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.” 
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:
- Who am I writing to?
- 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:
- members of an ethics committee; and
- 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. 
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. 
“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
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
- 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)
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 firstname.lastname@example.org
 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=
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