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Advances in Medicine often require innovation in ethical thinking too0
Posted by Admin in Human Research Ethics on December 22, 2019 / Keywords: Australia, Clinical trials, Consent, Good practice, Institutional Responsibilities, Medical research, Respect for persons
Nik Zeps and Tanya Symons
AHRECS Consultant
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.
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 Rep Spec 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. Anesthesiology 132, 44-54, doi:10.1097/ALN.0000000000003020 (2020).
3 Kharasch, E. D. Innovation in Clinical Research Regulation. Anesthesiology 132, 1-4, doi:10.1097/ALN.0000000000003026 (2020).
[1] https://involvementtoolkit.clinicaltrialsalliance.org.au/
This post may be cited as:
Zeps, N. (22 December 2019) Advances in Medicine often require innovation in ethical thinking too. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/advances-in-medicine-often-require-innovation-in-ethical-thinking-too-2
A preliminary geneaology of research ethics review and Māori0
Posted by Admin in Human Research Ethics on December 4, 2019 / Keywords: Consent, Ethical review, First Peoples, Good practice, Institutional Responsibilities, Maori, New Zealand, Participant protection, Respect for persons
Lindsey Te Ata o Tu MacDonald
AHRECS, Consultant
In New Zealand, we have two separate drivers for change in research ethics for working with Māori. The first are the institutional responses to the legal requirements of government institutions to accord justice to the principles of the Treaty of Waitangi (see Te Puni Kokiri, 2001). The second arise where Māori scholars have pulled on practices and ideas within their iwi and hapū to develop a Māori centred research philosophy, that in turn has created a distinctively Māori research ethics.
I made this argument at a recent conference, in a paper to honour the late Barry Smith. Barry, in reviewing ethics applications and creating ethics policy could articulate how to negotiate both with his usual insight, grace and wit and aloha. Without him to drive developments we must think carefully about how to follow his example of synthesising the best of ethical approaches to advance Māori wellbeing and rangatiratanga (roughly translated as indigenous self-determination, see Durie, 1988).
So what is the history of research ethics approaches to research with Māori? First, the radical 1984 Labour government's privatisation agenda enshrined 'the principles of the Treaty of Wāitangi' that put in critical pieces of legislation to ensure continued Māori support. The first, and most important of these Treaty clauses was in section 9 of the 1986 State-Owned Enterprise Act.
s9 nothing in the Act permitted the Crown to act in a manner that was inconsistent with the principles of the Treaty of Wāitangi.
When the government inevitably breached this section, a judicial review case allowed the Court of Appeal (at the time New Zealand's highest court) to set out its view of the relationship between the Crown and Māori. (New Zealand Māori Council v Attorney-General 1 NZLR 641, (1987) 6 NZAR 353). Later cases set out that consultation had to be conducted with an open mind, and Māori were to be given complete information about the subject. Wellington International Airport Ltd v Air NZ [1991] 1 NZLR 671 (Court of Appeal)
The case indicated that the courts expected any government institution (with a Treaty clause in its enabling legislation) to 'consult' – to the satisfaction of a court – with Māori individuals and groups who may be affected by its policies or practices. So all government agencies have since been on notice that they must consult with Māori fully on decisions that might affect Māori, and not to do so could lead to a judicial review of their decision-making by a court. Moreover, any Māori individual could also ask the Wāitangi Tribunal (an ongoing political commission of inquiry into Treaty breaches) to review a government action or inaction which breached the principles of the Treaty of Wāitangi.
Due to these incentives, government agencies got into the practice of consulting with Māori organisations on anything that might be of interest or affect Māori. So both the health sector ethics committees and the University ethics committees developed policies that asked applicants to demonstrate they had 'consulted' with Māori.
At the same time, a more humane approach to Māori research ethics was also being developed – it arose from Māori scholars grappling with how to inject Te Ao Māori (literally, the Māori world) into the systems around them. Models included, Te Whare Tapa Whā (Durie, 1984), The Meihana model (Pitama, 2007) and the Hui model (Lacey, 2011), to name but a few. In all of these models, there is a wealth of indigenous knowledge that is also discussed beautifully in Te Ara Tika (Smith, 2010), a guide to reviewing research involving Māori, that arose from Barry's concerns around gaps in knowledge about Māori and research ethics.
So there is an objective legal risk driving consultation with Māori over research on the one hand, and on the other, a philosophically normative Māori centred ethics, drawn from a Māori-centric approach. They can sit awkwardly together for researchers and reviewers. For instance, the two approaches are often combined as though they are one – so that researchers are left thinking they are legally required to adopt Māori normative ethics prescribed in the scholarly models of Māori research, and so do not listen to the tikanga (protocols) of the local community with whom they are researching. Alternatively, researchers may comply with the spirit of the law and do consultation – but as the government has proved time and time again; meeting the judicial test for consultation can still leave many feeling deeply unheard.
This leaves non-Māori, and I have seen this as a Māori research consultant for my University, in what Tolich called, 'Pakeha [non-Māori] Paralysis' – that is, paralysed by Māori concerns and thus avoiding doing research with Māori. Indeed I have counselled academics to avoid Māori centred research because they do not have skills to do it.
The deeper problem is that non-Māori researchers don't have the resources to research appropriately with Māori. And Māori don't, and should not have to have the capacity to serve the needs of non-Māori researchers.
I have pointed out the incentives for ethics review for Māori because I believe they can show us how to solve the problem. The law states that ethics reviewers must take seriously the voices of Māori in the research, but taking that seriously is not to follow the dictates of legal cases about consultation – those cases were decided about events unrelated to research or ethics. Nor must ethics committees think particular Māori philosophies of research must apply, since there are many more communities that have their own philosophies, and it is those local philosophies that should be privileged.
If we look to the underlying principles of both Māori research principles and legal cases, they combine to suggest we must take seriously the idea that research engages with Māori when it takes seriously the voices of the communities and participants involved in, or around the research. That is, the researchers should be seeking and assisting Māori voices to be heard in the research, if those Māori communities and individuals wish to be heard. To meet the legal needs, and to ensure Māori are given rangatiratanga, I suggest the appropriate question for a researcher to ask themselves (or be asked by the review committee) is 'how are you making it possible for the Māori individuals and communities to communicate and participate with you in the project should they wish?
Durie, M. (1998). Te Mana Te Kawanatanga: The politics of Maori self-determination. Auckland; New York: Oxford University Press.
Durie, M. (2001). Mauri Ora: The Dynamics of Māori Health.
Pitama, S., Robertson, P., Cram, F., Gillies, M., Huria, T., & dallas-katoa, W. (2007). Meihana Model: A Clinical Assessment Framework. New Zealand Journal of Psychology, 36.
Lacey, C., Huria, T. B.,Lutz, & Gilles, M. P., Suzanne. (2011). The Hui Process: a framework to enhance the doctor–patient relationship with Māori. New Zealand Medical Journal, 124(1347).
Smith, B., Reynolds, P., Russell, K.,& et.al. (2010). TE ARA TIKA Guidelines for Māori Research Ethics : A framework for researchers and ethics committee members. Health Research Council of New Zealand.
Te Puni KokirI (Ministry or Māori Development) (2001) He tirohanga o kawa ki te Tiriti o Waitangi: A guide to the principles of the Treaty of Waitangi as expressed by the Courts and the Waitangi Tribunal. Wellington, N.Z.: https://www.tpk.govt.nz/documents/download/179/tpk-treatyprinciples-2001-en.pdf
Tolich, M. (2002). Pakeha" paralysis": Cultural safety for those researching the general population of Aotearoa. Social Policy Journal of New Zealand, 164-178.
For a good guide to the history and impact of Treaty clauses in legislation see
Palmer, M. (2008). The Treaty of Waitangi in New Zealand's law and constitution. Wellington [N.Z.]: Victoria University Press.
Te Ata o Tu MacDonald, L. (4 December 2019) A preliminary geneaology of research ethics review and Māori. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-preliminary-geneaology-of-research-ethics-review-and-maori
Inclusion of Culturally and Linguistically Diverse populations in Clinical Trials:0
Posted by Admin in Human Research Ethics on December 4, 2019 / Keywords: Beneficence, Clinical trials, Institutional Responsibilities, Medical research, Methodology, Participant protection, Researcher responsibilities, Respect, Respect for persons, Vulnerable groups
Nik Zeps
Clinical trials have enormous value to society as they provide the most robust means of working out whether or not particular treatments used to improve the health of our population work or not. Governments have a stated objective to increase participation in clinical trials based upon a series of assumptions that extend beyond their utility as a means to derive the highest level of reliable evidence about the efficacy and safety of interventions. One of these is that those people who are included derive a tangible benefit from doing so. Whilst this may not be true in all cases, after all up to 50% of people may receive an inferior treatment by definition, there is the potential for people to derive individual benefit, and it is often stated that those involved in a trial receive a higher standard of care than those not included. Certainly, the additional testing and closer scrutiny of people on a trial may equate in some instances to better care, but this should not be seen as a major driver as it could be argued that equitable care should be available as a universal right. A less discussed benefit is the connectedness and satisfaction that people may derive from making a tangible contribution to society through participation in clinical research. Furthermore, there may be indeterminate peer group benefits even if an individual does not benefit.
In an Australian study Smith et al (1) found that CALD people whose preferred language was not-English (PLNE) had the lowest participation rates in clinical trials. Whilst CALD people whose preferred language was English (PLE) had greater levels of enrollment than the PLNE group, they were still underrepresented by population. This has been described across the world and is identified as a pressing concern (2). Understanding why this is the case is important for a number of reasons. In multiculturally diverse countries like Australia, testing interventions where a significant proportion of the population are not included could result in evidence that is not applicable to those people. This spans across biological differences which may be relevant to drug efficacy or toxicity through to interventions such as screening that may fail to be useful in those populations. Where there is evidence that participation in a clinical trial may present specific advantages there is also the issue of injustice through exclusion of a particular group or groups of persons. Certainly, from an implementation perspective, not including a diverse group of participants and analyzing for cultural and behavioral acceptability may mean that even if an intervention has merit it fails to be taken up.
The reasons for non-inclusion are likely more complex than those of language barriers, although having protocols for clinical trials that specifically exclude people who don't have higher levels of proficiency in English do not help. It would seem that the language barrier could be soluble through providing greater resources to enable translation services, particular in areas with a clear need for this. Certainly, multi-national trials already have PICFs in multiple languages and these could be readily deployed through use of innovative technologies including eConsent processes.[1] Funders of clinical trials could make it a requirement for such inclusivity and back it up through provision of specific funding for this in any grants they award. Legal means to enforce this, whilst possible, are unlikely to drive systemic change and could have the unintended consequence of making it harder to do any trials at all in an environment already subject to extreme financial pressures.
However, a major reason for low levels of participation in clinical trials may be attributed to equity of access to clinical services in the first place. It is hard to recruit people from the general population into clinical trials, but even harder if specific members of the population don't come to the health service in the first place. There is relatively little research on this topic and it would seem logical to do this as a priority in parallel with examining why people fail to participate in clinical trials due to language barriers. Perhaps clinical trials are simply the canary alerting us to broader inequities that need greater research and investment. Research into solutions to these inequities is accordingly a priority and may solve clinical trial participation rates as a consequence.
Smith A, Agar M, Delaney G, Descallar J, Dobell-Brown K, Grand M, et al. Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers. Asia Pac J Clin Oncol. 2018;14(1):52-60.
Clark LT, Watkins L, Pina IL, Elmer M, Akinboboye O, Gorham M, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019;44(5):148-72.
Nik Zeps participated in the CCV forum at the COSA ASM. A full report of the workshop and research by the CCV and MCCabe centre is forthcoming.
[1] https://ctiq.com.au/wp-content/uploads/eConsent-in-Clinical-Trials-compressed.pdf
Zeps, N. (4 December 2019) Inclusion of Culturally and Linguistically Diverse populations in Clinical Trials. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/inclusion-of-culturally-and-linguistically-diverse-populations-in-clinical-trials
The research use of online data/web 2.0 comments0
Posted by Admin in Human Research Ethics on November 23, 2019 / Keywords: Australia, Beneficence, Consent, Ethical review, Governance, HREC, Institutional Responsibilities, Online research, Outputs, Participant protection, Privacy, Research Ethics Committees, Researcher responsibilities, Respect for persons, Social media research
Does it require research ethics review and specified consent?
Dr Gary Allen
AHRECS Senior Consultant
The internet is a rich source of information for researchers. On the Web 2.0 we see extensive commentary on numerous life matters, which may be of interest to researchers in a wide range of (sub)disciplines. Research interest in these matters frequently prompts the following questions –Can I use that in my project? Hasn't that already been published? Is research ethics review required? Is it necessary to obtain express consent for the research use?
It's important to recognise that these questions aren't posed in isolation. Cases like the OkCupid data scraping scandal, the Ashley Madison hack, Emotional Contagion, Cambridge Analytica and others provide a disturbing context. At a time when the use of the internet and social media is startingly high (Nielsen 2019, Australian Bureau of Statistics 2018, commentaries such as the WebAlive blog 2019), there is also significant distrust of the platforms people are using. Consequently, there are good reasons for researchers and research ethics reviewers to be cautious about use of existing material for research, even if the terms and conditions of a site/platform specifically discuss research.
Like many ethics questions, there isn't a single simple answer that is correct all the time. The use of some kinds of data for research may not meet the National Statement's definition of human research. Use of other kinds of data may meet that definition but will be exempt from review and so not require explicit consent. Use of other kinds of data or other uses of data that involves no more than low risk can be reviewed outside an HREC meeting and others will actually have to be considered at an HREC meeting.
AHRECS proposes a three-part test, which can be applied to individual projects to test whether a proposed use of internet data is human research and needs ethics review and this will also guide whether explicit and project-specific consent is required. If this test is formally adopted by an institution and by its research ethics committees, it would provide a transparent, consistent, and predictable way to judge these matters.
You can find a word copy of the questions, as well as a png and pdf copy of the flow diagram in our subscribers' area.
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Part One of this test is whether the content of a site or platform is publicly available. One component of this test is whether the researcher will be using scraping, spoofing or hacking of the site/platform to obtain information.
Part Two of the test relates to whether individuals have consented and will be reasonably identifiable from the data and its proposed research use and whether there are risks to those individuals. A component of this test is exploring whether an exemption from the consent requirement is necessary (i.e. as provided for by paragraphs 2.3.9 -12 of the National Statement and are lawful under any privacy regulation that applies).
Part Three of the test relates to how the proposed project relates to the national human research ethics guidelines – the National Statement – and whether there are any matters that must be considered by a human research ethics committee. For example, Section 3 of the National Statement (2007 updated 2018) discusses some methodological matters and Section 4 some potential participant issues that must be considered by an HREC.
Individually, any one of these parts could determine that review and consent is required. But meeting all three parts of the test is necessary to indicate that the work is exempt before a project can be exempted from review.
Even if the tests indicate review/consent is required, that doesn't mean the research is ethically problematic, just a project requires for more due consideration.
The implication of this is that not all research based upon online comments or social media posts can be exempted from review but, conversely, not all such work must be ethically reviewed. The approach that should be taken depends upon project-specific design matters. A strong and justifiable institutional process will have nuanced criteria on these matters. Failing to establish transparent and predictable policies would be a serious lapse in an important area of research.
Booklet 37 of the Griffith University Research Ethics Manual now incorporates this three-part test.
In the subscribers' area you will find a suggested question set for the three-part test, as well as a graphic overview of the work flow for the questions.
It is recommended institutions adopt their own version of the test, including policy positions with regard to the use of hacked or scraped data, or the research use of material in a manner at odds with a site/platform's rules.
Australian agency to probe Facebook after shocking revelation – The New Daily. Accessed 16/11/19 from https://thenewdaily.com.au/news/world/2018/04/05/facebook-data-leak-australia/
Australian Bureau of Statistics (2018) 8153.0 – Internet Activity, Australia, June 2018. Retrieved from https://www.abs.gov.au/ausstats/abs@.nsf/mf/8153.0/ (accessed 27 September 2019)
Chamber, C. (2014 01 July) Facebook fiasco: was Cornell's study of 'emotional contagion' an ethics breach? The Guardian. Accessed 16/11/19 from http://www.theguardian.com/science/head-quarters/2014/jul/01/facebook-cornell-study-emotional-contagion-ethics-breach
Griffith University (Updated 2019) Griffith University Research Ethics Manual (GUREM). Accessed 16/11/19 from https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/gurem
McCook, A. (2016 16 May) Publicly available data on thousands of OKCupid users pulled over copyright claim. Retraction Watch. Accessed 16/11/19 from http://retractionwatch.com/2016/05/16/publicly-available-data-on-thousands-of-okcupid-users-pulled-over-copyright-claim/
Nielsen (2019, 26 July) TOTAL CONSUMER REPORT 2019: Navigating the trust economy in CPG. Retrieved from https://www.nielsen.com/us/en/insights/report/2019/total-consumer-report-2019/ (accessed 27 September 2019)
NHMRC (2007 updated 2018) National Statement on Ethical Conduct in Human Research. Accessed 17/11/19 from https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018
Satran, J. (2015 02 September) Ashley Madison Hack Creates Ethical Conundrum For Researchers. Huffington Post. Accessed 16/11/19 from http://www.huffingtonpost.com.au/entry/ashley-madison-hack-creates-ethical-conundrum-for-researchers_55e4ac43e4b0b7a96339dfe9?section=australia&adsSiteOverride=au
WebAlive (2019 24 June) The State of Australia's Ecommerce in 2019 Retrieved from https://www.webalive.com.au/ecommerce-statistics-australia/ (accessed 27 September 2019).
Recommendations for further reading
Editorial (2018 12 March) Cambridge Analytica controversy must spur researchers to update data ethics. Nature. Accessed 16/11/19 from https://www.nature.com/articles/d41586-018-03856-4?utm_source=briefing-dy&utm_medium=email&utm_campaign=briefing&utm_content=20180329
Neuroskeptic (2018 14 July) The Ethics of Research on Leaked Data: Ashley Madison. Discover. Accessed 16/11/19 from http://blogs.discovermagazine.com/neuroskeptic/2018/07/14/ethics-research-leaked-ashley-madison/#.Xc97NC1L0RU
Newman, L. (2017 3 July) WikiLeaks Just Dumped a Mega-Trove of CIA Hacking Secrets. Wired Magazine. Accessed 16/11/19 from https://www.wired.com/2017/03/wikileaks-cia-hacks-dump/
Weaver, M (2018 25 April) Cambridge University rejected Facebook study over 'deceptive' privacy standards. TheGuardian. Accessed 16/11/19 from https://www.theguardian.com/technology/2018/apr/24/cambridge-university-rejected-facebook-study-over-deceptive-privacy-standards
Woodfield, K (ed.) (2017) The Ethics of Online Research. Emerald Publishing. https://doi.org/10.1108/S2398-601820180000002004
Zhang, S. (2016 20 May ) Scientists are just as confused about the ethics of big-data research as you. Wired Magazine. Accessed 16/011/19 from http://www.wired.com/2016/05/scientists-just-confused-ethics-big-data-research/
Gary is the principal author of the Griffith University Research Ethics Manual (GUREM) and receives a proportion of license sales.
Allen, G. (23 November 2019) The research use of online data/web 2.0 comments. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-research-use-of-online-data-web-2-0-comments
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