Obtaining consent for research from people with dementia: Do we try hard enough?

A/Prof. Deirdre Fetherstonhaugh1, Professor Elizabeth  Beattie2, Dr  Maria  O’Reilly3, Mr  Mitchell  McMaster4, Professor  Wendy Moyle5, Dr  Elaine Fielding2

1La Trobe University, Bundoora, Australia, 2Queensland University of Technology, Brisbane, Australia, 3Central Queensland University, Bundaberg, Australia, 4Australian National University, Canberra, Australia, 5Griffith University, Brisbane, Australia

The Australian National Statement recognises the right of people with dementia to participate in research. However, the assumption is often made that people with dementia cannot provide their own informed consent to participate in research and therefore historically researchers default to seeking consent from a proxy or substitute decision-maker. In so doing however the person with dementia is denied their right to exercise their autonomous choices, and there is disregard for their agency.

As part of a national study into quality of life of people with dementia living in Australian nursing homes we sought to determine how many of the potential participants with dementia could provide their own informed consent as determined by the ‘Evaluation to Sign Consent (ESC)’ instrument; a tool designed to measure understanding.

The ESC instrument was administered to three hundred and ninety two people with dementia. Informed consent for participation in the research was then obtained from those people who met the criteria of the ESC. Demographic information was collected about their age, gender and level of cognitive impairment.

Just over one fifth (22%) of the people with dementia who were administered the ESC were deemed capable of providing consent to participate in this specific research project. This demonstrates that assuming all people diagnosed with dementia are unable to provide informed consent for research potentially denies them the autonomy to make a decision that they may be capable of making.

This paper will discuss the ethics and practicalities of obtaining consent for research from people with dementia.


Biography: 

Deirdre Fetherstonhaugh is a researcher and academic ethicist. Her research focuses on: the translation of research evidence into practice; the ethical implications of clinical practice; decision-making for people with dementia; sexuality and dementia; and clinical risk in aged care. Deirdre also develops and delivers education to health professionals and aged care workers. She is an associate professor and director of the Australian Centre for Evidence Based Aged Care (ACEBAC) at La Trobe University.

Researcher-Native Relations: Ethical considerations relating to emerging animal models in Australian science

Prof. Rachel A. Ankeny1, Karina Burns

1University Of Adelaide, Adelaide, Australia

This paper considers ethical issues relating to the use of native animals as emerging models in contemporary Australian research. Native animals often hold special social and cultural significance both within and outside of their home countries. In this paper using published scientific literature, supplemented by interviews and popular media coverage, we explore how researchers working with native Australian species think about their animal research subjects and how these attitudes or ways of thinking are influenced by broader structures such as existing norms within society and in various types of research as well as popular conceptions about ferals, invasives, or protected species. We also investigate the silences present when native organisms are utilized for research, and show ways in which native animal models simultaneously have multiple roles and types of relations with respect to researchers. We thus contend that in order to thoroughly consider the ethics of research with native animal models, it is critical to understand researcher-animal relations as deeply situated in relation to the particularities of the models utilised and closely tied to scientific practices.


Biography:

Professor Rachel A. Ankeny is in the School of Humanities (History and Philosophy) at the University of Adelaide, where she also serves as the Associate Dean Research and the Deputy Dean of the Faculty of Arts, and Vice President of AABHL. An interdisciplinary teacher and scholar whose areas of expertise cross three fields (bioethics and science policy, history/philosophy of science, and food studies), she is team leader of the ARC Discovery Project “Organisms and Us: How Living Things Help Us To Understand Our World.”

Inducement in research and lotteries – can a chance really be compensation?

A/Prof. David Hunter1

1Flinders University, Adelaide, Australia

The National Statement forbids the use of inducements to recruit research participants, but allows the appropriate compensation of participants for the time, inconvenience and out of pocket expenses involved in participating. One form of compensation that is commonly offered is a chance to win something. In this paper I will argue that this practice is more likely to function as an inducement than compensation and is unlikely to compensate participants for their involvement in research appropriately. Finally I will discuss whether the absolute prohibition of inducement in the National Statement is defensible.


Biography:

David teaches medical ethics at Flinders University Medical School and chairs their social and behavioral ethics committee. His background is in philosophy and his research interests include political philosophy, medical ethics and research ethics.

Ethics in personalised medicine research: Case study of an iPSC-based system for predicting individual treatment responses

Dr Mary Jean Walker1

1Monash University, Clayton, Australia, 2ARC Centre of Excellence for Electromaterials Science, Wollongong, Australia

Progress has recently been made into developing tissue cultures grown from induced pluripotent stem cells (iPSCs) suitable for testing how particular patients will respond to treatments. These would be of use in developing treatment regimens for conditions where multiple treatment options exist, but we lack definitive ways of telling which treatment will work best for which patient (e.g., schizophrenia, epilepsy). An iPSC tissue culture system could prevent patients from having to undergo sometimes significant periods of trialling various treatments before finding one that works for them. They could also provide data for individualising dosages.

Using iPSC cultures in this way is, we have argued elsewhere, a novel method of gaining knowledge for clinical practice, as it does not rely on the two traditional sources of evidence for predicting individual treatment responses (evidence about mechanisms and population-level correlational studies). Its novelty brings with it a number of unknowns, which raise practical and ethical questions. For instance, It is not clear what level of predictive certainty should be expected before results can be taken to direct clinical practice, and what sorts of studies should be used to test this. Candidate conditions for the system may have complex and contested subtype nosologies, implying potential variations in system reliability across patients, indicating the need for care in thinking through which patients are candidates for the system. Further, such a system does not clearly fit into current regulatory schemes, and decisions about their regulatory treatment could influence researcher decisions.

In this paper, we map the issues arising from the currently unique status of this method of predicting patient responses to treatment, with a view to developing a framework of ethical considerations for researchers working in this area.


Biography:

Mary Jean Walker is a Research Fellow at Monash University in Melbourne. She has research interests in bioethics, philosophy of medicine, health policy, and personal and narrative identity. In her current role she is researching ethical issues related to advanced medical devices and personalised medicine.

The need for ethics committees and evaluation agencies in coverage with evidence development: The case of crizotinib in Australia

Dr Drew Carter1, Ms Arlene Vogan1, Prof Tracy Merlin1

1Adelaide Health Technology Assessment, The University of Adelaide, Adelaide, Australia

In 2013 Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) requested a 30% price reduction from the pharmaceutical industry sponsor of crizotinib, a treatment for anaplastic lymphoma kinase-positive non-small cell lung cancer.  PBAC requested the price reduction after judging that the sponsor had over-estimated the effectiveness of the treatment.  The sponsor refused to reduce the price, so in 2014 PBAC and the sponsor agreed on a coverage-with-evidence-development (CED) arrangement.  The sponsor would collect and analyse data on a sub-set of Australian patients being treated with government-subsidised crizotinib in order to determine the effectiveness and cost-effectiveness of the treatment. Following analysis of this data, PBAC would recommend ongoing government subsidy but only at a price that was supported by the data.

The CED arrangement was innovative and testified to the feasibility of government and industry collaborating on CED in Australia.  But it also featured some problems.  In particular, we examine the following ethical issues.  Were patients aware that they could opt out of the evidence development?  Was an opt-out consent process ethically justified to begin with?  Were patients induced into participating in the evidence development?  Was the presence of any inducement ethically justified?  Who ought to have been recruiting patients into the evidence development?

We show that formal ethical review would solve a number of problems faced by CED arrangements.  We also show how engaging an independent body with relevant expertise in technology evaluation would enhance the ethical acceptability of CED arrangements.


Biography:

Drew Carter is a moral philosopher and health policy researcher. He applies insights made by Ludwig Wittgenstein to illuminate bioethical issues, especially relating to resource allocation.  He has published on assisted reproductive technology and pain.  His current research focusses on intensive care triage and the managed entry of health technologies.

Integrating Indigenous principles of human research ethics: The case of two Pacific Island Nations

Etivina Lovo1

1James Cook University, Townsville, Australia, 2Fiji National University, Suva, Fiji Islands

Principles of research bioethics are defined in the context of Western developed countries.  Understandings of Human Research Ethics (HRE) principles vary internationally which may be due to the influence of local beliefs and principles.  Indigenous Pacific Island researchers have experienced problems in human research activities because of these variations.

There seem to be two origins of HRE principles, internationally accepted principles that originated from developed countries and indigenous principles that originated from individual Pacific Island Nations.

Research activities within Pacific Island Nations are guided by internationally accepted principles that originated from developed countries.  Ethics committees govern HRE in countries accordingly.

The fundamentals of ethics in research in Pacific Island Nations have not been examined to identify important elements that can be used to strengthen human research and promote a high standard of HRE.  This is problematic because the protection of human participants in research is inadequate in the Pacific.

Although, human research has accelerated immensely in Pacific countries, HRE remains stagnant.   This PhD project proposes to conduct an in-depth investigation of the theoretical underpinning of indigenous and imported ethical principles that guide human research ethics activities in Fiji and Tonga.

A case study approach will employ qualitative methods of empirical inquiry which will allow in-depth assessment of HRE principles, Western and indigenous, and how they are applied in HRE activities in Fiji and Tonga.  A Fiji HRE Case Study and a Tonga HRE Case Study will be included. The case studies will identify priority setting processes and analyze the practices and views of HRE members and their affiliates that involve indigenous or foreign HRE principles.

The case studies will draw on a Critical Ethnographic theoretical perspective and framework to guide the PhD research project.


Biography:

Mrs Etivina Lovo was born in Tonga and now working in the Fiji National University.   Developing Pacific Ethics Education is her goal.

She teaches and conducts research in areas of Ethics & Governance, Research Bioethics and Medical Ethics.  She also serves in the Ethics Review Committee.   She developed a curriculum for a PG Certificate in Research Ethics, focusing on Pacific Islands.

Her qualifications include; BA Management and Psychology and Master of Public Health; University of the South Pacific.  Master of International Research Bioethics; Monash University, Australia.

She is currently a PhD candidate (Cotutelle), Fiji National University and James Cook University.

Stem cell registries: Collapsing the borders between research, commerce and clinical practice

A/Prof. Wendy Lipworth1, Dr Tereza Hendl,1 Prof Ian Kerridge,1,2 Assistant Professor Tamra Lysaght3, A/Prof Megan Munsie4, Catherine Waldby5, Prof Cameron Stewart6

1Sydney Health Ethics, University Of Sydney, University Of Sydney, Australia, 2Royal North Shore Hospital, Sydney, Australia, 3Centre for Biomedical Ethics, National University of Singapore,  Singapore, 4Centre for Stem Cell Systems, University of Melbourne, Melbourne, Australia, 5Research School of Social Sciences, ANU College of Arts and Social Sciences, Canberra, Australia, 6Sydney Law School, University of Sydney, Sydney, Australia

Background and Purpose: Clinical registries are databases that are used to monitor the “real world” outcomes of medical interventions. In recent years, the possibility of collecting registry data has been used to justify the introduction into practice of “unproven” uses of adult stem cells (e.g. to treat various degenerative diseases). While developing registries to gather data on unproven interventions may offer some value, there are signs that many of these registries have not been designed with the public interest in mind or to genuinely advance scientific knowledge. It is crucial, therefore, to find ways of distinguishing between legitimate registries and those that have been designed to serve the commercial interests of operators.

Method: We synthesised information about stem cell registries, examining their stated and implied purposes, methods and governance systems. We compared a well-established, publicly funded stem cell registry (the International Bone Marrow Transplant Registry) with smaller stem cell registries that are being established in the private sector.

Results: There are clear differences in how different registries are justified, managed, used and governed. Many privately funded registries are touted as alternatives—rather than as supplements—to robust clinical trials and are run in ways that are antithetical to the public interest and lack scientific rigour.

Discussion: Bioethicists need to focus on the impact of commercial imperatives on biomedical innovation so that a balance can be struck between promoting innovation and ensuring that that such innovation is beneficent and prudent.


Biography:

Wendy Lipworth is an Associate Professor of Bioethics at Sydney Health Ethics, University of Sydney. Her research focuses on the ethics of biomedical innovation, with a particular focus on 1) research using collections of tissue and data; access to “unproven” interventions; and 3) the conduct and influence of industry and (financial and non-financial) conflict of interest.

Research and people unable to give informed consent to participate. Should the NZ Code of Rights be changed?

Dr Cordelia Thomas1

1Health And Disability Commissioner, Wellington, New Zealand

In 2017 the Office of the Health and Disability Commissioner undertook a public consultation about  health and disability research involving adult consumers who are unable to consent to their participation in that research. Those consumers might, for example, be unconscious, or have significant cognitive impairments that prevent them from understanding the implications of the decision to participate. The existing law in New Zealand as set out in Right 7(4) of the Code of Health and Disability Services Consumers’ Rights (the Code) allows such studies to proceed if participation in the research is in the “best interests” of the individual.

The nature of research is that the purpose is not generally focused on individual benefit and in addition, outcomes are uncertain, so it is difficult to assess the potential risks and benefits for the proposed participants.

New Zealand law has a strong focus on the rights of consumers. The Code gives legally enforceable rights to all consumers of health and disability services, and places corresponding obligations on providers of those services.

It is difficult to decide where to draw the line regarding what research is appropriate if the participants are unable to give consent. Such people are particularly vulnerable to abuses of their rights and interests. However, research with such participants could lead to significant advances in the services and/or treatment provided to them or to other similar consumers in the future.

This presentation will discuss what was heard from the public and the matters considered by the Commissioner during the process of deciding whether change is required or appropriate.


Biography:

Dr Thomas has a PhD in law. She was a senior lecturer in law at Massey University then the senior legal advisor for the Bioethics Council. At HDC she has held a number of roles including Specialist Senior Legal Advisor, Acting Chief Legal Advisor, Investigations Manager and Associate Commissioner. She continues to teach Public Health Law and and is a member of the Central Health and Disability Ethics Committee. She is the author of textbooks and other publications.

Collapsing borders between researchers and participants: Ethical complexities

Dr Merle Spriggs, Lynn Gillam

1University Of Melbourne, Parkville, Australia, 2Murdoch Childrens Research Institute, Parkville, Australia

“I think our ethics committee had no idea what we were talking about … in retrospect I think, had no framework for ethical oversight of co-researchers … all of their feedback and responses and queries were for participants … I think there were a whole raft of ethical implications for the co-researchers that we didn’t really think about and the ethics committee didn’t know how to ask us about…” [Researcher]

Using research participants as co-researchers is a growing trend in social research in a range of research methodologies and research types such as participatory research and action research.  An example is participants collecting research data by interviewing other participants (sometimes referred to as peer-interviewing).  The role of the co-researcher may include accessing or recruiting other participants.

In this presentation, our focus is child co-research which has become popular in social research involving children. The popularity has been attributed to the emphasis on children’s rights.  It is a way of putting into practice the philosophy, common amongst childhood researchers, that children are experts on childhood.

Little attention, however, has been paid to ethical difficulties faced by child co-researchers.  There is little in the existing literature and there is nothing to guide Human Research Ethics Committees (HRECs) by identifying questions HRECs should be asking when faced with projects involving child co-researchers. This presentation addresses that gap by drawing on data from interviews we conducted with researchers who use co-research methodology.

We conclude with important questions for Human Research Ethics Committees to ask when they review projects using child co-research and questions for reflexive researchers to ask themselves when they use child co-research methodology.


Biography:

Dr Merle Spriggs is a Research Fellow at the Children’s Bioethics Centre, Royal Children’s Hospital and Melbourne School of Population and Global Health, University of Melbourne  and an Honorary Research Fellow at the Murdoch Childrens Research Institute. Her expertise is in the area of informed consent, patient autonomy, empirical ethics and the ethics of research practice. Merle has over 20 years experience on hospital and university Human Research Ethics Committees and has been retained by US law firms to review documents in a series of cases involving child research.

Beyond consent and anonymity in the big data era

Markus Labude1, Dr Vicki Xafis1, Dr Wendy Lipworth2, Dr Tamra Lysaght1, Dr Owen Schaefer1

1Centre for Biomedical Ethics, National University of Singapore, Singapore, Singapore, 2The University of Sydney, Sydney Health Ethics, Faculty of Medicine and Health, Sydney, Australia

The proposed workshop will explore the moral justifiability of waiving the requirement for informed consent for health research using existing “Big Data” resources (such as electronic health records, genomic databanks, pharmacovigilance surveillance systems and social media data). While consent waivers are often justified by the need to ensure the free flow of information and to further the ‘public good’, there is also concern that they fail to protect research participants and to respect individuals’ right to self-determination. Matters are made more complex by the impossibility—in the Big Data era—of promising that data will remain anonymous.

The workshop relates to the conference theme of Changing Paradigms with its exploration of alternatives to traditional informed consent models and it picks up the theme of Collapsing Borders with it discussion of how data from healthcare practice is used for research. The workshop will be convened under the auspices of an international Working Group of scholars from Singapore, Australia, New Zealand and the United Kingdom, which is developing a Framework for Big Data Ethics in Health and Research.


Biographies:

Vicki Xafis is a Senior Research Fellow at the Centre for Biomedical Ethics, National University of Singapore, leading the NMRC-funded SHAPES (Science, Health and Policy-relevant Ethics in Singapore) initiative. She has a background in bioethics, linguistics, education and research. Vicki has considerable professional expertise in research & clinical ethics and has recently moved to Singapore to join the SHAPES Team. In addition to interests in areas of clinical ethics, Vicki has an interest in big data ethics, privacy, consent, and research ethics.

Wendy Lipworth is an Associate Professor of Bioethics at Sydney Health Ethics at the University of Sydney. Her program of research focuses on the ethics and politics of biomedical innovation, with a particular focus on 1) research using databanks and real world evidence 2) access to “unproven” interventions and 3) commercialisation and (financial and non-financial) conflict of interest. She uses a combination of empirical and theoretical research methods understand stakeholders’ perspectives and contribute to policymaking and practice.

Owen Schaefer is a Research Assistant Professor at the Centre for Biomedical Ethics, National University of Singapore, working under the NMRC-funded SHAPES (Science, Health and Policy-relevant Ethics in Singapore) initiative. He received his DPhil in Philosophy from Oxford University, and has completed fellowships at the National Institutes of Health’s Department of Bioethics and the Oxford Centre for Neuroethics. His primary interests lie on the ethics of developing novel biomedical technologies.  He has written on big data, research ethics, the obligation to participate in research, human enhancement, gene testing and editing, assisted reproduction and in vitro meat.

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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.

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