© Springer International Publishing Switzerland 2016
Alireza Bagheri, Jonathan D. Moreno and Stefano Semplici (eds.)Global Bioethics: The Impact of the UNESCO International Bioethics CommitteeAdvancing Global Bioethics510.1007/978-3-319-22650-7_55. Consent and Bioethics
(1)
Law and Ethics in Medicine, Glasgow University, Glasgow, UK
Abstract
The Universal Declaration on Bioethics and Human Rights contains several articles that relate specifically to the question of consent. Importantly, both the Declaration and the subsequent International Bioethics Committee Report on Consent, which is designed to explicate the relevant articles, link what was historically a legal concept to broader and more nuanced concepts such as respect for dignity, integrity and autonomy. The link between these concepts (and particularly that of autonomy) is explored in this contribution, as is the influence of the concept of consent on bioethics as a whole and the work of the International Bioethics Committee in particular.
5.1 Introduction
It is probably no exaggeration to say that consent has become one of the most significant concepts in bioethical discourse. Sourced originally from the law (Rothman 2001) prohibiting unwanted or unauthorised touching of one person by another – the law of battery, assault or trespass to the person – the concept’s obvious attraction for the developing field of bioethics was its commitment to the inviolability of the human being. This view of the individual as worthy of both protection and respect was already present, albeit in a relatively elementary form, in some legal systems, but was forcefully dragged into the broader public consciousness by the revelations that followed the trials of Nazi doctors in the aftermath of the Second World War. The Nuremberg Code (1947) that resulted from these trials, and which was specifically addressed to the question of human experimentation, was unequivocal in its declaration that “The voluntary consent of the human subject is absolutely essential” (article 1). Although focused on human subject experimentation, the Code has had wider ramifications and influence, such that “[i]nformed consent has been an axiom of post-World War II clinical research and practice…” (Weindling 2011). The Nuremberg Code was followed by the United Nation s Declaration on Human Right s (1948) which starts with the commitment that, “[a]ll human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood”. Article 3 continues that “[e]veryone has the right to life, liberty and security of person”. Subsequently, organisations such as the World Medical Association have promulgated specific ethical codes concerning human experimentation, while nations in Europe, Africa and elsewhere have signed up to regional and international human rights declarations, all of which incorporate commitment to the inviolability of the human being.
In bioethical literature, the basic legal concept of consent has been further elaborated and developed using concepts such as respect for integrity, respect for human dignity and respect for autonomy. While ‘dignity’ remains a difficult concept to describe with any clarity, its implications are obvious; it is about respecting others, their values, their person and their beliefs. Equally, integrity might seem a somewhat vague notion, but we can broadly understand its purpose and content. While by no means a simple concept, as will be seen later, autonomy (or respect for autonomy) arguably played a central role in the developing jurisprudence on consent and significantly influenced the developing discipline of bioethics. This has influenced not just human experimentation (or more accurately research), but it has also affected clinical practice, such that the need to respect patient autonomy by obtaining the consent of individual research participants and patients is now almost taken for granted by scientists, physicians and their professional associations. As UNESCO’s International Bioethics Committee (IBC) stresses, “[c]onsent is one of the basic principles of bioethics because it is closely linked to the principle of autonomy and because it reflects affirmation of human rights and human dignity which are the core values of democratic societies.” (IBC Report on Consent 2008, para 141).
It is worth briefly noting that, although there was some early case law on consent, its recognition as a fundamental predictor of legally and ethically valid practice developed relatively slowly. Medicine has a long history of paternalism; the idea that ‘doctor knows best’, simply put. Pellegrino and Thomasma (1987) have said that paternalism was “….the dominant, and indeed the accepted, model of the clinical relationship for most of medicine’s history”. In a paternalistic relationship, patients’ rights could be, and often were, essentially unrecognised, or at least were not the primary concern. On the contrary, the assumption was that the doctor, as possessor of the relevant skill and information, was able, even entitled, to decide what was in the patient’s interests and act accordingly. However, in the aftermath of Nuremberg, and with growth in recognition of the importance of human rights, it became clear that the paternalistic model was, as O’Neill says “defective and failed to establish an adequate context for reasonable trust”; an essential component of the physician/patient relationship (O’Neill 2002, 18). Whatever value, if any, the paternalistic model of medicine may have had in the past, it is clear that it no longer enjoys widespread support. Rather, it is recognised that:
…many (if not most) patients want to be treated as an interested participant in healthcare decisions; this is hardly surprising. For them the importance of control over their lives is that it permits them to make decisions that reflect their own values and encapsulate their own interests (McLean 2010, 14).
In light of the increased focus on patients’ rights, the developing recognition of the importance of patient autonomy and the impact of the burgeoning discipline of bioethics, it is scarcely surprising that from its inception UNESCO’s International Bioethics Committee has engaged with consent, autonomy and related concepts on a regular basis.
The importance of consent, both in theory and in practice, is reinforced by the fact that it is referred to (sometimes very often) in all bar one of the reports produced by the International Bioethics Committee , even those that predate the promulgation of the IBC’s ground-breaking Declaration on Bioethics and Human Right s (2005). Indeed – unsurprisingly, perhaps given the subject matter – only the report on Food, Plant Biotechnology and Ethics (1996) contains no specific mention of consent.
As suggested earlier, consent in the IBC’s conception is intimately linked to other bioethical concepts, such as autonomy and dignity. For example, its most recent report on Traditional Medicine Systems and Their Ethical Implications, says, “[t]he principles of autonomy, informed consent and respect for human dignity are inseparable” (2013, para 4.2.1).
5.2 The Universal Declaration on Bioethics and Human Right s
One of the IBC’s most important actions must be the development and promulgation of the Declaration on Bioethics and Human Right s in 2005. This Declaration follows broadly in the footsteps of earlier documents, such as the Council of Europe ’s 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). However, the IBC’s formulation of the rights inherent in humanity is a global, as opposed to a regional, recognition of the importance of human rights in the healthcare setting and, being relatively recent, it allows for encapsulation of the developments in, and enhanced capacities of, modern medicine and the challenges posed by advances in technology. In terms of consent, and while the various articles of the Declaration are inter-dependent, the most directly relevant articles are as follows:
Article 3 – Human dignity and human rights
1.
Human dignity , human rights and fundamental freedoms are to be fully respected.
2.
The interests and welfare of the individual should have priority over the sole interest of science or society.
This general commitment to respect for the individual is then followed by three articles that refer specifically to autonomy and/or consent:
Article 5 – Autonomy and individual responsibility
The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests.
Article 6 – Consent
1.
Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.
2.
Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.
3.
In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.
Article 7 – Persons without the capacity to consent
In accordance with domestic law, special protection is to be given to persons who do not have the capacity to consent:
(a)
authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent;
(b)
research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual’s human rights. Refusal of such persons to take part in research should be respected.
5.3 Consent and the International Bioethics Committee
It was, of course, never intended that the Declaration should be a static or sterile document. Following its adoption, the IBC committed itself to future work exploring and explicating the articles of the Declaration in more depth. Given its centrality to respect for human dignity and personal autonomy, it is perhaps unsurprising that the first articles selected for consideration were those relating to consent. Importantly, the report on Consent (2008) based its conclusions firmly in the traditions of human rights law, as well as emphasising the need for vigilance in ensuring that human rights norms are truly respected:
Informed consent is a fundamental principle that has marked the emergence of modern medical ethics based on personal autonomy. The need for informed consent in biomedical research was emphasized by the Nuremberg trials that revealed inhuman experimentation on prisoners in concentration camps. Its importance in the context of scientific research was further strengthened by many examples of unethical human research that continued even in the post-World War II period. In the clinical context, the importance of informed consent has been recognized as a consequence of the rising patients’ rights movement and emerging biomedical technologies that emphasized the necessity to decide about the complex health-care choices to be made by the patient him/herself. The introduction of the practice of informed consent has also transformed the traditional paternalistic health-care professional-patient relationship (General Framework, para 5).Stay updated, free articles. Join our Telegram channel
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