Is medical ethics doing its job?
Mats G. Hansson, Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, UK.
(fax: +46 18 471 66 75; e-mail: email@example.com).
Arguably the chief task of medical ethics is to protect vital patient interests, e.g. the interest of receiving evidence-based medical treatment whilst not being exposed to unacceptable risks and the interests related to being an autonomous person. When different interests conflict, a balance has to be made and ethical guidelines as well as ethical review systems must be scrutinized to see whether the system is up to date with progress in medical sciences and with changing values in society. There are several indications at the present time about the need for revision.
In paediatric care, there is a lack of scientific studies backing up treatment decisions. The ethical difficulties in paediatric research are well known. Young children are vulnerable and unable to provide an informed consent. However, the other side of the coin is that lack of an evidence base for paediatric treatment implies that children are exposed to risks in association with ordinary care. EU regulation  aiming at facilitating the development and accessibility of medicinal products for use in the paediatric population and special paediatric investigation plans protecting vital ethical concerns is gradually but slowly improving the situation. Other areas are still waiting for a responsible balance of interests at stake. It should be acknowledged that the concept and implementation of informed consent are problematic even for adults.
For a long time, health concerns of women were frequently under-investigated [2, 3]. A significant progress in the participation of nonpregnant women in medical research has been made but as has recently been pointed out, the inclusion of pregnant women in clinical research is lagging far behind . Pregnant women are routinely excluded from clinical trials. Knowledge about medical treatment of women under these specific physiological and hormonal conditions is therefore lacking with the serious consequence that pregnant women are exposed to additional risks in ordinary clinical care . Similar situations are faced by other patient groups, e.g. patients with acute illness, temporarily unconscious patients and patients with decreased cognitive capacities. Adequate ethical frameworks are needed to handle this situation as well as ethical review boards who will assume responsibility for the balancing of interests when research subjects are unable to provide informed consent.
There is, however, increasing evidence that ethical review boards inflict extra risks on patients by applying standards of informed consent that are too strict and insensitive to patient interests at stake . There is a cost to this strict interpretation of consent requirements through the introduction of selection biases and reduced response rates that will lower the scientific value of the study, thus limiting the capacity to provide new medical knowledge that would be beneficial for patients. Regarding epidemiological register and biobank studies where risks are minimized through strict coding measures, these costs may arguably be considered to be too high [7–9]. On the other hand, even if reidentification of individuals who donate their samples is only a remote possibility, there is a view that rather than relying on informed consent, whilst promising privacy protection, it would be better to move to a concept of ‘open consent’ . In any case, there is an increasing awareness that ethics may be changing .
At the other end of a wide spectrum, one may ask whether medical ethics is really up to date with challenges associated with new developments in medical science. A debated issue is placebo, or sham surgery, used for comparison in clinical surgical trials in Parkinson disease . There are scientific reasons to include these controls but the long-term effects of these interventions may include risk of injurious effects, i.e. mechanical toxic, infectious, inflammatory, antigenic and neoplastic phenomena . This kind of clinical trial seems to challenge most established ethical frameworks for medical research.
The advent of new possibilities of genotyping genetic subpopulations to define more favourable balances between efficacy and risk of adverse reactions in drug treatment implies that one may soon be able to move from trial and error therapies to evidence-based personalized medicine in clinical practice [14, 15]. Several ethical issues arise in this context. Prospective genotyping in the clinic implies communication of complex risk information and advice to patients. Genetic relatives may also be concerned but there is no straightforward way to handle the ethical difficulties involved. One implication of the development of personalized medicine is that the new drugs will only be tested on small and genetically homogenous patient groups. Drugs may be marketed with less premarketing exposure and less information on adverse reactions for other populations. Rare adverse reactions will also be identified only after broad use. This constitutes a challenge in an increasingly risk-averse society. There are results of pharmacogenomics that have been challenged by ethicists and social scientists for ‘medicalization’ of race, implying that social and environmental factors of disease are neglected [16, 17]. These issues need to be elaborated based on sound research that is well informed both about pharmacogenetics and different social and ethical concerns [18, 19].
From 14 to 16 June 2010, a conference was arranged in Uppsala with the specific purpose to investigate and discuss whether medical ethics is doing its job as may be expected. The conference, entitled ‘Is medical ethics really in the best interest of the patient?’, was organized by The Centre for Research Ethics & Bioethics at Uppsala together with Cesagen at Cardiff and Lancaster Universities, with Journal of Internal Medicine as the main sponsor (see http://www.crb.uu.se for conference documentation). A selection of the keynote lectures with viewpoints and commentaries is presented in this issue of the journal.
The role of ideology in medical ethics
Arguments in medical research ethics do not refer only to patients’ health and well-being. Some bring in ideology to make a point. They may be different in kind. ‘Advanced treatment should not be expected by old patients who have passed the limits of a natural lifespan’ is one example. Another is resistance to the creation of hybrid embryos for research on the grounds that it is against nature, even if no implantation is ever considered. Patenting of human embryonic stem cells is denied because it implies a destruction of human embryos and so is believed to violate public morality. Gene therapy is still amongst some believed to be equal to playing God and tampering with life.
Hille Haker argues in her viewpoint that with regard to fundamental notions in medical research ethics such as respect for autonomy, also, there are ideological premises that influence our understanding . The rights of patients were first spelled out in the background of the ideological misuse of scientific research under the Nazi regime in Germany and were codified in the Nuremberg Declaration. Patient rights, Haker argues, must, however, not necessarily be interpreted as rights to have one’s desires always fulfilled, because these desires may also be driven by ideological interests, e.g. notions about perfect bodies lying behind individuals seeking cosmetic surgery. Respect for autonomy arguably has an ideological background with a strong emphasis on an individual’s right to self-determination that may not fit all situations. With reference to the Microbicides trials in East and South Africa, Haker suggests that in particular in transnational settings, one may need a more culture-sensitive approach where account is taken of community values and that trust in scientific research requires interaction with the whole community.
Margit Sutrop focuses in her viewpoint also on the role of respect for autonomy in medical ethics, questioning an alleged conflict between concerns about respect for autonomy and beneficence-based models of medical ethics . She suggests the need for wider views of autonomy where commitments to individual rights of patients and research subjects are balanced with communal values and the concern of public goods, e.g. health care provided on the basis of sound research.
In a similar vein as Haker and Sutrop, Alastair Campbell argues in his commentary that the term ‘autonomy’ is often conflated with ideas about self-sufficiency and independence . However, from a Kantian perspective, there is a much richer conception of autonomy available that underlines the interrelatedness of human life: the autonomy of an individual is manifested in cultural life with respect for others and is not at all in any real tension with justice or the appreciation of notions about community well-being. Campbell points to several examples of how bioethics is developing in Asia in a way that may enrich our understanding of autonomy, e.g. the combination of feminist theory with Confucianism resulting in a new conception of ‘relational autonomy’.
The distinction between ethics of medical research and medical practice
With reference to the ‘Provonost case’ in the United States, where the Office for Human Research Protection (OHRP) required ethical review of an intervention well within the limits of an ordinary, scientifically based quality improvement program aimed at reducing infection rates in intensive care, Tom Beauchamp takes, in his viewpoint, issue with the established distinction between research and practice . He suggests that ‘therapeutic research’ brings therapy and research together with a clear focus on the individual patients involved, whilst the further we get towards a focus on future patients, the definition will be less appropriate. The distinction should not be abandoned but it must be applied with more flexibility. The Provonost infection study fell into the therapeutic domain but was not research involving human subjects. The decision by OHRP caused a significant delay in the application of measures for the prevention of infections and the system in this case ‘worked more to damage than to protect patients’.
Marcel Verweij argues in a commentary to Beauchamp that the distinction between research and medical practice is morally relevant and that there should be more strict regulations and review procedures for research . Verweij suggests, however, that there is an open-texture nature of concepts like ‘medical research’ and that the different practices may overlap. He therefore emphasizes, in agreement with Beauchamp, that review bodies need some discretionary space and that they should use the power of judgement that is expected of them. A review process requires ethical reflection, not just the ‘checking of boxes on a checklist’. One of the central tasks in the review process should be to evaluate the quality of informed consent needed in association with different study protocols. Gaps in patients’ understanding are common both in medical practice and in research. Verweij argues, however, that one should be more concerned about these gaps in association with research where interventions deviate from established standards and risks often are higher. It seems that Beauchamp may disagree about this with reference to risks inflicted in association with different kinds of experimental treatment. It may be seen as a moral paradox that in association with medical treatment, a doctor is entitled to inflict almost any kind and level of risk as long as there is a slim hope of treatment success, whilst similar procedures in systematic studies will not be approved by a review board.
The appropriateness and cost of ethics regulation and review
Don Chalmers points in his viewpoint at the rapidly changing circumstances of biomedical research with a growing number of collaborations between commercial interests and academic science, cross-border data linkages and international multicentre clinical trials . These new conditions of research constitute great challenges for ethics regulation and review, and several reports have concluded that the review system seems not fit to meet these challenges. Regulation, for example, regarding epidemiological and biobank research is not proportionate to the risks involved for the research subjects. Chalmers suggests that there is a great need for a reform agenda that focuses also on institutional governance and not only on specific rules for research, e.g. specifying information and consent procedures. The globalized research context requires a wider approach to research ethics addressing issues about effective and proper management of research including standards of quality, risk management, ethical acceptability and insurance and indemnity arrangements. Such a wider focus would include the consideration of an accreditation system for ethical review boards.
Chalmers concludes that in the end, any system will have to rely on the integrity of the individual researcher. Simon Whitney and Carl Schneider take this point one step further in their viewpoint, questioning the overall validity and acceptability of ethical review boards . They refer to several examples where ethical review has stalled the research process – e.g. through lengthy information and consent requirements – thereby delaying new treatments that could benefit patients’ health and save lives. They argue that the review process may be responsible for the loss of a number of lives. It is therefore an open question as to whether ethics regulation and review boards do more good than harm.
Søren Holm challenges in his commentary this view and points to the fact that biomedical research also exposes research subjects to health risks . He argues, furthermore, that researchers are not only driven by benevolent motives of improving health and saving lives. They have interests related to career advancement, fame, recruiting premiums and making the research process run more efficiently. Holm suggests that self-regulation is not sufficient for an ethically acceptable balance of the different interests that may be at stake: ‘we need some way of protecting potential research subjects from unscrupulous and self-interested researchers’. Strict conformity to ethical rules may not be desirable but there seems to be no better alternative than the current system with ethical review boards.
Revision of bioethics and medical research ethics is a continuous imperative if ethics in the end shall serve patient short- and long-term interests as well as patient rights. Medical ethics is practised by doctors, researchers and ethical review boards as well as by legislators and policy makers. It needs ethical reflection based on sound research rather than considered opinions. The papers in this volume of Journal of Internal Medicine, with reports from the Uppsala conference, represent an important contribution to this reflection.
We are grateful for the valuable support by Journal of Internal Medicine, and we are planning a follow-up conference in Cardiff 2012.
Conflict of interest statement
No conflict of interest was declared.