THE LAW AND ETHICS OF MEDICAL RESEARCH:
INTERNATIONAL BIOETHICS AND HUMAN RIGHTS, by Aurora Plomer,
Cavendish Publishing, 2005, 158 pp, £50.00, ISBN 1-85941-687-X
Download options |
 |
 |
| DOI: 10.2966/scrip.040207.237 | ||
The relentless expansion of human
activities from purely local to global (in objective and consequence)
raises many new ethical and legal challenges. With respect to
medical research, the effects of globalisation are manifold, and
include, inter alia, the increased occurrence of:
developed world actors conducting research in the developing world (on particularly vulnerable subjects);
-
utilisation by developing world actors with short research histories, weak research infrastructures, and financially challenged and inequitable settings, of novel, expensive, and potentially harmful technologies; and
-
research agendas, wherever formulated or pursued, being driven in large part by commercial and market considerations.
Within this environment,
stakeholders must determine how best to govern the conduct of actors
operating across borders and around the world. However, more
fundamentally, they must come to grips with the question of the
extent to which international governance is possible at all. The
history of exploitation and abuse in international human subject
research does much to underline this latter conundrum.
In The
Law and Ethics of Medical Research, Aurora Plomer engages with
this debate, focusing on the governance of human subject research and
its evolution from a professionally-driven ethics model to an
international human rights-driven legal model. Her primary claim is
that the internationalisation of such research has increased the
plurality of the ethical environment, thereby inhibiting the
possibility of ethics instruments (with no direct legal force)
effectively governing this field. As an alternative to this regime,
she turns her attention to the instruments of the international human
rights movement, primarily the European Convention on Human Rights
(ECHR (1950)),i
and the Council of Europe’s Convention on Human Rights and
Biomedicineii
(CHRB (1997)). The former is legally enforceable by states and
individuals and contains rights that are particularly relevant to
medical practice and research (eg: rights to life, respect for
private life, etc.), whereas the latter can serve as an interpretive
aid for some of the rights contained in the former.iii
In
Chapter 1, “From Bioethics to Human Rights in Biomedicine”,
drawing largely on the Declaration of Helsinki, Plomer highlights the
rise of “principlism” and the difficulty of arriving at
universally accepted understandings of fundamental ethical
principles. While accepting the potential for broad consensus around
the core of certain principles, Plomer argues that there will
(always) remain indeterminacy and conflict around their boundaries.
Thus, philosophically-grounded ethical guidance has limited potential
to achieve uniform international application. As a consequence, she
suggests, it has gradually been replaced by legal regulation grounded
in human rights. She concludes that this shift in emphasis from the
ethical to the legal is significant insofar as legal instruments can
be enforced in courts, themselves bound by agreed procedures and
canons of interpretation.iv
[p. 16] Given her thesis, and recent references to the Nuremburg
Code in medical jurisprudence,v
I would have preferred that instrument as the starting point and some
more consideration of its past use and potential importance in the
new regime.
In Chapter 2, “Human Rights and Universal Principles”, against the background of the US radiation and other (obviously) morally suspect military-sponsored research trials, Plomer addresses the universality of ethical principles and legal rights by examining six ethical principles expounded by the US Advisory Committee on Human Radiation Experiments,vi on the one hand, and the various “legal” provisions of the CHRB (1997), on the other hand. [see pp. 27-35] This seems a curiously narrow basis for drawing any conclusions about the universalist claim or the convergence of understanding of ethical principles (either at their core or their peripheries); surely these examples, particularly that of the CHRB (1997), exemplifies a politically negotiated morality from which, in the absence of much greater reference to the constellation of relevant international instruments, very little can be concluded.vii Having said that, the chapter does make clear the need for flexible, enforceable, and overtly morally engaged international regulation in the human subject research arena.
The
following three chapters consider three particularly controversial
types of research and their interaction with international (and
predominantly European) human rights instruments. In Chapter 3,
“Non-Therapeutic Research: Domestic Remedies and Convention
Rights”, Plomer tests the allegations surrounding the UK Porton
Down chemical weapons experiments against existing legal remedies and
judicial decisions, and then offers some suggestions as to the
potential effect of the ECHR (1950) as an interpretive tool. [pp.
60-64] In Chapter 4, “Embryonic Stem Cell Research: Human
Dignity and the Right to Life” Plomer notes the divergence of
ethical opinion on the status of the embryo, linking it to
conflicting interpretations of human dignity, and states that:
… the unprecedented and massive increase in references to
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 … . [p. 74]
She concludes that, despite continuing ethical discord, there is some evidence of legal convergence (in a number of jurisdictions) insofar as the embryo (the person in potentia) has no status at law that would trump the rights of the woman (the person in being). In Chapter 5, “The Rights of the Dead: Research on Human Tissue and Body Parts After Bristol and Alder Hey”, Plomer rehearses various moral arguments for respecting the dead and revisits the common law position of denying property in the body.viii She claims that neither the property nor the consent model are adequate to govern this field, rather suggesting that a human rights framework (ie: the ECHR (1950)) could be extended to protect the dead while recognising the legitimate public interest in some forms of interference with the corpse for publicly beneficial scientific purposes.ix [pp. 105-111]
Chapter
6, “Research in Developing Countries: New Ethics and New
Threats to Human Rights”, motes the recent phenomenon of
exporting human subject research to less developed countries, and
highlights the difficulty of regulating same. Plomer states that:
… there are compelling reasons to doubt that the framework of
guidance offered by the (Helsinki) guidelines may be sufficient to
prevent abuse in practice. One major source of concern is the
absence of overarching regulatory mechanisms to monitor and control
adherence to the guidelines, even less to exact compliance and impose
penalties for breach. The guidelines assume that Research Ethics
Committees (RECs) may be entrusted with the task … but …
in developing countries, where research infrastructures are
practically non-existent, there are no RECs to review research
protocols. [p. 126]
She then considers the potential impact of the ECHR (1950), interpreted in conformity with the CHRB (1997) and its relevant Protocols, on human subject research conducted in developing countries. Ultimately, she concludes that aggrieved participants hoping to vindicate their human rights through this instrument in the European Court of Human Rights would have to overcome significant and in some cases fatal hurdles. [p. 134]
On the whole, Plomer’s book is interesting, informative and generally well researched with respect to the main ethical and legal issues in this field, and, as such, it is a useful resource. However, it suffers from a number of shortcomings which detract from its overall effectiveness. Most importantly, it suffers from a startling lack of continuity from one chapter to the next; their sometimes abrupt end and a regrettable absence of conclusions means the sometimes disparate contents of the chapter are neither drawn together nor linked to the overall themes of the book. This hinders a robust comprehension and testing of her primary theses. Related to this is (1) the inconsistent deployment of relevant instruments and case studies, which make one think that this is not a unified text but rather a collection of articles,x and (2) the troubling formatting (ie: the sometimes curious conception of section headings, which do not seem to transition smoothly or logically from one to another), which made understanding the argument more difficult that it should have been. Finally, and this may admittedly be a trifling complaint, the reference to Blackmun LJ and his “speech” in Roe v. Wadexi was unfortunate. [p. 91] As an Associate Justice of the US Supreme Court, he is Blackmun J., and he rendered the “majority opinion” or “majority decision”. Despite these reservations, I believe this is a worthy and stimulating read which draws profitably from the author’s legal and philosophical experience, and it represents a useful tool for anyone who is interested in human subject research, bioethics and emerging biolaw.
Shawn H.E. Harmon
2007
© Shawn H.E. Harmon 2007. This work is licensed
through SCRIPTed Open Licence (SOL).
i European Convention for the Protection of Human Rights and Fundamental Freedoms, 1950, Rome, ETS No. 005.
ii 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, Ovieda, ETS No. 164.
iii And this argument finds some preliminary support in Glass v. UK, [2004] 1 F.L.R. 1019 (E.C.H.R.).
iv Despite this shift, Plomer has not convinced me that the legal framework introduced by international human rights instruments is significantly more determinate (as far as its primary legal principles are concerned) than the ethical framework it is “replacing”.
v In Grimes v. Kennedy Krieger Institute (2001), 782 A. 2d 807 (Maryland C.A.), it was applied, whereas in Abdullahi v. Pfizer Inc., [2005] W.L. 1870811 (N.Y. Dist. Ct.), it was noted as being non-binding, but in both cases, it figured into the courts’ analysis.
vi Advisory Committee on Human Radiation Experiments, The Human Radiation Experiments: The Final Report of the Advisory Committee on Human Radiation Experiments (NY: OUP, 1996).
vii I believe that a more holistic evaluation, drawing on a more inclusive list of widely subscribed to instruments would strongly suggest that there are universally recognised values. Like Plomer, I recognise that differences in their interpretation, particularly at the boundaries, endure, and I am not so naïve as to believe that that will soon change. Stakeholders are self-interested, positions are entrenched, precarious power (im)balances are vigorously defended. As a realist, I believe that any attempt to draft a normative international rights instrument that is directive and enforceable is doomed to failure, at least in the short term. As such, the best we can hope for is a negotiated pseudo-moral order which might well be little more than a race to bottom.
viii A rule that is open to challenge, morally, legally and pragmatically: see S. Harmon, “A Penny For Your Thoughts, A Pound For Your Flesh: Implications of Recognizing Property in Human Body Parts” (2006) 7(4) Med. Law Int. 329-354.
ix Once again, I am left unconvinced by her argument insofar as I am not convinced that the human rights model, which is clearly associated with the concept of consent, is relevantly distinct from these models, particularly the consent model that she challenges.
x For example, I would have preferred a more consistent reference to and use of both the key instruments (eg: the Nuremburg Code, Helsinki Declaration, ECHR (1950), CHRB (1997)) and the core case studies (eg: US radiation trials, UK Porton Down trials, international Pfizer trials) throughout the book as a recurrent means of testing her claim that rights are more determinate than ethics.
xi (1973), 410 U.S. 113.