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A preliminary geneaology of research ethics review and Māori0

 

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?

References

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.

This post may be cited as:

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

 

Nik Zeps
AHRECS Consultant

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.

References

  1. 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.
  2. 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

This post may be cited as:

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

 

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.
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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.

References

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/

Competing interests

Gary is the principal author of the Griffith University Research Ethics Manual (GUREM) and receives a proportion of license sales.

This post may be cited as:
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

Empowering and enabling participation in human research: Reflections from two Queenslanders living with Multiple Sclerosis0

 

Dr Gary Allen
MS Qld Ambassador | AHRECS Senior Consultant | Member NS s4 review committee


Natalie Walsh
MS Qld Community Engagement Manager

Participation in ethical human research often provides four positive opportunities for persons living with MS:

(i) A welcome distraction from the sometimes-cruel realities of living with this progressive neurological condition.

(ii) An opportunity to provide insight into the practical challenges of symptoms that may be invisible to observers other than family, close friends and carers, and to give voice to the experiences of persons who are disenfranchised.

(iii) Access to whatever benefits are anticipated as a result of a project.

(iv) An opportunity to make a positive contribution to the body of knowledge and/or other public good.

The exclusion of people living with MS from research is a concern with regard to the ethical values of Justice (e.g. NS 4.5.3) and Beneficence because it denies access to the benefits described above, on the grounds of a disability. It is also a merit and integrity concern because, if a section of the community is excluded from a research project, there is at least the possibility the results might be different for people living with MS.

Prevalence in society
In Australia 1 in 5 people live with a disability. The average age of people diagnosed with MS is just 30 and 3 out of 4 are female.

On average, more than 10 Australians are diagnosed with MS every week. There are over 25,600 people in Australia living with MS, including 4,970 Queenslanders and the condition affects each person differently. The progress, severity and specific symptoms of MS cannot be predicted. MS is a lifelong condition for which a cure is yet to be found. However, doctors and scientists are making discoveries about the treatment and management of MS every day.

MS is one of the most common chronic neurological conditions of the Central Nervous System and may affect the brain, spinal cord and optic nerve and impacts more young people in Australia than any other chronic progressive neurological disease.

Symptoms and research
It is important to note that the symptoms associated with MS can be different differ in both presentation and severity for each individual.

Symptoms of MS will vary and are unpredictable.  No two people will experience the same symptoms to the same degree. Symptoms can come and go, and can also be affected temporarily by other factors such as hot weather or an infection.

Although MS can cause a wide variety of symptoms, most people only experience a small number of these.  For most of the common MS symptoms, there are now many effective forms of symptom management. It is also important to note that the symptoms listed here are not exclusive to MS and can appear in many different neurological conditions.

The symptoms of MS can be both visible and invisible to others and include:

  • Changes in memory, concentration or reasoning
  • Slurring or slowing of speech
  • Extreme tiredness (unusual fatigue): a debilitating kind of general exhaustion and weariness which is unpredictable disproportionate to the activity
  • Visual disturbance, including blurring of vision, double vision (diplopia), inflammation of the optic nerve (optic neuritis), pain and (rarely) loss of vision
  • Dizziness and vertigo
  • Emotional and mood changes
  • Pain
  • Altered sensation, such as tingling, numbness or pins and needles
  • Altered muscle tone, such as muscle weakness, tremor, stiffness or spasms
  • Difficulties with walking, balance or coordination: – these include loss of balance, tremors, unstable walking (ataxia), dizziness (vertigo), clumsiness of a limb, lack of coordination, and weakness (affecting in particular the legs)
  • Sexual changes
  • Bladder and bowel changes
  • Sensitivity to heat and/or cold

Exclusion
The exclusion of persons living with MS can typically occur in one of two ways:

(i) Intentionally because of the perceived vulnerability of the population, especially if an individual’s symptoms include impact on executive function, such as cognition and memory.

(ii) Unintentionally
……..a. because the research activities don’t accommodate the limitations imposed by an individual’s symptoms.
……..b. because communication is not extended to the networks outside of the research community.

Empowering and enabling participation
The exclusion of persons living with MS from research should be limited to circumstances where an individual’s symptoms would confound the collected data (e.g. a person with a severe intention tremor in their lead hand is unlikely to be able to quickly draw a shape they saw) or where they are especially vulnerable to harm (e.g. high-intensity exercise when their symptoms include autonomic impact on their cardiovascular system).

Rather than excluding potential participants who live with MS, researchers and review bodies are encouraged to consider:

(i) Whether the complexity of the research and nature of the risks are such that the competence of potential participants should be established. This might be explored in a simple conversation, as is recommended by paragraph 4.5.10 of the National Statement, e.g.

…….a. in the case of low risk anonymous data collection, accepting consent without establishing competence.

…….b. considering strategies to scaffold consent and respecting the wishes of individuals, even if substitute consent is required.

…….c. including a support person to provide individual assistance to participants

(ii) Conducting testing in a cool and bright location and at preferred times, such as mornings.

(iii) Allowing participants to request rest breaks with refreshments available

(iv) Supporting screen readers and closed captioning.

(v) Supporting suitable interface controls other than a mouse.

(vi) Reimbursing transport, parking or companion costs if travel is required.

Reference groups
The establishment of a reference group can be a valuable way to explore whether the anticipated benefits of a project are perceived as justifying the risks (as recommended by paragraph 2.1.5 of the National Statement), whether the support strategies are sufficient, and whether the language of the recruitment and consent materials are appropriate.

References:
National Statement on Ethical Conduct in Human Research (2007 updated 2018)

This post may be cited as:
Allen, G. & Walsh N. (1 October 2019) Empowering and enabling participation in human research: Reflections from two Queenslanders living with Multiple Sclerosis. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/empowering-and-enabling-participation-in-human-research-reflections-from-two-queenslanders-living-with-multiple-sclerosis

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