Mark Israel (AHRECS and Murdoch University) and Farida Fozdar (The University of Western Australia).
There is considerable momentum behind the argument that public data is a national asset and should be made more easily available for research purposes. In introducing the Data Sharing and Release Legislative Reforms Discussion Paper in September 2019, the Australian Commonwealth Minister for Government Services argued that proposed changes to data use in the public sector would mean that
Australia’s research sector will be able to use public data to improve the development of solutions to public problems and to test which programs are delivering as intended—and which ones are not.
Data reuse is seen as a cost-efficient use of public funds, reducing the burden on participants and communities. And, the argument is not restricted to government. Journals, universities and funding agencies are increasingly requiring social scientists to make their data available to other researchers, and even to the public, in the interests of scientific inquiry, accountability, innovation and progress. For example, the Research Councils United Kingdom (RCUK) takes the benefits associated with data sharing for granted
Publicly-funded research data are a public good, produced in the public interest; Publicly-funded research data should be openly available to the maximum extent possible.
In Australia, both the National Health and Medical Research Council (NHMRC) and the Australian Research Council (ARC) have adopted open access policies that apply to research funded by those councils. While the ARC policy only refers to research outputs and excludes research data and research data outputs, the NHMRC strongly encourages open access to research data.
And yet, several social researchers have argued that data sharing requirements, developed in the context of medical research using quantitative data, may be inappropriate for qualitative research. Their arguments rest on a mix of ethical, practical and legal grounds.
In an article entitled ‘Whose Data Are They Anyway?’, Parry and Mauthner (2004) recognised unique issues associated with archiving qualitative data. The main considerations are around confidentiality (is it possible to anonymise the data by changing the details without losing validity) and informed consent (can participants know and consent to all potential future uses of their data at a single point in time?, and alternatively what extra burden do repeated requests for consent place on participants?).
There is also the more philosophical issue of the reconfiguration of the relationship between researchers and participants including moral responsibilities and commitments, potential violations of trust, and the risk of data misrepresentation. There are deeper epistemological issues, including the joint construction of qualitative data, and the reflexivity involved in preparing data for secondary analysis. As a result, Mauthner (2016) critiqued ‘regulation creep’ whereby regulators in the United Kingdom have made data sharing a moral responsibility associated with ethical research, when in fact it may be more ethical not to share data.
In addition, there is a growing movement to recognise the rights of some communities to control their own data. Based on the fundamental principle of self-determination, some Indigenous peoples have claimed sovereignty over their own data: ‘The concept of data sovereignty, … is linked with indigenous peoples’ right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions, as well as their right to maintain, control, protect and develop their intellectual property over these.’ (Tauli-Corpuz, in Kukutai and Taylor, 2016:xxii). The goal is that its use should enhance self-determination and development.
To be fair to both the Commonwealth Minister and the RCUK, each recognises that data sharing should only occur prudently and safely and acknowledges that the benefits of sharing need to be balanced against rights to privacy (the balance proposed for earlier Australian legislative proposals have already been subjected to academic critique). The challenge is to ensure that our understanding of how these competing claims should be assessed is informed by an understanding of the nature of qualitative as well as quantitative data, of how data might be co-constructed or owned, of the cultural sensitivity that might be required to interpret and present it, and the damage that might be done as a result of misuse or misrepresentation.
Acknowledgements This article draws on material drafted for Fozdar and Israel (under review). .
References:
Fozdar, F. and Israel, M. (under review) Sociological ethics. In Mackay, D. and Iltis, A. (eds) The Oxford Handbook of Research Ethics. Oxford: Oxford University Press.
Kukutai, T. and Taylor, J. (Eds.) (2016) Indigenous data sovereignty: Toward an agenda (Vol. 38). Canberra: ANU Press.
Mauthner, N.S. (2016) Should data sharing be regulated? In van den Hoonard, W. and Hamilton, A. (eds) The Ethics Rupture: Exploring alternatives to formal research-ethics review. University of Toronto Press. pp.206-229.
Parry, O. and Mauthner, N.S. (2004) Whose data are they anyway? Practical, legal and ethical issues in archiving qualitative research data. Sociology, 38(1), 139-152.
Suat Chin Ng. MBBS, BMedSc, FRACS. Department of Surgery, Eastern Health, Melbourne, Australia.
Wei Ming Ong MBBS Department of Surgery, Eastern Health, Melbourne, Australia.
Shane Belvedere MBBS Department of Surgery, Melbourne Health, Melbourne, Australia
Creski Gilong. MBBS Department of Surgery, Austin Health, Melbourne, Australia.
Dr Nikolajs Zeps. BSc, PhD Research and Development, Epworth HealthCare, Melbourne, Australia. Eastern Clinical School, Monash University, Melbourne, Australia
Philip Smart MBBS, D.Med.Sci, FRACS. Gastrointestinal Clinical Institute, Epworth HealthCare, Australia Department of Surgery, Austin Health, Melbourne, Australia.
Compliance with ethical standards is fundamental to conducting human research. While there is a need for a thorough review process to prevent unethical research, the administrative workload required can often be significant. Indeed, researchers largely regard the ethics process as an obstacle that needs to be overcome, rather than a key part of the research process itself. In a recent blog on the AHRECS website entitled “Research Ethics Review as a Box-Ticking Exercise”, A/prof Angela Romano identified a significant problem with our current approach to ethical review as being one that promotes a compliance mentality rather than one that actively encourages appropriate and useful ethical reflection throughout the lifecycle of a research project.
Health and Medical Research is aimed at providing new knowledge to improve the health and wellbeing of the community and the fruits of this work will hopefully translate into tangible benefits for everyone. Significant concerns have been expressed by others that the current processes employed to regulate this work in fulfilment of ethical and legal requirements can itself be unethical. For instance, in a recent Blog by Prof Julian Savulescu he comments that whilst no-one is suggesting that research should not be subject to appropriate regulation and ethical review, given the potential to unnecessarily delay important research, all review processes should be as efficient and proportionate to the risk as is possible. Whilst we cannot immediately fix the lamentable lack of investment in undergraduate and post-graduate training in and practical application of ethics, the processes for review of projects could, in our view, be vastly improved with some fairly low-cost interventions.
What are researchers supposed to do to obtain ethical approval?
We reviewed the webpages of 78 Human Research Ethics Committees (HREC) associated with both public and private health services that we identified from the NHMRC list of registered HRECs. This list is only current to 1st March 2018 and we noted that several of the listed HRECs have in fact closed leaving just 71 that could be assessed. We also excluded from our review websites of small clinics which appear to serve only their own needs, eg IVF clinics.
Our review aimed to assess the ease with which researchers could find the webpages of the HREC, or the office of research and/or governance responsible for research oversight, and the level of information provided in terms of 1) instructions relating to how to make a submission itself, and 2) instructions about ethical considerations that may assist researchers to make a sound submission along the lines of A/Prof Romano’s wishes. We scored these objectively using a binary score of 1 if they had a readily accessible website and 0 if they did not. We scored the information related to the submission process in the same way, that is it was either present or not. We decided to include whether or not there was a clear process for considering low risk research in an expedited way consistent with the National Statement as this provided an insight into whether or not the institution regarded such research in a proportionate manner. We further checked on some of the linked documents and policies provided by the HREC, such as guidance on reporting of Serious Adverse Events (SAEs), to check for consistency and whether they were up to date with current guidelines.
We were surprised to find that 8 of 71 hospital based HRECs did not have a website that we could find. In some instances, the information about the HREC was provided via a central state-based portal where elements of the submission process and key local contact details were provided for each of the HRECs. We checked all of the links present in these websites and found that many were broken and in over half of all cases the links to the relevant policies, procedures, and key guidance documents were significantly out of date.
In contrast, we did find several websites that provided excellent resources such as those provided by the St Vincent’s HREC based in Melbourne and the Bellberry private HREC, which are exemplary in the level of useful information and easily accessible guidance they provide to researchers. We observed that of all of the HREC websites reviewed, 30 of the top 37 HRECs which all had accessible websites with useful information about submission were certified HRECs. Only 6 of the bottom 31, with what we considered to be inadequate levels of guidance information, were certified. This raises an interesting question as to whether the need to become certified led them to invest significantly in all aspects of the administrative process, including the development of useful websites.
Table 1: Key findings overall
Criteria
No of HRECs scoring 1 (total 71)
Easily accessible information about key functions
62 (87%)
Clear instructions about submission process
62 (87%)
Additional information to guide applicants about ensuring their project met ethical requirements
27 (38%)
Clear and proportionate pathway for low risk research
43 (61%)
Up to date policies and guidance documents
31 (44%)
. Our findings suggest that many health services that run HRECs could significantly improve the researcher experience by simply upgrading their websites to guide researchers more clearly about what is expected of them. As Angela Romano highlighted, the process should not be a box checking exercise and we suggest that if there was clear guidance about what was substantive ethical considerations that needed to be met rather than simply how to fill in the relevant forms we might achieve this, or at least take a step in the right direction.
Whilst we cannot provide any analytical evidence of a correlation it would not be surprising if the improved guidance provided by some HRECs meant that the time to approval was shorter due to a reduction in non-compliant submissions and perhaps even the quality of submission in terms of covering the substantive ethical concerns likely to arise. It is fair to argue that researchers themselves should take the time and effort to ensure that they find out what is expected of them but we suggest that it would be a highly cost efficient exercise to start by making the websites themselves more useful and geared toward this end.
Would you like to find out the score for your institution’s web site/or have an assessment conducted? If you are a https://www.ahrecs.vip subscriber this can be done for free. Send an email to enquiry@ahrecs.com to discuss.
We did note in reviewing all of the websites that they were all designed differently and put information in different places and in different formats. We would also like to suggest that there would be some value in establishing a national standard for the presentation of core information regarding ethical submission and that there really is no reason that we can see for such wide variation in the way documents are provided. Efforts to harmonise content are evident in groups of hospitals such as Ramsay Healthcare, and we did note that several institutions now utilise the services of a central HREC, either their own for a group of hospitals or of other (certified) HRECs as part of the National Mutual Acceptance (NMA) scheme. We did not observe a great deal of harmonisation of content though outside of mandatory state-specific forms. .
Australia is committed to fostering health and medical research to improve the lives of patients as demonstrated by the State, Federal and charitable sector financial commitments that run to several billion dollars. Enhancing and harmonising website content would seem one way in which a small amount of effort would go a very long way to boosting our capability of doing ethically sound research. .
References: National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra.
Breakthroughs in medicine often highlight the existing limitations of the frameworks established to manage the ethical responsibilities arising in healthcare. The contraceptive pill, organ transplantation, assisted reproductive technology, gene therapy and more recently gene editing are notable examples that have stimulated major debates and, in several instances, prompted changes to not only ethical guidelines but also legislation. However, there are also more subtle ethical issues that arise from doing established activities in a different context or scale. Think of so-called Big Data applied to health care or to uses of machine-based learning which promise to revolutionize practice but are really just larger scale applications of business as usual using more sophisticated technology than before. One result of these two developments is the amassing of personal data online which coupled with improvements in reidentification techniques present challenges to how we manage the privacy of individuals. These have prompted amendments in regulation that facilitate the use of personal data whilst also strengthening protections for individuals (link to GDPR).
Less well known, are changes in the way we evaluate existing healthcare practices to ensure they are truly safe, effective and economical. One such example is the increasing focus on Comparative Effectiveness Research (CER). These studies compare two or more existing practices that are in widespread use and have been found safe and efficacious. CER is an extension of audit/QI practices in that it uses clinical trial methodology and the power of randomisation to remove the biases inherent in the observed outcomes in a population of non-randomised patients receiving a particular health service. These studies generally include large numbers of patients (sometimes several thousand) so that they can detect differences between the interventions that, while relatively small, can nonetheless be clinically meaningful at a population level.
There is an over-riding ethical need to do this work constantly within what can be termed a ‘learning healthcare system’ 1. Conceptually this means that every single instance that a person interacts with the health system should be captured in a manner in which it can be evaluated to make sure that optimal care is provided. Both patients and health system leaders expect this to be happening and yet in truth, the lack of standardisation in data capture, storage and interoperability means that few do this efficiently and effectively as part of routine healthcare activity. Moreover, existing research ethics frameworks impede the integration of healthcare and research by failing to recognise the differences between studies that involve standard care treatments from studies testing novel interventions with unknown safety profiles. One example is the requirement to apply to comparative effectiveness studies informed consent processes that differ so greatly from routine consent to treatment they are impossible to integrate into routine clinical workflows.
In a recent paper, (Symons et al 2) we have considered whether approaches that utilise modified consent pathways for CER are permissible from an ethical and regulatory perspective. In an accompanying editorial 3Dr Evan Kharasch challenges the readers of the journal to consider how the existing ethical and legal frameworks can be complied with for trials where the risk of harm is small. There is a perception that as soon as a study employs randomisation it becomes more than low risk when this may not, in fact, be true. It is also important to consider the ethical issues that arise when this type of ‘public good’ trial is simply not done because using consent processes suitable for interventional trials of unapproved therapeutics makes them impracticable. If indeed a particular treatment is less effective or causes more harm and we continue to use it because we consider that currently required ethics processes render them impracticable, then those processes have led to potentially unethical outcomes.
To achieve the best healthcare outcomes, greater sophistication of thought is needed at the ethics committee level. It also seems obvious that greater engagement with consumers is a necessary and relevant pathway to designing and conducting trials that deliver on expectations. The Australian Clinical Trials Alliance (ACTA) together with the Trials Clinical Trials: Impact & Quality (CT:IQ) have developed a consumer involvement and engagement toolkit that serves this purpose [1]. By working more closely together and encouraging more flexible and contemporary approaches to research ethics compliance, we can achieve the ideal of encouraging and supporting clinicians and health services to undertake continuous improvements to health services using the best methodologies to achieve this for the benefit of the community they serve.
References
1 Faden, R. R. et al. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent RepSpec No, S16-27, doi:10.1002/hast.134 (2013).
2 Symons, T. J., Zeps, N., Myles, P. S., Morris, J. M. & Sessler, D. I. International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology132, 44-54, doi:10.1097/ALN.0000000000003020 (2020).
3 Kharasch, E. D. Innovation in Clinical Research Regulation. Anesthesiology132, 1-4, doi:10.1097/ALN.0000000000003026 (2020).
Nerida Quatermass | University Copyright Officer | Project Manager, Creative Commons Australia at Queensland University of Technology
As a university copyright officer, I provide copyright information for research and scholarly communication – from ethics applications to publication.
What’s up, Doc?
Copyright questions can often be a manifestation of a larger issue than copyright. For example, a question about the mining or use of Twitter posts while involving third party copyright is also a matter of contract – what use of content is allowed under platform terms. Alternatively, the question might be about copyright, but it’s one where the law doesn’t provide the answer – does the scope of the fair dealing for research exception extend to publication? These types of enquiries illustrate that researchers need to understand copyright and a range of related issues relevant to research and communication.]
Myth-busting
Couple these uncertainties with the fact that there is no harmony in copyright laws between jurisdictions in a global research and communication community, and it means there are sure to be some persistent copyright myths to de-bunk in order to understand what is allowed. For example, the concept of “fair use” of copyright is well known globally and researchers in Australia often ask if the use they want to make of third-party copyright is a “fair use”. They are not aware that they cannot rely on it in Australia and are not generally aware of the “fair dealing” provisions that are available to them. Misinformation combined with limited confident knowledge about re-use rights leave researchers confused and anxious about copyright matters.
Back to basics
The savvy 21st century researcher needs some basic copyright knowledge to feel confident to manage their own copyright, their use of third-party copyright, and related publication matters. Researchers have always been required by traditional publishers to manage copyright, but today funder and institutional requirements for Open Access require a level of knowledge about open licensing and the effect of a Creative Commons licence on communication and reuse.\
Out with the old
Copyright is a pretty dry topic. At Queensland University of Technology, within the Research Support Team I am a member of, a wide range of copyright guidance is available including self-help, workshop and direct enquiry. When we “teach” in traditional workshops I am not confident that transferrable learning occurs in a way that will enable future decision making. In part, I put this down to a lack of engagement in traditionally-delivered workshops and seminars.
Making a game of it
Game play has benefits to adult learning, and this is a direction that copyright education has gone in. The UK Copyright Literacy organisation mantra is “decoding copyright and bringing you enlightenment”. Jane Secker and Chris Morrison (2016) have led the way by creating games which are played in workshops. They have found that the interactivity of a games situation engages learners in training, but is also a drawcard to attend. Chris and Jane have created two games: Copyright the Card Game which teaches the basics of copyright law and application; and The Publishing Trap which facilitates informed decision making for the research lifecycle including IP and copyright. Following suit and inspired by this, Tohatoha – Aotearoa New Zealand’s peak open advocacy body have released Creative Commons Release ‘Em Poker– a poker style card game about Creative Commons licensing. This game is correct for all jurisdictions because CC licences are global.
Back to the thorn that is jurisdictional copyright, this year I worked with the Australian Libraries Copyright Committee and a number of librarians to localise Copyright the Card Game to Australian copyright law. The resulting Copyright the Card Came: Australian Edition is correct for Australian law; and it has an Australian look and feel to it.
The proof is in the pudding
This year, Australian librarians and copyright officers have played Copyright the Card Came: Australian Edition in workshops, and professional development programs and at conferences. The feedback has been very positive. The interactive environment and scenario-based play is a positive contribution to learning which has made the copyright workshop a much more enjoyable prospect for teachers and learners.
If you are interested in playing, ask your librarian or copyright officer if they can organise it. Alternatively, all the resources including the card deck and workshop presentation are available online.
A beautiful deck of Creative Commons Release ‘Em Poker cards can be purchased online. Copyright: The Card Game and The Publishing Trap resources can be printed from the websites below.
The senior consultants started AHRECS in 2007. We were looking for a way of responding to requests for advice on research ethics and integrity from the government, health and education sectors read more...
Comments’ rules
We decided to include comment functionality in the Blog because we want to encourage the Research Integrity and Human Research Ethics communities to contribute to public discourse about resourcing and improving practice. read more...
Random image from the AHRECS library. These were all purchased from iStockPhoto. These are images we use in our workshops and Dr Allen used in the GUREM. Less
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Making a game of it
The proof is in the pudding