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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

Plain English communications and the PICF – and beyond0

 

Bob Milstein
See below

For many of us, preparing the Participant Information and Consent Form (PICF) for a research project is an irksome, time-consuming and unexciting “hoop-jumping” task. Albeit, essential.

Indeed, the National Statement shows how essential the PICF task is. In particular, the Statement’s guiding principle for researchers is that:

“… a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.” [1]

For the purposes of this blogpost, the emphasis is on the ”understanding”.

The PICF provides the key avenue through which research participants are educated and informed ― though oral communications often supplement the document in important ways.

But to educate and inform the research participant, we need to do more than simply give them a lengthy document they find confusing, complex and perhaps impenetrable.

Rather, authors (or teams) who create a PICF need to do more ― they need to:

  • reflect on, and identify, factors that impede clear and concise communication; and
  • create a document that services the information needs (and sometimes the limitations) of the target readers — those readers include the potential research participant as well as the members of the ethics committee who scrutinise (and sometimes criticise) the document to determine its appropriateness for those participants.

Roadblocks to comprehension and ease of use

The roadblocks to generating a clear, concise and easy to easy to read PICF are often:

  • the many topics that need to be covered ― as required by the National Statement
  • the complexities of the project or of the underlying medical, technical, scientific etc issues;
  • the constraints of a – sometimes helpful — template. But even within a template, the writer has an opportunity – and an obligation — to ensure that the text inserted into the template is well-expressed and well-structured — and (most importantly) reader-focused; and
  • the language constraints imposed ― sometimes not so helpfully — by pharmaceutical companies or their legal advisors. Sometimes, that imposed language seems less concerned to inform the reader and more concerned to protect the sponsoring organisation.

For all of these reasons, PICFs can be long, complex, hard to read, and therefore unread.

These challenges are compounded by pressures ― actual and perceived ― that operate on PICF authors. For instance, many scientific writers:

  • under time and performance pressure, seek to cut and paste existing materials in the hope that a cobbled together PICF will do the job;
  • adopt an inflated and excessively formal writing style ― they do this because they wrongly equate formality with professionalism;
  • are concerned that an easier-to-read document might oversimplify (“dumb down”) important information, and generate inaccuracies; and
  • write in a way that works for them and their technical peers, but that ignores or forgets the key reading audience’s needs, priorities and (sometimes exceptionally importantly) limitations.

Reflecting on the key reading audience/audiences, and using the principles of plain language communication to speak to those audiences

The key questions every writer must ask and answer are:

  1. Who am I writing to?
  2. Why am I writing to them? What do I want them to know, do, understand et cetera?

A PICF usually has two key reading audiences:

  1. members of an ethics committee; and
  2. more importantly, potential research participants.

Research in Australia consistently shows adult literacy rates to be low — and even lower when it comes to the issues of health and scientific literacy. These challenges to participant comprehension are even greater for a participant whose thought processes are influenced by fear, false beliefs, denial, anxiety and distress. [2]

Yet unlike the research participant, the writer of the PICF is hyper-literate. And massively informed about the topic ― indeed, they are likely to be as informed about the topic as anyone could be, given the state of the research.

Hyper-literate and highly informed authors struggle to “unburden” themselves of their assumptions around the audience-appropriateness and reader-friendliness of their writing. Most scientists think they are good, or very good, writers. So do most lawyers. Hah!

But unburden themselves PICF authors must. At all times, they need to focus on the information needs — and limitations — of the target reader, so that the participant can, with relative ease, understand:

  • How and why this research is relevant to them or their condition;
  • What problem the research is addressing;
  • What solution the researcher is seeking;
  • What it is they are testing; and
  • How the findings might help the potential participant, or others, with the relevant condition. That is, how the research might improve future care – its cost, complexity, frequency, efficiency et cetera.

Working towards a plain English PICF

For these reasons, we need to reflect on the principles of plain English communication to help readers work their way through the PICF. By doing so, we help satisfy the demands of the National Statement.

When talking about “plain English”, we rely on the internationally accepted definition developed and adopted by the International Plain Language Federation. [3]

“A communication is in plain language if its wording, structure, and design are so clear that the intended readers can easily find what they need, understand what they find, and use that information.”

A starting point: George Orwell

A good starting point on how to achieve a clear and reader-focused document is a famous essay by the novelist George Orwell entitled “Politics and the English Language”. Although he was writing to a general audience, many of Orwell’s observations are directly relevant to the writing of a PICF.

Among his key points:

Never use a metaphor, simile, or other figure of speech which you are used to seeing in print. These days, we say avoid clichés.

Never use a long word where a short one will do. Bernard Dixon, formerly the editor of the New Scientist, tells the story of a manuscript he received containing the following opening sentence:

”The mode of action of anti-lymphocytic serum has not yet been determined by research workers in this country or abroad.”

The author was outraged when he received the following revision from Mr Dickson:

“We don’t know how anti-lymphocytic serum works.”

Dixon says it took him 20 minutes of close textual analysis until he finally persuaded the author that  the meaning of the sentence had not been altered despite the fact that the shorter version was now more direct, more readable and one third its original length

https://www.newscientist.com/article/mg13718654-300-science-and-fiction-plain-words-please/

If it is possible to cut a word out, always cut it out. A first draft is almost never the most concise draft.

Never use the passive where you can use the active. Occasionally, the passive voice has a legitimate — and sometimes an important — role in scientific writing. But it also can be hard work for the target reader: wordy, pompous, unclear, confusing and sometimes deceptive. It is often overused (or to use the active voice, “we often overuse it”; see for instance, Passive Voice in Scientific Writing  https://cgi.duke.edu/web/sciwriting/index.php?action=passive_voice). For these reasons, many scientific journals actively encourage authors to use the active voice when submitting articles

Never use a foreign phrase, a scientific word, or a jargon word if you can think of an everyday English equivalent. In a PICF, which often has a necessary and unavoidable degree of scientific/medical technicality, this can be hard to achieve. But sometimes, it might be helpful to supplement the necessarily technical text with additional text that walks the reader through the concept in ways that will work for them. And remember: many research participants might struggle with language that the researcher will take for granted — for example words like “positive”, “negative”, “lateral”, “terminal”, “ante”, “hyper”, “hypo”, “significant”, “natural”, “theory”, “monitor” etc.

Break any of these rules sooner than say anything outright barbarous. As Orwell acknowledges in this, his final, point, the language (and for that matter, structure and design) is there to be used, and the options for generating clear and reader focused text are limitless.

But whatever the approach, and whatever the setting, we must all reflect on the importance of generating text for our target readers that is not only accurate and comprehensive, but is also clear, concise and effective from the reader’s perspective. While these writing principles are clearly important in the writing of a PICF, they are also important in the wide range of settings where  researchers seek to inform, educate, engage and persuade their readers — including the general public, potential funding sources, policymakers and politicians.

Some Further Reading

Australia has for many decades played a leading role in the so-called plain language “movement”, particularly in connection with a number of important law reform initiatives. Currently, Australian plain language practitioner and advocate  Christopher Balmford chairs the Standards Committee of the International Plain Language Federation. In 2019, the Federation proposed to Standards Australia that it in turn propose a plain language standard to ISO. Both proposals were approved. ISO has established a committee, chaired by Balmford, to develop an optional, multi-language, plain language standard.  The first draft is due to be reviewed at a meeting in Bangor, Wales in June 2020.

Although Australia has done a lot of excellent work, some of the key resources around scientific writing come from other countries.

Here is a list of some of the key resources that might help with future PICF writing:

  • Writing about biomedical and health research in plain English; A guide for authors

http://www.access2understanding.org/wp-content/uploads/2014/11/Access-to-Understanding-writing-guidance_v1.pdf     

  • Simply put: a Guide for Creating Easy-to-Understand Materials150 (Centers for Disease Control and Prevention, United States)

www.cdc.gov/ health communication/ToolsTemplates/Simply_ Put_082010.pdf

  • Everyday Words for Public Health Communication, May 2016 (USA)

https://www.cdc.gov/other/pdf/everydaywords-060216-final.pdf

Bob Milstein, Words and Beyond

Bob Milstein is a practising health lawyer and a member of an ethics committee.

He is also lead trainer in Words and Beyond, one of Australia’s leading providers of plain-language training, document rewriting, and cultural change (www.wordsandbeyond.com). He can be contacted on milstein@bigpond.net.au

Footnotes

[1] https://ahrecs.com/human-research-ethics/release-of-the-national-statement-on-ethical-conduct-in-human-research-2007-updated-2018-with-interview . See in particular Ch 2.2.1.

[2]  Australian Bureau of Statistics, Adult Literacy and Life Skills Survey 2006  https://www.abs.gov.au/AUSSTATS/abs@.nsf/Previousproducts/4228.0Main%20Features22006%20(Reissue)?opendocument&tabname=Summary&prodno=4228.0&issue=2006%20(Reissue)&num=&view=

[3] http://www.iplfederation.org/plain-language/

This post may be cited as:
Milstein, B. (6 March 2020) Plain English communications and the PICF – and beyond. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/plain-english-communications-and-the-picf-and-beyond

A users perspective on the ethics application process in Australia-room for improvement0

 

  1. Suat Chin Ng. MBBS, BMedSc, FRACS. Department of Surgery, Eastern Health, Melbourne, Australia.
  2. Wei Ming Ong MBBS Department of Surgery, Eastern Health, Melbourne, Australia.
  3. Shane Belvedere MBBS Department of Surgery, Melbourne Health, Melbourne, Australia
  4. Creski Gilong. MBBS Department of Surgery, Austin Health, Melbourne, Australia.
  5. Dr Nikolajs Zeps. BSc, PhD Research and Development, Epworth HealthCare, Melbourne, Australia. Eastern Clinical School, Monash University, Melbourne, Australia
  6. Philip Smart MBBS, D.Med.Sci, FRACS. Gastrointestinal Clinical Institute, Epworth HealthCare, Australia  Department of Surgery, Austin Health, Melbourne, Australia.

Compliance with ethical standards is fundamental to conducting human research. While there is a need for a thorough review process to prevent unethical research, the administrative workload required can often be significant. Indeed, researchers largely regard the ethics process as an obstacle that needs to be overcome, rather than a key part of the research process itself. In a recent blog on the AHRECS website entitled “Research Ethics Review as a Box-Ticking Exercise”, A/prof Angela Romano identified a significant problem with our current approach to ethical review as being one that promotes a compliance mentality rather than one that actively encourages appropriate and useful ethical reflection throughout the lifecycle of a research project.

Health and Medical Research is aimed at providing new knowledge to improve the health and wellbeing of the community and the fruits of this work will hopefully translate into tangible benefits for everyone. Significant concerns have been expressed by others that the current processes employed to regulate this work in fulfilment of ethical and legal requirements can itself be unethical. For instance, in a recent Blog by Prof Julian Savulescu he comments that whilst no-one is suggesting that research should not be subject to appropriate regulation and ethical review, given the potential to unnecessarily delay important research, all review processes should be as efficient and proportionate to the risk as is possible. Whilst we cannot immediately fix the lamentable lack of investment in undergraduate and post-graduate training in and practical application of ethics, the processes for review of projects could, in our view, be vastly improved with some fairly low-cost interventions.

What are researchers supposed to do to obtain ethical approval?

We reviewed the webpages of 78 Human Research Ethics Committees (HREC) associated with both public and private health services that we identified from the NHMRC list of registered HRECs. This list is only current to 1st March 2018 and we noted that several of the listed HRECs have in fact closed leaving just 71 that could be assessed. We also excluded from our review websites of small clinics which appear to serve only their own needs, eg IVF clinics.

Our review aimed to assess the ease with which researchers could find the webpages of the HREC, or the office of research and/or governance responsible for research oversight, and the level of information provided in terms of 1) instructions relating to how to make a submission itself, and 2) instructions about ethical considerations that may assist researchers to make a sound submission along the lines of A/Prof Romano’s wishes. We scored these objectively using a binary score of 1 if they had a readily accessible website and 0 if they did not. We scored the information related to the submission process in the same way, that is it was either present or not. We decided to include whether or not there was a clear process for considering low risk research in an expedited way consistent with the National Statement as this provided an insight into whether or not the institution regarded such research in a proportionate manner. We further checked on some of the linked documents and policies provided by the HREC, such as guidance on reporting of Serious Adverse Events (SAEs), to check for consistency and whether they were up to date with current guidelines.

We were surprised to find that 8 of 71 hospital based HRECs did not have a website that we could find. In some instances, the information about the HREC was provided via a central state-based portal where elements of the submission process and key local contact details were provided for each of the HRECs. We checked all of the links present in these websites and found that many were broken and in over half of all cases the links to the relevant policies, procedures, and key guidance documents were significantly out of date.

In contrast, we did find several websites that provided excellent resources such as those provided by the St Vincent’s HREC based in Melbourne and the Bellberry private HREC, which are exemplary in the level of useful information and easily accessible guidance they provide to researchers. We observed that of all of the HREC websites reviewed, 30 of the top 37 HRECs which all had accessible websites with useful information about submission were certified HRECs. Only 6 of the bottom 31, with what we considered to be inadequate levels of guidance information, were certified. This raises an interesting question as to whether the need to become certified led them to invest significantly in all aspects of the administrative process, including the development of useful websites.

Table 1: Key findings overall

CriteriaNo of HRECs scoring 1 (total 71)
Easily accessible information about key functions62 (87%)
Clear instructions about submission process62 (87%)
Additional information to guide applicants about ensuring their project met ethical requirements27 (38%)
Clear and proportionate pathway for low risk research43 (61%)
Up to date policies and guidance documents31 (44%)

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Our findings suggest that many health services that run HRECs could significantly improve the researcher experience by simply upgrading their websites to guide researchers more clearly about what is expected of them. As Angela Romano highlighted, the process should not be a box checking exercise and we suggest that if there was clear guidance about what was substantive ethical considerations that needed to be met rather than simply how to fill in the relevant forms we might achieve this, or at least take a step in the right direction.

Whilst we cannot provide any analytical evidence of a correlation it would not be surprising if the improved guidance provided by some HRECs meant that the time to approval was shorter due to a reduction in non-compliant submissions and perhaps even the quality of submission in terms of covering the substantive ethical concerns likely to arise. It is fair to argue that researchers themselves should take the time and effort to ensure that they find out what is expected of them but we suggest that it would be a highly cost efficient exercise to start by making the websites themselves more useful and geared toward this end.

Would you like to find out the score for your institution’s web site/or have an assessment conducted? If you are a https://www.ahrecs.vip subscriber this can be done for free.  Send an email to enquiry@ahrecs.com to discuss.

We did note in reviewing all of the websites that they were all designed differently and put information in different places and in different formats. We would also like to suggest that there would be some value in establishing a national standard for the presentation of core information regarding ethical submission and that there really is no reason that we can see for such wide variation in the way documents are provided. Efforts to harmonise content are evident in groups of hospitals such as Ramsay Healthcare, and we did note that several institutions now utilise the services of a central HREC, either their own for a group of hospitals or of other (certified) HRECs as part of the National Mutual Acceptance (NMA) scheme. We did not observe a great deal of harmonisation of content though outside of mandatory state-specific forms.
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Australia is committed to fostering health and medical research to improve the lives of patients as demonstrated by the State, Federal and charitable sector financial commitments that run to several billion dollars. Enhancing and harmonising website content would seem one way in which a small amount of effort would go a very long way to boosting our capability of doing ethically sound research.
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References:
National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra.

Romano, A. (22 June 2019) Research Ethics Review as a Box-Ticking Exercise Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-review-as-a-box-ticking-exercise

This post may be cited as:
Ng, S. C., Ong, W. M., Belvedere. S., Gilong, C., Zeps, N. & Smart, P. (4 February 2020) A users perspective on the ethics application process in Australia-Room for improvement. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-users-perspective-on-the-ethics-application-process-in-australia-room-for-improvement

Advances in Medicine often require innovation in ethical thinking too0

 

Nik Zeps and Tanya Symons
AHRECS Consultant

Breakthroughs in medicine often highlight the existing limitations of the frameworks established to manage the ethical responsibilities arising in healthcare. The contraceptive pill, organ transplantation, assisted reproductive technology, gene therapy and more recently gene editing are notable examples that have stimulated major debates and, in several instances, prompted changes to not only ethical guidelines but also legislation. However, there are also more subtle ethical issues that arise from doing established activities in a different context or scale. Think of so-called Big Data applied to health care or to uses of machine-based learning which promise to revolutionize practice but are really just larger scale applications of business as usual using more sophisticated technology than before. One result of these two developments is the amassing of personal data online which coupled with improvements in reidentification techniques present challenges to how we manage the privacy of individuals.  These have prompted amendments in regulation that facilitate the use of personal data whilst also strengthening protections for individuals (link to GDPR).

Less well known, are changes in the way we evaluate existing healthcare practices to ensure they are truly safe, effective and economical.  One such example is the increasing focus on Comparative Effectiveness Research (CER). These studies compare two or more existing practices that are in widespread use and have been found safe and efficacious. CER is an extension of audit/QI practices in that it uses clinical trial methodology and the power of randomisation to remove the biases inherent in the observed outcomes in a population of non-randomised patients receiving a particular health service. These studies generally include large numbers of patients (sometimes several thousand) so that they can detect differences between the interventions that, while relatively small, can nonetheless be clinically meaningful at a population level.

There is an over-riding ethical need to do this work constantly within what can be termed a ‘learning healthcare system’ 1.  Conceptually this means that every single instance that a person interacts with the health system should be captured in a manner in which it can be evaluated to make sure that optimal care is provided. Both patients and health system leaders expect this to be happening and yet in truth, the lack of standardisation in data capture, storage and interoperability means that few do this efficiently and effectively as part of routine healthcare activity. Moreover, existing research ethics frameworks impede the integration of healthcare and research by failing to recognise the differences between studies that involve standard care treatments from studies testing novel interventions with unknown safety profiles.  One example is the requirement to apply to comparative effectiveness studies informed consent processes that differ so greatly from routine consent to treatment they are impossible to integrate into routine clinical workflows.

In a recent paper, (Symons et al 2) we have considered whether approaches that utilise modified consent pathways for CER are permissible from an ethical and regulatory perspective. In an accompanying editorial 3Dr Evan Kharasch challenges the readers of the journal to consider how the existing ethical and legal frameworks can be complied with for trials where the risk of harm is small. There is a perception that as soon as a study employs randomisation it becomes more than low risk when this may not, in fact, be true. It is also important to consider the ethical issues that arise when this type of ‘public good’ trial is simply not done because using consent processes suitable for interventional trials of unapproved therapeutics makes them impracticable. If indeed a particular treatment is less effective or causes more harm and we continue to use it because we consider that currently required ethics processes render them impracticable, then those processes have led to potentially unethical outcomes.

To achieve the best healthcare outcomes, greater sophistication of thought is needed at the ethics committee level. It also seems obvious that greater engagement with consumers is a necessary and relevant pathway to designing and conducting trials that deliver on expectations. The Australian Clinical Trials Alliance (ACTA) together with the Trials Clinical Trials: Impact & Quality (CT:IQ) have developed a consumer involvement and engagement toolkit that serves this purpose [1]. By working more closely together and encouraging more flexible and contemporary approaches to research ethics compliance, we can achieve the ideal of encouraging and supporting clinicians and health services to undertake continuous improvements to health services using the best methodologies to achieve this for the benefit of the community they serve.

References

1          Faden, R. R. et al. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep Spec No, S16-27, doi:10.1002/hast.134 (2013).

2          Symons, T. J., Zeps, N., Myles, P. S., Morris, J. M. & Sessler, D. I. International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology 132, 44-54, doi:10.1097/ALN.0000000000003020 (2020).

3          Kharasch, E. D. Innovation in Clinical Research Regulation. Anesthesiology 132, 1-4, doi:10.1097/ALN.0000000000003026 (2020).

[1] https://involvementtoolkit.clinicaltrialsalliance.org.au/

This post may be cited as:

Zeps, N. (22 December 2019) Advances in Medicine often require innovation in ethical thinking too. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/advances-in-medicine-often-require-innovation-in-ethical-thinking-too-2

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