latvian authorities. While the Petrova case choose to examine if the law was sufficiently clear for the authorities to apply, the Elberte decision had a specific point of inquiry as to the actual obligation to inform relatives. 28 Para 93 of the Judgement. 29 Para 113 of Elberte v Latvia, Application no 61243/08, 13 January 2015. 30 Council of Europe Treaty Series no 186, Strasbourg, 24.01.2002. 31 The Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning transplantation of organs and tissues of human origin, was drawn up under the responsibility of the Secretary General of the Council of Europe and provides information to clarify the object and purpose of the Protocol, available at < http://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/186> accessed 15 June 2016. 32 Para 113 of Elberte v Latvia, Application no 61243/08, 13 January 2015. 33 Para 117 of the Judgement. 34 Art 3 of the European Convention on Human Rights reads: ‘No one shall be subjected to torture or to inhuman or degrading treatment or punishment.’ 35 Medstra-online case note 2/2015. 36 A Maclean, Autonomy, Informed Consent and Medical Law (CUP 2009). 37 Ibid; text to n 32. 38 For example, Principle 28, Helsinki Declaration on Ethical Principles for Medical Research Involving Human Subjects and Art 6 of Oviedo Convention, 4.IV.1997. 39 For example, France, Italy, and Finland have an opt-out model for organ donation, for more information on the point see L Shepherd and others, ‘An International Comparison of Deceased and Living Organ Donation/Transplant Rates in Opt-In and Opt-Out Systems: A Panel Study’ (2014) 12 BMC Med 131. 40 Text to n 37. 41 L Shepherd and RE O’Carroll, ‘Awareness of Legislation Moderates the Effect of Opt-Out Consent on Organ Donation Intentions’ (2013) 95(8) J Transplant 1058–63. 42 In all, 72% of the participants did not have any idea of the legislation , see also Eurobarometer survey 2010. 43 See, for eg, Swiss transplant reports in PJ Schulz and others, ‘Prior Family Communication and Consent to Organ Donation: Using Intensive Care Physicians’ Perception to Model Decision Processes’ (2012) 1(2) J Pub Health Res 130–36. 44 See for instance Armstrong v H&C communications, 575 So 2d 280 (Dist Ct App 1991), Waters v Fleetwood et al 212 Ga 161 (1956), Hubenschmidt v Shears - 270 NW2d 2, 403 Mich 486. 45 For more discussions on this see text to n 7, p 210. 46 No 151/2003, see R Gertz, ‘An Analysis of the Icelandic Supreme Court Judgement on the Health Sector Database Act’ (2004) 1/2 SCRIPT-ed 241–58. 47 Para 113 of Elberte v Latvia, Application no 61243/08, 13 January 2015. 48 R Brownsword, ‘The Cult of Consent: Fixation and Fallacy’ (2004) 15 KCLJ 223. 49 Ibid. 50 Moore v Regents of the University of California, 51 Cal 3d 120; 271 Cal Rptr 146, the Californian Supreme Court rejected this part of Moore’s claim, declining to recognize a property right because the defendants did not violate a relevant right and, without a relevant right, the fact that they acted without Moore’s consent was not material. 51 117 of Judgement in Elberte v Latvia, Application no 61243/08, 13 January 2015. © The Author 2016. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com
TI - ELBERTE v LATVIA: The To be or not to be question of Consent
JF - Medical Law Review
DO - 10.1093/medlaw/fww028
DA - 2017-07-01
UR - https://www.deepdyve.com/lp/oxford-university-press/elberte-v-latvia-the-to-be-or-not-to-be-question-of-consent-P1kkCreBnv
SP - 484
EP - 493
VL - 25
IS - 3
DP - DeepDyve
ER -