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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Can I use your answers anyway?0

 

Dr Gary Allen
AHRECS Senior Consultant

Many national frameworks for human research ethics, such as the National Statement (2007 updated 2018) in Australia have respect as a core principle.  An essential component of respect is obtaining the prior consent of potential participants.

The role of consent in ethical research can be traced back through the Belmont Report, through the Declaration of Helsinki, back to the Nuremberg Code and earlier to philosophical, bioethics and clinical texts.

Recent egregious ethical breaches such as the Cambridge Analytica, OKCupid and Emotional Contagion cases highlight that consent problems in research are not just an issue for biomedical research and not just a 20th Century concern.

Where national and/or institutional policies discuss consent and questionnaire-based research, they will generally indicate that completion and return of a completed consent form is a valid expression of consent.

Which is indeed reasonable, especially when it is important to conceal from the researcher who has participated in their research (e.g. where an academic is surveying their own students).

Most frameworks and guidance documents for the ethical conduct of human research will indicate participants should be able to freely withdraw from research without comment of penalty.

Indeed, this is again quite a reasonable position, given that genuine respect for our participants should include acknowledging that they must ordinarily be able to withdraw their consent without comment or penalty.

Solid ground thus far?  Good because now we’re approaching the conundrum that prompted us writing this post dear readers.  However, for on-line questionnaires, does this mean stopping the completion of a survey whenever they want and not clicking the “submit” button?   Will this mean that the data already entered is not collected?  What if a participant changes her mind after submitting the data and wants to then withdraw her answers? If that survey is anonymous, consent and the submitted data cannot be withdrawn after submission, because the researchers won’t be able to tell which data was from which individual.

The advent of online questionnaires enabled the resolution of some problems that were largely only an online anyway and presented another practical ethics challenge.

A1        Using cookies to reduce the likelihood that an individual completes a survey more than once.

A2        Enabling an individual to save their progress through the survey and complete it over more than one session.

For A1 researchers should ensure the cookie does not enable them to identify respondents and ensure it will not compile any previous or future web activity.  This must be explained in the consent material and assurances provided with regard to these two matters.

For A2 the consent material should explain how password information is saved and the degree to which it can be used to identify respondents.

However, as our scenario indicates, the interesting question comes up if a respondent doesn’t finish the survey.

What happens to the information already entered into the incomplete survey?

What are the wishes of the respondents as to what should happen with these data?

The answers to these questions also depend on why the survey wasn’t completed.

Was it a combination of the participant forgetting, not having time, losing interest or struggling to log in?

Alternatively, was there a reason the individual no longer wished to participate?

Regardless of the reason, what does the individual want to happen with the use of their data?

Simple answers here are not necessarily helpful.  Assuming they forgot, etc may not be accurate and the use of their answers may be absolutely contrary to their wishes.  By the same token, losing potentially useful data merely because participants forgot might be a significant loss – especially if the number of participants is already low.

One approach in the National Statement could be used:

The relevant HREC could be asked to approve a waiver of the consent requirement, so as to enable the use of the partially completed surveys (as per NS Chapter 2.3) if they were accessible and this would need to be made clear in the survey instructions.

While the opt-out approach (also discussed in NS 2.3) might seem a promising strategy, the fact the researchers cannot correspond a set of answers with an individual means that an individual’s decision to opt-out could not be honoured.

Depending on why the individual didn’t complete the survey, the waiver of the consent requirement approach is not especially ideal.  It involves time and other resources that might be in short supply.

Proposals about the use of partially completed surveys should be discussed in the research ethics review application, the recruitment materials and consent materials.

This raises a related point: the reasons someone withdraws from a project might be of interest/importance to the researcher, their research centre, the research ethics review body or other researchers.

We propose the following strategy for a survey in which participants can be linked to their answers:

  • The consent material should discuss what will be done with the answers if the survey is only partially completed;
  • The revocation of consent process and form should be explained; and
  • The resource material for researchers and research ethics reviewers should provide a matrix that explains the treatment of survey responses.

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You will find suggested wording for the consent material and revocation form in the subscribers’ area for institutions and individuals.
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This mechanism uses an optional revocation of consent form.  It is essential that participants are told this form is optional, they can stop participating at any time, without explanation, but then using the form would be very informative to researchers.  In the subscribers’ area is both a suggestion for the questions in the revocation form and the associated text for the consent material.
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We suggest the revocation form would provide some further clarity about the matters above.  In the case of situations where a revocation form is not provided it is perhaps prudent to conclude those individuals don’t want their partially completed survey to be used.
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The same approach could be used for other kinds of research designs where data is collected at more than one sitting/point/session.
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For surveys in which participants cannot be linked to their answers, we propose the following strategy:
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  • The consent material should discuss what will be done with the answers if the survey is only partially completed;
  • The consent material could include an optional incomplete submission advice that provides researchers with information about why the survey was not completed, e.g. chosen from a dot-point list; and
  • The consent material should also clearly state that once submitted, data in completed surveys cannot be withdrawn.

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This post may be cited as:
Allen, G. (30 March 2020) Can I use your answers anyway? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/can-i-use-your-answers-anyway

Towards a code of conduct for ethical post-disaster research0

 

JC Gaillard
School of Environment, The University of Auckland, New Zealand
Unit for Environmental Sciences and Management, North-West University, South Africa
Profile | jc.gaillard@auckland.ac.nz

Lori Peek
Department of Sociology and Natural Hazards Center, University of Colorado Boulder, USA
Profile | Lori.Peek@colorado.edu

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We recently called for a code of conduct in disaster research. This call is rooted in our respect for the research process itself and our care for affected people and the researchers who do this work. To be clear, we are calling for a cross-disciplinary conversation to advance a shared set of moral and ethical principles to help guide what we study, who we study, how we conduct studies, and who is involved in the research process itself. We are not arguing for another layer of bureaucratic or regulatory oversight such as those required in some countries by internal review boards and ethics committees. Our hope is that such a discussion will launch first within focused academic and policy meetings, before it can be scaled up to the regional and eventually international levels.

Our intent is to prompt further reflection and conversation around the following three possibilities for ensuring that disaster scholarship is relevant, fair, and ethically sound.

First, it is essential that research has a clear purpose that is rooted in present knowledge gaps and emergent context-specific research priorities in the disaster aftermath. The collaborative work that happens before disaster and in the immediate aftermath can help clarify the focus of research studies and ensure that the knowledge generated is locally-relevant and hence more likely to effectively inform response, recovery and future disaster risk reduction efforts.

Second, ensuring that research is filling relevant knowledge gaps requires that local voices be put at the forefront of the research effort. Local voices may include a range of perspectives, including those of local researchers and those who hail from elsewhere but hold deep knowledge of the places and people affected by disasters. They also comprise those voices of the survivors whose ability to deal with the event and contribute to the recovery effort is central to rebuilding damaged physical infrastructure as well as people’s lives and livelihoods. Ensuring that local researchers and survivors are in the driving seat does not exclude outside researchers when prompted by local colleagues. In many instances, outside scholars have access to a wide range of resources (e.g., equipment, funding, time) that may be unavailable locally in times of collective hardship. Crucial, though, is that local researchers have the opportunity to lead efforts associated with research design, data collection and analysis, and ultimately the sharing of findings.

Third, it is crucial that research agendas and projects launched in the disaster aftermath be ethically coordinated and involve locals and outsiders. This means that local researchers need to be identified quickly after disaster—the National Science Foundation-supported Extreme Events Research and Reconnaissance networks have already jump-started these efforts. There are many other organizations and networks globally that have advanced new methods for identifying researchers and communicating creatively in the disaster aftermath through virtual forums and virtual reconnaissance efforts that allow for a wider range of researchers to connect, communicate, and ultimately collaborate.

Engaging with the three aforementioned areas of possibility is crucial given the rising number of disasters and disaster studies. It is clear that disasters stir the interest of researchers, as evidenced by the growing number of academic publications on the topic. Most of these researchers are driven by a genuine desire to contribute to reducing suffering, but researching disasters can be difficult and there is not a clear ethical playbook for how to proceed.

This becomes especially pressing because researching disasters entails navigating a complex and sensitive environment where survivors may struggle with both the consequences of the event and the task of recovering. Meanwhile, local and outside responders try to support the relief and recovery effort. To fully grasp the complexity of the situation, researchers need to be equipped with an appropriate ethical toolkit that goes beyond the requirements of the research ethics committees of universities and other research institutions. It entails a nuanced understanding of the cultural, social, economic and political context wherein disasters unfold. For scholars who choose to work in new contexts following disasters, this sort of competence is difficult to acquire ad-hoc and in a short span of time.

With these challenges in mind, it remains a dominant pattern after major disasters that outside researchers converge and lead studies conducted in locations beyond their familiar cultural environment. In fact, disaster studies are often driven by scholars located in Northern America, Europe, East Asia, and Australasia. A review of publications on disasters over the past four decades shows that there are fewer researchers publishing studies from Africa, South and Southeast Asia, the Pacific, and Latin America although these regions of the world are those where disasters claim more lives and occur more frequently.

Such unequal power relationships in terms of who leads, conducts, and communicates research on disasters influences how disaster scholarship is framed and approached on the ground. Disaster studies are largely informed by Western ontologies and epistemologies that do not necessarily reflect local worldviews and ways of generating knowledge, which means that implications for policy and practice may be misleading.

Identifying these gaps opens up the possibility for reconsidering some of the fundamental assumptions about how research is conducted and ultimately how knowledge is generated and shared. Our call for a code of conduct is about ensuring that ethical concerns have the same primacy as our research questions. We look forward to continuing the conversation.

This post may be cited as:
Gaillard, JC. & Peek, L.  (21 March 2020) Towards a code of conduct for ethical post-disaster research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/towards-a-code-of-conduct-for-ethical-post-disaster-research

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

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