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Raising some pointed questions about research, ethics and the law

Research ethics and research misconduct, Indigenous Data Sovereignty, socioecological justice, and harmful treatments were among wide-ranging topics up for discussion at the recent Australasian Association of Bioethics and Health Law 2022 Conference in nipaluna/Hobart.

Dr Rebekah McWhirter, Senior Lecturer in Health Ethics Law and Professionalism at Deakin University, was co-chair of the conference, together with Dr Lisa Eckstein from the University of Tasmania, and also put in some serious tweeting effort at Croakey’s rotated Twitter account, @WePublicHealth.

See her detailed summary of the conference discussions below, as well as some reflections on how the organisers prioritised COVID safety for participants.


Rebekah McWhirter tweets:

Tweeting this morning from the opening session of #AABHL2022, coming to you from muwinina country here in nipaluna/Hobart, right by the sparkling River Derwent.

After a beautiful welcome to Country from Alison Overeem, the conference was officially opened by Lt-Gov Alan Blow AO.

Up first is @EdwardSDove – Dr Ted Dove, Reader In Health Law And Regulation At The School Of Law, University Of Edinburgh, asking whether research ethics committees are still fit for purpose?

Fantastic opening plenary on the changes needed to optimise ethics committees, Dove notes that HRECs are regulators, contributing to protecting participants within a complex system. They’ve evolved from modest origins in the 1950s to provide ethical scrutiny of research to protect interests, minimise harm and promote socially valuable research.

HRECs are criticised for red tape/tick box approach to ethics; overly risk-averse (preventing valuable research); trying to achieve too many (conflicting) aims; regulatory gaps; limited ability to monitor research post-approval; over reliance on consent; lack of consistency.

Argues that ethics committees are still largely fit for purpose – not perfect but the least bad option.

Despite black box nature of HRECs, they are surprisingly homogeneous in approach.

Committee members see themselves as stewards encouraging/supporting ethical and robust research – not gatekeepers but rather aligned with other stakeholders. There’s room for more flexibility in the system. Despite challenges, inconsistencies, members enjoy their role.

Issues with high turnover of members, inadequate recognition, threatening sustainability. Difficulties in combining roles in ethics, science and law/governance. Ethics committees are not well suited to all three (should focus on ethics).

Rather than trying to replace RECs, need to embed a culture of ethical research across the lifecycle of project. More resources needed, and possibly professionalising/paying members. Accreditation systems to ensure competence/consistency. Separating ethics and governance key.

Dove calls for more joined-upness, so committees can benefit from each other’s expertise and experience. This will also promote recognition of review by other committees, avoiding duplication.

Regulatory apparatus for animal ethics superior (on the face of it) to that for human research – more rigorously regulated and monitored. Benefits (and challenges) to moving to a system more like that.

• Also see this Twitter thread by Cynthia Forlini summarising his talk.

Wide-ranging

Sam Boyle now explaining how health issues can increase risk of youth reoffending, and also nurse interventions can reduce offending as well as leading to improvements across domains like housing, connectedness etc.

Imogen Goold looking at best interest decisions on behalf of children (eg infants like Charlie Gard and also Gillick competent kids refusing treatment).

Court has wide jurisdiction, engaged as soon as welfare is affected. Court frames it as if it is possible to come to one right answer – “best interests” – but really based on values. Need courts to understand this and for a harm threshold to be introduced before involving courts.

Linda Sheehan highlights need for organisational ethics – getting institutions accountable for decisions, eg ‘wise’ drug use/access. Tendency to just approve high cost drugs because of challenges in dealing with value judgments/proportionality.

Simone Henriksen identifies challenges in monitoring and enforcement with alcohol and drug treatment national quality framework, esp with differences across jurisdictions and links with funding.

Mikey Dunn now breaking down the way we integrate empirical and normative work in bioethics – ie how do we join descriptive activity with prescriptive claims? A lot of the difficulty comes from confusion around terms and muddying of boundaries. Eg empirical work is never merely descriptive, it’s always informed by values and normative claims. The real difference lies in mode of justification. We need to integrate because “the real world matters” – fundamental connection to practice.

Thin integration: identifying ethical issues (ready for normative answers); providing data for norm arguments (fleshing out normative process with real world info); or using empirical evidence to evaluate ethical interventions (moving from norm to emp).

Can we get more out of empirical approaches to improve ethical arts? Thick integration: more directly shaping norm arrangements with reference to people’s views/values (but is-ought problem arises!). Justifications for thick integration are contested. Most useful for policy-relevant guidance.

Consumer law

Joel Grieger is analysing the relationship between consumer law and negligence, using the recent pelvic mesh controversy as a case study.

Manufacturers aware of the likelihood of complications from use of the device but failed to disclose these risks to patients for commercial reasons. Patients succeeded on both common law and statutory bases.

What relevance does consumer law (misleading and deceptive conduct, fitness for purpose, acceptable quality etc) have to medical law, when negligence is available?

Wider range of remedies available under consumer law – penalties, compensation, conduct orders and more, as well as used when negligence not available, Hence being used increasingly either alone or in addition to negligence claims.

Bridget Pratt is sharing her conception of socioecological justice and applying it to just healthcare systems. Social injustices and ecological injustices often closely intertwined, eg climate change worsening poverty and widening health inequities.

Another example: NHS produces more CO2 emissions than all aircraft leaving from Heathrow, in addition to producing huge amounts of waste (inc toxic) and other environmental impacts. So may be trying to improve health, but neg effect on environment. What should we do about this?

Theories of social justice, environmental justice, and ecological justice are very separate and don’t talk to each other. Need better integration as well as inclusion of Global South and marginalised pops. Pratt provides principles for guiding health system design to promote different…forms of justice (social, ecological, enviro) without exacerbating inequities, across five dimensions: power, recognition, harmony, inclusion and wellbeing, with a focus on relationships between humans and nature.

Complexities of consent

Professor Dominique E. Martin from Deakin University – @DrDEMartin – is now explaining the ethical and legal complexities with consent when undertaking research with potential deceased donors of organs for transplantation (eg research to improve success rates, survival rates etc but also research on braindead individuals not possible otherwise).

Tricky for HRECs/clinician researchers/people making consent decisions. Who can legally provide consent? Not clear. In some cases, possibly no one. How should they make these decisions? Substituted judgment approach – good if you know wishes of deceased person.

If wishes not known, perhaps best interests approach is useful: risks v benefits for dying/dead person or their family (esp where genomic research is involved, or grieving processes are delayed). Can also consider interests of the public – benefits and risks.

Also concerns around voluntariness and potential vulnerability of decision-makers at this sensitive time, and how specific/informed consent needs to be. Key here is that donor/research participant roles are blurry here, making ethical analysis difficult.

@DrDEMartin recommends legal reform and development of ethical guidance that recognises the transition in status (alive to dead), and implications of relationality.

Sexy and dangerous

Kavisha Shah explaining that data is both sexy and dangerous! Useful for many things, including practice analytics to inform quality improvement. Notes that many see data collection in governance as divorced from healthcare improvement, but argues for important role in ethical d-m.

Dr Lisa Eckstein – @lisa_xstein – asks who’s responsible for ethical oversight once research starts?

Data monitoring committees play a key role in clinical trials, and can recommend a trial stops, be modified, or continue, based on confidential data.

Huge power equals high ethical stakes; eg when intervention arm is associated with increased adverse events – a data monitoring committee (DMC) can choose to end trial on safety grounds even if some indication that the intervention is effective. But how do they make these difficult decisions?

Guidance often include value-laden terms like ‘beyond reasonable doubt’, other guidance less helpful – her project is working on rectifying this gap.

Lisa Fry explains the difficulty in ethical approval processes for conducting multisite research in regional and rural areas, and suggests possible solutions in collaboration with stakeholders.

Health law

Often self-deprecating, sometimes witty and always wise: Professor Cameron Stewart is taking us through what modern Australian health law is and what it’s for. He starts, as you do, with Ancient Greek mythology: daughters of Themis (Dike/justice, Eumonia/good laws, Eirene/peace).

(Western) Traditionally, law’s primary task was seen to be to bring forth excellent behaviours in citizens that enhanced human flourishing. Ethics and law are interdependent and law has to maintain an ethical core to both maintain its legitimacy. But now?

Law today is merely an instrument to achieve some outcome – doesn’t have ethical objective/content. Possibly morally neutral. Laws are either: prohibitive, mandatory, or permissive. They impact: people as subjects, objects/property, relationships between subjects, or environment.

Ok, but how do we do it well? Where do we talk about the good/better/excellent in laws?

We discuss this prior to law reform, in interpreting the law, and within the bureaucratic administrative state (application/experts/guidelines).

The benefits? Increasing freedom from overbearing moral/religious claims; technical competence leading to more rational outcomes. Weaknesses? Fragile public discourse; rejection of expertise. Do we want more virtue/morality in law? Whose vision of virtue?

The forms of law are ethically neutral; their purposes are not & their implementation in the bureaucratic-admin state is not. Ethics must take precedence in the decision-making BUT perhaps greater quasi-legal values also need to be adopted for transparency/accountability/review.

Loving data

A glorious and sparkly day 2 of #AAABHL2022 kicking off with Dr Kalinda Griffiths –  @Klick22 – sharing her deep and abiding love for data, and how she thinks it can be better used for advocating for positive change, especially for advancing Aboriginal and Torres Strait Islander health.

She notes the importance of data in Aboriginal identity and recognition in a human rights context. Identification of Indigenous peoples is key to data collection, incl official stats. How are Indigenous people counted? By whom? What is the quality of data used for reporting?

Definitions of Indigeneity and operationalisation of definitions represent ongoing challenges in tracking health, compounded by the ongoing impacts of colonisation.

UNDRIP: right to recognition of identity inherent in right to self-determination. This can be in tension with coloniser-recognised forms of identity. Efforts to address this have been patchy, leading to inconsistencies.

Data matter – it has power because it tells us who needs what, where; data can support protection of human rights. Who has control of data matters – Indigenous data collection needs to be Indigenous-led to address power disparities, but need support – all hands on deck.

Indigenous Data Sovereignty – rights and interests of Indigenous peoples over their data, achieved in practice through data governance. Must be driven by Indigenous people, but can be supported by non-indigenous people in giving effect to data governance.

Workforce is a critical component here: need to develop the next generation of Indigenous data nerds! Need close collaboration with communities. Need to monitor progress closely to effectively direct resources, with improved reporting obligations. Reporting needs to reflect…Indigenous ways on knowing and doing to avoid repeating mistakes of the past.

Getting experimental

Bioethicist Assistant Professor G. Owen Schaefer – @G_Owen_Schaefer – is talking about Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) – started with Ebola and recently adapted to COVID.

The idea is to give an ethical framework for deploying beneficial but unproven treatments.

Justifications: public health emergency, absence of proven interventions etc but needs oversight to monitor for safety and efficacy.

Positioned as ‘non-research’ – eg excludes clinical trials etc from definition, and it is justified on the basis that research is not feasible.

This means MEURI can avoid burdensome regulation (replaces research ethics framework) and get benefits out faster. BUT if it looks like a duck, quacks like a duck…?

Owen argues that six features indicate it is really research (in disguise?)

These features are: motivation (knowledge to improve healthcare); protocol (just like research); approval process (ethics committee approval recommended); monitoring (must contribute to generation of evidence); self-analysis (aware that MEURI ‘similar’ to research); applications.

Research papers describe ‘single arm MEURI study design’ – so seem to be thinking of it as not-RCT, rather than not-research. Owen argues we should just stop pretending, and start treating MEURI as research (which it really is).

Misconduct

Naomi Holbeach now exploring who is responsible for published studies with falsified data. Different stakeholders have different priorities in this field and what they are interested in enforcing.

CLUE recommendations ask for better communication between institutions and journals.

Research misconduct is an increasing problem (exact extent is contested). Consequences are extremely costly, and harmful to patients/wider public, as well as undermining public trust.

COPE guidelines include clear actions for journals but not always obvious what ‘clear evidence’ of research misconduct/unreliable data is in practice. Tricky for smaller journals to implement. There is no legal obligation for journals to ensure accuracy of info published. By contrast, US has tort of negligent publication.

Most actions, however, have been unsuccessful. Other options: misleading and deceptive conduct, employment contracts, fraud, professional regulations (eg AHPRA and Code of Conduct). Restoring confidence relies on all stakeholders.

Machine learning

Joshua Hatherley and Robert Sparrow argue that adaptive machine learning systems in medicine raise more ethical issues than has previously been recognised. While they promise benefits of ongoing performance updates and site/patient specific tuning.

These strong incentives are balanced by algorithmic biases/erroneous associations. There are more concerns though. Costs of federated learning make eliminating synchronic variation challenging. This makes it hard to interpret algorithmic outputs, to get meaningful informed…consent, may lead to significant variation in quality of care between sites, and lead to disproportionate costs for some patients.

Dr Cynthia Forlini – @cynforlini – up now to critically appraise her very own field: ethics of cognitive enhancement. The field started on the assumption that it would be a big problem, be really prevalent, and that cognitive enhancement works. Doesn’t seem to have panned out that way.

The successes: identified limits of acceptability (restoring ok, enhancing not ok); contention among stakeholders; identified key ethical issues. Blind spots: lack of diversity; lack of regulatory options; no idea who is/should be responsible. So what should we do?

Data collected in an anticipatory fashion (expecting a problem) – is it time to hit pause? Critically assess early claims/assumptions; plan sensibly for the future.

Ian Stevens presenting his masters research in the ethical examination of non-validated closed-loop deep-brain stimulation treatments in psychiatric surgery. Part of the problem is working out what the methodology is underpinning dual-role non-validate