Respect as a precondition for use of human tissue for research purposes
Abstract and Keywords
Medicine has long been one of the battlefields over which ideological warfare relating to whether it is imperative to respect human beings as ends has been fought. Part of the conflict has been concerned with medical use of the human body and its constituent parts. Demand for such a use has burgeoned in the last century and increasingly become a hook upon which to attack emphasis on respect, obfuscate what it entails, and undermine commitment to protecting it. This chapter explores how this is specifically evident within discourse, practice, and governance concerned with use of tissue for research purposes and why it is problematic not only as a matter of ethics but also in the light of human rights principles.
In large parts of the world, medical orthodoxy has long been grounded on a classical paradigm of science that is largely mechanistic, atomistic, and reductionist rather than holistic in character. This orientation has contributed to medicine developing into a vast industrial complex, one of the characteristics of which has been to progressively develop and exploit ways of using the body to meet wider ends. This chapter will argue that such use is only acceptable where it is consistent with respect for the individual and will explore some of the key implications of this for discourse, practice, and governance concerned with the use of tissue for research purposes.
3.2 Normative standards
Through the World Medical Association, the international medical community responded to the medical atrocities carried out during the Second World War by creating such initiatives as the Declaration of Geneva Physicians Oath 1948, which requires medical professionals to swear that they will treat the health of their patients as their ‘first consideration’, and the International Code of Medical Ethics 1949, which stipulates that ‘any act, or advice which could weaken physical or mental resistance of a human being may be used only in his interest’. The Association also built on the Nuremburg Code’s protective emphasis in medical research by creating the Declaration of Helsinki 1964 (as amended most recently in Seoul 2008). Principle 6 of the Declaration states that: ‘[i]n medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests’. A number of other principles elaborate on some of the implications of this emphasis, including Principle 9 which stresses the need for special protection of the vulnerable.
The post-war period also saw important human rights developments at the inter-state level, such as the Universal Declaration of Human Rights 1948 and the European Convention on Human Rights (ECHR) 1950, both of which emphasize non-discrimination and provide bodily protection of the individual through their emphasis on freedom from inhuman and degrading treatment and on such rights as life, liberty, and private life.
More recently, inter-state initiatives specific to the protection of human rights in the health context have also been developed, not least in the wake of the capacity of new medical technologies to bring new threats to human life. The most significant of these instruments for immediate purposes are the Council of Europe’s Convention on Human Rights and Biomedicine (CHRB) 1997, UNESCO’s Universal Declaration on the Human Genome and Human Rights (UDHGHR) 1997, and the Universal Declaration on Bioethics and Human Rights (UDBHR) 2005. The core of all three documents includes a general emphasis on human rights and dignity, and a more specific (p.26) emphasis on such values as integrity, non-discrimination, and equality. Thus, for example, Article 1 of the CHRB requires parties to ‘protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine’, adding that ‘[e]ach Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention’. Article 2 states that ‘the interests and welfare of the human being shall prevail over the sole interest of society or science’. Article 26 may restrict these and many of the CHRB’s other rights and protective provisions, but only in a manner prescribed by law and necessary in a democratic society for protection of one or more of public safety, prevention of crime, protection of public health, or protection of the rights and freedoms of others. Dute (2005:5) has suggested that the human dignity and identity aspects of Article 1 are so basic that restriction of them cannot be accepted. He has also concluded that Article 2 makes ‘clear that the human being must never be used as a [mere] means to an end’ (ibid.:8). Even if this were not the case, one may observe in the context of discussing both the CHRB and the ECHR that it is contrary to, rather than necessary in, a democratic society to dilute something as fundamental as bodily protection of the individual to meet the mere perceived needs of others.
The legal impact of international instruments at a national level varies with both the instrument and the jurisdiction concerned. International medical community provisions are of merely persuasive effect. However, they can clearly become more significant where used as a template to develop domestic legislation, as has often occurred, for example, in relation to the Declaration of Helsinki. The effect of inter-state initiatives is more varied. In some jurisdictions, such as France, international agreements take precedence over domestic provisions in the event of a conflict. In contrast, in the UK this is only so for EU law, although the ECHR has a very important status not only because the UK Parliament has bound itself, subject to powers of derogation, to act on the decisions of the European Court of Human Rights (ECtHR), but also because nearly all the rights protected by the ECHR form part of domestic law via the Human Rights Act (HRA) 1998 and ECtHR jurisprudence is utilized by the domestic courts to interpret these rights. There are no parallel methods of enforcing the CHRB in the UK. However, it must be borne in mind that CHRB provisions were designed partly as an aid to the development of ECtHR jurisprudence in cases involving the nature of human rights in medical contexts1 and accordingly may be extremely significant in domestic interpretations of the HRA in medical cases. However, the point of focusing on international instruments is not merely that in some respects they tend to be legally significant but that they are also morally and politically significant. The aforementioned instruments specifically, when taken as a whole, generate a broad consensus of medical and state powers in favour of respect for the individual. One implication of this is that medical use of the body must either be genuinely required to protect that individual’s overall interests or be justifiable by reference to the rights of others, rather than simply being an overt or covert attempt to meet the needs of others. A good example of the application to tissue use is the case of S and Marper v. UK  48 EHRR 50. Here the Grand Chamber of the ECtHR found that the UK had violated Articles 8 and 14 of the ECHR by allowing the police too much leeway in their retention of fingerprints and samples from persons who, having been arrested and charged, had subsequently been acquitted or had their charge discontinued.
(p.27) 3.3 Defending a respect-based approach
Human rights instruments appear to view the individual as having an a priori right to be respected. In the light of a long history and future potential for abuse of power, they also appear to view mere means to an end treatment as politically and pragmatically unattractive. Nonetheless, in the medical context, as elsewhere, many authors have supported such use with utilitarian-based arguments (e.g. Harris 1970; Calabresi 1991) and justice-based arguments (e.g. Calabresi 1991; Harris 1997, 2002; Gunn et. al. 2000; Fabre 2006; Brownsword 2008). These arguments tend to be uncritical about ends that might be pursued and to ignore the negative effects that can stem from legally enforcing a conception of morality in the domain of something as fundamental and personal as the body (see further Garwood-Gowers 2008).
Arguments against a respect-based approach are also made on a class-specific basis. Attempts to justify lesser treatment of certain classes often focus on the embryo and fetus at one end and/or the dead at the other. Sometimes they additionally or alternatively focus on those ‘in-between classes’ who have certain disabilities or disorders. Palazzani (2008:89) notes that, whilst many ethicists embrace ‘personalism’ within which the term person and human being are synonymous, others embrace ‘personism’, within which persons are treated as a narrower and preferred class—often on the basis that only they, rather than human beings as a whole, exhibit the capacity for rationality or, more narrowly, awareness. Personism is problematic not only because it is focused on what potentially divides us as human beings and as aspects of reality in general, but also because it generates difficulties of definition and measurement. In particular, it is hard to see how one can definitively measure lack of awareness and hence, for example, declare a patient to have so-called persistent vegetative state (McCullagh 2004).
3.4 Respect as a basis for a robust approach to information- and consent-related standards
Shortfalls of protection in governance and practice in this area particularly relate to the applicability and nature of information and consent standards in specific circumstances and in relation to specific classes. Samples are increasingly being obtained specifically for research purposes, not least in the context of local and national biobanks. However, a large proportion of them continue to end up being used for research purposes although they have been removed for other purposes. Price (2005) notes that this includes over 3 million samples removed annually for treatment or diagnostic purposes within the UK National Health Service alone. Article 22 of the CHRB states that:
[w]hen in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.
The basic need for Article 22 is elaborated in paragraph 135 of the Explanatory Report which states that:
Parts of the human body are often removed in the course of interventions, for example surgery. The aim of this article is to ensure the protection of individuals with regard to parts of their body which are thus removed and then stored or used for a purpose different from that for which they have been removed. Such a provision is necessary in particular, because much information on the individual may be derived from any part of the body, however small (for example blood, hair, bone, skin, organ). Even when the sample is anonymous the analysis may yield information about identity.
(p.28) Unfortunately, paragraph 137 of the Explanatory Report is rather muted in its assessment of the scope of Article 22, stating that:
The information and consent arrangements may vary according to the circumstances, thus allowing for flexibility since the express consent of an individual to the use of parts of his body is not systematically needed. Thus, sometimes, it will not be possible, or very difficult, to find the persons concerned again in order to ask for their consent. In some cases, it will be sufficient for a patient or his or her representative, who have been duly informed (for instance, by means of leaflets handed to the persons concerned at the hospital), not to express their opposition. In other cases, depending on the nature of the use to which the removed parts are to be put, express and specific consent will be necessary, in particular where sensitive information is collected about identifiable individuals.
This paragraph treats limited provision of information as potentially adequate (i.e. a leaflet) and disingenuously associates non-opposition by patients or their representatives with consent. It also rather weakly proposes that the necessity for express and specific consent is selective without precisely identifying the kinds of circumstances in which it would or would not be required and why. In these regards it seems to promote the meeting of needs in a manner that is incompatible with respect for the individual. So, more blatantly, does Article 14 of the 2008 Additional Protocol to the CHRB concerning Genetic Testing for Health Purposes. It allows some scope for genetic tests to be performed on the previously removed biological materials of a person who cannot be contacted for the benefit of his/her family ‘in accordance with the principle of proportionality, where the expected benefit cannot be otherwise obtained and where the test cannot be deferred’. Both these provisions should be read down given that respect for the individual is one of the pillars of the Convention, is specifically emphasized in the genetic testing context by the Additional Protocol (most notably Articles 1 and 3), and underpins Rec (2006)4 of the Committee of Ministers to member states on research on biological materials of human beings.
Nonetheless, the idea of sacrificing respect to meet need is a common driver for perspectives on appropriate information provision and consent standards in the use of tissue for research purposes—sometimes explicitly so (see Chapter 14, section 14.4)—and one does not need to look hard to find domestic practices and laws that reflect its influence. Starting at the practice levels, the following three case studies are illustrative.
1. The NHANES III project: the last of a three-part series of medical and epidemiological studies carried out in the USA by the Centers for Disease Control and Prevention involving 40,000 people, of whom 29,314 had samples taken with a generic consent for storage and testing but without any more specific information or consent. By the mid-1990s the samples were being used for molecular research with DNA but the option of ‘re-consenting’ participants at a cost of $2 million was rejected.
2. Genetic data collection and use under Iceland's Health Sector Database Act (No. 139/1998): The Act enabled genetic data stored by the National Health Service to be used for the database without regard for the wishes of its source and genetic material to be used on a presumed consent basis. It was abandoned after opposition, which included a successful legal challenge to its impact on the privacy of those with forebears on it (Icelandic Supreme Court judgment No.151/2003).
3. Practices of materials being routinely retained and used for research and other purposes in England and Wales following post-mortems, in particular material taken from dead children without parental consent or even knowledge.
Failures at Bristol Royal Infirmary and the Royal Liverpool Children’s Hospital (Alder Hey) were respectively highlighted in Learning from Bristol: the report of the public inquiry into children’s (p.29) heart surgery at the Bristol Royal Infirmary (Bristol Royal Infirmary Inquiry 2001) and The Royal Liverpool Children’s Inquiry Report (Department of Health 2001). However, it quickly became apparent that the problem was much more widespread. A census carried out by the Chief Medical Officer (Chief Medical Officer 2001) found that by the end of 1999, 54,300 organs and body parts from stillborn children and fetuses alone had been retained following post-mortem. The country-wide picture was explored in the Isaacs Report (HM Inspector of Anatomy 2003).
Many laws covering the use of tissue for research purposes allow consent to be broadly given rather than requiring it to be purpose specific (for a qualified vindication of broad consent, see Chapter 2). Some allow material removed for one purpose to be used for others without consent being given for this, and many dispense with the requirement altogether in certain circumstances (e.g. where a donor cannot be found). Many jurisdictions allow use of body materials for research and certain other purposes, such as transplantation, to occur post-mortem simply on the basis that, following reasonable enquiry, there was no evidence of the deceased having objected during his/ her life (strong opt out or strong presumed consent), or that additionally there was either consent of those with parental authority or next of kin (weak opt in) or no evidence following reasonable enquiry that they objected (weak opt out or weak presumed consent).
The law in England and Wales provides a good illustration of these problems. The Human Tissue Act 2004 (for a critical appraisal, see Chapter 8) requires appropriate consent for storage and use of the body for most purposes under section 1(1) in conjunction with schedule 1, part 1. This includes most research. However, storage for the purpose of research, and actual use of material for the purpose of research, in connection with disorders, or the functioning, of the human body is exempted from the requirement for ‘appropriate consent’ if the material has come from the body of a living person and is part of research that is ethically approved in accordance with regulations made by the Secretary of State, and is to be, or is, carried out in circumstances such that the person carrying it out is not in possession, and is not likely to come into possession, of information from which the person from whose body the material has come can be identified (sections 1(7)–1(9)). This provision represents a rejection of even the generic consent approach initially recommended by the Royal College of Pathologists in its Transitional guidelines to facilitate changes in procedures for handling ‘surplus’ tissue and archival material from human biological samples (Royal College of Pathologists 2001) The basis of this rejection appears to have been cost. Furness and Sullivan (2004) estimated that if one minute was spent on obtaining consent for each of the relevant tissue samples obtained by the NHS each year, an extra 1339 full-time staff would need to be employed. One might counter that an immensely disturbing state of affairs must have been reached for a principle as important as consent to be considered not worthy of spending a minute on per case.
The Act also contains several other exemptions from the section 1 requirement for appropriate consent. It is also true that sections 1(5) and 1(6) exempt bodies and materials where they are imported or of a person who died at least a hundred years before section 1 came into force. Section 47 gives a limited power, but not a duty, to those running the Armouries and various museums to return material that was less than a thousand years old when it came into force. Several museums have aboriginal ancestral body materials, amongst them the Natural History Museum which was initially reluctant to give those materials back but eventually did so using its section 47 power. Section 45 makes it possible to perform non-consensual analysis of DNA under certain conditions, whilst section 43(1) makes non-consensual post-mortem preservation possible to facilitate transplantation. In addition, where appropriate consent does apply, satisfying it typically entails mere adherence to a weak rather than a strong opt-in system, although the latter is adopted for public display and, barring excepted material, anatomical examination (see sections 2(4) and 2(5) for children and sections 3(3) and 3(4) for adults).
(p.30) The overall picture is hard to reconcile with the protective approach that the government repeatedly promised to develop in the wake of the retention and use scandals. The report Human bodies, human choices (Department of Health 2002) stated that the following guiding principles would underpin its review and development of legislation:
◆ respect (for people who have died and their families)
◆ understanding (that love and feelings of responsibility remain after death)
◆ informed consent (enabling fully informed choices to be made)
◆ time and space (to consider what decisions to make)
◆ skill and sensitivity (in dealing with those close to a patient or deceased person)
◆ information (to improve understanding and decision-making)
◆ cultural competence (ensuring that different attitudes to post-mortems, burial, and use of organs and tissue are recognized)
◆ a gift relationship (shifting the emphasis from organ retention to organ donation).
Developed by the Chief Medical Officer Liam Donaldson, these principles not only allude specifically to respect but, by talking of donation and gift, appear to imply the need for the kind of positive act of will that can only be guaranteed by a strong opt-in system. Similarly, the subsequent Department of Health report Proposals for new legislation on human organs and tissue stated that explicit consent would be the fundamental principle underpinning the new legislation (Department of Health 2003:2). However, ultimately it seems that the government was easily persuaded by medical lobbying to support medical use in such a fashion as to hollow out the principle of consent to the point where little more than rhetoric was left. Commin has similarly observed that, for biobanking in France, the notion of informed consent has been emptied of much of its meaning by Article L1211-2, paragraph 2 of the Public Health Code, not least because consent can be disregarded altogether when the donor cannot be found or is deceased (see Chapter 11, section 11.2.1).
Whilst the Human Tissue Act is good for illustrating shortfalls with respect to consent in relation to the deceased (as well as in general),2 one can also find governance problems elsewhere with respect to other specific classes. For example, general research provisions are not always fully protective of the incapable. This is certainly true of Article 17 (ii) of the CHRB and Principle 24 of the Declaration of Helsinki. However, these provisions should be read down in light of the fact that both these instruments have, as already noted, an overarching orientation towards respect for the individual—one that in the case of the CHRB is specifically re-emphasized in its Protocol on Biomedical Research (not least in Article 15). Nonetheless, they are likely to generate confusion about whether respect for the individual is the critical concern, or at least undermine an appropriate understanding of what it entails. The approach of the Mental Capacity Act 2005 to intrusive research on the incapable adult is a good example of how this kind of confusion can adversely influence national lawmaking processes. One of the pillars of the Act is to protect the interests of the incapable (see particularly section 1(5)) but sections 31(5) and (6) seem to conflictingly point towards the possibility of trading such protection against needs for research (for further analysis see Chapter 2).
(p.31) Use of tissue for research purposes without full protection is already widely evident with respect to in vitro embryos. Article 18 of the CHRB prohibits the creation of in vitro embryos for research purposes but allows research on existing embryos subject to a proviso of ‘adequate protection’. Whether ‘adequate protection’ is synonymous with ‘full protection’ must be doubted. Furthermore, whilst some jurisdictions take a more protective approach, a few go as far as allowing embryos to be created for research, including the UK under the Human Fertilization and Embryology Act 1990, which also allows for the creation of cloned and hybrid embryos, in contravention of Article 12 of the CHRB.
3.5 Respect as a basis for prohibiting commodification
Commodification of the human body clearly takes place where a provider or user of body material is able to gain money or money’s worth from their activity at a level which exceeds due compensation for time, effort, and reasonable costs incurred. Such excess would appear to be precluded by Article 21 of the CHRB which states that the human body and its parts shall not, as such, give rise to financial gain. According to the Explanatory Report, Article 21 ‘applies the principle of human dignity set forth in the preamble and in Article 1’ (para 131). Under it:
…organs and tissues proper, including blood, should not be bought or sold or give rise to financial gain for the person from whom they have been removed or for a third party, whether an individual or a corporate entity such as, for example, a hospital. (para 132)
However, technical acts (sampling, testing, pasteurization, fractionation, purification, storage, culture, transport, etc.) which are performed on the basis of these items may legitimately give rise to reasonable remuneration. For instance, this Article does not prohibit the sale of a medical device incorporating human tissue which has been subjected to a manufacturing process as long as the tissue is not sold as such. Further, this Article does not prevent a person from whom an organ or tissue has been taken from receiving compensation which, while not constituting remuneration, compensates that person equitably for expenses incurred or loss of income (for example as a result of hospitalization).
The Article does not apply to ‘products as hair and nails, which are discarded tissues, and the sale of which is not an affront to human dignity’ (para 133) and most controversially was not considered in relation to, and hence does not yet apply to, issues relating to the patentability and patenting of biotechnological inventions (para 134).
Whilst most jurisdictions have prohibitions on commercial dealing on materials in place, not all accompany these with effective enforcement (in countries like India, for example, a massive black market in kidneys and various other body materials exists). Furthermore, some jurisdictions exclude clearly significant materials such as blood (for example, the USA has a commercial system of blood donation). In addition, extracted material can often give rise to property rights that are not constrained sufficiently to avoid excess (for example, open-ended profit can be obtained from patents for the application of ingenuity to body material). The case of Moore v. Regents of University of California  793 Pd 479 is a good illustration of this. John Moore was diagnosed with hair cell leukaemia in 1976. On the clinically appropriate advice of Dr Golde at the UCLA Medical Center of Los Angeles he had his spleen removed. Dr Golde spotted the rare properties and potential commercial value of Moore’s blood cells and encouraged him to travel regularly to the Center over the next seven years from his home in Seattle, giving him the impression that these visits and the extractions of various samples that occurred during them were necessarily and solely designed to help ensure his continued health. In fact, Dr Golde and his associate Dr Quan were developing an immortal cell line from his material. By 1990, mated as having a potential commercial value of $3.01 billion. Having found out what had occurred, Moore made numerous claims. By the time the case ended up in the Supreme Court of (p.32) California, these had been filtered down to breach of fiduciary duty and a property-based claim, the former of which was accepted as giving rise to a duty to give information about planned further use and the latter of which was rejected.
The eventual outcome of a small settlement on the breach of fiduciary duty point might have been sufficient to pay Moore’s legal costs and avoided the dignity-adverse outcome of him profiting from his own material. On the other hand it left the best part of the potential profit intact, thus enabling Dr Golde and the University to gain at a level unrelated to effort. This and other forms of excess have since become thoroughly ingrained in the field of use of tissue for research purposes, not least via the mushrooming of for-profit biobanks and those which operate on a not-for-profit basis but allow commercial exploitation of their data by third parties. Realigning systems away from market power and its Lockean underpinnings will not only be inherently valuable but also remove at least some of the incentives for other types of violation of respect-related norms, such as the breach of trust that occurred in Moore.
Tissue use is becoming ever more systematic, with an increasing amount of it being used for research, not least through the burgeoning development of biobanking initiatives. This chapter has demonstrated the importance of medical use of the body being compatible with respect for the individual and has illustrated some shortfalls of practice and governance related to the use of tissue for research purposes in this regard. It has been observed that ‘individual and collective interests are not per se mutually exclusive in the field of biobank research’ ( Chapter 7, section 7.4). Furthermore, on a more philosophical level one might argue that collective interests are only ever ultimately served when they are pursued in a manner compatible with respect for the individual (Garwood-Gowers 2008). However, conceptions of justice, utility, and self-interest that conflict with this philosophy have often been pursued, not least in the context of medical use of the body. Thus whilst those designing, implementing, and regulating programmes of use of tissue for research purposes have a heavy responsibility to guard respect-related norms better, we must recognize that history stands as a warning to the public that they would be wise never to take that guardianship for granted.
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(1) See, for example, Glass v. UK  1 FLR 101.
(2) However, it is argued by other authors that since human rights protect basic interests of embodied persons, human rights cannot protect cadavers as well as anything that has no interests (see Barilan in this volume), leading to less strict requirements of informed consent and the usage of human tissues and bodily remains. (p.34)