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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

Clergy service to HRECs: the useful paradox within secular governance of research involving human participants0

 

Aviva Kipen, Union for Progressive Judaism and Progressive Judaism Victoria.

In 2015, I earned a Doctor of Ministry Studies degree from the University of Divinity in Melbourne. The thesis, investigating how 13 Christian and Jewish clergy experienced HREC service in their pastoral care roles, arose from my own human research ethics committee and Victorian Biotechnologies Ethics Advisory Committee service and extensive interfaith work. I had been mentored into my service to the Monash University HREC by the Rev’d Dr Judy Redman, the then Victorian Uniting Church Outreach Ministries Coordinator. I found myself in the company of Anglican clergy and had succeeded Catholics – nuns and priests – Buddhist monks and also male rabbis who had served before me. Joining Judy, the serving female minister, made the gender issue less remarkable than it might otherwise have been, even in the late 1990s. The faith interchanges on succession raised my immediate curiosity that would later lead to the research question and the project on which this piece draws.

The then National Guidelines were clear: we clergy appointees were not there to push our own denominational barrows. Still, I became curious about what was really going on in the minds of others who served HRECs interchangeably from a range of faiths and traditions regardless of often-irreconcilable theologies in the ‘pastoral chairs’. My interfaith work meant I was confident that, in the event of content matters being beyond my own repertoire, I would have an extensive network from which to seek expert guidance if asked to do so. But HREC appointment provides an opportunity to serve far beyond the specifics of faith content occasionally referenced in research applications.

I became aware that the recruitment of ‘the pastor’ in other committees was not always simple. I had been spotted at a meeting about chaplaincy in women’s prisons! How had others been identified and invited to join committees? What constituted their self-understanding of the ministry service being gifted to the committees they served? Would my interviews disclose any kind of ‘evangelism by stealth’?  Did faiths or denominations target access to committees assessing large amounts politically/theologically/ethically sensitive, kinds of research?

I discovered no documents showing the means by which the Catholic Church became an early adopter of the opportunity to be represented, but clearly there were Catholic clergy leading the discussion in the early years. My research showed great diversity within the voices of the Christian ministers. Even within denominations, including between current serving Catholics, there was diversity of expression on ground-breaking issues. It became clear that the one participant who asserted his role as being to represent the Catholic position, was the exceptional Catholic voice. Other Catholics applied the provisions of the current National Statement informed by their own faith understanding, but with broad appreciation for other communities’ concerns.

Many clergy enjoyed the intellectual effort of meeting preparation and assessing applications, perhaps indicating a somewhat obsessive character trait. The rigor of disciplined meetings, the collegiality with co-assessors and committee colleagues was experienced by many as a valued counterweight to congregational demands. When appointed, some experienced a bit of resistance and some took a gentle ribbing. But as they became known and trusted on their merits and performance, tenures were frequently extended. There was some inference that if individuals had theologies unable to embrace the content or methodologies required in assessing projects, it would be unlikely that they would find their way onto committees. A few references to short tenures alluded to non-renewal of clergy who were not a good fit.

The diversity of appointments reflects the neighbourhoods/communities served by HRECs and is appropriately representative of our national diversity. One participant was from a highly conservative evangelical denomination. The interview triggered deeply thoughtful reaction about personal identity relative to the HREC work. I would later find out that the reflection resulted in some major theological grappling as a consequence of the conversation. Regardless of denomination, interviewees found themselves intrigued by the attention my investigation was bringing to HREC clergy/pastoral work, which had almost invariably been out of the faiths’ hierarchical spotlights. Most remained entirely grateful for the freedom to do the HREC work without such attention.

One pastor described choosing not to participate in a committee discussion because he was aware his personal knowledge was not sufficient. It was a frank admission. The example begs the question of how applications need to enable comprehension and how lay and other non-disciplinary experts are enabled in their roles. Others found solutions to specific matters of dogma by offering wordings that would provide enough cues to the faith’s adherents to ensure they were going to be able to make informed choices without imperilling projects. What emerged was that clergy were clear about their denominational obligations and the tension between them and the needs of others in the general community.

Given that the task of assessing applications and contributing to meetings is identical for all HREC members, how do clergy understand themselves alongside their colleagues (who may be harbouring strong religious views but are not required to disclose them and which need not be presumed) as contributors to the wellbeing of the research landscape? Several clergy described pastoral care for committee colleagues and secretariat staff, by virtue of regular contact with them. This was implicit and automatic pastoral work. Care for researchers and participants whom the HREC members will never meet, is also natural pastoral work and a clear driver for clergy in their appointments.

Serving HRECs also provides clergy with a window to unfolding knowledge, a forward-looking perspective, regular use of critical faculties not always appreciated in congregational work, intelligent company, confidential settings in which they can be full participants without any oversight from their hierarchies resulting in contributions that don’t need to follow predictable, dogmatic lines, and a chance to serve beyond the faith or denomination. Australia has encoded high standards for itself in the research domain. Participants in my research were clear that high ethical research standards fit congruently into their understanding of their ministry work and several specialise in HREC work as their ministry interest. Many of these have high-level academic qualifications and years of expertise, which are offered repeatedly to the Australian community through HREC service.

Rabbi Dr Aviva Kipen has held Monash University HREC appointments and served on the Victorian Bio-Ethics Advisory Committee. She returned to serve a second term on the Australian Health Ethics Committee of NHMRC in 2019 and has begun the current triennium for the Victorian DHHS HREC. All comments reflect material in the thesis Kipen, A. (2015) Serving God and The Commonwealth of Australia: The Ministry Experiences of Clergy in Victorian Human Research Ethics Committees. Melbourne: University of Divinity.

This post may be cited as:
Kipen, A. (3 November 2019) Clergy service to HRECs: the useful paradox within secular governance of research involving human participants. Retrieved from: https://ahrecs.com/human-research-ethics/clergy-service-to-hrecs-the-useful-paradox-within-secular-governance-of-research-involving-human-participants

Keywords
Clergy, religion, denomination, ministry, faith

Fighting Fiction with Fiction: A novel approach to engaging the public in bioethics of medical research0

 

Cathal O’Connell
Centre Manager, BioFab3D, St Vincent’s Hospital Melbourne.
About the laboratory discussed in this post

(Video credit: Benjamin Sheen)

To the surprise of its inventors, the cochlear implant was greeted with protest by some in the Deaf community in the 1980s and early 1990s. This well-known story underlines how important it is for developers of new medical technologies to discuss the potential impacts from all possible angles, and in advance.

As a researcher, I am concerned by the public misconceptions around new technologies which might hamper meaningful conversation.

My field of research is biofabrication, where the goal is to build new tissues to treat or model disease and injury. I have written before about how media sensationalism has distorted the public’s perception of this technology, and how ultimately this may have negative effects on patient consent and other impacts.

Here, I want to focus on another kind of distortion of technology: science fiction.

Public lectures by experts in my field often open with videos cut from science fiction movies and TV shows: Luke Skywalker’s robotic hand, the extruded sinews of an artificial horse from Westworld, the 3D printed heroine from The Fifth Element.

These examples can be effective devices to engage with the public: they provide a familiar touchstone while also generating excitement about how technology is propelling us towards that exotic ‘Future’.

But science fiction can also cast a shadow across active research. It can define how an issue is first framed in the public consciousness and influence the public’s perception and expectation around new technologies. This is most obvious in how the monsters of the Terminator and the Matrix haunt almost every discussion about artificial intelligence.

Recognising the striking power of fiction to frame debate, we at the BioFab3D lab based at St Vincent’s Hospital Melbourne, have recently taken a ‘fight fire with fire’ approach: we have collaborated with artists to create science fiction which realistically portrays the issues around our research.

Last year, BioFab3D teamed up with a local playwright, Rohan Byrne, and theatre production company Playreactive to develop a new science-fiction play, RUR_2020, which explored potential dangers and ethical questions around biofabrication.

Byrne’s play is a reimagining of a sci-fi classic; Rossum’s Universal Robots (or R.U.R) by Karel Čapek. First performed a century ago, R.U.R is famous for being the origin of the word ‘robot’ in English. It might surprise you that Čapek’s robots were not mechanical; they were flesh and blood facsimiles of people. The play is largely set inside a factory where these ‘robots’ are fabricated.

Now with labs like ours being created specifically to build new body parts, actual science research is catching up to this classic sci-fi vision. This motivated us to update RUR for a modern context.

To conceive and write his adaptation, Byrne visited BioFab3D to be immersed in the science; he interviewed lab researchers about the current state-of-the-art and the future of the technology, and studied the bioethical literature on the subject. He also consulted with BioFab3D researchers as the play took shape. The resulting science fiction story was grounded in reality; it was born, in a sense, in a real lab.

And that’s also where it was performed. In August 2018, BioFab3D was transformed from a working laboratory by day into a theatre venue by night. Researchers were always on hand to answer audience questions after each show. The lab thus became a platform for introducing a burgeoning technology, and a forum for discussing the direction this new technology might take in the future.

By all accounts the play was a great success: well received and well attended, across eight sell-out shows (and by a diverse audience of artists and nerds alike; many had never visited a research lab before, some had never attended a live play).   For us researchers, the play had a lasting impact in how it encouraged us to think about the bigger bioethical questions around our work.

Using dystopic fiction for the purpose of science outreach does carry risks, perhaps, of framing the technology in a poor light. We argue that it is critical to be transparent about the disruption that new medical technologies may cause.

In our case, the story was developed in consultation with real biofabrication researchers. The concerns discussed were thus genuine, the fiction itself a springboard for a needed conversation.

As is the nature of performance art, the play lived its moment and was no more. But the conversation lives on.

This post may be cited as:
O’Connell0, C. (31 October 2019) Fighting Fiction with Fiction: A novel approach to engaging the public in bioethics of medical research. Retrieved from: https://ahrecs.com/human-research-ethics/fighting-fiction-with-fiction-a-novel-approach-to-engaging-the-public-in-bioethics-of-medical-research

BioFab3D is Australia’s first hospital-based biofabrication lab dedicated to researching the artificial generation of living human tissues for implantation and medical research. It hosts collaborative efforts between researchers, clinicians, engineers, and industry partners to deliver therapeutic outcomes from cutting-edge science and technology. BioFab3D is a collaborative facility shared by St Vincent’s Hospital Melbourne, the University of MelbourneRMITSwinburne University and the University of Wollongong. Read more about BioFab3D on their website, biofab3D.org

 

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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