It is widely accepted that human research ethics committees (HRECs) devote much of their time to the review of plain language statements or participant information and consent forms (PICFs). It should be noted that, unlike the US, Australia’s human research ethics arrangements have not been enacted into law. While chapter 2.2 of the National Statement does identify some required components of a consent strategy, the number and specificity of its provisions are much less than those often demanded by Australian research ethics committees. Historically, this amount of attention may have been due to the fact that, without guidance or experience, researchers devised their own PICFs, resulting in a possibly bewildering variety of structure, grammar and expression. In more recent decades, the focus of pharmaceutical sponsors on maximising disclosure has caused much of the increased length and detail.
Probably in response to this variety and the increasing time devoted to review and the often detailed and even pedantic correction, HRECs hit on the idea of providing templates or standard forms for researchers to follow. The likely purpose behind these initiatives was to reduce the variety of PICFs and so in turn reduce the time that committees spent on them, correcting spelling, grammar and adding information the committees saw as being key to informing potential participants. An implicit message in the provision of standard forms and templates was that if researchers used these forms, it was more likely that the forms, and the projects, would be approved.
Ironically, the use of standard forms and templates may have generated perverse consequences, reversing the problem that they were designed to address. Frequently, templates contain expressions that, in the context of the research project under review, become meaningless, implausible or at least ambiguous so that committees increasingly need to ask researchers to clarify how commonly used terminology fits their project in order to provide appropriate disclosure to potential participants. Some phrases appear to be used like magical incantations to ward off the evil eye of the reviewer.
Here are some recurrent examples. We encourage readers to add to this list through the discussion forum, but not in a way that ridicules researchers. While there may be some comfort in acknowledging that the experience is shared, we would like to support better practices.
1. Participants can withdraw at any time. Although these words are a response to the National Statement (paragraph 2.2.6 (g)), they are often ambiguous or meaningless if not further explained. Accordingly, HREC members tire of asking (and researchers of responding) how this can be the case when participants and their information are not identified, either on collection or when participants’ data are merged. Often, the issue of whether participants who do withdraw can withdraw the data is also left open and needs clarification.
2. Counselling will be available or participants may contact Lifeline or Beyondblue. Again, a response to the National Statement (paragraph 2.2.6(c)), the context of particular projects demands some explanation: what counselling, by whom will it be provided, will they be independent from the research team and do participants have ready access to suitable communication technology etc.
3. All your information will be kept confidential. Again, although a response to the National Statement (paragraph 2.2.6 (f)), the statement is often inadequate because participants are likely to understand confidentiality to mean something like secrecy. At its broadest, confidentiality in this context means that the information will be used for the purposes of the research project but, without further consent, for no other purpose. So understood, consent would permit the use of participants’ information in the publication of results and outcomes of the research. However, it is more likely that participants understand this to mean no more that only research team members will have access to information, which is also incomplete. However, the major shortcoming of this statement is the lack of detail – a description of the manner in which participants’ information will be collected, stored, analysed and used is most likely to provide clarity: facts are usually better than assurances.
4. All responses will be anonymous. This may also be intended as a response to the same National Statement paragraph as in 3, but it suffers from a similar degree of ambiguity. Sometimes, HREC members find it necessary to ask how information collected in a face-to-face interview can be anonymous, a question unlikely to please a researcher who has carefully planned how to conceal the identity of interviewees in the way that interview data is analysed and stored. Sometimes, responses cannot be anonymised either because of the process of collection – a focus group, for example – or because there are not that many alternative personal meanings for an “anonymous” description (e.g. senior Australian politicians describing their former careers as a merchant banker, journalist and lawyer). Sometimes, participants do not want to be anonymised and failing to allow for identification precludes this possibility and denies a participant’s choice.
5. All research information will be kept in a locked filing cabinet in a locked office. This is, as all the previous examples, a response to the National Statement, and where applicable, to the mandates of the Good Clinical Practice guidelines, but when it is used in relation to a project that collects and stores data digitally, it is simply irrelevant and entirely inadequate as a description of secure storage of such data. (In our experience, the use of digital data has lead to a decline in the use of this outdated expression, but it still recurs). It can also offer a shield to processes that necessitate data transfer across borders, sometimes between field sites and the research base, sometimes between multinational collaborators, and sometimes just because of naivete in relation to cloud-computing.
Some HRECs have adopted templates that look like they were drafted by a group of contract lawyers after a long lunch. One could imagine them saying to each other ‘go on, add those four paragraphs about liability for reputational damage. See if anyone notices’. Such examples, however jocular, usually reflect the fact that boilerplate language is used in contract to protect the drafting party, not to facilitate communication. We have observed some reactions that suggest the carefully crafted language can cause derision and/or be seen as a ‘do not sue us’ exercise.
Some HRECs adopt and police expression preferences, for example, participants should only be ‘invited’ to participate and not ‘requested’ etc; researchers should refer to ‘participants’ rather than ‘subjects’ even when such a term would simply mask a research design that provides for no meaningful participation; these idiosyncrasies can be particularly frustrating for researchers conducting multisite projects.
Use of templates and standard forms risks incomplete and even misleading communication and can lead to apparent pedantry in HREC responses. Use of templates with groups of participants for whom such a template is inappropriate because of their level of literacy, language impairment, cultural emphasis on oral provision of information or distrust of official forms, also undermines any effort to gain real consent rather than just documenting apparent compliance.
Perverse consequences can be reduced if not eliminated with a focus on the purpose of these documents and a preference for short descriptions of how researchers conduct research, collect, store, analyse and destroy data rather than bland assurances that participants’ expectations will be addressed.
A significant question that remains largely unasked and unanswered is whether the consent strategies that are based upon a review body’s template actually facilitate the informed and voluntary consent of potential participants? How are the language and objectives of such consent processes actually perceived? There has been research on related questions of the effectiveness of consent strategies more generally, in both social science and clinical research, but it is not clear whether the insights gained in these studies have informed the development of templates. The growth of consumer groups focussing on specific health conditions offer opportunities for collaborative development of templates more likely to be effective.
Good guides implement principles. Accordingly, good consent guides implement the principle of respect: for participants, researchers and HREC members: respect for participants’ capacity and freedom to decide about participation; respect for researchers’ expertise to devise clear means of informing participants and respect for HREC members’ ability to recognise specific contexts of proposed research to which applications apply and review those accordingly.
The following advice in the National Statement, at page 7, about its use, applies equally to the use of consent templates:
“These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement and an appreciation of context.”
With grateful thanks to Mark Israel and Nik Zeps for their input.
This post may be cited as:
Thomson C. (2017, 22 December 2017) Magical incantations and the tyranny of the template. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/magical-incantations-tyranny-template