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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Disaster Research and its Ethical Review0

 

Disaster research ethics is a growing area of interest within the research ethics field. Given the lack of a universal definition of disasters, it should not be a surprise that disaster research ethics is defined in various ways. Early approaches focused on ethical issues in conducting research in the acute phase of disasters (O’Mathúna 2010). Given the similarities of some of the ethical issues, it came to include humanitarian crises and emergencies. A recent review combined mental health research in natural disasters, armed conflicts and the associated refugee and internally displaced persons (IDP) settings (Chiumento et al. 2017). Each of these settings raises distinct ethical issues, as well as practical challenges for those ethically reviewing disaster research. The 2016 revision of the Council for International Organizations of Medical Sciences (CIOMS) research ethics guidelines included a section on disaster research (https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf). This blog will highlight a few of the practical challenges and note some efforts to respond to these.

One issue is how some disasters happen suddenly, while research ethics review takes time. The 2016 CIOMS guidelines call for innovative approaches to research ethics review, including ways to pre-assess protocols so that they can be reviewed rapidly once a relevant disaster occurs. As committees develop ways to adapt to disaster research, other review practices can be examined to identify innovative approaches to the challenges.

A key ethical issue to address with disaster research is whether a particular project should be conducted at this time with these particular participants. In the most immediate phase of an acute disaster, resources and energy should be focused on search and rescue. Researchers could hinder this, or divert scarce resources. At the same time, data should be collected as soon as possible to contribute to the evidence based for first responders. Ethics review committees should ensure justifications are provided for why a project needs to be done during the acute phase. Questions also need to be asked about whether disaster survivors have more important needs than to participate in research. For example, some have questioned whether children who survive war should be asked to participate in research when there are few resources available to help them with the mental health challenges of surviving war (Euwema et al. 2008).

With the move towards a more evidence-based approach to humanitarian work, international and non-governmental organisations (NGOs) are increasingly engaging in research and other evaluation programmes. Some of these organisations may have little experience with research or research ethics, and hence need additional support in developing and conducting projects. Much debate has occurred over what ‘counts’ as research and is therefore required to undergo formal research ethics approval. Rather than asking if a project is research or not, it is more important to identify the ethical issues in the project and ensure they are being addressed as carefully and thoroughly as possible (Chiumento et al. 2017). Needs assessments, projects that monitor or evaluate programmes, public health surveillance, and many other activities raise ethical issues whether or not they are formal academic research studies. At the same time, every project does not need to submit the same sort of detailed research ethics application as a randomised control trial of an experimental drug. Some sort of ethical evaluation should be conducted, and here again there is an opportunity to be innovative. Different formal and informal review mechanisms could be developed to support groups conducting different types of projects. The key concern should be that the ethical issues are being examined and addressed.

Also key here is that people in the communities from which participants will be sought are involved from the design of the project (O’Mathúna 2018). Too many ‘parachute projects’ have been conducted (some with ethical approval) whereby the project is designed completely by outsiders. Once everything has been decided, the team approaches the community only to identify a lack of interest in participating or that certain ethical challenges have been overlooked. Research in other cultures, especially in the midst of armed conflicts, is especially prone to such challenges. Review committees may need to encourage exploratory discussions between researchers and participant communities, or seek evidence of how such discussions have gone.

Unexpected ethical issues often arise in disaster research given the instability and complexity of its settings (O’Mathúna & Siriwardhana 2017). An approach where ethics review bodies give approval to projects and then have little or no engagement other than an annual report is especially inadequate in disasters. Researchers may be forced to make changes in fluid settings, or may encounter unexpected issues. Submitting amendments may not be practical or fast enough, when what is needed is advice and direction from those with research ethics expertise. Thus, initiatives are being developed to provide “on call” ethics advice.

This points to how disaster research often requires additional support and protection for researchers than other types of research. Researchers may enter danger zones (natural or violent) and may see or learn of horrors and atrocities. Researchers can be subjected to physical dangers or traumatised psychologically.. In addition to the normal stresses of conducting research, these additional factors can lead to mistakes and even ethical corner-cutting. Therefore, review committees need to carefully investigate how the physical and mental well-being of researchers will be protected and supported.

These are some examples of how research ethics needs to go beyond approval processes to mechanisms that promote ethical decision-making and personal integrity during research. One such project in which I am involved is seeking insight from humanitarian researchers into the ethical issues experienced in the field (http://PREAportal.org). We are also conducting a systematic review of such issues and collecting case studies from researchers. The goal is to produce a practical tool to facilitate learning lessons from disaster researchers and promote ethical decision-making within teams.

The world is increasingly experiencing disasters and conflicts and huge amounts of resources are put into responses. Some of these resources are put towards evaluating disaster responses, and developing evidence to support disaster responders. We can expect disaster research to increase and to be increasingly seen by research ethics committees. It is therefore important that ethics committees prepare themselves to respond to the ethical challenges that disaster research raises.

References

Chiumento, A., Rahman, A., Frith, L., Snider, L., & Tol, W. A. (2017). Ethical standards for mental health and psychosocial support research in emergencies: Review of literature and current debates. Globalization and Health 13(8). doi 10.1186/s12992-017-0231-y

Euwema, M., de Graaff, D., de Jager, A., & Kalksma-Van Lith, B. (2008). Research with children in war-affected areas. In: Research with Children, Perspectives and Practices, 2nd edition. Eds. Christensen, P. & James, A. Abingdon, UK: Routledge; 189-204.

O’Mathúna, D.  (2010). Conducting research in the aftermath of disasters: Ethical considerations. Journal of Evidence-Based Medicine 3(2):65-75.

O’Mathúna, D. (2018). The dual imperative in disaster research ethics. In: SAGE Handbook of Qualitative Research Ethics. Eds. Iphofen, R. & Tolich M. London: SAGE; 441-454.

O’Mathúna, D., & Siriwardhana, C. (2017). Research ethics and evidence for humanitarian health. Lancet 390(10109):2228-9.

Declaration of interests

Dónal O’Mathúna has been involved in research ethics for over twenty years. He was chair of the Research Ethics Committee at Dublin City University (DCU) for six years. In addition to his joint position at DCU and The Ohio State University, he is Visiting Professor of Ethics in the European Master in Disaster Medicine, Università del Piemonte Orientale, Italy. His research interests focus on ethical issues in disasters, in particular disaster research ethics. He was Chair of the EU-funded COST Action (2012-2016) on Disaster Bioethics (http://DisasterBioethics.eu) and is the Principal Investigator on the R2HC-funded research project, Post-Research Ethics Analysis (http://PREAportal.org).

Contributor
Dónal O’Mathúna, PhD
Associate Professor, School of Nursing & Human Sciences, Dublin City University, Ireland
Associate Professor, College of Nursing, The Ohio State University, Columbus, Ohio, USA
Dónal’s DCU profiledonal.omathuna@dcu.ie
Twitter: @domathuna
http://BioethicsIreland.ie

This post may be cited as:
O’Mathúna D. (2018, 26 February 2018) ‘Disaster Research and its Ethical Review’. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/disaster-research-ethical-review

Ethical Use of Student Data in Higher Education – Advancing the conversation0

 

In a 2016 conference paper discussing ethical use of student data I noted that there was a ‘disconnect between national and international perspectives of the importance of institutional policy and guidelines regarding ethical use of student data, and the perceptions of academics about these guidelines’ (Jones, 2016, p300). I suggested that one strategy for bridging this divide was for conversations to be held both within and between institutions with an aim of informing and enhancing learning and teaching practice and culture. This post provides an overview of some of the conversations that have occurred in this area in the last 12 months in Australasia, particularly through the Australasian Society for Computers in Learning in Tertiary Education (ASCILITE).

First though, my interpretation of the phrase ‘ethical use of student data’. To me, and I am sure many others, this is much more than applying for, and being granted, clearance from your institution’s Human Research Ethics Committee. Certainly, this is an important step if you are intending to disseminate your findings as research and publish, and is sometimes a step that academic staff can overlook if research in their discipline does not normally involve ethics approval, or they do not consider this as they are not directly researching students, just their data. Ethical use also considers:

  • Protection of student privacy
  • Conversations with students regarding reasons for collection and use of data
  • Ensuring that data is used for informing and enhancing practice and the student experience
  • Obtaining consent from students; or, at least, informing students how and why their data will be used

The ability for students to ‘opt out’ of any data collection is a sensitive issue as there are some circumstances, for example, research into online discussion forums where this could adversely affect the research if students were given this option. This is just one aspect that needs further conversations and development of policy and guidelines.

ASCILITE is considered a leading organisation in the southern hemisphere for staff working in tertiary education in ‘fields associated with enhancing learning and teaching through the pedagogical use of technologies’ (ASCILITE, 2014) and as such is well placed to be leading the cross-institutional conversation on ethical use of student data. In 2017 some of the ways these conversations were facilitated included

  • Learning Analytics Special Interest Group ran a series of webinars with one facilitated by Paul Prinsloo having the topic of Responsible Learning Analytics: A Tentative Proposal
  • The 2017 ASCILITE Conference included an Exploratory Panel Session discussing ‘emerging ethical, legal, educational, and technological issues surrounding the collection and use of student data by universities, and the impact these strategies have on student trust and privacy.’
  • The Learning Analytics SIG also held a panel session discussing scenarios for Utopian/Dystopian future in regards to Learning Analytics

However, there was only one submitted paper with reference to ethical use of data (Brooker, Corrin, Mirriahi & Fisher, 2017). Similarly for the upcoming Learning Analytics Knowledge conference (LAK18), only one paper has any reference to ethics in the title, and at the 2017 conference there was one session with 3 papers. This suggests that whilst national and international bodies are promoting the conversations, there is still a way to go before these happen widely within institutions. Are there other organisations that are facilitating similar discussions?

Whilst promoting these conversations is a useful first step, there is also a need to continue to develop guidelines and processes. These will help ensure that staff are submitting ethics applications and their work with student data is conducted in an ethical manner. Additionally, Human Ethics staff need to work alongside academics and Learning & Teaching support staff; journals and conferences need to ensure that appropriate ethics approvals have been obtained and institutions need to involve students in all facets of Learning Analytics. These strategies will promote more widespread adoption of ethical practices in use of student data to inform and enhance learning and teaching practice and culture, and, ultimately, the student experience. Hopefully initiatives such as those outlined in this post will continue to grow and spark the necessary conversations – who will join us?

References

ASCILITE (2014) About ASCILITE. Retrieved from http://ascilite.org/about-ascilite/

Brooker, A., Corrin, L., Mirriahi, N. & Fisher, J. (2017). Defining ‘data’ in conversations with students about the ethical use of learning analytics. In H. Partridge, K. Davis, & J. Thomas. (Eds.), Me, Us, IT! Proceedings ASCILITE2017: 34th International Conference on Innovation, Practice and Research in the Use of Educational Technologies in Tertiary Education (pp. 27-31). Retrieved from http://2017conference.ascilite.org/wp-content/uploads/2017/11/Concise-BROOKER.pdf

Jones, H. (2016). Ethical considerations in the use of student data: International perspectives and educators’ perceptions. In S. Barker, S. Dawson, A. Pardo, & C. Colvin (Eds.), Show Me The Learning. Proceedings ASCILITE 2016 Adelaide (pp. 300-304). Retrieved from http://2016conference.ascilite.org/wp-content/uploads/ascilite2016_jonesh_concise.pdf

Declaration of Interests

Hazel Jones is a member of the ASCILITE Executive Committee and one of the facilitators for the Learning Analytics SIG.

Contributor
Hazel Jones
PhD candidiate/Educational Designer | University of Southern Queensland | USQ Staff ProfileHazel.Jones@usq.edu.au

This post may be cited as:
Jones H. (2018, 22 February 2018) ‘Ethical Use of Student Data in Higher Education – Advancing the conversation’. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/ethical-use-student-data-higher-education-advancing-conversation

What’s at risk? Who’s responsible? Moving beyond the physical, the immediate, the proximate, and the individual0

 

Building the Conversation

This month’s addition to the Building the Conversation series reflects upon how we approach risks beyond those that are physical, harm people other than a project’s participants and harms that are not immediate.

To some extent, when researchers reflect upon those harms associated with a project, they may well limit their assessment of risk to the here and now and to identifiable individuals. In addition, for projects in the medical sciences, those risks were long understood as predominantly physical in the form of injury, infection or disability and related to direct participants (e.g. persons who received an experimental pharmacological agent). This limited vision is not particularly surprising. One of the perverse consequences of requiring researchers to reflect on whether the potential benefits of research justify risk to participants is that some researchers are dissuaded from looking too carefully for risks and therefore avoid developing strategies for minimising these risks and mitigating possible harms. Even more perversely, this reluctance can trigger in human research ethics committees an unrealistic level of risk aversion.

It is vital that we remember that it is primarily the responsibility of researchers to identify, gauge and weigh the risk. Research ethics review bodies have the role of providing feedback to researchers to facilitate projects, not catch out researchers and chastise them for neglecting a risk. This is especially true if we do not have resource material to assist researchers with regard to this wider focus.

We need to improve our understanding of the complexity of risks, extending our vision to look beyond the physical, the immediate, the proximate, and the individual risks. At the same time, we need to review our understanding of on whom the responsibility for the identification, mitigation ad management of all of these risks should fall.

In recent decades, national human research ethics frameworks, such as the Australian National Statement on Ethical Conduct in Human Research (National Statement) (NHMRC 2007a) have augmented their original interest in physical harm with a much broader set of psychological, legal, economic and social harms. Documents such as the Australian Code for the Responsible Conduct of Research (NHMRC 2007b) cast this net wider still to include societal and environmental risks. However, the likelihood of incidence, the significance of the harm and the timing of such harms can be harder to predict, quantify and mitigate.

We are fuelling the potential for an adversarial climate (Israel et al., 2016) if we fail to provide researchers and our research ethics reviewers with guidance on how to approach such matters.

Human research ethics committees, guided by the frameworks in which they function, focus on immediate risks directly to the participants in a project. For example, the National Statement requires committees to be satisfied that “the likely benefit of the research must justify any risks or discomfort to participants.” (NHMRC, 2007, 10). Committees can feel less equipped to tackle risks that can affect participants after the active phase of a project, such as harms to the reputation and standing of a group that can come from the research output that is distributed long after data collection and perhaps years after the research ethics review.

Harm can also impact upon populations and social/professional/community groups much wider than the actual participants. For, example, research into the academic performance of children from schools in a low socio-economic area if reported insensitively by researchers or, indeed by the media, can further stigmatise the kids, and harm the reputation of the schools and teachers. Again, work on the informal income of members of marginalised communities might be used subsequently by government to target tax avoidance by the already vulnerable. Lastly, research on the attitudes of residents in coastal communities to climate change and rising sea levels can detrimentally effect the value of surrounding land. Indeed, some review processes require researchers to consider the possibility of adverse findings (both medical and non-medical in nature). Although the National Statement, (NHMRC, 2007 p.13), recognises risks of this kind, it leaves unclear whose responsibility they are.

Focussing on the rights of individuals from a Western liberal democratic perspective is unlikely to be helpful in other contexts, such as an Aboriginal and Torres Strait Islander community, in a cultural context where a Confucian approach would be more appropriate (Katyal, 2011), or even in some organisational settings where accountability is partly achieved through openness to external scrutiny in the form of research and evaluation. As a result, there have also been prompts to consider risks to identifiable third parties, groups, institutions, communities (Weijer et al., 1999). Values and Ethics and the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) do recognise such matters might be considered by some potential participant pools on a collective basis and perhaps with an knowledge of a history of research abuse and exploitation of their communities and this attention to collective interests can be echoed in other work on research ethics and Indigenous peoples around the world (Israel, 2015).

This is perhaps one of the reasons why some minorities have produced their own research ethics guidance documents (for examples, see Hudson et al. (2010), Nordling (2017) and Islamic Council of Victoria (2017)). The value of this kind of guidan this on some for the moments that it clarifies that it is on researchers that the important responsibility lies to foresee, mitigate and manage these risks.

Another example of deleterious impacts from research that might not be immediately obvious to researchers, research ethics reviewers or research office staff arises in the category of ‘dual use’ research (Miller and Selgelid, 2007). This where a technique, technology or an apparently non-military discovery can be used for military or terrorist purposes – sometimes with devastating effect. Initially, the concern of biomedical scientists, the issue has also troubled anthropologists, geographers, sociologists, political scientists and international relations experts in the face of overt or covert funding by military or intelligence agencies (Israel, 2015). One of the growing challenges for a significant proportion of such work (e.g. quantum computing, computer security/intrusion/hacking, smart materials, computer vision and energy storage) is the work will not typically require research ethics or any other form of independent review. The existing model of human research ethics review is initially attractive as a response, but some reflection will quickly show that ethics committees are not likely to possess the expertise/information to identify the dual use and the work may be occurring in disciplines that have not built their capacity to think through the ethics of working with human participants.

Australia has a strengthened export control framework with regard to security classification, Defence Department permits/approvals and other requirements (e.g. data security). Many Australian universities have established dedicated teams and processes for this particular area of concern. It remains an area of community concern (see Hamilton and Joske, 2017). Such controls involve balancing academic freedom, a commitment to open science and the value of scientific discovery against (inter)national security, trade and diplomatic interests. Such a balancing exercise is plainly beyond the capacity required for human research ethics review, so that the responsibility needs to rely on another mechanism.

The implications of all of this are not trivial. This all requires a change in thinking for researchers, institutions, funding bodies, learned academies and regulators. Our attention to the potential harms from a project needs to encapsulate research outputs, impacts upon communities, persons who were not direct participants in the project as well as national interests. At the same time, the consideration of a project vis-à-vis the ethical principle of research merit needs to include broader societal benefits and contributions to knowledge that might also involve a much wider group and a longer timeframe than the ones to which we are accustomed. However, in order to reach a more sophisticated analysis of the balance between potential harms and benefits, we need to more clearly allocate responsibility for such risks and devise mechanisms that reassure the community that these responsibilities have been fulfilled.

In our view, merely widening the scope of the responsibilities of human research ethics committees to address all these risks could not only exacerbate the propensity for risk aversion, but could also distort their important focus on the welfare of research participants. The current review system needs to find ways of working constructively with other processes that build the capacity of researchers and their institutions to work with these broader risks and benefits.

Institutions must have resource materials for researchers and research ethics reviewers that have the primary objective of resourcing reflective practice and building expertise in risk assessment and mitigation. Researchers must recognise these matters as their primary responsibility and research ethics reviewers must focus upon facilitation not enforcing compliance. We have written about how institutions can implement such an approach (Israel and Allen, in press).

In short, we cannot afford to ignore these challenges. Instead, we should take innovation seriously and seek constructive solutions.

References

Allen, G. and Israel, M. (in press, 2018) Moving beyond Regulatory Compliance: Building Institutional Support for Ethical Reflection in Research. In Iphofen, R. and Tolich, M. (eds) The SAGE Handbook of Qualitative Research Ethics. London: Sage.

Hamilton, C. and Joske, A. (2017) Australian taxes may help finance Chinese military capability. The Australian. http://www.theaustralian.com.au/news/inquirer/australian-taxes-may-help-finance-chinese-military-capability/news-story/6aa9780c6a907b24993d006ef25f9654 [accessed 31 December 2017).

Hudson, M., Milne, M., Reynolds, P., Russell, K. and Smith B. (2010) Te Ara Tika. Guidelines for Māori Research Ethics: A Framework for Researchers and Ethics Committee Members. http://www.hrc.govt.nz/sites/default/files/Te%20Ara%20Tika%20Guidelines%20for%20Maori%20Research%20Ethics.pdf (accessed 29 December 2017).

Islamic Council of Victoria (2017) ICV Guidelines for Muslim Community-University Research Partnerships. http://www.icv.org.au/new/wp-content/uploads/2017/09/ICV-Community-University-Partnership-Guidelines-Sept-2017.pdf (accessed 29 December 2017)

Israel, M. (2015) Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. London: Sage.

Israel, M., Allen, G. and Thomson, C. (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W. and Hamilton, A. (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp 285-316. http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Katyal, K.R. (2011) Gate-keeping and the ambiguities in the nature of ‘informed consent’ in Confucian societies. International Journal of Research & Method in Education 34(2): 147-159.

Miller, S. and Selgelid, M. (2007) Ethical and philosophical consideration of the dual use dilemma in the biological sciences. Science and Engineering Ethics 13: 523-580.

NHMRC (2007a) National Statement on Ethical Conduct in Human Research. http://www.nhmrc.gov.au/guidelines-publications/e72 (accessed 29 December 2017).

NHMRC (2007b) Australian Code for the Responsible Conduct of Research. http://www.nhmrc.gov.au/guidelines-publications/r39 (accessed 29 December 2017).

Nordling, L. (2017) San people of Africa draft code of ethics for researchers. Science, March 17. http://www.sciencemag.org/news/2017/03/san-people-africa-draft-code-ethics-researchers (accessed 29 December 2017).

Weijer, C., Goldsand, G. and Emanuel, E.J. (1999) Protecting communities in research: Current guidelines and limits of extrapolation. Nature Genetics 23: 275-280.

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. (2018, 1 February 2018) What’s at risk? Who’s responsible? Moving beyond the physical, the immediate, the proximate, and the individual. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/whats-risk-whos-responsible-moving-beyond-physical-immediate-proximate-individual

Magical incantations and the tyranny of the template0

 

Building the Conversation

This month’s addition to the Building 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

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