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.


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.

How compliant are dental practice Facebook pages with Australian health care advertising regulations? A Netnographic review

Dr Alexander Holden1

1The University of Sydney, Milsons Point, Australia

Background:The National Law that regulates the dental and other health care professions in Australia sets out regulations that dictate how dental practices are to advertise. This study examines the extent to which the profession complies with these regulations and the potential impact that advertising may have upon professionalism.Methods:A Facebook search of 38 local government areas in Sydney, New South Wales, was carried out to identify dental practices that had pages on this social media site. A framework for assessment of compliance was developed using the regulatory guidelines and was used to conduct a netnographic review.Results:Two hundred and sixty-six practice pages were identified from across the 38 regions. Of these pages, 71.05%were in breach of the National Law in their use of testimonials, 5.26% displayed misleading or false information,4.14% displayed offers that had no clear terms and conditions or had inexact pricing, 19.55% had pictures or text that was likely to create unrealistic expectations of treatment benefit and 16.92% encouraged the indiscriminate and unnecessary utilization of health services.Conclusions:This study found that compliance with the National Law by the Facebook pages surveyed was poor.


Alexander Holden graduated with a Bachelor of Dental Surgery from the University of Sheffield in 2011 and worked in public and private dental care in the UK, before moving to Australia in 2015. He has gained Masters degrees in law and dental public health. Alexander is registered to practice as a dentist in both the UK and Australia. Alexander is currently responsible for teaching within the Discipline of Professional Practice in the School. This area covers ethics, law, professionalism and communications as applied to dental practice. He is also actively engaged in clinical practice, as well as clinical teaching.

The use of coercive public health and human biosecurity law in Australia: An empirical analysis

Dr David J. Carter1

1Law | Health | Justice Research Centre, Faculty Of Law University Of Technology Sydney, Broadway , Australia

The powers available to the state in the name of advancing or protecting the public’s health or human biosecurity are extensive and highly elastic. These powers include disease surveillance; the power to compel provision of information; the monitoring, prohibiting or compelling of particular behaviours; involuntary social distancing measures including detention, isolation and quarantine; and, finally involuntary medical testing and treatment.

Drawing on the findings of an empirical project on the use of public health and human biosecurity law in Australia, this paper provides the first comprehensive account of the use of these coercive public health powers by Australian state and territory governments and their public health apparatus.

The overarching claim made by this article is that the use of coercive public health and biosecurity legal powers in Australia is active but not currently accompanied by sufficient transparency or public accountability for their use. Moreover, the research reported here reveals some serious concerns about the use of these powers. This includes, amongst other things, evidence of the indefinite detention of multiple individuals by public health authorities, public health orders made without time limits and never rescinded, and the practice of ‘pre-emptive’ warrants issued for the arrest and detention of individuals who had not yet failed to report for isolation and thus had not absconded.

This research reveal a pronounced resistance to disclosing the use of these powers by a number of jurisdictions and a failure to maintain adequate records of their use by others.  This lack of publicly available information must be rebalanced in light of the strong public interest arguments for transparency and accountability.


David Carter is a lecturer in the Faculty of Law at the University of Technology Sydney where he focuses on the legal, regulatory and governance challenges involved in the delivery of safe, effective and sustainable healthcare services. At present, he teaches and writes on the regulatory practice of health law, public health law and criminal law, applying theoretical and empirical methods in aid of advancing legal and regulatory strategies for reducing the burden of healthcare-related harm and death.

Bringing the old into the new: the integration of traditional health knowledge perspectives into modern health law

Dr Jon Wardle1

1University Of Technology Sydney, Ultimo, Australia

International regulatory and legislative developments are increasingly acknowledging traditional health knowledge – evidence based not on scientific methods but on longstanding traditions of use. For example: the World Intellectual Property Organization has developed an extensive body of work promoting recognition of the validity of traditional knowledge globally, including explicit work on traditional health; UNESCO’s Convention on the Protection and Promotion of the Diversity of Cultural Expression extends its recommendations to traditional health approaches; Traditional medicine terminology is now incorporated into the most recent  International Classification of Diseases update; and the World Health Organization has developed a raft of recommendations that member states incorporate traditional medical knowledge into healthcare delivery and into regulatory systems. Case law in Australia and internationally increasingly acknowledges traditional health knowledge: traditional health knowledge can be sufficient in-and-of itself in some instances and need not be assessed in accordance with medical standards; and breaching traditional medicine norms has been held to be the same as misrepresenting scientific health claims. These developments bring opportunities for the recognition of rich healing traditions into modern regulatory and legal settings, but implementation can often be controversial, as recent controversy around inclusion of approved traditional claims in Australian therapeutic goods legislation reforms demonstrates. Increased legal and regulatory recognition of traditional health knowledge also brings unique challenges – such as lack of evidence standards for traditional use, or lack of protection for intellectual property owners against misappropriation of their traditional health knowledge. This presentation examines national and international developments in legal and regulatory mechanisms acknowledging traditional health knowledge, and examines their effectiveness at upholding their stated aims of improving standards and protecting the public. This presentation also discusses safeguard mechanisms required to ensure that increased incorporation and recognition of traditional health knowledge does not result in more established forms of evidence becoming compromised.


Jon Wardle is a Senior Lecturer and NHMRC Research Fellow in Public Health at the Faculty of Health, University of Technology Sydney. Jon is also Head of the Regulatory, Policy and Legislative Stream at the Australian Research Centre in Complementary and Integrative Medicine. Jon has clinical backgrounds in nursing and naturopathy, and postgraduate qualifications in public health, and health and medical law. Jon’s research interests focus on the impact of unconventional, unorthodox and unproven health care approaches on global health care systems, and the regulatory, legislative and policy protections that protect the public in this area.

A proposal for recognising semen as a special class of property

Benjamin Hofmann1

1Law Graduate, Melbourne, Australia

This presentation will focus on the proprietary rights in semen, particularly in relation to artificially assisted human conception that is conducted posthumously. Presently, these rights arise due to exceptions to the long-standing legal rule that there is ‘no property in the human body/a corpse’. The contention is that with the evolution of assisted reproductive technology, the law must also evolve.

The presentation will begin by outlining the two types of posthumous reproduction cases: first, the ‘usual’ type of case involving the death of the gamete provider after extraction (ie: semen in storage) but before the use of the gametes; and second, the increasingly common type of case involving posthumous extraction with the intention of using the semen for artificially assisted conception. The former has led to the generally accepted position that some proprietary rights must exist in stored semen and that those rights can transfer upon the provider’s death. The latter, however, present the relatively novel situation of the creation of proprietary rights when they first vest in the intended beneficiary.

The presentation will consider the recent case law, and it will assert that the successive court decisions recognise the existence of rights in semen in this context, albeit through the use of exceptions to the ‘no property’ rule.

The presentation will ultimately contend that the law must instead adopt a commonsense approach: to recognise the existence of a special class of property in semen, thereby foregoing the need to identify a relevant exception to an historic rule that is merely a legal fiction in this context.


Benjamin Hofmann completed an LLB at the University of New England in 2017, and he is currently completing a Graduate Diploma in Legal Practice at The College of Law. Benjamin’s research interests relate to beginning of life issues.

The missing link: Legal education and active involvement by doctors in the medical negligence claims process as tools to reduce medical error and patient harm

Dr Tina Popa1Fiona Milnes2

1RMIT University, Melbourne, Australia, 2RMIT University, Melbourne, Australia

Medical negligence claims arise when a medical practitioner has breached their duty of care and that breach has caused injury to the patient. Despite emphasis on open disclosure and continuing legal education, extant literature suggests that medical practitioners have little knowledge of the legal consequences of medical error and are rarely involved in the dispute resolution process following negligence. When a medical negligence claim is instigated, the parties are encouraged to partake in mediation pursuant to statutory civil procedure requirements. Mediation is an opportunity for practitioners to participate in the dispute resolution process which allows them to learn from the medical error, ascertain how the alleged negligence can be avoided in the future and thus promote best practice. Yet doctors rarely participate in mediation, with this role subrogated by the insurance representative. The purpose of this paper is to evaluate the opportunity and need for medical practitioners to have mandatory legal education in negligence, designed as a tool to mitigate the risk of medical errors and patient harm. This paper draws on a 2016 qualitative study with interviews with 24 senior tort lawyers specialising in medical negligence. The majority of participants stated that doctors’ involvement in dispute resolution following medical error is severely limited. Whilst medical indemnity reform has provided industry stability and imposed caps on compensation, there is an opportunity to educate practitioners to better understand negligence liability and encourage active participation in the mediation process. The authors propose mandatory legal education for medical practitioners and active involvement by doctors in dispute resolution processes. Ultimately such reform may reduce the risk of medical error and can encourage implementation of ‘best practice’ protocol to benefit healthcare more broadly.


Tina Popa is a law lecturer at RMIT University, researching in medical law, tort law and alternative dispute resolution. Tina’s doctoral research explored the challenges in litigation and mediation of medical negligence disputes from the perspective of medical negligence lawyers. Tina is passionate about legal issues in medical negligence compensation and rights of patients, regulation of human embryo research and health practitioner regulation.

Fiona Milnes is a Juris Doctor Candidate at RMIT University with an interest in medical negligence, which stems from her career in the healthcare industry of over fifteen years.  Passionate about best patient outcomes, her global experience, coupled with an education in science, business and law, has identified an opportunity for the healthcare industry to be proactive rather than reactive in the area of medical negligence.

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.


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.


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.


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.

Remember when health ethics seemed simple

A/Prof. Clare Delany1

1Children’s Bioethics Centre, Royal Children’s Hospital, Melbourne , West Brunswick , Australia

In simpler times (1767), doctors informed patients so they could take courage for whatever the doctor deemed necessary.  Doctors’ ethical obligations seemed simple; decide necessary and appropriate treatment and administer it. Patients’ separate or differing values were a likely hindrance to good care.  This was especially so for children, where clinical goals trumped all other interests.

‘Taking courage’ was overtaken in 1914 by the more enlightened view that patients should determine what is done to their body.  But even with this progress, the decision-making, mode of communicating and overall authority remained clearly and simply, with and determined by the doctor.

Fast forward to 2018. Children have rights and interests.  Parents have moral authority to decide what is best for their child.  A clinician’s advice concerning treatment is now only one component of the information informing parents and children. Social media, crowdfunding and “dr google” make ethical responses by doctors anything but simple.  The discharge by doctors of their ethical roles and obligations can only be described as complex. Some question whether doctors are needed at all.  In this talk I discuss how ethical goals and standards developed for simpler times might be used for today’s complex times.


Associate Professor Clare Delany, PhD, Master Hlth and Med Law, Master of Physio, BApp Sci (Physio)

Clare Delany is a clinical ethicist at the Royal Children’s Hospital Children’s Bioethics Centre in Melbourne.  She is also an Associate Professor at the University of Melbourne, Department of Medical Education, where she is responsible for coordination of research higher degrees and the masters year of the EXCITE (Excellence in Clinical Teaching) program. Clare is Chair of the University of Melbourne ‘Education, Fine Arts, Music and Business’ Human Research Ethics Committee.  Clare’s research expertise is in the area of qualitative methodology and methods and this is applied across broad subject areas of clinical ethics, clinical education and paediatric bioethics.


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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