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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Embedding clinical research as part of routine healthcare: Managing the potential for competing interests.0

 

Nik Zeps
AHRECS Consultant

 

Clinical trials are widely accepted as the best method for understanding whether any particular medical intervention is safe, efficacious, acceptable to patients and cost-effective. Almost every Health Service in Australia runs clinical trials of one sort or another. Enrolment of patients (in this instance they are all patients and not healthy volunteers) into clinical trials through health services operates as a separate activity to routine health care delivery and is managed through its own governance processes rather than as a part of clinical governance. This is widely recognised to be necessary but is unfortunately inefficient, duplicative in many instances, has a lack of objectivity and as a result of poor resourcing and training, is often slow and regarded as problematic by the research community. Sadly, there is a fairly widespread view amongst researchers that Research Governance is a bureaucratic hurdle rather than a means to ensure their research will be safe, quality work, be well managed and have significant impact.

One of the problems with the current system is that it treats all clinical trials as a single category rather than recognising the profound differences between trials that are seeking to establish new evidence for experimental therapeutics and those that are comparing existing therapeutic interventions (so-called Comparative Effectiveness Trials-CETs). It is clear that the risks of being enrolled in a CET are likely to be less than if being enrolled in a trial involving an unapproved therapeutic. Indeed many patients expect clinicians to deliver evidence based care, rather than practice variation, which can only elicited from high quality CETs  However, it is also true that if a person is randomised into the standard-of-care control arm of a trial of an unapproved therapeutic is at no greater risk than if they were not in the trial. Indeed, there is a broad range of evidence that participation in trials has an overall benefit in terms of safety and outcomes even for the control arms so one could argue that being in trial is by and large better than not being in a trial. It is also widely believed that the act of randomisation, the key feature underlying the power of clinical trials, is in itself risky and lifts any trial into a category that requires careful management. The National Statement does not make any such comment about risk related to randomisation and this view is one of subjective convention rather than one based on any proper assessment of risk.

Another feature of managing clinical trials is ensuring that potential participants are given appropriate information free of any coercion or inducements so that they can make a completely autonomous and sufficiently informed decision to participate or not. To ensure this a great deal of time and attention is paid to reviewing increasingly lengthy and complicated Participant Information Sheets and Consent forms (PICFs). In contrast almost no meaningful time is spent on evaluating the skills of the team in providing the information and being able to answer questions in a manner that ensures there is no coercive or inducive behaviour. Moreover, to my knowledge, no HREC has ever sent observers to audit how a participant is recruited, whether consumer input was sought in the development of the enrolment strategy or to evaluate notes taken as part of the consent process. This would appear to be the more important component of understanding whether the ethical issues arising from enrolling participants in a trial are being met.

Another area of research governance in need of an overhaul is a proper evaluation of the competing interests involved in running clinical trials in the first place. The term ‘conflict of interest’ is problematic in itself because it inherently assumes a negative position rather than recognising that instead there are legitimate instances of competing interests that have to be balanced and that it is not a black and white scenario. The NHMRC National Ethics Conference held in 2005 had this topic as it’s central theme and attendees discussed the need to take a more nuanced approach that included a broader consideration of competing rather than conflicting interests. These competing interests apply to participants themselves, the health professionals running the trials, the institutions responsible for operating the site where the trials are being done and finally the funders of the trials who may also be the ‘sponsor’ in the definition adopted by the TGA, that is, those with a direct vested interest in proving an unapproved therapeutic is better than existing practice so they can market their product for profit. Frameworks for managing these competing interests are often little more than answering ‘conflict of interest’ questions in the ethics application forms or on institutional declaration forms and stating that any institutional policy is being followed. This is clearly inadequate for a variety of reasons. Firstly, in my view after having worked in public and private institutions for 20 years, is that there is a check box mentality to managing potential competing interests with no resources deployed to either teaching staff about it or exploring the more subtle elements as opposed to simply addressing the blatantly obvious ones such as a direct financial conflicts. Secondly,

Given the earlier statements about the potential benefits of being enrolled in trials, and also the fact that for a subset of people the trial may be the only way to access a potentially life-saving treatment, participants themselves may have a profound self interest in participation. At the end of the day who are we doing research for if not the end-users, therefore system generated research barriers inadvertently have a direct impact on patients and members of the public.

It is also possible that participation in the trial leads to funding of components of care that would otherwise be a cost to the person. Some hold the view that people on trials should not experience any out-of-pocket expenses, even where those expenses would occur if they were not on the study. Arguments presented by investigators and sponsors that people should still have to pay any out-of-pocket expenses for standard-of-care components of a trial have been met with opposition by HRECs and institutions in some instances.

Health services are encouraged to run clinical trials for a variety of reasons that include being seen to be a centre of innovation and learning as well as providing access to cutting edge treatments. The reputational benefits are a discrete interest of the organisation that may, if connected to revenue from increased referrals, also be regarded as a potential marketing tool.  In addition, some have argued that government funders or health funds should not have to pay for treatments provided during any part of a clinical trial and therefore enrolment in trials is a means to offset some of the expenses associated with providing care to people in the health service. Some also argue that to promote clinical trial activity health services should have enrolment of patients in trials as a Key Performance Indicator (KPI) despite the obvious issues arising from simply working in ways that focus on meeting this that may not align with the best interests of participants. Indeed, whilst setting KPIs may seem like a good idea they create perverse incentives that are difficult to manage in the existing framework.

A topic that is rarely adequately discussed is the conflicts of interest of the institution that is both the site of the research, enjoying some of financial and reputation benefit from doing so, having a degree of duty of care for the participant, plus conducting the ethical and governance review. Commercially sponsored studies bring in revenue which is used to offset the costs of managing a clinical trial infrastructure. Ironically, making HRECs and Research Governance Offices dependent on revenue from commercial sponsors through fees is a major potential risk for conflicts of interest to arise, particularly where pressure is put to streamline approvals which could compromise more thorough evaluation of risks. Clearly a need to balance efficiency with due process is needed, but the dependence on fees that are not linked in any way to actual work done in terms of proportionate fee structures creates a clear conflict of interest within organisations. There is also a significant issue with using clinical trial revenue from commercially sponsored studies to subsidise the costs of Investigator led studies which do not otherwise enjoy such financial support. Whilst highly attractive to cash-strapped organisation unwilling to invest in such trials, the dependence on such revenue is far from ideal, and in some instances means that these trials cannot be opened as they may compete for recruitment of the same patient population and revenue generating trials will take precedence. I have observed this on several occasions at my own and other institutions, so it is far from a hypothetical risk.

Finally, investigators themselves may have competing interests with respect to enrolling people into trials and there have been arguments against permitting doctors who are both a chief investigator and the primary care provider for a patient from being involved in enrolling a person into a study. This is a fundamentally flawed argument and not one supported in the National Statement. Health Professionals have a primary responsibility to ensure the safety of those in their care and this is enshrined in a legal framework that could result in them losing their status as a health provider for any serious transgressions. Health Professionals should be in true equipoise regarding whether a person participates in a study or not and only suggest it if it would not be against their interests. Those paid to do research (study coordinators and Research Nurses) have competing interests to enrol people with no such equipoise and penalty for failing to exercise good judgement about whether a person should or should not participate. For this reason for medical interventions only doctors should decide whether a person should be invited to participate and should provide independent advice regarding the risks and benefits. Recognising where competing interests to enrol a person exist are managed well on the whole although I have also experienced instances in which obliviousness to the actual conflict of interest of being an investigator and having a financial interest in a product were not identified by doctors as being a direct conflict despite filling in forms that asked them to identify these. Therefore, it is not enough to simply write policies and ask people to fill in forms and appropriate training and the development of a culture that supports people to think about what they are doing is needed.

With our thanks to Nicola Straiton for her helpful comments on an earlier draft.

It is perhaps worthwhile for institutions implementing the Australian Clinical Trial Governance Framework overseen by the Australian Commission for Safety and Quality in Health Care (ACSQHC) to incorporate key parts of managing competing interests used in clinical governance for research activities as these likely overlap. A reasonable question can be asked: Do potential participants appreciate the conflicts of the parties they might assume are supposed to safeguard their welfare and interests? What is therefore needed is more than simply listing financial interests or relationships in ethics and governance applications. Instead a systematic and sophisticated approach is required that weighs up the risks and benefits of running research at a strategic level that is deployed as a core part of the culture of an organisation rather than as check box approach in research applications.
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This post may be cited as:

Zeps, N. (29 June 2020) Embedding clinical research as part of routine healthcare: Managing the potential for competing interests. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/embedding-clinical-research-as-part-of-routine-healthcare-managing-the-potential-for-competing-interests

When Research is the treatment: why the research/clinical care divide doesn’t always work0

 

Nik Zeps
AHRECS Consultant

Health services are often operated by people who strive to improve the way they deliver care. In the public imagination improvements arise from ‘breakthroughs’ such as the discovery of new disease mechanisms and drugs or devices to address these. However, it is not just novel treatments that lead to better outcomes. Sadly, it is not widely recognised that eliminating sub-optimal practices or variations in healthcare practices play a major role in improving clinical outcomes. Indeed, I don’t recall a headline announcing an increase in operational efficiency in any health service as this is hardly exciting news regardless of its value. Funders of healthcare are interested though, and in a report entitled Exploring HealthCare Variation in Australia: Analyses resulting from an OECD Study, published by the Australian Commission on Safety and Quality in Health Care in 2014, the authors stated that:

Unwarranted variation may also mean that scarce health resources are not being put to best use. As countries face increasing pressure on health budgets, there is growing interest in reducing unwarranted variation in order to improve equity of access to appropriate services, the health outcomes of populations, and the value derived from investment in health care.

All consumers of health care should therefore be interested in this and support those working toward improving health services. Unfortunately doing this work is difficult and often unrewarding. The ethical imperative to do this work is also often thwarted by the ‘ethics’ and governance framework that too often encumbers those doing it {Clay-Williams, 2018 #516}. It is also largely left to the NHMRC to fund Health Services Research (HSR) and the Comparative Effectiveness Research (CER) studies that generate evidence to reduce wasteful practice. In contrast, very little funding from health services themselves go to these activities despite them being the direct beneficiaries of the research.[1] Importantly, those engaged in HSR and CER are becoming an increasingly larger proportion of the total medical research endeavour in Australia, and by classification constituted almost one third of NHMRC competitive funding in 2019[2]. This is despite the fact that the studies undertaken often take several years to complete and therefore the number of publications is smaller than for life sciences. For HSR, publication is rarely in the ‘higher impact’ journals, whereas for some CER Trials the outcomes are so profound that they are of international significance and will be published in widely read international journals. Pleasingly this suggests that the criteria for assessment do not necessarily disadvantage such research in terms of competitiveness for funding, but also reflects the fact that clinical trial funding from the NHMRC supports a great deal of CER studies.

Those doing HSR and CER are also often involved in working in health services as clinicians which reduces the amount of time they can devote to academic research and to build a competitive personal research portfolio. The NHMRC has implemented a “Relative to opportunity” process in an attempt to address the almost impossible task of taking into account personal circumstances, but I doubt anyone is truly comfortable in applying it across the breadth of candidates and disciplines. Indeed, it could be argued that it is a surprisingly unscientific and subjective approach to use in schemes that are rewarding the quality of scientific approaches to address major societal issues. In 2019, only 7% of investigator grants went to applicants identified as HSR researchers.

It is difficult to think of what could replace this system across all areas of scientific endeavour but there is a possibility of rethinking how we fund and manage HSR and CER clinical trials. In both types of activity the end points are focussed on providing evidence to inform changes to clinical practice and health service delivery. As such the end users are health care providers and their funders. It would therefore seem much more appropriate that the end users play a much greater role in judging what kind of research should be done as well as the value of the outcomes of existing projects. The problem with this is that Health Services do not have the internal infrastructure and capability to manage research and have no incentive or means to do so.

What is particularly important to reflect on here is that publication metrics and university-based career milestones are largely irrelevant to the health services and arguably should not be the drivers of why the work is done. It would be more appropriate to have a regular employment relationship between the health services researchers and the health services in a manner that does not differ to clinical safety and quality activities. Sadly, health services have not seen the need to invest in this out of their operating budget and one can see why they would not if universities will do so. The problem though is that health service managers inevitably regard them as academic exercises with no direct relevance to routine health practice and when budgets are tight any support rapidly evaporates.

Like other industries that are reliant on R&D, it could be argued that a defined proportion of all health funding should go to HSR and CER that is conducted and run within the health services themselves. In the UK the National Institute for Health Research (NIHR) was established in 2016 with £1 billion to do just this, representing just under 1% of the total National Health Service Budget at the time (£126 billion[3]). The current public expenditure on health in Australia is $81.8 billion AUD, however, the total health spend, including private and personal (out of pocket) expenditure was $185 billion in 2017/2018[4]. The combined NHMRC and MRFF expenditure on all HSR and clinical research is estimated to be around $800million in 2019, less than 0.5% of the total health expenditure. The difference with the UK is that the Australian funding is largely administered through universities and not by the health services as in the UK.

I would propose that researchers engaged in HSR and CER should be employed by the health services themselves and be regarded as intrinsic to the operations of the health service. In addition, I propose that these staff would not publish papers under their own names but instead publish under the health service banners, either singly or as collaborations of organisations. In this way individual career progression would be based upon demonstration of outcomes in the same way that other activities in the health service are evaluated. Staff who do their job well would continue in their employment and be eligible for ongoing employment. Career progression would be through building a demonstrated portfolio of achievement that is attested to by their employers in a similar way that professional references are provided. Success for individuals would therefore be entirely based on being able to show how they had contributed to productive activity within the organisation.

If this major change to operating this type of research was made then it might also change one of the other major barriers that currently exists, the disproportionately burdensome ethical and governance requirements for such ‘research’ which is mostly treated as having the same risk profile as novel interventional studies. The aims of research are stated to differ from those of providing clinical care to patients, and this is at the heart of the Declaration of Helsinki’s ethical principles as well as those known as The Belmont Report published in 1979. In the Australian National Statement on Ethical Conduct in Human Research, such a distinction between clinical care and research is no longer identified and not commented on so explicitly.

For HSR and CER the distinction between what is routine practice and what is research is extremely blurred, particularly within the context of a self-improving/self-learning healthcare system in which a constant cycle of analysis of the current status of clinical activity informs the delivery of healthcare into the future. The robust methodologies employed to do the analysis and to test potential alternative practices aimed at improving care are indistinguishable to those used for researching novel and potentially more risky interventions. However, the risk profile is completely different, particularly where the research involves one or more practices already in widespread use. A more embedded framework that ensures that ethical issues are addressed at a systemic level rather than through the existing ethics and governance system that treats such work as ‘other’ is needed. The 2019 draft Clinical Trial Governance Framework developed by the ACSQHC goes some way toward creating a culture in which this can be delivered although it will likely require significant cultural change at most health services engaged in research.

We need a system that values those doing this work as core employees and is directly vested in the outcomes of the work and their implementation into improved practice as the prime demonstration of productivity. Such a cultural change will provide the drive to streamline the overly burdensome regulatory framework that currently exists. Such a framework would deliver its own efficiency dividends in a positive cycle enabling more of this work to be done and an acceleration in avoiding wasteful practice and generation of data that brings real improvements to people’s lives. It would seem that this is the very definition of an ethical outcome.

[1] ACSQHC/ACTA report on clinical trial benefits https://www.safetyandquality.gov.au/publications-and-resources/resource-library/economic-evaluation-investigator-initiated-clinical-trials-conducted-networks-final-report

[2] https://www.nhmrc.gov.au/file/14808/download?token=GAkwLHj0

[3] https://fullfact.org/health/spending-english-nhs/

[4] https://www.aihw.gov.au/reports/health-welfare-expenditure/health-expenditure-australia-2017-18/contents/summary

This post may be cited as:

Zeps, N. (04 June 2020) HWhen Research is the treatment: why the research/clinical care divide doesn’t always work Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/when-research-is-the-treatment-why-the-research-clinical-care-divide-doesnt-always-work

Why autism research needs more input from autistic people0

 

Elle Loughran
Student, Trinity College Dublin
Elle Loughran is a Laidlaw scholar studying genetics at Trinity College Dublin in Ireland

This post first appeared in Spectrum, the leading site for autism research news.

I am a student and researcher studying evolutionary genetics, and I am autistic. I often come across papers on autism research, but unfortunately, reading them is rarely a positive experience.

Too much autism research fails to acknowledge autistics as people who can read and make valuable contributions to the field. Instead, it casts them as little more than passive study participants or recipients of treatment. This shortsightedness damages research and scientists’ ability to help autistic people.

Reading autism research as an autistic person can feel like being treated as an alien. For example, consider a 2019 paper that stated: “This finding reinforces other work which shows that autistic people can have, maintain, and value close romantic relationships and friendships.” Imagine how bizarre it would be to read that about yourself.

I do not mean to pick on that paper in particular, but on a research culture in which anyone would think that sort of statement needs to be made.

This sort of culture results in seeing top researchers throw around blatantly wrong and offensive ideas about my community. For an old but powerful example, British researcher Simon Baron-Cohen endorsed a quote that suggested autistic individuals experience people at dinner parties as “noisy skin bags” that are “draped over chairs.” In my view, the appropriate response to that is, “No, that is absolutely not how we experience anything. What the hell?” Of course, that would not be an appropriate academic reply.

I understand that even seemingly obvious things need to be examined and tested in science, but if someone were to suggest that the moon is made of cheese, I doubt researchers would insist on disproving it with a study. Yet somehow autistic people must be so strange and unknowable to researchers that they cannot dismiss equally implausible characterizations of us.

In fact, many autistic people are available to answer questions about how we see things. Many of us speak up and share our stories proactively. It can seem to us as if scientists are not listening.

Then there are papers that suggest society would rather fewer people like me existed — and not because they care about my suffering. Or those that survey the prospects of preventing autism, pointing out that these are “high priorities for researchers, parents, advocates, clinicians, and educators.” Why is there is no mention of autistic people on that list?

Integration barriers:

The opportunities for someone like me to correct the culture in autism research are limited.

Often when I see these things in the course of my work, I just sigh and ignore them. If I’m discussing a paper with my scientific peers, I do not want to bring up issues with the paper’s treatment of autism and be seen as an ideologue, research subject or object of pity rather than as a respected colleague.

Other people’s responses can also thwart meaningful exchange. Last summer, I ‘came out’ as autistic while in conversation with an autism researcher and several of her colleagues. The people in the group responded with something along the lines of,  “Oh, well, you’re not like other autistic people, so those points do not apply to them.”

If a person’s ability to converse with you makes you assume she is not like ‘real autistics,’ then your idea of autism is automatically going to be ‘people who can’t talk to me.’  You will have a flawed understanding of autism and may not be able to see autistic people as potential colleagues. This risks researchers perceiving autistic people purely as research subjects who do not talk back, have opinions or contribute to the process.

Autistic people are treasure troves of information on their own lives. By including more autistic voices in research, we as scientists could improve our ability to gather knowledge about the condition.

Given the flaws in prevailing theories of autistic psychology, I believe we should encourage more qualitative, open-ended research that seeks input from autistic people and establishes a firmer basis for future studies. We could also seek their help in prioritizing treatment targets. Likewise, if biomedical researchers are going to get funding for studying autism, they must make more of an effort to engage with the autistic community and their wishes.

Things are getting better, and many researchers are doing good work. But listening to autistic people could help them make faster progress. Autistic people are not aliens with whom scientists cannot communicate. We are right here. We are reading what you have to say, and that communication can go both ways.

This post may be cited as:

Loughran, E.  (27 April 2020) Why autism research needs more input from autistic people. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/why-autism-research-needs-more-input-from-autistic-people

Endometriosis, women’s health and the ‘hysteria myth’0

 

Kate Young, Research Fellow, School of Public Health and Preventive Medicine, Monash University
Profile | Kate.Young@monash.edu.au

This post originally appeared on Monash Lens

Endometriosis is finally a hot topic.

We’re hearing more and more women’s stories of having their pain dismissed by loved ones and doctors. Stories of lives being derailed by debilitating symptoms. And stories of strength and determination to make the next woman’s experience a little better.

About 1.5 per cent of the female population worldwide has endometriosis. It’s a chronic disease formed by tissue such as the lining of the uterus (the endometrium). This tissue forms lesions that stick on, and sometimes invade, organs such as the ovaries and bowel.

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Symptoms of endometriosis include painful and heavy periods, diarrhoea and painful sexual intercourse, to name a few. The most accurate form of diagnosis is through surgery. The disease can be removed by surgery and managed with hormonal therapies (such as the contraceptive pill), though about half of all women will redevelop symptoms after treatment.

As a public health researcher, I’m interested in how healthcare for endometriosis can improve women’s experiences of the disease and lives overall.

My research addresses the social, cultural and historical factors that shape what goes on between women and their doctors. Are these interactions meeting women’s diverse needs? And does their healthcare foster their full participation in society?

Room for improvement

My research with doctors suggests there’s room for improvement.

I interviewed eight gynaecologists and four GPs about their views on providing care to women with endometriosis.

The doctors expressed empathy and concern for women with endometriosis. However, they were challenged by those they didn’t know how to help. (This is a lot of patients, considering there’s no effective long-term treatment for at least half of all women.) In response to this challenge, clinicians often turned to the ‘hysteria myth’.

The hysteria myth attributes the cause of women’s illnesses – usually ones that have no clear medical explanation at the time – to their psyche (mind) and failure to uphold their ‘biologically destined’ role of mother. An example of this is Plato’s wandering womb – disease in women was attributed to their uterus wandering around their body, with the ‘cure’ being pregnancy to anchor it. This is echoed in the modern-day trend of doctors recommending pregnancy to women with endometriosis, despite no research evidence for benefit.

There’s little quality research to guide doctors in their care of women with endometriosis. They’re expected to always have an answer for the people who seek their care.

Most doctors began their interview by distinguishing between what we termed ‘good’ and ‘difficult’ patients (labelled by one gynaecologist, the “endometriotic cripple”).

‘Good’ patients were women who accepted their doctor’s interpretation of their disease and symptoms, and didn’t pose a challenge to their doctor.

‘Difficult’ patients were typically women who didn’t find relief from available treatments and who repeatedly returned for help. These women’s symptoms were attributed to their psyche. As one gynaecologist said:

“They [women] make that the focus of a lot of things that go wrong, and perhaps endometriosis has to play a larger part in their lives than it necessarily has … Depending on their … psychological system and ability, I think they make that the focus of their lives, the reason why they can’t go on and do things. They’ve got something to blame.”

Another gynaecologist, however, made a similar distinction but with no value judgement. She said:

“Some people are able to be philosophical about those kinds of things and think, ‘Oh, you know, that’s what nature’s dealt me and I’m just going to have to deal with it and get on with it.’ And for other people it’s a grief response that is much more difficult to deal with and find their way through, and the extent to which that’s influenced by things like people’s sense of self-worth that might relate to their employment or other roles in life … There’s a whole lot of things; I don’t think it’s simple.”

When asked about the potential impact of living with endometriosis on women’s mental health, one gynaecologist stated: “Do mad people get endo or does endo make you mad? It’s probably a bit of both.” Another hypothesised that one of his patient’s symptoms was a “psychosomatic expression” of “matrimonial disharmony”.

Women deserve better

As a woman and feminist, these things were hard to hear. But they weren’t surprising. These findings are consistent with the research into women’s experiences of endometriosis and with the stories shared in the press and social media. There’s no question that women deserve better than this.

But the answer doesn’t lie in condemning individual doctors.

Doctors attributing women’s symptoms to their psyche reflects society-wide beliefs about women and their bodies that have persisted for much of documented human history. (Remembering that it’s largely men who have been doing the documenting.) Beliefs that the sole purpose of women is to reproduce, that they are volatile and controlled only by their raging hormones, and that they’re not to be trusted or believed. These are beliefs that we all, including myself, participate in perpetuating to varying extents.

There’s little quality research to guide doctors in their care of women with endometriosis. They’re expected to always have an answer for the people who seek their care. Our medical system and culture make it difficult for a doctor to say, “I’m sorry, but I don’t know how to help you.” (Though the women in my research valued doctors who did do this.)

We must give clinicians the training and support they need to provide comprehensive healthcare for women with endometriosis. This care should foster women’s full social and economic participation; clinicians need the skills to recognise when their practice may be impeding it.

We must do better.

Read more: About endometriosis (The Royal Women’s Hospital)

This post may be cited as:
Young, K. (13 March 2020) Endometriosis, women’s health and the ‘hysteria myth’. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/endometriosis-womens-health-and-the-hysteria-myth

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