Are you ethical? Sharing practices in assessing medical ethics workshop

A/Prof. David Hunter, Drew Carter 

Organised by the Teaching Ethics stream.

This workshop aims to share, discuss and develop good practices in assessing medical ethics, both by reflecting on the nature of medical ethics and assessment, sharing practices used elsewhere and finally by a hands on development workshop where groups design and share their own assessment tool.

Introduction: Some conceptual and practical challenges in assessing ethics

David Hunter (10 minute presentation with 10 minutes for discussion)

Can ethics really be assessed? Does someone demonstrating the ability to understand ethical reasoning show that they will behave ethically? In this brief talk I will discuss how taking a holistic approach to assessment that reaches beyond the demonstration of an academic understanding of ethical practices can help address these issues.

Sharing Good Practices:

(20 minutes for combined presentation, 15 minutes for discussion)

Representatives from Adelaide, Deakin & Flinders will give brief talks describing some of their assessment practices.

Design your own assessment item Workshop

(20 minutes for development, 15 minutes for sharing)

Small groups will be invited to develop and share a mini-assessment item – either an short answer question or a multi-choice question.

The ethics of market withdrawal of and disinvestment from medicines

Jessica Pace1, A/Prof Wendy Lipworth1

1University Of Sydney, Sydney Health Ethics , Sydney, Australia

The option to withdraw marketing approval or subsidy for medicines underpins a number of healthcare policies governing access to medicines. For example, a number of jurisdictions have introduced mechanisms that allow for the conditional approval and funding of medicines, whereby a medicine is granted marketing approval or subsidy on the condition that further data is collected to confirm its safety, effectiveness or cost-effectiveness once it has entered the market. This data is then used to decide if the medicine should remain on the market, if it should continue to be subsidised and, if so, whether a price adjustment is needed. There is also hope that the increased availability of biomedical real world and big data will allow for faster identification of low-value technologies, providing guidance on technologies to be targeted for withdrawal of regulatory approval or subsidy in order to make best use of scarce healthcare resources and deliver more effective, cost-effective and affordable care for both individual patients and society as a whole.

However, regulatory withdrawal and disinvestment of medicines also raises a range of important ethical and philosophical issues. These include questions related to clinical ethics (such as what responsibilities do physicians have to protect patients who have had a positive effect from medicines that are subject to disinvestment and withdrawal), epistemology (what is considered to be sufficient evidence of harm- either to individual patients or the broader community- that would justify a disinvestment or regulatory withdrawal initiative), distributive justice (how do we ensure that the benefits and burdens of any regulatory withdrawal and/or disinvestment initiative are distributed fairly) and procedural justice (what are considered to be “fair” processes for determining when market withdrawal and disinvestment are to take place). To date there has been minimal attention paid to these issues in either the empirical or theoretical ethics literature or policies in this area and these issues have not been subject to rigorous ethical analysis.

In this workshop, we aim to develop a more nuanced bioethical perspective of the ethics of market withdrawal of and disinvestment from medicines. We will begin with a series of short presentations outlining our research (both empirical and theoretical) in this area (40 minutes). We will then involve the audience in a series of group discussions utilising real and hypothetical disinvestment scenarios to examine the following questions:

  • How might a bioethicist conceptualise the risks and benefits of disinvestment and communicate this to varied stakeholder groups (including patients and their families, physicians, members of the pharmaceutical industry and policy makers)? (25 minutes)
  • What safeguards could we implement to minimise the risks of market withdrawal and disinvestment? Which (if any) of these should we implement? Is it feasible to do this or are other approaches needed? (25 minutes)

Biographies:

Jessica Pace is a PhD candidate at Sydney Health Ethics (SHE) at the University of Sydney, with undergraduate degrees in biochemistry, law, and pharmacy.  She is pursuing research that examines stakeholder values and beliefs surrounding accelerated access to medicines, including initiatives that bypass or circumvent existing political processes in order to provide faster and/or broader access to new therapies.

Wendy Lipworth is a bioethicist and health social scientist at Sydney Health Ethics (SHE) at the University of Sydney. Her research, which is supported by an NHMRC Career Development Fellowship, focuses on the ethic and politics of health technology innovation.

What can we learn from diverse cultures that could/should change our approaches to teaching bioethics?

Dr Yvonne Cadet_James1, Dr Ben Gray2, Professor Emma Kowal3, Dr Richard Matthews4, Dr Camilla Scanlan5

1James Cook University, Cairns, Australia, 2University of Otago, , New Zealand, 3Deakin University, Melbourne, Australia, 4Bond University, Robina, Australia, 5University of Sydney, Sydney, Australia

The term ‘Bioethics’ has been popularised in response to advances in science and medicine over the last fifty or so years. Despite the fact that bioethical discussions have occurred throughout the world, the dominant approach has been one derived from an Anglo-American culture perspective. The kinds of ethical issues discussed, and the values and theoretical perspectives that have been drawn upon, have tended to come from a narrow range. For example, the dominant value in the brief history of bioethics has clearly been individual autonomy (defined as having the freedom to make choices), and the answer to many problems in bioethics has been the provision of so-called ‘informed consent’. This model assumes that individuals are the relevant social unit and that key values relate to protecting individual interests. Much of the teaching of Bioethics in higher education settings in Australasia has adopted this approach.

This picture of bioethics has been challenged over the last few years from many different directions. One particular challenge claims that it fails to recognise that there are many different peoples, cultures and ethical traditions that might be drawn upon during discussion of bioethical issues. There is, surely, an ethical imperative to ensure that such voices are heard.

This workshop provides a unique opportunity to bring together expertise ranging across a number of different perspectives including cultural perspectives.

The goal of this interactive workshop is to explore how we can use the diverse cultural perspectives of our world to inform issues in bioethics and how we can thus teach bioethics in a more relevant, and culturally safe and sensitive manner.


Biographies:

Yvonne Cadet-James is a Gugu Badhun woman from the Valley of Lagoons in north Queensland. She has an extensive background in health as a registered nurse and an academic. Yvonne’s focus is on Indigenous health and education and in her present position at James Cook University she is involved in teaching, research and community development activities. She is currently chief investigator on several research projects examining empowerment as a tool in improving Indigenous health wellbeing. Yvonne’s other area of interest is research into her family’s history and language.

Emma Kowal is Professor of Anthropology at the Alfred Deakin Institute and Convener of the Science and Society Network at Deakin University. She is a cultural anthropologist who previously worked as a medical doctor and public health researcher in Indigenous health. Much of her work is at the intersection of science and technology studies, postcolonial studies and indigenous studies. Her publications include the monograph Trapped in the Gap: Doing Good in Indigenous Australia and the collection (co-edited with Joanna Radin) Cryopolitics: Frozen Life in a Melting World. Her current book project is entitled Haunting Biology: Science and Indigeneity in Australia.

Ben Gray has worked in General Practice for 30 years, first in Waitara Taranaki where he had significant engagement with the Māori community and for the last 25 years in Wellington at a high needs central city practice with an ethnically very diverse population. He currently works at University of Otago, Wellington in the Primary Health Care and General Practice Department. He convenes the course in Professional Skills Attitudes and Ethics and 2014 completed a Masters in Bioethics and Health Law with a dissertation titled How does the concept of cultural competence affect the practice of bioethics and health law.

Richard Matthews is a bioethicist, philosopher and social justice theorist. He has had academic roles in Canada and Australia, and has practical experience as a clinical and public health ethics consultant in Ontario, Canada. In that role he has worked as an anti-racism and health ethics consultant at the Meno Ya Win Health Centre in Sioux Lookout, Ontario – Anishnaabe Treaty 3 territory as well as in Thunder Bay – on Robinson-Superior Treaty land. He has specific research interests in violence and in health ethics with Indigenous peoples. He is the author of a book (The absolute violation: why torture must be prohibited. 2007).

Camilla Scanlan is an academic at University of Sydney. Her interest lies mainly around the nexus of ethics, law and clinical practice, and extends to the study of personal and professional ethics.

Practices and standards in empirical (bio)ethics research: An open discussion

Prof. Stacy Carter1, Prof  Vikki Entwistle2, Dr Bek McWhirter3, Assistant Professor Tamra Lysaght2

1Research for Social Change, Faculty of Social Science, The University Of Wollongong, Australia, 2Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, 3Centre for Law and Genetics, Faculty of Law & Menzies Institute for Medical Research, University of Tasmania, Australia

If you do empirical ethics research, please come along to this workshop to talk about your own practices, and about how we might develop shared methodological understanding in empirical bioethics. We will assume that empirical ethics is worth doing: our focus will not be whether empirical bioethics should be done, but how it should be done.

Recently, European groups have attempted to develop standards for empirical ethics research. We will use that work as a jumping-off point, but will spend most of our time discussing three sets of questions in small groups and together:

  1. Why do you do empirical ethics research? What do you think the goals of such research should be? What kinds of research questions do you think should be asked in this work?
  2. How helpful is it to attempt to develop standards for empirical ethics research? How might practices in empirical ethics research relate to existing standards for empirical and theoretical research from other disciplines?
  3. How do you think about and work between the empirical and normative aspects of your work?

This is an opportunity for a supportive and robust discussion about how and why we do what we do. We welcome participants with all levels of experience, from complete beginners to old hands. Please come along and join in the conversation.


Biographies:

Stacy Carter is Professor and Founding Director at Research for Social Change, a research unit of the Faculty of Social Science at the University of Wollongong.

Vikki Entwistle is Professor and Director at the Centre for Biomedical Ethics in the Yong Loo Lin School of Medicine, National University of Singapore. Tamra Lysaght is an Assistant Professor in the same centre.

Bek McWhirter is a Research Fellow at the Centre for Law and Genetics, in the Faculty of Law & Menzies Institute for Medical Research at the University of Tasmania.

Stacy, Bek and Tamra are the stream leaders of the Empirical Ethics stream of AABHL. All four presenters are empirical bioethics researchers.

Exploring the implications of collapsing boundaries in health law and ethics

Dr Lisa Eckstein1, Professor Dianne Nicol1, Associate Professor Mark Taylor2, Dr Jessica Bell2

1University of Tasmania, Hobart, Australia, 2Melbourne Law School, University of Melbourne, Carlton, Australia

New technological developments, alongside changing social and funding conditions, are blurring boundaries that have long served to determine responsibilities of persons and entities. This workshop aims to explore the ongoing pertinence of traditionally binary distinctions between, for example, research and clinical practice, private and public, and identified and de-identified. The workshop will provide an opportunity for a facilitated conversation among participants about the potential destabilisation of these demarcations, and what this might mean for future regulatory regimes. Discussion will be triggered by the below scenario: a hopefully realistic portrayal of collapsing boundaries in health law and ethics.

A rare disease program is being run out of a public hospital with funding sourced from a major drug company. A 14-year old patient is admitted to the program after a long-running odyssey to diagnose her progressive muscle wasting. To assist diagnosis, whole-genome sequencing (WGS) is performed on the patient and her biological parents. The program identifies a rare mutation in the patient leading to a diagnosis that previously has only been recorded in fourteen known cases. Based on one available case study, the treating team administer the patient with a drug currently approved for marketing for certain forms of cancer. The patient shows early signs of improvement and her ‘miracle cure’ gains widespread media attention. As a part of the standard protocol for the program, the three WGSs are uploaded to an online database, stripped of identifiers other than country of origin, clinical diagnosis, and self-identified racial/ethnic ancestry. An external research team accesses the sequences and finds a cancer predisposition. They question whether the finding should be returned.


Biographies:

This workshop will be presented by Dr Lisa Eckstein, Professor Dianne Nicol, A/Professor Mark Taylor, and Dr Jessica Bell. The presenters are members of the Centre for Law and Genetics and Helex@Melbourne respectively, where their research focuses on the ethical and legal implications of genetic and other emergent technologies, from multi-disciplinary perspectives. The idea for this workshop stems from a joint meeting of the CLG and Helex@Melbourne, and the presenting authors gratefully acknowledge the contributions of all in attendance.

Authors: Dr Lisa Eckstein, Professor Dianne Nicol, A/Prof Mark Taylor, Dr Jessica Bell, Professor Don Chalmers, Professor Margaret Otlowski, Professor Jane Kaye, Dr Harriet Teare, Dr Megan Prictor, Dr Rebekah McWhirter, Dr Jane Nielson

Finding the ‘mean’ in debates about access to high cost cancer medicines

Narcyz Ghinea1, Jessica Pace1, Claudia Harper1, Wendy Lipworth1

1 Centre for Values, Ethics and the Law in Medicine, the University of Sydney, Medical Foundation Building K25, NSW 2006.

The cost of medicines is currently an issue of major concern to Australian patients, physicians and government. Exorbitant prices for some medicines mean that most patients rely on Pharmaceutical Benefits Scheme (PBS) to ensure access to medicines. When medicines are not listed on the PBS, physicians often have to lobby hospitals or pharmaceutical companies to provide their patients with free or subsidised access. Many consider this to be an ethically untenable situation, and they appeal to ‘goods’ such as ‘innovation’, ‘compassion’ and ‘affirmative action’ as arguments for increased access to medicines. All of this places immense pressure on the government to fund more medicines more quickly, even if these medicines provide only marginal benefits, are supported by relatively little evidence, and/or threaten the sustainability of the PBS.

In this workshop, we aim to develop a more nuanced bioethical perspective of the debate about access to high cost medicines. We will begin with a series of short presentations that describe empirical research we have recently conducted into debates about access to high cost medicines. We will then involve the audience in a series of group discussions, exploring the following questions:

  • Activity 1: Is it desirable and possible to ‘push back’ against demands for enhanced access to high cost medicines? (20 minutes)
  • Activity 2: How might a bioethicist might conceptualise, and weigh up, the risks and benefits of ‘accelerated access’ to high cost medicines? (20 minutes)
  • Activity 3 (Time permitting): How might a bioethicist might think about resource allocation decisions in a manner that accounts for values other than safety, efficacy and cost-effectiveness?

Biographies

Narcyz Ghinea is a researcher at the Centre for Values, Ethics and the Law in Medicine investigating how to improve the funding of high cost cancer medicines in Australia.

Jessica Pace is a pharmacist and PhD candidate at the Centre for Values, Ethics and the Law in Medicine. She has undergraduate degrees in biochemistry, law and pharmacy. Her doctoral research is examining the ethics of debates surrounding accelerated access to medicines. 

Claudia Harper is a science and law student at the University of Sydney. She has broad research interests in resource allocation in the health system and access to medicines.

Wendy Lipworth is a bioethicist and health social scientist at the Centre for Values, Ethics and the Law in Medicine, University of Sydney. Her research, which is supported by a NH&MRC Career Development Fellowship, focuses on the ethics and politics of health technology innovation.

Doing bioethics: (How) should we engage with those we critique?

Jane Williams1, Christopher Mayes1, Wendy Lipworth1

1 Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25) University of Sydney, NSW 2006 Australia

Successful research is increasingly characterised as that which has ‘impact’, engages with stakeholders, and informs policy and practice. However policymakers can be slow to respond to evidence and practitioners can be hostile to recommendations. These problems may be greater for bioethicists as our work often adds further nuance to already complex issues and may involve critiques of those whose engagement is sought. At best, our work tends to be viewed as peripheral in the eyes of policymakers and practitioners and it can be difficult to even find a voice in “real world” debates. In this workshop, we will generate discussion about the challenges faced by bioethicists who want to both critique current practice and influence policy and practice. We will begin by describing our attempts to engage with the Assisted Reproductive Technology (ART) industry on our work in conflicts of interest (COI). Following recent media focus on perceived COI in ART in Australia, we wrote a paper which called for debate and set out clear parameters for deliberation. Response from reviewers was positive yet the paper remains unpublished, ostensibly because it lacks “primary source evidence”.  There was also acknowledgement of the controversial nature of the topic and potential to alienate their professional readers.

We will use this experience to prompt group discussion, asking:

  • Should bioethicists strive to engage with stakeholders and influence policy and practice? If so, how?
    • How can bioethics research most effectively find its voice?
    • How can different conceptions of evidence be negotiated?
  • More generally, what do concepts like ‘impact’, ‘significance’, ‘innovation’ ‘engagement’, and ‘translation’ mean in the context of bioethical scholarship?

We will ask audience members to reflect upon and share their own experiences of “doing bioethics” with a view to informing policy and practice.


Biographies

Ms Williams is a final year PhD student at the Centre for Values, Ethics, and the Law in Medicine (VELiM). She is working on the ethics of cancer screening, and conflicts of interest in medicine.

Dr Mayes is a post-doctoral researcher at VELiM. His areas of work include conflicts of interest in medicine, continental philosophy, and food ethics.

Dr Lipworth is a senior research fellow at VELiM. She works on conflicts of interest in medicine, the ethics of biobanking, and the ethics of drug development.

Emerging technologies and the ‘too much medicine’ problem

Ainsley J. Newson1, Wendy Rogers2, Stacy Carter1

1 Centre for Values, Ethics and the Law in Medicine, School of Public Health, University of Sydney, NSW 2006
2 Centre for Agency, Values and Ethics and Australian School of Advanced Medicine, Macquarie University, NSW 2109

Emerging technologies such as genomics, biomarkers and imaging modalities are increasingly being implemented into healthcare. This is often an appropriate course of action. Genomic testing, for example is being used to increase diagnostic yield in groups living with rare disease. Alongside this, however, scholars are highlighting medicine’s increasing tendency to overdiagnose and overtreat. This is driven at least in part by enthusiasm among policymakers and the public for initiatives including screening for disease risk and personalised and precision medicine. Without appropriate reflection, these technologies may contribute to the problem of ‘too much medicine’; including by unnecessarily widening definitions of disease or ‘pre-disease’. In this workshop, we will argue that considerations of ‘too much medicine’ and overdiagnosis need to be made more visible in the planning and delivery of emerging technologies in health care. The workshop will comprise presentations from three academics who work in theoretical and empirical bioethics. The presenters will consider concepts such as: the balance of benefits and harm, the technological imperative, technology-led demand, our natural inclination to be ‘information seekers’, public communication, and some of the vulnerabilities created by these technologies. The workshop will advocate for critical implementation of these technologies in healthcare, including evaluation of possible concepts that can usefully inform ethical debate.


Biography

Ainsley Newson is Associate Professor of Bioethics at the University of Sydney. She undertakes research on a range of ethical issues arising from emerging technologies in health care; focusing on genetics, genomics and human reproduction. Ainsley has degrees in science and law and a PhD in Bioethics. She also leads the Sydney Bioethics Program of postgraduate coursework.

One Health approaches to emerging infectious diseases: Considering the ethical issues

Dr Chris Degeling1,2, Dr Jane Johnson1, Prof Gwendolyn (Lyn) Gilbert1,2, Ass Prof Tamra Lysaght3

1 Centre for Values, Ethics and the Law in Medicine, School of Public Health, Level 1, Medical Foundation Building K25, The University of Sydney, NSW, 2006. E: chris.degeling@sydney.edu.au
2 Marie Bashir Institute for Infectious Disease and Biosecurity, The University of Sydney, NSW, 2006.

3 Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Level 2 Block MD11, Clinical Research Centre, 10 Medical Drive Singapore 117576.

Emerging and re-emerging infectious diseases (EIDs) continue to represent a significant threat to human health. A management approach grounded in ‘One Health’ is increasingly viewed as the most effective way of responding to these threats since it organizes action around the reality that human, animal and environmental health are interdependent. We argue, however, that in spite of the scientific consensus about adopting a One Health approach, such an approach will not be effective if it fails to engage with the values and ethical issues at stake. In this workshop we will present a number of hypothetical case studies to tease out the ethical issues generated by One Health responses to EIDs.

The format of this workshop will be highly interactive. We will begin by providing background on One Health and EIDs, before dividing the audience into groups to consider a number of case studies. Each group will be assigned one case and asked to identify the ethical issues it raises and to discuss and justify what action should follow from the scenario. Groups will then report back their findings to all workshop participants.

These cases have been used as the basis for online Delphi panels (questionnaires involving experts over multiple rounds) run in Australia and Singapore by the workshop authors. Insights from these panels will be used to inform and enrich workshop discussions. We will take the opportunity to highlight, amongst other things, similarities and differences between the Australian and Singaporean experiences.

We will conclude the workshop with a summary of the common themes and issues raised by the cases and how this work on ethical issues can be used to inform improved strategies and policies for implementing One Health responses to EIDs.


Biographies

Chris is a Research Fellow at the Centre for Values, Ethics and the Law in Medicine at Sydney School of Public Health and a practicing veterinarian. His research and teaching interests revolve around the ethics and politics of human interactions with nonhuman animals, and the social and cultural dimensions of public health. Current projects include the NHMRC funded study: Can One Health strategies be more effectively implemented through prior identification of public values?

Jane is a Research Fellow at the Centre for Values, Ethics and the Law in Medicine. From 2009 until the end of 2014 she was a postdoctoral research fellow at Macquarie University where she worked on projects regarding the ethics of innovative surgery, and the ethical and epistemological implications of reconceptualizing the use of nonhuman animals in biomedical research. Jane has research interests in applied ethics, interdisciplinary research and philosophical pedagogy; her distinctive expertise involves the philosophical and normative analysis of empirical problems.

Lyn is an infectious diseases physician and clinical microbiologist. She is a professor of infectious diseases and senior researcher at the Marie Bashir Institute for Infectious Diseases and Biosecurity and the Centre for Values, Ethics and the Law in Medicine and, until recently, was a senior staff specialist in Microbiology and Infectious Diseases at Westmead Hospital. She has had longstanding research and clinical interests in: communicable diseases of public health importance and ethical implications of infectious diseases and antimicrobial resistance.

Tamra researches ethical and regulatory issues in stem cell science and clinical translation of regenerative medicines and genomics. She has expertise in empirical ethics and experience using qualitative and quantitative research methods. Tamra has worked on policy with the Committee for Ethics Law and Society of the Human Genome Organisation, the Technical Working Group on Ethics at the World Health Organization, the Translational Clinical Research Programme of the Institute of Mental Health in Singapore, and the Human Health Division of the International Atomic Energy Agency. Tamra is an Assistant Professor, Centre for Biomedical Ethics, National University of Singapore.

 

Should healthcare providers boycott working in Australian asylum seeker detention?

Associate Professor Deborah Zion1, Professor Louise Newman2, Professor Linda Briskman3

1 Centre for Cultrual Diversity and Wellbeing and Office for Research, Victoria University, Victoria, 8001.
2 Director of the Centre for Women’s Mental Health at the Royal Women’s Hospital and Professor of Psychiatry, University of Melbourne, 3053.
3 Swinburne Institute for Social Research, Swinburne University of Technology, 3122.

Australian immigration detention has been identified as perpetuating ongoing human rights violations. Concern has been heightened by the assessment of clinicians involved and by the United Nations that this treatment may in fact constitute torture.  On this basis there has been increasing discussion as to whether or not healthcare providers should continue to work in detention, especially under the employ of the prison providers, and the Department of Immigration. In essence such employment has been described as a “dual loyalty” conflict, where the care of the patient is in conflict with the demands of the employer and the state.

The question then remains: What are morally acceptable roles for healthcare providers in the current asylum system, and is there any role for health care providers in detention? If so, what might that be?

In order to answer these questions, we will present short papers on the meaning of boycotts, the role of witnessing and dual loyalty conflict. We will then draw on the experience of those who have worked in the detention setting to try and resolve these questions.


Biography

Associate Professor Deborah Zion IS the Chair of the HREC at Victoria University, and an adjunct fellow at the Centre for Cultural Diversity and well being. She is a Eureka Prize finalist, and has for many years, been engaged in research concerning ethics, healthcare and asylum.

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About the Association

The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

The AABHL seeks to foster a distinctive Australasian voice in bioethics, and provide opportunities for international engagement through its membership, journal and conferences.

Members come from all the contributing humanities, social science and science disciplines that make up contemporary bioethics.

Many members have cross-disciplinary interests and all seek to broaden the dialogues in which all members of the wider community ultimately have an interest.

The AABHL is a supportive, creative and challenging community that provides a rich source of continuing academic refreshment and renewal.

Conference Managers

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