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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Magical incantations and the tyranny of the template0

Posted by Admin in Human Research Ethics on December 21, 2017 / Keywords: , , , ,
 

Building the Conversation

This month’s addition to the Buildinding the Conversation series reflects upon how institutional template consent material can have odd results/ill suited/nonsensical consequences.

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.

Cartoon female figure holding a massive consent form with a confused expression.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.”

Acknowledgement

With grateful thanks to Mark Israel and Nik Zeps for their input.

Contributors
Colin Thomson – Senior Consultant, AHRECS | AHRECS biocolin.thomson@ahrecs.com

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

Ethical use of social media as a recruitment tool0

 

Building the Conversation

From this month we will start including posts about the ethical design of human research. Our intent is not to present these ideas as the definitive or only way to approach a particular challenge/need but instead as prompts to get us all – participants, researchers, reviewers, regulators, administrators and other stakeholders – discussing useful and helpful approaches to the design, research ethics review and conduct of human research.

There are numerous reasons why social media can appear an attractive way to reach potential participants – it may be free or at least relatively inexpensive, it is increasingly ubiquitous across a range of Australian age groups (Sensis, 2017), and can be a powerful way to build an ongoing connection with a cohort of potential participants.

A recent issue of The American Journal of Bioethics focussed on the ethics of using social media as research platforms. An article by Luke Galinas and his colleagues (Galinas et al., 2017) noted the lack of resources and regulatory guidance in the United States on the use of social media as a recruitment tool. They concluded that this was a significant problem since, for all its benefits, use of social media is not without ethical and practical challenges and traps. Fortunately, these are not insurmountable. Galinas’ article explored how biomedical researchers might respond in the United States by attending to the issues of researcher transparency and respect for the privacy of participants; in this blog post, we provide advice for Australian researchers and reviewers in an effort to stimulate further discussion between them.

Excluding some potential participants – The penetration of social media platforms across all age groups of the Australian population over the last ten years has been truly remarkable. There do remain, however, some significant differences on the extent of usage depending on age, geographic location and socio-economic status. Consequently, open recruitment via social media may skew a participant pool towards area where social media use is more prevalent and may inadvertently exclude some groups of people with perspectives, views or voices that might undermine the value of a project’s finding.

Platform differences and exclusion – Not every social media platforms had the same user demographics; someone who uses social media 15 times per day may only be frequenting one platform. There is no single platform that is used by most social media users. Indeed, even platforms such as Facebook seem to be used more by a particular age-range of people within the Global North. Other countries have their own platforms that are heavily used within the region (e.g. China – WeChat (微信; Wēixìn) and Russia – VK social media (Vkontakte) and Odnoklassniki), but hardly ever by people outside that region.

Privacy rules and concerns – Privacy concerns are amongst the more significant reasons why some people do not currently use social media (Sensis, 2017). Indeed, many users do not understand the privacy rules of their preferred platform(s) and remain concerned about privacy. One large survey conducted by Evans et al. (2015) suggested that concern was greater among younger and more frequent users.

Comments from participants and others – Enabling participants to comment on the recruitment social media pages for a project might be an effective way to engage with potential participants. However, there are important reasons for caution about allowing participants to comment on such pages as they might expose themselves to risk. Individuals might divulge whether they are participants or were excluded by the screening tool. In addition, they might distort the data collected from others by prompting particular responses to their own comments.

Pseudonyms and de-identification –The presumptive remedy to many social media challenges is to delete, modify or otherwise obfuscate personal identifiers such as user names. However, some platform rules often specifically preclude such an approach (e.g. Twitter treats any such de-identification as a copyright concern). Furthermore, modifications of comments or descriptions raises at least the possibility the researcher fabricated or falsified data (much as occurred in Alice Goffman’s offline study, see Neyfakh, 2015).

Recruitment materials – Many national human research ethics arrangements, such as Australia’s National Statement on Ethical Conduct in Human Research specify that review bodies must consider and first approve recruitment materials, including the text of posts to go on a social media page. In most cases, this role will be delegated to the Chair (for executive review) or the Ethics Officer (for administrative review). The rigour and substance of this review should be proportionate to the risks and ethical sensitivities of a project. The need and purpose of this review reflects the potential for risks, privacy and other human research ethics matters that can be associated with a project’s recruitment strategy.

The application for research ethics review should cover the above matters and explain why the applicant believes the proposed approach is ethical, appropriate, respectful and justified. Such matters may also need to be discussed in the consent (if not the recruitment) materials. Similarly, research ethics reviewers should expect such a justification to be provided, be open to and accepting of innovation, offer praise where due, and share their thinking where uncomfortable with a proposed approach.

Like most topics in human research ethics, there is no single ‘correct’ approach with regard to recruitment and social media. Ethical research may be best pursued through reflection and collegial discussion.

References

Evans H, Ginnis S and Bartlett J (2015) #SocialEthics: A guide to embedding ethics in social media research.

Gelinas L. et al. (2017) Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations. The American Journal of Bioethics, Vol. 17, No. 3. DOI: 10.1080/15265161.2016.1276644

Neyfakh, L. (2015) The Ethics of Ethnography. Slate Magazine. Retrieved 8 November 2017, from http://www.slate.com/articles/news_and_politics/crime/2015/06/alice_goffman…

NHMRC (2007) National Statement on ethical conduct in human research. http://www.nhmrc.gov.au/guidelines-publications/e72.

Sensis (2017) Social Media Report 2017. Retrieved from: https://www.sensis.com.au/asset/PDFdirectory/Sensis_Social_Media_Report_2017-Chapter-1.pdf (accessed 7 November 2017)

Other reading

Chamber C (2014, 1 July) Facebook fiasco: was Cornell’s study of ‘emotional contagion’ an ethics breach? The Guardian. Retrieved from http://www.theguardian.com/science/head-quarters/2014/jul/01/facebook-cornell-study-emotional-contagion-ethics-breach (accessed 8 November 2015)

Leetaru K (2016, 17 June) Are Research Ethics Obsolete in the Era of Big Data? Forbes/Tech
http://www.forbes.com/sites/kalevleetaru/2016/06/17/are-research-ethics-obsolete-in-the-era-of-big-data/#1a083ad31cb9

Contributors
Dr Gary Allen | Senior Consultant AHRECS | Gary’s AHRECS biogary.allen@ahrecs.com

Prof. Mark Israel | Senior Consultant AHRECS | Mark’s AHRECS biomark.israel@ahrecs.com

This post may be cited as:
Allen G. and Israel M. (2017, 20 November 2017) Ethical use of social media as a recruitment tool Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/ethical-use-social-media-recruitment-tool

Ethics and the Participation of Indigenous Children and Young People in Research0

 

Indigenous children and young people’s participation in social research raises a range of ethical issues that researchers and participants must grapple with prior to and throughout the research process. These issues include for example, matters to do with protocols for seeking consent, ensuring the research process is culturally respectful and age appropriate, whether the research environment and methods used are child friendly and participants can freely express their views, and ensuring the research endeavour is mutually beneficial.

In Australia, all research involving Indigenous children and young people must be guided by, and adhere to the principles articulated in the National Statement on Ethical Conduct in Human Research (‘National Statement’), particularly chapter 4.2 of that Statement. If the research is health related it must comply with the National Health and Medical Research Council’s Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (‘NHMRC Values and Ethics Guidelines’). These documents instruct researchers about how to undertake research in an ethically sound manner, and the principles they contain are fundamental to the manner in which Australian ethics committees assess human research applications. Additionally, the Guidelines for Ethical Research in Australian Indigenous Studies (‘AIATSIS Guidelines’) are particularly instructive and helpful and are becoming more widely used by researchers and ethics committees alike.

There is a gap however, in relation to a comprehensive ethical framework for the involvement of Indigenous children and young people in social research. The National Statement communicates the ethical parameters for the involvement of children in research; and the NHMRC Values and Ethics Guidelines and the AIATSIS Guidelines set out a framework for the involvement of Indigenous people in research. The National Statement specifically refers to research relating to children and young people, but does not mention research relating to Indigenous children and young people; and there is no mention of children or young people in either the NHMRC Values and Ethics Guidelines nor the AIATSIS Guidelines. Thus, in Australia there is no single overarching ethical framework that specifically pertains to the involvement of Indigenous children and young people in research. Read together however, these three documents provide a firm basis upon which to develop and assess the breadth of ethical considerations regarding the involvement of Indigenous children and young people in research, particularly when read in conjunction with the Convention on the Rights of the Child (CRC) and the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP).

There is much to say about the CRC and the UNDRIP in relation to Indigenous children and young people’s participation in research. All research endeavours involving children and young people must uphold the comprehensive body of children’s rights set out in the CRC. These rights are numerous, therefore the task of ensuring compliance with the CRC for child related research may at first instance appear overwhelming for researchers. One vital provision in the CRC is worthy of focused attention. This is the principle articulated in article 12—children’s right to participate in ‘all matters affecting’ them. This is an instructive and appropriate starting point for researchers to base their considerations of how a research process can adhere to children’s rights principles, and in doing so create a child friendly, culturally respectful and age appropriate research environment that reduces risks participants may experience as a result of taking part in the research. Article 12 of the CRC provides that:

States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child.

Article 12 aligns well with the ethical considerations specific to children and young people outlined in chapter 4.2 of the National Statement. Article 12 is widely accepted as the ‘lynchpin’ of the CRC, and a foundational right upon which other rights depend and emerge. The Committee responsible for overseeing the global implementation of the CRC makes this clear when they said article 12 ‘establishes not only a right in itself, but should also be considered in the interpretation and implementation of all other rights.’

The language of this provision is strong. Note the use of compelling words such as ‘shall assure’ emphasising children’s right to free expression, and the all-encompassing subject matter to which the provision applies, namely to ‘all matters affecting’ them. These words are emphatic and when they came into force this drastically altered the pre-CRC, and post CRC, rights framework for children globally.

Involving Indigenous children and young people in research processes, particularly by non-Indigenous researchers, must be carried out in accordance with national guidelines, and in a way that upholds participant’s rights as children in accordance with the CRC, as well as their rights as Indigenous peoples in line with the UNDRIP.

In the absence of a comprehensive and unified ethical framework for engaging Indigenous children and young people in research I developed a model and detailed this in my PhD as well as in the Monash University Law Review. This model is a child rights-based approach informed by Indigenous research methodologies that uses child friendly and culturally sensitive research methods: yarning and peer-to-peer video interviewing to engage children and young people in research. This model is based on national ethics guidelines, the provisions set out in the CRC and UNDRIP, and draws on current scholarship in the area. The development of this model contributes to enhancing the ethical framework that regulates and guides the participation of Indigenous children and young people in social research.

References

Australian Institute of Aboriginal and Torres Strait Islander Studies, Guidelines for Ethical Research in Australian Indigenous Studies (2nd revised ed, 2012)

Bessarab, Dawn and Bridget Ng’andu, ‘Yarning About Yarning as a Legitimate Method in Indigenous Research’ (2010) 3(1) Journal of Critical Indigenous Studies 37

Convention on the Rights of the Child opened for signature 20 November 1989, 44 UNTS 25 (entered into force 2 September 1990)

Doel-Mackaway, Holly, ‘“I think it’s Okay … But it’s Racist, it’s Bad Racism”: Aboriginal Children and Young People’s Views about the Intervention’ (2017) 43(1) Monash University Law Review (forthcoming Sept, 2017)

Freeman, Michael, ‘Whither Children: Protection, Participation, Autonomy?’ (1994) 22(3) Manitoba Law Journal 307

National Health and Medical Research Council, the Australian Research Council and the Australian Vice-Chancellors’ Committee, ‘National Statement on Ethical Conduct in Human Research’ (2007, updated December 2013)

National Health and Medical Research Council, Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (Commonwealth of Australia, 2003)

UN Committee on the Rights of the Child, General Comment No 12, ‘The Right of the Child to be Heard,’ UN Doc CRC/C/GC/12 (1 July 2009)

United Nations Declaration on the Rights of Indigenous Peoples, GA Res 61/295, UN GAOR, 61st sess, 107th plen mtg, Supp No 49, UN Doc A/RES/61/295 (13 September 2007)

Contributor
Dr Holly Doel-Mackaway | Lecturer | Macquarie Law School | Dr Doel-Mackaway’s Macquarie staff pageholly.doel-mackaway@mq.edu.au

This post may be cited as:
Doel-Mackaway H. (2017, 21 September 2017) Ethics and the Participation of Indigenous Children and Young People in Research Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/ethics-participation-indigenous-children-young-people-research

Terms and conditions apply0

 

Kids tell us that making decisions can sometimes be hard (anyone who has taken a child to an ice cream shop can attest to this). Adults don’t often give children choices and kids tell us that when they do it can be confusing: ‘what am I being asked?’, ‘can I really say no?’, ‘do they seriously care?’ and ‘what will happen if I make a decision the adult doesn’t like?’ are questions that might spring to mind. After all, they tell us that it’s not usual for adults to seek out children’s views, to let them make big decisions or to give up some of their ‘adult power’ and act on children’s wishes.

And yet children are required to ‘assent’ to research, often with little information about what research actually is and what they will be required to do. In most cases, they know that their parents have already given permission for them to be involved – which may be reassuring but also a bit daunting (how often is it that kids can say ‘no’ when their parents have already said ‘yes’?) – but in most cases a complete stranger comes into their home or schoolroom and pulls out a note pad and asks them whether their happy to answer a few questions. “Um OK?”

Since the Helsinki Declaration there has been an expectation that children provide assent to their participation in research. Often this entails providing them with a long-winded, legalistic and ‘pretty boring’ information letter, telling them that if they agree they might get a movie voucher or at least a packet of chips and a can of soft drink before asking them to tick a box to show that they agree. As a child in one of my studies reported, the process is ‘kinda like’ the terms and conditions process they go through when downloading a new app from i-Tunes. Like 73% of Terms and Conditions non-readers, kids in research often have no idea what they are signing up for and what their rights are when things go wrong.

In a recent study my colleagues and I conducted for the Australian Royal Commission into Institutional Responses to Child Sexual Abuse we got advice from children and young people about how to best help kids understand and consent to participating in research on a fairly sensitive topic. Based on this advice we conceptualized consent as an ongoing process that included six steps: (1) present information in a child-friendly and accessible way; (2) make sure they understand what research is and what they are expected to do; (3) give them the choice to participate (or not) and ask them to formally agree; (4) give them lots of opportunities (and the skills or tools) to bow out of the research (particularly after they’ve got a ‘feel’ for what they are being asked to do) or to change the way that they are participating; (5) be aware of the ways that kids resist or ‘dissent’ (yawning or sneaking out of the room might give it away) and constantly ‘check in’ with them in child-friendly ways (6) Get an agreement with them at the end of the research activity that they are still happy for their input to be included in the study and negotiate what, if anything, they’re happy for the researcher to share with their parent, teacher or older sibling who is standing behind the door.

In the paper “More a marathon than a hurdle: towards children’s consent in a safety study” my colleagues and I outline how we went through these steps with kids, we describe how we used felt toys, ‘stop signs’ and ‘rights posters’ to help children and young people consent and, most importantly, quote advice and feedback from children and young people on how adult researchers might best help kids to make decisions within the research context.

One tool we feature in the article is our “Charter of Rights” poster which we provide kids in our studies. The poster informs them of what they should expect from us, as researchers, and what to do if they are unhappy. The poster is given to the children prior to them meeting with our staff and is further explained before assent is sought. On the advice of children and young people who have advised our projects, the rights charter has also been used as the basis of a series of games and activities that can be used to help children understand their rights in research (and in welfare practice). More detail about these can be found here. My team at the Institute of Child Protection Studies are working with peers from the Centre from Children and Young People (Southern Cross University), UNSW and the University of Melbourne to progress ethical research with children and young people. We’re currently hosting a survey on ethical decision-making – take a minute to fill it in! We’re keen to chat with others who are grappling with how to meaningfully engage kids in research (and support them to make good decisions) and would love to hear from you. *Terms and Conditions Apply.

Contributor
Dr Tim Moore
Senior Research Fellow | Institute of Child Protection Studies, ACU
Bio page at ACUTim.Moore@acu.edu.au

This post may be cited as:
Moore T. (2017, 21 July) Terms and conditions apply; Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/terms-conditions-apply

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