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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

Tracing the Patterns of Research Ethics Regulation in Taiwan0

 

台灣的研究倫理規範之發展

甘偵蓉 Gan Zhen-Rong1 and 馬克·伊瑟利 Mark Israel2

Many commentators on research ethics have been based in the Global North and, when we find research ethics regulations that look very much like our own, we tend to make assumptions about the ways in which these patterns of regulation have unfolded. Apart from being disrespectful to local histories, insensitive to difference and intellectually lazy, failure to engage with the rich history of regulatory practices in different jurisdictions makes it hard for research ethicists to learn from others. That is hardly a position with which most people working in the field of research ethics would want to be associated.

In earlier editions of Research Ethics Monthly, guest posts from the Philippines have introduced developments in regulation there (Miguel, 2018). In this article, we briefly trace the growth of regulation in Taiwan. It is based on an article recently published in Developing World Bioethics (Gan and Israel, 2019). The pattern of research ethics in Taiwan reflects three distinct but interacting processes.

 

Transnational Policy Migration
Taiwan transitioned from an authoritarian regime towards democracy through the legalization of opposition parties in 1986 and the end of martial law in 1987. Legislative initiatives to regulate research ethics need to be understood within larger national moves towards good regulatory practice, economic growth and competitiveness and globalization on the one hand, and democratization, Taiwanese nationalism, recognition of multiculturalism and Indigenous rights on the other. Given their country’s political, economic and educational ties to the United States, it is not a surprise that Taiwanese regulators looked to that country for legislative models.

The first legislation governing human trials in Taiwan, the Medical Care Act, was passed in 1986. Subsequent enforcement rules included the Department of Health’s3 Ethical Guidelines for Human Subjects Research in 2007 and its Regulations on Human Trials in 2009 which mandated the application procedure, review criteria and information to be disclosed relating to a human trial, and the 2011 administrative regulations for the Human Biobank Management Act.

Partly in response to a series of biomedical scandals, in 2011 the Taiwan legislature passed the Human Subjects Research Act (HSRA). Before the HSRA came into effect, ethics review was only required by law for clinical trial and human biobank research. The main legislative purpose of the HSRA was to regulate biomedical, healthcare, and behavioural research involving human participants no matter where the work was to be conducted, with whom the principal investigator was affiliated, or which government department funded the research.

Interdisciplinary Policy Transfer
A series of administrative decisions championed by some social scientists, implemented by professionals with experience with health research ethics committees and reinforced by an oversight regime aligned with the biomedical sciences facilitated the extension of a particular form of research ethics regulation from biomedical sciences to other disciplines.

Until the HSRA came into effect in 2011, social scientists were only affected by the regulation of biomedical research ethics if they were funded by particular government departments or conducted research in or were employed by hospitals. Despite the stated purpose of the Act, HSRA changed that. Furthermore, there is evidence that both the legislature and the Department of Health made efforts to avoid extending the ambit of the HSRA. Ultimately, they failed. In time, a range of processes extended the regulation well beyond health sciences.

The first extension came as a result of a change in administrative rules by a government department responsible for funding social research that had already been developing initiatives around research ethics. The National Science Council4 attempted to create research ethics review processes more suitable for social research than those adopted in medical institutions. However, once the HSRA had passed, each time an initiative strayed from the requirements of HSRA the weight of the legislation and its accompanying bureaucracy pulled social science review into line with biomedical standards.
This intensification of scrutiny on social research was not imposed by biomedical organisations but by senior social scientists and legal scholars. These advocates included some who had been socialized into biomedical research ethics practices and had built up professional expertise in that area – either because they had undertaken their postgraduate work in countries like the United States where research ethics review had already been extended to the social sciences or because they had participated in health institutional review boards.

University compliance with the HSRA has been enforced by the Ministry of Education (MOE). MOE took the conservative path of adopting the oversight regulations that had already been operating for ten years at the Department of Health. MOE also invited biomedical researchers with experience of the processes of the Department of Health to support MOE’s inspection role. In turn, most universities had neither the time nor the resources to build up discipline-specific responses. Rather than hiring people with expertise in social research ethics, they appointed as committee chairs or administrative directors those who had already worked on or for biomedical research ethics committees. Application forms, standard operating procedures and resources were often generated quickly by making only minor modifications to existing biomedical resources.

The threat of government sanctions and the associated reputational damage encouraged research institutions and their ethics committees to take risk-averse positions. Some universities required all research involving human participants to follow the HSRA irrespective of methodology or discipline. In these ways, biomedical approaches to research ethics were generalized across all disciplines.

Decolonization
The expansion of the universalist model of research ethics has not been inexorable and was disrupted when power relations between the state and Taiwan’s Indigenous peoples changed. This moment reflected larger scale processes of democratization and Taiwanization, processes that were sometimes antagonistic towards decolonization and the struggle for Indigenous self-determination. It was also made possible by a period when Indigenous legislators held the balance of power in the national legislature and used it to formalize communal rights, rights that might be asserted when negotiating with external researchers. As a result, and partly in reaction to three biomedical scandals concerning Indigenous peoples, Article 15 of the HSRA mandated that researchers who conducted biomedical and healthcare research involving Indigenous peoples not only had to seek individual informed consent but also had to seek consent from their communities in relation to their participation, publication of research results, and commercial benefits.

The various regulations relating to group consent aimed at granting greater liberty to Indigenous communities and tribes, ensuring that conversations occurred between equals and that benefits were shared. Given the history of exploitation of Indigenous peoples in Taiwan, the prospect of strengthening the hand of Indigenous communities in negotiating with researchers is to be welcomed and could be aligned with the current government’s ongoing reconciliation efforts.

Comparative Research Ethics
Expansion of research ethics regulation from a biomedical legislative base and the existence of biomedical scandals prompting further regulatory intervention will not surprise readers in North America or Australasia, nor will the failure to attend specifically to the needs of social researchers.
However, some features of the Taiwan experience are unusual. The role of some social scientists in advocating for the regulations concerning research ethics review to be applied to social research through administrative processes is surprising given the resistance to such moves by most social scientists across the globe. Again, the constitutional position and the slowly unfolding political power of Indigenous people in Taiwan might afford them more say in how they are affected by research than might be the case in some other ‘settler nations’.

Acknowledgements
This article appears in Research Ethics Monthly with the agreement of Wiley and Sons, publishers of Developing World Bioethics.

Gan, Z-R. and Israel, M. (2019) Transnational Policy Migration, Interdisciplinary Policy Transfer and Decolonization: Tracing the Patterns of Research Ethics Regulation in Taiwan. Developing World Bioethics. DOI: 10.1111/dewb.12224

Miguel, T.D. (2018) Undue Influence in Research Between High-Income and Lower-Income Countries. Research Ethics Monthly. 27 September. https://ahrecs.com/human-research-ethics/undue-influence-in-research-between-high-income-and-lower-income-countries

1 Member, Human Research Ethics Committee; Assistant Research Fellow, Research Center for Humanities and Social Sciences; Adjunct Assistant Professor, Center for General Education, National Cheng Kung University, Taiwan. ganrrec@mail.ncku.edu.tw

2 Senior Consultant, Australasian Human Research Ethics Consultancy Services. mark.israel@ahrecs.com

3 The Department of Health of the Executive Yuan, the top-level administrative arm of government, was renamed as the Ministry of Health and Welfare in 2013.

4 The Department of Health of the Executive Yuan, the top-level administrative arm of government, was renamed as the Ministry of Health and Welfare in 2013.

This post may be cited as:
Gan, Z-R. and Israel, M. (24  April 2019) Tracing the Patterns of Research Ethics Regulation in Taiwan. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/transnational-policy-migration-interdisciplinary-policy-transfer-and-decolonization-tracing-the-patterns-of-research-ethics-regulation-in-taiwan

Kua hinga te tōtara i Te Waonui-a-Tāne, the tōtara tree has fallen in Tāne’s great forest1

 

It is with great sorrow that we note the passing of one of our consultants, Barry Smith.

Of Te Rarawa and Ngāti Kahu descent, Barry was an extraordinary man. A true kaumatua, his wit and wisdom on matters of indigenous health and indigenous research ethics is irreplaceable.

Showcasing the best of the leadership through humility, Barry was relied upon by committees to bring an appreciation of Maori – and research ethics more generally – to their work. More than that, because of his diplomacy and humanity he became the kamatua of the process that bought Māori ideas and ways of knowing to the research ethics sector in New Zealand. Just a small list of his appointments is indicative of the status accorded to him senior scientists, ethicists, and government officials and ministers; he was or had been a member (and often a chair) on all the national bodies that set ethical standards and/or reviewed the ethics of research in New Zealand.

– Chair, Royal Society of New Zealand Maori Reference Group on indigenous matters to the Society’s project on gene editing
– Chair, Ministry of Social Development Ethics Committee
– Chair, the Lakes DHB Research and Ethics Committee
– Former Chair, Ethics Committee of the Health Research Council
– Former Chair, multiregional health and disability ethics committee
– Member, Advisory Committee on Assisted Reproductive Technology (ACART)
– Member, Auckland Regional Tissue Bank Governance Advisory Board
– Member, Health and Quality Safety Commission’s (HQSC) Perioperative Mortality Review Committee (POMRC)
– Member, committee re-writing New Zealand’s National Ethics Guidelines.
– Member, Marsden Fund project led by Tim Dare examining the ethics of predictive analytics.

Tena koe BarryGreetings Barry
kua wheturangitia KoeYou who have been adorned as stars
ki te korowai o Ranginuiain the heavens
kua wehe atu Koe ki te poYou who have departed to the night
Ki  tua o Te AraiTo beyond
Ki te okiokingTo the resting place 
o o tatou tupunaOf our ancestors
Haere, haere, haere.Farewell, farewell, farewell

 

How do we ‘do’ consent?0

 

This blog post expands on ideas from our recent publication: McWhirter, R. E., & Eckstein, L. (2018). Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry, 1-15.

Recently I participated in a research study. With the research nurse sitting opposite me expectantly, I moved quickly to sign in the appropriate place.

Hang on a minute. I’m a researcher, and an HREC member. I’ve published papers on informed consent, for goodness’ sake. I know better than this. Dutifully, I went back to the information sheet to read it properly.

After a couple of lines, I got bored and started scanning for key phrases. What will they do with my data? Which HREC approved this? Am I signing myself into eternal servitude?

Oh, who am I kidding, I thought. I’ve already made my decision. So, I just signed it, the research nurse smiled, and we got on with it.

Research suggests that I am not alone in my reaction to consent forms. They are boring, sometimes bordering on impenetrable. HRECs blame researchers for not writing in plain English. Researchers blame HRECs for being too inflexible and demanding a ridiculously long list of things to be included in a rigid format. There’s probably some truth on both sides, as well as some misunderstanding. And so, we end up with long, boring and ultimately unhelpful consent documents.

This is not to suggest that everyone is doing consent badly. There are lots of examples of research groups working with communities – whose members are usually potentially vulnerable in some way – to develop consent materials or processes that actually meet the needs of participants. Sometimes the solutions are technological– involving multimedia tools to overcome literacy or language barriers – and sometimes structural – such as by undertaking consent over several visits, so that individuals can decline to participate either by saying no or by avoiding the researchers, which can be an important option in communities where this is considered a more culturally acceptable method for refusal.

So, consent doesn’t have to be boring.

But what of the other problem indicated by my experience above? I had already made up my mind to participate before I’d been given the information sheet. Those with experience in study recruitment will know that I’m not unusual in this respect either. Depending on how the recruitment is undertaken, first contact might be a phone call, an email or letter, or a face to face conversation. In most cases, there will be some kind of blurb that precedes a participant’s reading of the consent documents and this is largely what people are basing their decision on.

These initial contacts are difficult to standardize (and it’s not necessarily desirable to do so) and difficult for HRECs to review, especially if they are verbal. A lot depends upon the character of the person doing the recruiting (usually a research nurse or research assistant rather than a principal investigator).

For one study in remote Aboriginal communities that I was involved in, I undertook several months of community consultation prior to commencing recruitment. I worked with community members to develop the study design and consent materials, employed local research assistants, and was helped enormously by senior women from each community. The relationships we developed meant that the study better met the needs of the communities, was more ethically sound (complying with both the National Statement and Values and Ethics) and resulted in a wider range of benefits than would otherwise have arisen.

These relationships also created trust between us. And that no doubt had an effect on our recruitment. The women liked me and wanted to help me. I had the support of influential elders. And by the time we got to use our carefully designed audio books, with information recorded in multiple dialects and with culturally relevant illustrations, most participants had already heard about the study, either from the community meetings during the consultation phase or through word of mouth. Although I stressed that participation was voluntary, and they were welcome to say no, everyone I invited agreed to participate.

So, what was the point of informed consent here? Well, it’s still polite to ask. The process of consultation that preceded it was effectively a form of community consent. And although individual decisions were probably influenced by their relationship with me and other study team members, these participants arguably had a greater understanding of the study than many participants in studies using more traditional methods.

I’m not sure there is a perfect way to ‘do’ consent. But it helps to be aware that the process is wider than just the consent documents. Providing training and ongoing team-based reflection for recruiters would help to address concerns over the quality of the less formal elements of consent. And it would be useful for HRECs to recognize the value of community consultation and consumer engagement in the study design phase, and to be open to non-traditional approaches to undertaking consent, rather than focusing unduly on the precise wording of consent forms.

We can’t ‘protect’ participants from researchers through mandating lists of information to be conveyed through formal documents, but we can encourage a culture of ethical research that better addresses community interests by reflecting on what we’re actually doing when we ‘do’ consent.

Contributor
Rebekah McWhirter
Centre for Law and Genetics, Faculty of Law, University of Tasmania
http://www.utas.edu.au/profiles/staff/law/rebekah-mcwhirter

This post may be cited as:
McWhirter R. (26  August 2018) How do we ‘do’ consent?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/how-do-we-do-consent

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