Vol. 16 No.2 (February 2006), pp.173-176

 

THE LAW AND ETHICS OF MEDICAL RESEARCH: INTERNATIONAL BIOETHICS AND HUMAN RIGHTS, by Aurora Plomer.  London/Sydney/Portland: Cavendish Publishing, 2005. 240pp. Paperback. $100.00/£50.00 ISBN: 185941687X.

 

Reviewed by Gonzalo Arruego, BMW Center for German and European Studies, Georgetown University.  Email: ga87 [at] georgetown.edu

 

During the past decades, the fast developments experienced by the medical sciences have opened a deep interdisciplinary debate on the principles that should guide and rule them. The debate has progressively changed the attitude of the medical profession regarding the relationship with the patients, now mainly understood in the language of patients’ rights, and it is facing progressively deeper and more intense ethical and legal discussions concerning both the possibilities and the limits of the new biomedical advances, especially regarding biomedical research. This is a field where different fundamental rights and diverse social interests converge, a convergence which obliges legislators and juridical operators to find an adequate balance between the different rights at stake and the social benefits derived from biomedical research.

 

In this context, Aurora Plomer’s THE LAW AND ETHICS OF MEDICAL RESEARCH focuses on the ethical and legal debate surrounding medical research, particularly when involving human subjects. More precisely, and as Plomer points out, the object of the book is an analysis of the evolution in the form and content of international instruments regulating biomedical research, an analysis where the author pays special attention to the Council of Europe’s Convention on Human Rights and Biomedicine (CHRB), signed in Oviedo, Spain, in 1997.  Plomer explores the strengths and weaknesses of the Convention and its ability to guarantee the fundamental rights of the individual in some of the most controversial areas of biomedical research.

 

THE LAW AND ETHICS OF MEDICAL RESEARCH is guided by three main ideas and concerns:

1) How increasingly globalized medical research is heightening the tension between the aspiration to universality of ethics-driven regulation and the emerging reality of diversity in moral cultures of democratic societies. This plurality can be found both within a certain democratic society and among societies, despite their shared democratic traditions. The reluctance of some European countries to sign the Convention on Human Rights and Biomedicine, “largely because of deep divisions over the legitimacy of embryo research,” is a good example of these problems. In this context, “whilst countries such as Germany and Ireland will not ratify the Convention because they consider it too liberal in allowing research to be conducted on human embryos, countries such as the UK and Belgium hold the opposite view and have in fact adopted legislation which permits the creation of embryos for [*174] research purposes directly at odds with Art. 18 of the CHRB” (p.77).

 

2) The difficulties to determine the exact scope and content of the principles and values underlying the international instruments regulating medical research, and how depending on the philosophical point of view adopted when interpreting the international instruments regulating biomedical research, the same principle may lead to opposite conclusions in a certain matter. From this perspective, the achievement of an international consensus regarding the principles ruling biomedical research could be illusory, as the remaining question would not be whether research must be guided, for example, by the principle of human dignity, but what the exact nature, content and requirements of the principle are in a concrete matter like embryonic stem cell research. As Plomer remarks, “social convergence and agreement on the universal or fundamental character of general values such as human dignity or life need not therefore connote or reflect agreement on the particular interpretation or concrete application to be given to these concepts. . . In short, convergence on general ethical values or principles need not imply agreement, and indeed may obscure deep disagreement, in the determination and concrete application of the principles in particular cases” (p.71).

 

3) One of the great recent achievements in the international debate on the protection of human subjects in biomedical research is the shift from the realm of ethics to the realm of legal enforceable human rights in biomedicine, a transcendental step taken by the Council of Europe through the CHRB, “which has the potential to offer greater protection to human subjects.” As Plomer points out, though fundamental legal and ethical principles both carry the potential for indeterminacy and controversy over their scope of application, “in the case of legal principles, however, the controversy admits of a resolution through a legal forum such as a court, which is itself bound to follow agreed procedures and cannons of interpretation. The outcome is legally binding on the parties.” Therefore, the adoption of a human rights instrument in the area of biomedical research, previously characterised by the prevalence of “ethics driven self regulation,” is a highly significant development, as it “marks the introduction of an external set of standards and procedures by which the biomedical profession’s own standards may be judged, against which it may be held legally accountable by victims seeking redress” (p.16).

 

These three guidelines are strongly present in the first chapter of the book, “From Bioethics to Human Rights in Biomedicine,” where Plomer examines the evolution in the form and content of international instruments regulating biomedical research, within the framework of the origins of international bioethics. From this point of view, an exploration of the origins and evolution of the 1964 Declaration of Helsinki is carried out “against the global growth of the bioethics movement, its impact on public policy and the emergence of national and international bioethics committees” (p.1), then focusing on the Council of Europe’s Convention on [*175] Human Rights and Biomedicine and the problems regarding its legal force and its relations with the European Convention for the Protection of Human Rights and Fundamental Freedoms.

 

The second chapter, “Human Rights and Universal Principles,” focuses on the theoretical difficulties in identifying the exact meaning and status of ethical and legal principles in the field of biomedical research. The departure point of the chapter is the diverse nature and content of norms regulating biomedical research both within and outside Europe, and the legal vacuum caused by the fact that in such a fast developing field as biomedicine – think for example on stem cell research or research on human tissue – law tends to lag behind science. In such a complex context, though the adoption of an international legal instrument which aspires to capture fundamental values constitutes a highly important step, the remaining problem to uniformity is the diversity of norms and forms of regulation among different countries, thus risking the effectiveness of any uniform international regulation, which could become a mere minimum common denominator, diluting the rights of the individuals.  The question addressed in the chapter is whether the rights contained in the CHRB reflect universal principles against which to judge domestic legal regimes on medical research, a question Plomer deals with by comparing the Convention with the 1996 report adopted by the US Advisory Committee on Human Radiation Experiments and its claim of having identified fundamental ethical principles valid across all cultures and times.

 

Chapter 3, “Non-therapeutic Research: Domestic Remedies and Convention Rights,” examines the CHRB rules of consent with regard to non-therapeutic research and whether the fundamental rights system of the Convention offers to individuals a higher degree of protection as compared to that provided by domestic law in the UK, Canada and US. After exploring the meaning of the principle of informed consent in diverse human rights instruments, Plomer focuses on the Port Down experiments in the UK and compares the civil remedies available under domestic British Law with litigation surrounding radiation experiments in the US and compares the protection provided by the CHRB. This analysis highlights the existing differences between the Convention and The European Convention on Human Rights.

 

Chapter 4 examines one of the most problematic issues in biomedical research, embryonic stem cell research. The central question is whether embryonic stem cell research constitutes a violation of the principle of respect to human dignity and the fundamental right to life. Plomer examines the meaning of these principles applied to human embryo and to stem cell research, through the analysis of the judicial decisions derived from the European Convention of Human Rights and the Convention on Human Rights and Biomedicine, some of the decisions emanated from some of the European Constitutional Courts and the policy adopted in the United States and the decisions taken by US courts concerning the status of frozen embryos. The chapter again underlines the difficulties [*176] in determining the exact content and scope of the principles and values ruling biomedical research. As Plomer stresses, the unprecedented and massive references to the principle of human dignity in the new human rights instruments in biomedicine does not conclusively dispel the uncertainty and controversy regarding the scope of application of the concept.  Despite its prominent use, there remains considerable uncertainty about its meaning and scope, and its role as a background principle.

 

In the fifth chapter, “The Rights of the Dead: Research on Human Tissues and Body Parts,” Plomer analyses the question of biomedical research on human tissues and body parts. She reviews both the moral background and legal framework vis à vis corpses in the UK and considers how European human rights law could be extended to secure adequate legal protection of the dead, while recognising the public interest and legitimacy of some forms of interference with human corpses in order to facilitate scientific research. After analysing the weaknesses of the property, consent and authorisation models concerning use of human tissue and body parts in biomedical research, Plomer suggests that articulation of relevant principles may be best secured within a human rights framework, thus allowing legislators and policy makers to balance individual rights and the interest of society. Moreover, she finds application of the European CHR to the dead is warranted and consistent with the ideal of the Convention as a “living document.” In her view, though the right to life proclaimed in Article 2 could not be applied to the dead, Articles 8 (the right to privacy) and 3 (the right to freedom from degrading treatment) would be applicable.

 

The closing chapter reviews new international and regional ethical guidelines on research in developing countries and their compatibility with fundamental principles of human rights law within the framework of controversial medical trials in developing countries to address the AIDS pandemic. Plomer compares the 2000 revision of the Declaration of Helsinki with new ethical guidelines on research in developing countries and assesses their compatibility with the European Convention on Human Rights and Convention on Human Rights and Biomedicine, with special attention to the principle of the equal dignity of every human being and the prohibition of discrimination. Plomer suggests that, although the move from ethics-driven regulation towards human rights-driven regulation of biomedical research “is a landmark achievement which has the potential to bring greater justice to participants in research trials . . . for the potential to be realised, further advances are needed. On the one hand the normative gap between the European Convention on Human Rights and the Convention on Human Rights and Biomedicine has to be filled. On the other hand fundamental, procedural limitations on enforcement have to be lifted. Only then will transnational justice be truly achieved” (p.135).

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© Copyright 2006 by the author, Gonzalo Arruego.