Miles Little Annual Lecture 2018

The Miles Little Annual Lecture is hosted by Sydney Health Ethics, University of Sydney. It honours our inaugural Director, Professor Miles Little, who founded the Centre for Values, Ethics and the Law in Medicine (VELiM) in 1996. The centre was renamed Sydney Health Ethics in 2017. The annual lecture celebrates Professor Little’s significant and continuing contribution to scholarship in this area.

The 2018 Miles Little Annual Lecture will be given by Dr Bridget Haire:

Considering the impact of communities on research practice – the case of HIV

Across the globe, activism by communities affected by HIV has shaped research, policy and treatment. From ACT-UP die-ins in the 80s, through to the treatment access actions in the 90s and major sex worker led protests in the 2000s, HIV activism has presented an informed and often photogenic face to global media. In Australia and elsewhere, behind the attention-grabbing activist antics sat great networks of community-based collectives that gradually morphed into sober and respectable NGOs that provided care for the sick, health promotion to the potentially at risk and advice to government.

In this presentation I will consider some of the key lessons that AIDS has taught us about the role of communities in emergent infectious disease epidemics, drawing on my experiences as an HIV community sector worker turned bioethics researcher. I will argue that HIV has demonstrated how the involvement of affected communities is critical to ethical responses to infectious disease threats and provide examples from my colleagues in Nigeria about how this has been leveraged in the response to Ebola. I’ll finish with some reflections on funding community collaboration in research and health programming.

Dr Bridget Haire, Kirby Institute, UNSW

Photo of a person with a microphone on front of a small audience

Bridget Haire

Dr Bridget Haire is a senior research fellow at the Kirby Institute, University of NSW, where she conducts research in the areas of research ethics, public health and human rights, particularly with regard to HIV and other blood-borne infections and sexual health. She is the current President of the Australian Federation of AIDS Organisations (AFAO), the federation for the community-based response to HIV in Australia. Bridget has a strong commitment to community-based health responses and prior to academia was involved with HIV and sexual and reproductive rights for more than 20 years as an advocate, editor, journalist and policy analyst. She completed her masters and PhD at Sydney Health Ethics.

Wednesday 31 October 2018
12pm – 2pm
A light lunch will be served at the beginning of this event.

Footbridge Lecture Theatre
Holme Building A09
The University of Sydney
NSW 2006
View the location in Google Maps
RSVP: Registration is free, but essential by 20 October for catering purposes –

Whiteness as a bioethical problem — A Disorder of Things

Below is a link to a pdf of my keynote at the Australasian Association for Bioethics and Health Law conference in Townsville, 22nd-25th September, 2018. Link: Mayes_Whiteness_as_a_bioethical_problem_AABHL_2018 Abstract In March 2018 the Nursing and Midwifery Board of Australia (NMBA) released new editions of their codes of conduct, standards of practice, and code of ethics. […]

via Whiteness as a bioethical problem — A Disorder of Things

The Unspoken Limits of Liquid Biopsies

By Ainsley Newson

This article was originally published in Australasian Science and is reproduced with permission. It can be cited as Newson, A (2018) The Unspoken Limits of Liquid Biopsies. Australasian Science, 39(4): 49. Retrieved from:
Ainsley DNA-test

Photo of a test tube containing bubbles forming a double helix. Credit: Connect World/Amazon

Liquid biopsies promise early detection of cancer, but some of their current limitations risk being overlooked.

Many of the difficulties in efforts to reduce cancer incidence and deaths arise because we don’t yet have reliable ways to effectively identify, pinpoint and treat it in its early stages.

But what if there was a blood test that could pick up a range of early cancers, show where tumours might be and suggest the best treatment? Sounds amazing, doesn’t it?

The exciting thing is that researchers are making some headway in identifying cancer-specific DNA sequences and proteins from blood samples: a so-called “liquid biopsy”.

The technology is based on the knowledge that cancer tumours shed mutated DNA. If an over-abundance of certain DNA sequences is detected in our blood, this suggests there could be a tumour. The hope is that one day there will be a single blood test that could be used to routinely screen anyone in the population.

One study published in Science in January showed promising results, including a false-positive rate (where a healthy person’s sample erroneously suggests cancer) of less than 1%. But because we don’t yet know enough about the required DNA markers, it was better at detecting some cancers (such as ovarian cancer) than others (such as breast cancer). This work is now being extended to a bigger trial.

It’s a lucrative area with a potentially enormous market. There is significant start-up funding being invested, and even more media hype. A US company even took a test to market a couple of years ago, although this was swiftly met with a stern warning letter from the US Food and Drug Administration.

But let’s not get ahead of ourselves. As the authors of another review paper pointed out in March, this test is by no means ready for population-wide roll-out. And even if we get to the point of a fantastic test that correctly identifies and pinpoints tumours within all scientifically important parameters, these may not necessarily be cancers that need to be found. Liquid biopsy could suffer the same problem that befalls many current cancerscreening technologies: while we are getting much better at finding tumours, we are much less good at working out which ones need to be treated and which can be left alone.

Overdiagnosis is said to occur when a test or screen makes a true finding (i.e. not a false-positive) but whatever was identified never needed to be found because it would not have developed further. Conversations about overdiagnosis following cancer screening are not easy. If we hear the word “cancer” our (understandable) reaction is to want it gone immediately.

However, overdiagnosis causes problems because people are given treatments that they don’t need, including treatments that cause harm and cost the health care system money (which in turn impacts access to care down the line). But, it is often hard to tell in advance who needs treatment and who doesn’t.

Overdiagnosis is being talked about by some commentators on liquid biopsy, but it’s notable in its absence from exuberant media releases extolling progress in liquid biopsy research. Some also think it’s their right to demand access to unproven tests or treatments, and see any move to prevent this as medical paternalism or denial of treatment. Yet those responsibly for publicly funded health care are likely to want greater reassurance before committing resources. At the same time, it is terrible when a progressive cancer is missed in a patient when the prognosis would have been better if it was found and treated early.

As a DNA-based technology, and given the significant hype that currently surrounds all things genetic, liquid biopsy may give populations a false sense of security. Its perceived precision may make public conversations about overdiagnosis difficult. We are conditioned to seek information rather than not, we search for our own health information online, and are usually keener to do something rather than “watch and wait”.

How good should a test be before it is introduced to the wider population? Should we discuss not testing? For how long should we measure patient outcomes before rolling a test out to healthy people in a world increasingly less willing to wait? Should we discuss not intervening?

Liquid biopsy won’t give us these answers, but the questions are sure to come around soon.


Ainsley Newson is Associate Professor of Bioethics and Deputy Director of Sydney Health Ethics at the University of Sydney.

‘Except as required by law’: Australian researchers’ legal rights and obligations regarding participant confidentiality

Anna Olsen, Research School of Population Health, ANU

Julie Mooney-Somers, Centre for Values, Ethics and the Law in Medicine, University of Sydney

*Neither of us are lawyers and, as such, our interpretations are as social scientists and HREC members. Interested lawyers and legal scholars are encouraged to contribute!

Researchers’ promises of confidentiality are often easily and genuinely made. However, our experience in research ethics review (Julie through an NGO-run ethics review committee; Anna through formally constituted university and hospital human research ethics committees), in qualitative research and in teaching qualitative research ethics has led us to think about the limits of these promises.

Australian researchers generally rely on the National Statement (National Health and Medical Research Council, 2015) and Human Research Ethics Committees (HRECs) for guidance around ethical and legal conduct in research. For example, Chapter 4.6 in the National Statement notes that researchers may discover illegal activity and guides researchers and HRECs to consider what researchers might be obliged to disclose in a legal situation and how to best protect (and inform) participants of this threat to confidentiality.

The National Statement is currently under revision (National Health and Medical Research Council, 2016) and the review submitted for public consultation in late-2016 contains a proposal to include additional information on “Disclosure to third parties of findings or results” in Section 3 of the National Statement. Here the NHMRC explicitly state that: “There can be situations where researchers have a legal, contractual or professional obligation to divulge findings or results to third parties”. That is, researchers should concern themselves not only with the legal implications of revealing potential illegal activity, but any instance in which they may be asked to break participant confidentiality.

The recent review of the National Statement extends the NHMRC recommendations around potential data disclosure in a number of ways: it makes much more explicit that researchers (as opposed to HRECs or institutions) are responsible for understanding the risks to patient confidentiality: “researchers should be aware of situations where a court, law enforcement agency or regulator may seek to compel the release of findings or results”. Researchers are expected to anticipate legal risks to participant confidentiality by: identifying “(a) whether, to whom and under what circumstances the findings or results will be disclosed; (b) whether potential participants will be forewarned that there may be such a disclosure; (c) the risks associated with such a disclosure and how they will be managed; and (d) the rationale for communicating and/or withholding the findings or results and the relative benefits and/or risks to participants of disclosure/non-disclosure”. And, researchers should advise participants on legal risks to confidentiality and how they will be handled: “(a) have a strategy in place to address this possibility; (b) advise participants of the potential for this to occur; and (c) advise participants as to how the situation will be managed”.

For many researchers in health, legal risks are a very vague reality and legal intervention a remote threat. They may feel confident that their research does not and will not uncover illegal activity, or that their data would simply be irrelevant to a legal case. Or they may feel confident that they have taken sufficient steps to protect their participants’ confidentiality by following guidelines; researchers working in illicit drug use, for example.

Many Australian HRECs articulate the NHMRC guidelines on legal risks of disclosure to third parties by requiring that researchers inform participants that any data collected during research will kept confidential, “except as required by law”. In keeping with the ethical concept of informed consent, participants are thereby warned that researchers are not able to unconditionally offer confidentially. It has become clear to us that the intention of this phrase, to flag the legal limits of confidentiality, is not well understood by researchers (Olsen & Mooney-Somers, 2014).

The National Statement details some aspects of human research that is subject to specific statutory regulation however stresses that compliance with legal obligations is not within the scope of the National Statement: “It is the responsibility of institutions and researchers to be aware of both general and specific legal requirements, wherever relevant”. Moreover, in the document we are directed that it is not the role of a HREC to provide legal advice. It is relatively rare for Australian HRECs to provide explicit guidance on the relevant legal obligations for researchers, including: how they differ across jurisdictions; what protective strategies researchers could employ to better protect patient confidentiality; or how to best inform participants about the risks of legal action (Some useful HREC-produced resources are Alfred Hospital Ethics Committee, 2010; QUT Office of Research Ethics and Integrity, 2016) Criminology scholars have (unsurprisingly) considered these issues in their own field (Chalmers & Israel. 2005; Israel, 2004; Israel & Gelsthorpe, 2017; Palys & Lowman, 2014).

We believe there are real risks to participants, researchers and research institutions.

Recent international cases of research dealing with illegal activity becoming subject to legal action include The Belfast Project/The Boston Tapes (BBC News, 2014; Emmerich, 2016; Israel, 2014) and Bradley Garrett’s ethnographic work with urban explorers (Fish, 2014; Times Higher Education, 2014) (See also Israel & Gelsthorpe, 2017). On the whole, legal action was anticipatable in these cases as they involved illicit activities and the legal action was driven by law enforcement interest. In some instances, researchers took extensive steps to protect participant confidentiality. In other cases the promise of absolute confidentiality seems a little naïve (and in our opinion, perhaps negligent).

Perhaps of more concern are cases in which legal action was instigated by interested others, not law enforcement. Of particular interest to us are recent cases of tobacco companies using Freedom of Information laws in Australia to obtain research data from Cancer Council Victoria on young people’s attitudes to and use of tobacco, and an earlier attempt to seek data on adults from Cancer Council NSW (McKenzie & Baker, 2015; Schetzer & Medew, 2015). As these cases do not involve illegal activity, it is much less likely that researchers could have anticipated the specific legal actions that undermined participant confidentiality. (The tobacco industry has taken these actions in other countries (Hastings, 2015; McMurtrie, 2002)).

Our point here is that the promise of confidentiality should never be casually made. Researchers have an ethical obligation to think through what “except as required by law” may mean for each particular research project. Although it has been argued elsewhere that as professionals, researchers should be provided the same participant confidentiality rights as doctors and lawyers (Emmerich, 2016), the current state of affairs is that research data is not (necessarily) safe from legal, contractual or professional obligation to divulge findings or results to third parties.


Alfred Hospital Ethics Committee. (2010, Updated September 2016). Alfred Hospital ethics committee guidelines: Research that potentially involves legal risks for participants and researchers. Retrieved from

BBC News. (1 May 2014). What are the Boston tapes? Retrieved from

Chalmers, R., & Israel, M. (2005). Caring for Data: Law, Professional Codes and the Negotiation of Confidentiality in Australian Criminological Research. Retrieved from

Emmerich, N. (9 December 2016). Why researchers should get the same client confidentiality as doctors. Retrieved from

Fish, A. (23 May 2014). Urban geographer’s brush with the law risks sending cold chill through social science. Retrieved from

Hastings, G. (31 August 2015). We got an FOI request from Big Tobacco – here’s how it went. Retrieved from

Israel, M. (2004). Strictly confidential? Integrity and the disclosure of criminological and socio-legal research. British Journal of Criminology, 44(5), 715-740.

Israel, M. (6 May 2014). Gerry Adams arrest: when is it right for academics to hand over information to the courts? Retrieved from

Israel, M., & Gelsthorpe, L. (2017). Ethics in Criminological Research: A Powerful Force, or a Force for the Powerful? . In M. Cowburn, L. Gelsthorpe, & A. Wahidin (Eds.), Research Ethics in Criminology and Criminal Justice: Politics, Dilemmas, Issues and Solutions. London: Routledge.

McKenzie, N., & Baker, R. (15 August 2015). Tobacco company wants schools survey for insights into children and teens. The Age. Retrieved from

McMurtrie, B. (8 February 2002). Tobacco companies seek university documents. Chronicle of Higher Education. Retrieved from

National Health and Medical Research Council. (2015). National Statement on Ethical Conduct in Human Research (2007) Retrieved from

National Health and Medical Research Council. (2016). Public consultation on Section 3 (chapters 3.1 & 3.5), Glossary and Revisions to Section 5: National Statement on Ethical Conduct in Human Research (2007). Retrieved from

Olsen, A., & Mooney-Somers, J. (2014). Is there a problem with the status quo? Debating the need for standalone ethical guidelines for research with people who use alcohol and other drugs. Drug Alcohol Rev, 33(6), 637-642. doi:10.1111/dar.12140

Palys, T., & Lowman, J. (2014). Protecting research confidentiality: What happens when law and ethics collide. Toronto: Lorimer.

QUT Office of Research Ethics and Integrity. (10 Novembeer 2016). Participants and illegal activities. Retrieved from

Schetzer, A., & Medew, J. (20 August 2015). Cancer Council spends thousands fighting big tobacco over children’s survey data. The Sydney Morning Herald. Retrieved from

Times Higher Education. (5 June 2014). Place-hacker Bradley Garrett: research at the edge of the law. Retrieved from


Anna Olsen is a Senior Lecturer at the Research School of Population Health, Australian National University. She leads a number of qualitative and mixed methods public health research projects, teaches qualitative research methods and supervises post-graduate students. Dr Olsen is an experienced member of formally constituted university and hospital human research ethics committees.

Julie Mooney-Somers is a Senior Lecturer in Qualitative Research in the Centre for Values, Ethics and the Law in Medicine, University of Sydney. She is the director of the Masters of Qualitative Health Research at the University of Sydney. An experienced qualitative researcher, teacher and supervisor, she has taught qualitative research ethics and sat on a NGO-run ethics review committee for six years. and

This article was originally published on Research Ethics Monthly. Read the original article.

This post may be cited as:
Olsen A, and Mooney-Somers J. (2017, 24 February) ‘Except as required by law’: Australian researchers’ legal rights and obligations regarding participant confidentiality. Research Ethics Monthly. Retrieved from:

Don’t dismiss conflict-of-interest concerns in IVF, they have a basis

It’s estimated over 5 million children have been born worldwide as a result of assisted reproductive technology treatments. Assisted reproductive technology, an umbrella term that includes in vitro fertilisation (IVF), is a highly profitable global industry, and fertility clinics are increasingly regarded as an attractive investment option.

In 2014, two major IVF clinics – Virtus and Monash IVF — floated on the stock exchange. Excited financial analysts observed at the time that:

people will pay almost anything to have a baby.

Over the past 12 months, there have been numerous critical media analyses of the IVF industry in Australia, including Monday night’s ABC Four Corners program, The Baby Business. The episode suggested IVF doctors are recommending treatments that are expensive, unsafe and likely to be futile.

The following morning the Fertility Society of Australia rejected these assertions, saying:

Four Corners presented no evidence to support these claims.

One of the claims made in the program was that IVF doctors have a financial incentive to treat women with the more invasive practice of IVF. The program suggested this financial incentive conflicts with the doctor’s duty of care towards the patient.

Four Corners highlighted the conflicted nature of commercialised IVF, where some IVF doctors are more concerned about their own interests (making money for themselves or their clinics) than they are about their patients.

Not surprisingly, the Fertility Society of Australia strongly denied such conflicts of interest exist. It argued that the profession is both highly ethical and highly regulated.

Why might doctors be conflicted?

While it is certainly a big call to claim some IVF doctors may not be sufficiently committed to their patients, the possibility that practice is being shaped — at least in part — by conflict of interest cannot simply be dismissed. There are three key reasons individuals working in the IVF industry, and the industry more broadly, may be perceived to be conflicted.

First, every time a doctor advises patients to consider IVF treatment, he or she profits financially from the recommendation. While all Australian doctors receive fees for their services, many IVF doctors also own shares in assisted reproductive technology companies, so they receive passive income that reflects the amount of assisted reproductive technology the company sells.

It is also worth noting that, as employees of publicly listed companies, doctors at clinics such as Monash IVF, according to their code of conduct, must:

recognise that (their) primary responsibility is to the Company and its shareholders as a whole.

It is therefore not unreasonable for people to be concerned some clinicians may be motivated (perhaps unconsciously) by financial conflicts of interest to make decisions that may not be in the best interests of their patients.

Second, there appears to be a lack of transparency about IVF success rates. Success, as measured by a live birth, is very dependent on age and the reason for seeking assistance.

In the youngest age bracket in Australia and New Zealand in 2013, the live birth per cycle rate was 27%. In the oldest it was between 1% and 5%, depending on whether a fresh or frozen egg was used. It is more likely that a cycle will result in failure than not, and some argue there is a lack of transparency about the likelihood of a live birth.

Even in the youngest age bracket, in Australia and New Zealand in 2013 the live birth per cycle rate was just 27%

A striking example of this was seen on Four Corners when Dr Gab Kovacs, ex-medical director of Monash IVF, claimed:

I know that if you hang in there you get pregnant, because one of my patients got pregnant after 37 cycles. And, ah, so I encourage people to stay on.

While it is quite possible this woman made a fully informed decision to undergo this number of cycles, Dr Kovacs’ subsequent claim that he couldn’t say “no” and had no choice but to continue to offer the woman what she wanted inevitably makes one wonder what she knew about her real chances of success.

A third reason for concern about conflicts of interest, and one that might distinguish conflicts of interest in IVF from those in other medical settings, is the potential for exploitation of strong personal and social values associated with reproduction.

A strong discourse of hope runs through the IVF industry, and people seeking assisted reproductive technology are often very vulnerable. The profit motive of these companies has the potential to exploit these cultural norms and social pressures for ends that are not necessarily in the best interest of patients.

There are now two positions being taken: by those who consider some IVF practices are exploitative and unethical, and by those who consider that conflicts of interest are inherent in medical practice and are sufficiently well managed.

Rather than simply dismissing concerns about conflicts of interest, as the Fertility Society of Australia has just done, IVF specialists, ethicists and other stakeholders need to create a forum in which these concerns can be discussed openly and constructively.

The Conversation

Jane Williams, Doctoral student at the Centre for Values, Ethics and the Law in Medicine (VELiM), University of Sydney; Brette Blakely, Post-Doctoral Research Fellow; Christopher Mayes, Post-Doctoral Fellow in Bioethics, University of Sydney, and Wendy Lipworth, Senior Research Fellow, Bioethics, University of Sydney

This article was originally published on The Conversation. Read the original article.

What should we eat?

Answers to this simple question often appeal to science. Nutrition science, we are told, can tell us what we should or shouldn’t eat if we want to be healthy, fit and prevent disease. But are these appeals to nutrition science legitimate? We think in many cases the answer is “no”.

Some of the most egregious offenders misusing nutritional science are listicles – “10 Unbelievable Diet Rules Backed By Science,” the “14 Things You Should Never Eat,” or “10 Foods Science Says Are Healthier For Your Hair.” But even more legitimate sources of advice can be prone to misuse science and are guilty of what we label nutritional scientism.

In a recent article in the Journal of Bioethical Inquiry we critiqued three types of nutritional scientism: (1) the oversimplification of complex science (including suggesting causation from probabilistic conclusions from observational studies) to increase the persuasiveness of dietary guidance, (2) superficial and honorific references to science in order to justify cultural or ideological views about food and health, and (3) the presumption that nutritional value is the primary value of food. We discuss the first and third of these here.


Widespread concern over diet-related chronic diseases partly explains the appeal of nutritional scientism. We want to give and receive clear dietary guidance. We want to know how diets affect our health and use that knowledge to control and prevent disease. However, the relationship among food, health and chronic disease is complex.

Diet and Causality

While scientific knowledge about the relationship between diet and chronic disease is unclear, scientific knowledge of nutrition has led to improved health dramatically with respect to nutritional deficiency diseases. For example, the relationship between dietary vitamin C and scurvy is causatively simple.  Vitamin C is an essential nutrient for all humans. If someone eats a diet that does not contain sufficient amount of Vitamin C for long enough, they will contract the deficiency disease. For nutrient deficiency, cause has a direct, non-probabilistic meaning, in the sense that if I hit my hand with a hammer, I will cause it to hurt every time.

The success of nutritional science in addressing problems of nutrient-deficiency disease might be so impressive that the aura of scientific success is extended to nutrition and chronic diseases, which are far more complex phenomena.

Chronic diseases are considered to be multifactorial.  Unlike nutrient-deficiency diseases, the meaning of causation for chronic disease is harder to understand, and thus establishment of causation is a far trickier problem.  Factors are understood in the mathematical sense, not as causes but as elements in a mathematical model.  Not everyone for whom factors are in place will get the disease, and not everyone for whom none of the factors apply can be assured of not getting the disease.  The evidence is fundamentally probabilistic, concerned with differential risk (population-level incidence) associated with the factors in the model.

Oversimplified dietary guidance may suggest that the relationship between the food and health status is more simply deterministic, an oversimplification of a highly complex situation.  Black and white dietary advice, for example to “never eat sugar” or “always avoid a particular food,” is a gross oversimplification. Invoking the science to justify oversimplified recommendations is our first form of scientism.  There are times when oversimplified recommendations are couched as a moral responsibility of the individual.

Food and diet, more than nutritional value

A second problem with nutritional scientism is that it reduces the value of food to the way it contributes to a biomedical model of health. This excludes of other values, such as pleasure, identity or culture. If we think of health more broadly, as the World Health Organization does, nutritional scientism is exposed as having a limited  understanding of the relationship between food and health.  In contrast to a focus on the biomedical model, the WHO defines health as a ‘state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity’. If health is broadly considered as social wellbeing, rather than narrowly defined as biomedical, it can be argued that an inordinate reduction of food to nutritional value is likely to be undesirable as it leads to the exclusion of values that are significant for identity, belonging, and wellbeing.

Food is central to bodily survival and nutritional health, but it is also essential for human flourishing through communal relations, religious rites, personal milestones, cultural festivals and a wide variety of everyday interactions that contribute to human well-being. When scientific understandings of food, diet, and cuisine become the dominant or exclusive mode of understanding of food and diet, the label of nutritional scientism is again warranted.

Nutrition science properly contributes to answering the question—“What should we eat?”—but its contribution should be placed in the larger context of a plurality of values that include culture, ethics, pleasure, and well-being.

By Christopher Mayes and Donald Thompson

Why I always get an ISBN for my research reports

Julie Mooney-Somers

Mooney-Somers, J, Erick, W, Brockman, D, Scott, R. & Maher, L (2008). Indigenous Resiliency Project Participatory Action Research Component: A report on the Research Training and Development Workshop, Townsville, February 2008. National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, NSW. ISBN: 978 0 7334 2647 6.

See that bit at the end, that’s my first ISBN. I can’t recall where I got the notion from, and I wonder now at my presumptuousness. I don’t think it was standard practice in my research centre to get ISBNs for research reports. But I had just come out of a horrid job that I’d stayed put in to get publications (it didn’t really work). I was in a new job and determined to get as much on my CV as I could. The first output was a report on a training workshop. I was thoroughly engrossed…

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