Is Medical Ethics Really in the Best Interest of the Patient?
Medical Ethics Conference
14-16 June 2010, Uppsala, Sweden
The next conference in this series will be held in June 2013.
Conference articles in the JIM April issue!
From Monday morning to Wednesday aftenoon, more than 70 speakers from over 20 countries discussed whether medical ethics really is in the best interest of the patient.
Every morning started with two keynote lectures followed by a response prepared in advance.
- June 14:
Should ideology be allowed to trump patient well-being?
- June 15:
What is the role of informed consent in medical research?
- June 16
Ethical review boards: are they important ethical safeguards or over-burdensome and unnecessary bureaucracy?
About the conference
Medical ethics is practised by doctors and nurses on an everyday basis. It is also a rapidly expanding academic discipline and ethical review boards for medical research play a key role in the life sciences. The primary concern is, or at least should be, the best interest of current and future patients. But is this really so?
This multi-disciplinary international conference raised questions about some of the key ethical issues of concern regarding medical research. The possibility to increase knowledge about diagnosis, prevention and treatment of disease is the primary motive of medical research. Ethics is there in order to protect patients and promote their interests. But, the conference asked, is medical ethics instrumental to this end?
The conference discussed three themes:
- Should ideology be allowed to trump patient well-being?
- What is the role of informed consent in medical research?
- Ethical review boards: are they important ethical safeguards or over-burdensome and unnecessary bureaucracy?
Tom L Beauchamp, Georgetown University, Washington
Anne Cambon-Thomsen, French National Center for Scientific Research, Toulouse
Alastair V. Campbell, National University of Singapore
Don Chalmers, Tasmania University
Hille Haker, Goethe University, Frankfurt am Main
Søren Holm, Manchester University
Margit Sutrop, Tartu University
Marcel Verweij, Utrecht University
Simon Whitney, Baylor College of Medicine, Houston
The conferences was chaired by Mats G. Hansson and Ruth Chadwick
Mats Hansson opened the conference with an introduction to the provocative question posed by the title, giving some background context to the first day’s focus on the question Should ideology be allowed to trump patient well-being? He suggested that medical ethics has become more focused on the arguments in themselves as and highlighted the importance of regulation and policy making being based on sound research and scholarship.
He was therefore very pleased and proud to welcome some of the best scholars in this area among the key note speakers and thanked them for coming to take part in the debates. In this first plenary session, Hille Haker set out the historical context of this conference explaining that the Tuskagee case in the US and the eugenic research programmes of WW2 led to a radical reflection on medical ethics and reminded us that is was actually discrimination and injustice that shaped our ideas about medical ethics. “Historically speaking” she said, “interests of the patient were trumped by ideology.” However, the main focus of her paper was on conceptualizing the correlation of personal interests, rights and well being.
Margit Sutrop followed with her paper discussing challenges to balancing the interests of individuals and society and addressed the question of whether a dichotomy between “autonomy” and “beneficience” can be avoided. She pointed out that attempts to strike a new balance between these concepts have also been seen as problematic, especially in the face of challenges posed by biobanks and electronic health records, as these create particular vulnerabilities for patients in terms of access and disclosure of this information. She suggested that such a dichotomy can be avoided if medical ethics is able to accommodate both the values of liberal individualism and communitarianim.
Alastair Campbell’s response to these keynotes, drew attention to the areas of agreement they shared and also raised more questions, which were debated more fully in the discussions following. He deepened the discussion about autonomy and individualization, asking how we might strengthen the notion of autonomy and suggesting that encouraging agency is central to an enriched idea of autonomy. Given his current position at the University of Singapore, he also reflected on multicultural approaches to thinking about these questions and considered how they can lead us to an enhanced conceptualization of autonomy - to value the human agent as one bound in human relationships, interactions and dependency.
While supporting notion of cultural diversity, and suggesting that autonomy is crucial but should not be equated with individualism, he asserted that the risk in moving in this direction too far is the possibility of a compromise of rights where the individual swallowed up by family, that the danger is we get to mere relativism from pluralism–where morality could dissolve entirely. This prompted lively discussion of the issues raised in this first plenary session amongst the keynote speakers and the conference participants in the audience.
The second day of the conference began with Ruth Chadwick’s introduction to the day’s theme which asked What is the role of informed consent in medical research? She introduced the concepts of broad consent in contrast to narrow informed consent before welcoming the morning’s plenary speakers who explored these ideas further and from different perspectives.
Tom Beauchamp set the scene for the morning by presenting his critique of the traditional distinction between research and practice. He illustrated this by describing and analyzing some cases to show that how we regulate research can cause trouble when what is actually going on looks more like clinical practice.
He suggested that a more appropriate conceptualisation is that a continuum exists in the way that contemporary medicine works, the continuum stretching between therapeutic and non-therapeutic research, allowing for pure examples of each but also everything in between. He argued that ethical and legal regulation that takes account of this and increases the flexibility of informed consent offers more potential to protect the best interest of the patient, rather than favouring the interests of research.
Anne Cambon-Thomsen then spoke about how different types/designs of research have different implications for our conceptions of informed consent. She considered ethical issues raised in cohort studies, case/control studies and family studies and how these affect the way we need to conceptualise informed consent. She focused on the area of research she is concerned with, epidemioplogical, genetic and genomic research, arguing that the key is to foresee the issue and concerns that will be raised and discuss these with research participants.
Marcel Verweij responded by defending traditional distinctions between research and practice rather than taking what he called Beauchamp’s “more modern” stance - that we should rethink this distinction. He argued that what regulation also requires is moral judgement. He went on to elaborate on what he sees as the key problems with definitions of legal/ethical regulation: that they are unclear, characterized by an open texture, and are vague.
The different perspectives presented made for an interesting discussion between the speakers following this as they considered the areas of agreement they shared and the sources of dissonance. The discussion was opened up to the floor and the session proved to have provided plenty to stimulate questions and comments from the conference participants and elicit some strongly expressed points of view.
Wednesday: Ethical review boards: are they important ethical safeguards or over-burdensome and unnecessary bureaucracy?
In this morning’s plenary session Donald Chalmers addressed the question of whether Research Ethics Committees (RECs) are properly equipped to work in the best interests of participants in an increasingly globalised research environment. He considered some of the changes emerging and required to ensure that the RECs are equipped to handle contemporary and future medical research.
He began by considering different drivers in this changing research environment, including increasing competition and the growing importance of governance as viewed by RECs.. He went on to elaborate on the changes in the review agenda that are currently emerging including: the ‘management’ of conflicts of interests; issues related to consent and databases and the need for new principles around broad consent; the growth in research with indigenous people and other overseas research; privacy being seen as an impediment to research (he suggests more respect of privacy legislation is needed); the openness and transparency brought about by clinical trial registers.
Looking to the future, he suggested that pharmacogenetics for example would require new ways of designing clinical trials and wonders whether RECs are prepared for this. He highlighted the need for harmonization of standards to facilitate research quality, and suggests that this can be done without government input, giving the example of the International Society of Stem Cell Research which has produced outstanding guidelines for clinical transaltion of this research without this input (http://www.isscr.org/clinical_trans/index.cfm).
He finished by quoting Peter Singer “Science is barreling forward, ethics are not. I don’t want science to slow down, I want ethics to speed up”.
Simon Whitney presented a provocative account of his view that regulation slows research and therefore costs lives. He referred to Tom Beauchamp’s example yesterday of the study in the US to reduce infection in intensive care units, that was delayed by the OHRP with the consequence that 1000’s of lives that could have been saved, were not. He suggested that the comment made in the introduction to the conference that regulation of research is necessary was an important one to make 40 years ago, but that today the question should be “what is the impact of this system on our lives, health and deaths?”
He demonstrated a calculation of the number of deaths daily resulting from a delay in research into the use of ISIS 2 in 1987, which put the figure of lives lost in the 6 month delay in this case at about 3000 (more, as he said, that were killed in the terrorist attacks of 9/11). He questioned why no-one pays this any attention? In contrast, he considered how many lives had been saved by the regulation of research, dismissing some of the justifications of this regulation e.g. that it can improve the scientific method of the protocol; that informed consent is a critical tool in patient safety, stating that the risks are smaller in a clinical trial than when a patient is treated in standard medical practice; that teaching researchers to respect patients i.e. “the mush that passes for ethics education” is laughable.
In making his case that the ethical review system is making it hard to do research and costing lives, he advocates a focus on what is actually happening on the ground, rather than a focus on principles and rules. He said that the cost in terms of lives is not the end of the story but should be brought to the table and be part of the deliberation.
In response to these keynotes Soren Holm steered a course between the perspectives presented, providing a case study to illustrate the different types of delay that might occur within a clinical trial, considering whether they are equally problematic and in what sense?
He spent time considering the sources of conflicts of interest among different actors in the research process (including patients, clinicians, institutions and researchers), some which are shared, some not and how these should be dealt with. He suggested that we need external control of these unless we believe that informed consent with full disclosure of interests alone can solve the conflict of interest issue.
In terms of obtaining informed consent, he sees no reason why this should be presented in exactly the same way for all projects: “consistency shouldn’t be a matter of linguistic conformity”.
He says, in response to the title of the session, that he thinks it is a false dichotomy. In his view, ethical review is both an important ethical safeguard and overburdensome and unnecessarily bureaucratic.
These three keynotes, sparked an animated and diverse discussion between panel members and from the floor. The comments, questions and discussion ranged from: where might regulation of research be reassigned to if not RECs and how could this happen; how might review being made more efficient to prevent delays and can this be done.
A variety of perspectives on the history of research ethics review were expressed by the keynote speakers and respondent. Amongst the discussion following this, Simon Whitney wanted to clarify that he does not think that lives and deaths should be counted and pitted against human rights. Donald Chalmers wanted to make clear that he thought regulation should be driven by evidence based ethics and that we should be informed by the past but we should look at the challenges of today.
An important final question raised in discussion was whether life is the most important value, to what extent do we agree with this.
The Centre for Research Ethics and Bioethics is an interfaculty centre at Uppsala University.
Cesagen is a collaborative research centre which is funded as part of the ESRC Genomics Network. The Centre is based at the universities of Lancaster and Cardiff.