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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Embedding clinical research as part of routine healthcare: Managing the potential for competing interests.0

 

Nik Zeps
AHRECS Consultant

 

Clinical trials are widely accepted as the best method for understanding whether any particular medical intervention is safe, efficacious, acceptable to patients and cost-effective. Almost every Health Service in Australia runs clinical trials of one sort or another. Enrolment of patients (in this instance they are all patients and not healthy volunteers) into clinical trials through health services operates as a separate activity to routine health care delivery and is managed through its own governance processes rather than as a part of clinical governance. This is widely recognised to be necessary but is unfortunately inefficient, duplicative in many instances, has a lack of objectivity and as a result of poor resourcing and training, is often slow and regarded as problematic by the research community. Sadly, there is a fairly widespread view amongst researchers that Research Governance is a bureaucratic hurdle rather than a means to ensure their research will be safe, quality work, be well managed and have significant impact.

One of the problems with the current system is that it treats all clinical trials as a single category rather than recognising the profound differences between trials that are seeking to establish new evidence for experimental therapeutics and those that are comparing existing therapeutic interventions (so-called Comparative Effectiveness Trials-CETs). It is clear that the risks of being enrolled in a CET are likely to be less than if being enrolled in a trial involving an unapproved therapeutic. Indeed many patients expect clinicians to deliver evidence based care, rather than practice variation, which can only elicited from high quality CETs  However, it is also true that if a person is randomised into the standard-of-care control arm of a trial of an unapproved therapeutic is at no greater risk than if they were not in the trial. Indeed, there is a broad range of evidence that participation in trials has an overall benefit in terms of safety and outcomes even for the control arms so one could argue that being in trial is by and large better than not being in a trial. It is also widely believed that the act of randomisation, the key feature underlying the power of clinical trials, is in itself risky and lifts any trial into a category that requires careful management. The National Statement does not make any such comment about risk related to randomisation and this view is one of subjective convention rather than one based on any proper assessment of risk.

Another feature of managing clinical trials is ensuring that potential participants are given appropriate information free of any coercion or inducements so that they can make a completely autonomous and sufficiently informed decision to participate or not. To ensure this a great deal of time and attention is paid to reviewing increasingly lengthy and complicated Participant Information Sheets and Consent forms (PICFs). In contrast almost no meaningful time is spent on evaluating the skills of the team in providing the information and being able to answer questions in a manner that ensures there is no coercive or inducive behaviour. Moreover, to my knowledge, no HREC has ever sent observers to audit how a participant is recruited, whether consumer input was sought in the development of the enrolment strategy or to evaluate notes taken as part of the consent process. This would appear to be the more important component of understanding whether the ethical issues arising from enrolling participants in a trial are being met.

Another area of research governance in need of an overhaul is a proper evaluation of the competing interests involved in running clinical trials in the first place. The term ‘conflict of interest’ is problematic in itself because it inherently assumes a negative position rather than recognising that instead there are legitimate instances of competing interests that have to be balanced and that it is not a black and white scenario. The NHMRC National Ethics Conference held in 2005 had this topic as it’s central theme and attendees discussed the need to take a more nuanced approach that included a broader consideration of competing rather than conflicting interests. These competing interests apply to participants themselves, the health professionals running the trials, the institutions responsible for operating the site where the trials are being done and finally the funders of the trials who may also be the ‘sponsor’ in the definition adopted by the TGA, that is, those with a direct vested interest in proving an unapproved therapeutic is better than existing practice so they can market their product for profit. Frameworks for managing these competing interests are often little more than answering ‘conflict of interest’ questions in the ethics application forms or on institutional declaration forms and stating that any institutional policy is being followed. This is clearly inadequate for a variety of reasons. Firstly, in my view after having worked in public and private institutions for 20 years, is that there is a check box mentality to managing potential competing interests with no resources deployed to either teaching staff about it or exploring the more subtle elements as opposed to simply addressing the blatantly obvious ones such as a direct financial conflicts. Secondly,

Given the earlier statements about the potential benefits of being enrolled in trials, and also the fact that for a subset of people the trial may be the only way to access a potentially life-saving treatment, participants themselves may have a profound self interest in participation. At the end of the day who are we doing research for if not the end-users, therefore system generated research barriers inadvertently have a direct impact on patients and members of the public.

It is also possible that participation in the trial leads to funding of components of care that would otherwise be a cost to the person. Some hold the view that people on trials should not experience any out-of-pocket expenses, even where those expenses would occur if they were not on the study. Arguments presented by investigators and sponsors that people should still have to pay any out-of-pocket expenses for standard-of-care components of a trial have been met with opposition by HRECs and institutions in some instances.

Health services are encouraged to run clinical trials for a variety of reasons that include being seen to be a centre of innovation and learning as well as providing access to cutting edge treatments. The reputational benefits are a discrete interest of the organisation that may, if connected to revenue from increased referrals, also be regarded as a potential marketing tool.  In addition, some have argued that government funders or health funds should not have to pay for treatments provided during any part of a clinical trial and therefore enrolment in trials is a means to offset some of the expenses associated with providing care to people in the health service. Some also argue that to promote clinical trial activity health services should have enrolment of patients in trials as a Key Performance Indicator (KPI) despite the obvious issues arising from simply working in ways that focus on meeting this that may not align with the best interests of participants. Indeed, whilst setting KPIs may seem like a good idea they create perverse incentives that are difficult to manage in the existing framework.

A topic that is rarely adequately discussed is the conflicts of interest of the institution that is both the site of the research, enjoying some of financial and reputation benefit from doing so, having a degree of duty of care for the participant, plus conducting the ethical and governance review. Commercially sponsored studies bring in revenue which is used to offset the costs of managing a clinical trial infrastructure. Ironically, making HRECs and Research Governance Offices dependent on revenue from commercial sponsors through fees is a major potential risk for conflicts of interest to arise, particularly where pressure is put to streamline approvals which could compromise more thorough evaluation of risks. Clearly a need to balance efficiency with due process is needed, but the dependence on fees that are not linked in any way to actual work done in terms of proportionate fee structures creates a clear conflict of interest within organisations. There is also a significant issue with using clinical trial revenue from commercially sponsored studies to subsidise the costs of Investigator led studies which do not otherwise enjoy such financial support. Whilst highly attractive to cash-strapped organisation unwilling to invest in such trials, the dependence on such revenue is far from ideal, and in some instances means that these trials cannot be opened as they may compete for recruitment of the same patient population and revenue generating trials will take precedence. I have observed this on several occasions at my own and other institutions, so it is far from a hypothetical risk.

Finally, investigators themselves may have competing interests with respect to enrolling people into trials and there have been arguments against permitting doctors who are both a chief investigator and the primary care provider for a patient from being involved in enrolling a person into a study. This is a fundamentally flawed argument and not one supported in the National Statement. Health Professionals have a primary responsibility to ensure the safety of those in their care and this is enshrined in a legal framework that could result in them losing their status as a health provider for any serious transgressions. Health Professionals should be in true equipoise regarding whether a person participates in a study or not and only suggest it if it would not be against their interests. Those paid to do research (study coordinators and Research Nurses) have competing interests to enrol people with no such equipoise and penalty for failing to exercise good judgement about whether a person should or should not participate. For this reason for medical interventions only doctors should decide whether a person should be invited to participate and should provide independent advice regarding the risks and benefits. Recognising where competing interests to enrol a person exist are managed well on the whole although I have also experienced instances in which obliviousness to the actual conflict of interest of being an investigator and having a financial interest in a product were not identified by doctors as being a direct conflict despite filling in forms that asked them to identify these. Therefore, it is not enough to simply write policies and ask people to fill in forms and appropriate training and the development of a culture that supports people to think about what they are doing is needed.

With our thanks to Nicola Straiton for her helpful comments on an earlier draft.

It is perhaps worthwhile for institutions implementing the Australian Clinical Trial Governance Framework overseen by the Australian Commission for Safety and Quality in Health Care (ACSQHC) to incorporate key parts of managing competing interests used in clinical governance for research activities as these likely overlap. A reasonable question can be asked: Do potential participants appreciate the conflicts of the parties they might assume are supposed to safeguard their welfare and interests? What is therefore needed is more than simply listing financial interests or relationships in ethics and governance applications. Instead a systematic and sophisticated approach is required that weighs up the risks and benefits of running research at a strategic level that is deployed as a core part of the culture of an organisation rather than as check box approach in research applications.
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This post may be cited as:

Zeps, N. (29 June 2020) Embedding clinical research as part of routine healthcare: Managing the potential for competing interests. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/embedding-clinical-research-as-part-of-routine-healthcare-managing-the-potential-for-competing-interests

Worried your researchers might not be treating human research ethics as a core component of good research practice? Concerned they are not seeing it as their responsibility?0

 

All of us might be part of the problem.

Dr Gary Allen
AHRECS Senior Consultant

Consider a hypothetical problem:

You find a partially submerged car bobbing in the local harbour. 

A big problem

So, you rush out to hire a crane and pay an operator to lift it out of there.

 

It’s working perfectly.  Soon the pesky vehicle will be out of everyone’s way and normal life can resume.

Except…

 

Except you hadn’t allowed for the weight of the car and water, and you hadn’t factored in the leverage effect of the degree to which the car was below the crane.

WOOSH, ARGH! SPLASH

So now you have both a crane and car blocking the harbour.

And by the way you might now also have a crane operator who is badly injured.

 

This latest development really isn’t a problem because you rush out to get an even bigger crane to lift out the first crane with the attached pesky car.

All is going well.

Until it isn’t.

 

Most of these images record a costly sequence of blunders in Galway, Ireland (which apparently was initiated by a parking accident).

At the risk of undermining my metaphor, the last image is a photoshop fake.

For human research ethics, the big problem is that researchers might not be seeing human research ethics as a vital component of doing research well, and researchers might not perceive ethics as their responsibility.  A related problem is ensuring the ethical design and conduct of research might not be perceived as also institutional responsibility.

The usual response has been to

  1. grab research ethics review as a governance weapon to be wielded with ardent fervour.
  2. slam submitted applications we perceive as being incomplete or ill-advised,
  3. respond with scores of directive conditions. And
  4. use enforcement and sanctions procedures to punish the researchers who dare to resist.

But in attempting to solve this problem, have we created a worse one?

Reflections on the limitations of our current approach

  • The international approach was created as a response to some egregious biomedical and psychology scandals. Safeguarding against such incidents has driven our implementation and the continue evolution of the arrangements.
  • The approach is wedded to a compliance and enforcement way of seeing any problem.
  • The approach tends to treat the 99+% harshly because of the misbehaviour of <1%.
  • It also assumes it is possible and helpful to try to direct the complex behaviour of professionals across a vast array of (sub)disciplines, methods, topics, populations and contexts.

Reflecting back on the time, effort and the resources we have expended over the last 60 years, we find ourselves confronted with an uncomfortable question: Does this approach catch the dangerous minority? I would suggest it does not.

Symptoms of the problem

  • Institutions that almost exclusively focus their human research ethics efforts on ethics review.
  • The institution’s executive is anxious about institutional risk exposure.
  • There is a crippling workload for reviewers and administrators.
  • It is not uncommon to hear researchers ask each other, “Have you done ethics yet?”
  • Too many researchers outsource their ethical responsibility to the research ethics committee.
  • There is evidence of unthinking or grudging compliance, avoidance and misrepresentation.
  • Ethics training at the institution has been reduced to better form filling.

The National Statement (2007 updated 2018)

  • The National Statement is not the problem, though it has its limitations.
  • Are we trapped by past practice? “This is the way it has always been done.”
  • Both the National Statement and the Australian Code stress institutional responsibility for research culture and research training.
  • We recognise the challenges and flexibility that are open to us by the framing of the national arrangements (by way of example, the Australian National Statement on Ethical Conduct in Human Research (2007 updated 2018) allows for great diversity in the selection of a consent strategy, even though there are committees that treat an information sheet and consent form as the preferred consent strategy).
  • Having excellent policies, processes and forms aren’t enough for us to claim we are promoting a culture of ethical and appropriate conduct.
  • Could we actually be encouraging researchers not to be reflective? Could we actually be making things worse?

 

 But there is a better way: resourcing reflective practice

  • Stressing personal, rather than outsourced, ethical responsibility.
  • Encouraging ethical thinking before commencing an ethics application.
  • Seeing an approval certificate as a step, not the end of thinking about human research ethics.
  • Continued reflection on: merit and integrity matters (such as non-financial conflicts of interest); beneficence (such as public goods and community harms); respect for persons (such as a communal approach to consent); and justice (such as ensuring an otherwise disenfranchised voice is not lost).
  • Developing skills to monitor ethical conduct throughout the lifecycle of a project.
  • Responsibilities continue through analysis, write up, reporting/publication, and management of data/material after a project is completed.
  • Regarding research ethics as a design, conduct, quality and professional responsibility – not ‘just’ a matter of compliance and bureaucratic concern.
  • Recognising a reciprocal obligation for those of us who participate in and/or administer research ethics reviews, to approach the review as facilitating research, not policing it.

Strategies to resource reflective practice

  • Shift institutional ethos – from relying solely on HREC review as a demonstration that the institution is serious about ethical conduct – to an ethical research culture.
  • Ethics review to advise and inform, rather than to clear/approve/police.
  • Ethics administrators empowered to work with both researchers and reviewers.
  • The institution having resource materials rather than rules.
  • Use of mentors and collegiate advisors, such as a network of Research Ethics Advisors.
  • An ongoing commitment to upskilling ethics reviewers.
  • Training, training, training – professional development focused upon principles, strategies to apply the principles to challenges, not just form filling.
  • Top down (institutional and discipline leaders) and bottom up (HDR and supervisor training, new staff and experienced staff).
  • Inviting two-way communication – welcoming innovation, praising thoughtful and elegant strategies, inviting feedback, and supporting creative problem solving.
  • Continuous improvement and striving towards a learning institutional approach, where complaints and negative feedback are opportunities to improve.

No cranes were harmed in the drafting of this post

See also

Israel, M, Allen, G & Thomson, C (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W & Hamilton, A (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp 285-316. http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Israel, M, Allen, G & Thomson, C (2016) Whiteboard: resourcing reflective practice.
https://ahrecs.com/previous-projects/whiteboard-resourcing-reflective-practice

This post may be cited as:

Allen, G. (19 June 2020) Worried your researchers might not be treating human research ethics as a core component of good research practice? Concerned they are not seeing it as their responsibility? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/worried-your-researchers-might-not-be-treating-human-research-ethics-as-a-core-component-of-good-research-practice-concerned-they-are-not-seeing-it-as-their-responsibility

The ethical petri-dish: recommendations for the design of university science curricula0

 

Dr Jo-Anne Kelder, Senior Lecturer, Curriculum Innovation and Development, University of Tasmania, https://www.linkedin.com/in/jokelder/
Professor Sue Jones, Honorary Researcher, School of Natural Sciences, University of Tasmania,
Professor Liz Johnson, DVC of Education, Deakin University, https://www.linkedin.com/in/elizabeth-johnson-24292773/
Associate Professor Tina Acuna, ADL&T College of Sciences and Engineering, University of Tasmania, https://www.linkedin.com/in/tina-acuna-25a35965/

Ethics (thinking and practice) is intrinsic to the nature of science. Ethical practices within science-related professions are mandated by policies, frameworks, standards and cultural norms. A scientist should also consider the broader implications for society when applying scientific knowledge..

...
.Does our laboratory start working to develop a vaccine for Covid-19 or continue working on that potential cure for childhood leukemia? What will happen to the endangered Giant Freshwater Lobster if we remodel the hydrology of that major river so farmers in North-West Tasmania can grow more potatoes? Should we approve the use of GM technology to develop Vitamin A-rich rice?.
...

Science graduates must be equipped to contribute to such complex debates, and empowered to make scientific decisions within a sound ethical framework (Johnson, 2010).

The Science Standards Statement (Jones, Yates and Kelder, 2011), the national benchmark for bachelor-level science degrees in Australia, specifies that graduates will demonstrate a coherent understanding of science, and be able to explain the role and relevance of science in society. society (TLO 1: Jones et al., 2011: p.12). Furthermore, they will be equipped to understand and work within ethical frameworks, and “have some understanding of their social and cultural responsibilities as they investigate the natural world.” (TLO 5.3: Jones et al., 2011: p.15).

The argument that there is ‘no space’ for ethics in the science curriculum is no longer valid (Booth and Garrett, 2004; McGowan 2013). However there remain significant barriers to the teaching and assessment of ethical knowledge, skills and capabilities in undergraduate science curricula. We summarise these as: debate and dissent around what should be taught, who should teach ethical thinking, and how should it be taught and assessed.

It’s not just about plagiarism

Ethics in science falls into two broad categories:

  1. Ethics in the practice of science
  2. Ethics in the application of science.

Ethics in the practice of science relates to integrity in research management (including data collection, analysis and presentation); plagiarism, and authorship. Ethics curricula must ensure students’ familiarity with relevant legislative frameworks such as the National Statement on Ethical Conduct in Human Research. In professionally oriented/applied disciplines such as Agriculture and Environmental Science students must also be prepared for working ethically in a business environment and to understand their ethical and legal obligations as workplace leaders (Botwright-Acuna and Able, 2016).

Ethics in the application of science requires a broader and deeper perspective: appreciating and accepting responsibility for the impacts of scientific work upon society (Evers, 2001; Schultz, 2014). Graduates need to be aware that the ethical frameworks within which science is practised are not static, but adapt as social norms change. They must understand how their personal ethical perspectives interact with and may clash with, formal mandated frameworks, and be prepared to engage in debate around the ethical implications of applying discovery science in the real world. They must be prepared to defend ethical decisions and to appreciate that others may hold conflicting views. As Evers puts it: “the study of ethics should therefore be an integral part of the education and training of all scientists with the purpose of increasing future scientists’ ethical competence” (2001: p. 97).

Recommendation – that students are encouraged to debate, discuss, and appreciate that people will hold different points of view on, ethical questions.

Teachers may need some training

Practising scientists who themselves operate within relevant ethical frameworks are best placed to guide students about ethics in the practice of science (Kabasenche, 2014). However, while some scientists have taken up the teaching challenge of including ethics explicitly in their curriculum, this is not yet mainstream (Booth and Garrett, 2004). Most science academics are not themselves formally trained in ethical thinking (Johansen and Harris, 2000) and may express legitimate concern that they are not best placed to design and teach curricula on ethics (van Leeuwen, Lamberts, Newitt and Errington, 2007).

Recommendation – that science faculties provide professional development and community of practice opportunities to teaching staff to ensure that they have the confidence, skills and knowledge to teach ethical practice within a science curriculum.

There is a strong argument for a collaborative, interdisciplinary approach, with both science academics and philosophically trained ethicists involved in teaching ‘science ethics’ (Kabasenche, 2014). The scientist contributes expertise in the relevant science and their understanding of the ethical practice of science, while the philosopher brings critical thinking skills and decision-making tools that support ethical understandings and analysis of relative consequences. For example, in The Responsible Scientist, Forge (2008) argues that responsibility in scientific work has implications beyond intended outcomes, and includes taking into account foreseen and foreseeable outcomes.

Recommendation – that science faculties pursue opportunities for collaborative, interdisciplinary design and delivery of ‘science ethics’ across the undergraduate science curriculum.

It’s not just for the first year students

Teaching ethics to science students must do more than ensuring that first years are familiar with university policies on plagiarism and academic integrity (Botwright-Acuna et al., 2016). Ethics must be an explicitly assessed component of the curriculum at each level of study, and overtly aligned to the core science curriculum. Assessment tasks must distinguish between students’ knowledge of relevant ethical frameworks, and their ability to apply those frameworks in practice.

For example, an assessment task for third level Zoology students models an Animal Ethics application: students construct a scientific research question within an ethical framework, and justify that research in language accessible to lay people (Jones and Edwards, 2013). In the undergraduate course ‘Communities of Practice in Biochemistry and Molecular Biology’, students develop research skills alongside their capacity for ethical analysis of the impacts of science on society (Keiler et al., 2017) while in a subject on ‘Energy and Sustainability’, students develop a national energy plan that addresses equity issues as well as technical and political feasibility (McGowan, 2013). Schultz (2014) suggests several strategies for assessing Chemistry students’ knowledge of ethical thinking, such as writing a Code of Conduct for practising chemists.

Recommendation – that ethics is a compulsory and explicitly assessed component of a bachelor-level science curriculum, and that students are exposed to ethical thinking in the context of science from their first year onwards.

It’s everybody’s business

Good practice is a teaching team approach to curriculum design, delivery and scholarly evaluation (Kelder et al., 2017; TEQSA, 2018). A whole-of-curriculum approach will involve team members meeting regularly to discuss and coordinate connecting the ethical implications of scientific knowledge and practice being taught; to ensure that ethical thinking is embedded at each curriculum level; to scaffold and develop learning from introductory to assured level. At the broader level, the science curriculum must provide a framework within which students are supported to develop personal and professional responsibility for their learning and later professional life (Loughlin, 2013).

Recommendation – that the degree curriculum is discussed and agreed upon by the whole teaching team prior to curriculum design (and ongoing, as it matures) to ensure that students’ learning is built upon, and assessed coherently and developmentally.

Recommendation – that scholarship promoting and recommending content and delivery methods, and, especially, effective assessment strategies for the teaching of ethics to science undergraduates, is encouraged and rewarded.

References

Booth, J. M. and Garrett, J. M. (2004). Instructors’ practices in and attitudes toward teaching ethics in the genetics classroom. Genetics, 168(3), 1111-1117.

Botwright Acuña, T.L. and Able, A.J. (Eds.). (2016). Good Practice Guide: Threshold Learning Outcomes for Agriculture. Sydney, Australia: Office for Learning and Teaching. https://ltr.edu.au/resources/ID13_2982_Acuna_Guide_2016.pdf

Evers, K. (2001). Standards for ethics and responsibility in science: An analysis and evaluation of their content, background and function. International Council for Science, Paris.

Forge, J. (2008). The Responsible Scientist: A Philosophical Inquiry. University of Pittsburgh Press.

Johnson, J (2010). Teaching Ethics to Science Students: Challenges and a Strategy. In: Education and Ethics in the Life Sciences, Rappert, B. (ed.) ANU E Press, 197–213.

Jones, S. M. and A. Edwards (2013). Placing ethics within the formal science curriculum: a case study. In: Frielick, S. et al. (Eds.) Research and Development in Higher Education: the place of learning and teaching, 36 (pp 243-252). Auckland, New Zealand, 1-4 July 2013. http://herdsa.org.au/publications/conference-proceedings/research-and-development-higher-education-place-learning-and-21

Jones, S. M., Yates, B. F. and Kelder, J.-A. (2011). Learning and Teaching Academic Standards Project: Science Learning and Teaching Academic Standards Statement. Sydney: Australian Learning and Teaching Council. http://www.acds-tlcc.edu.au/science-threshold-learning-outcomes-tlos/science-tlos/

Kabasenche W. P. (2014). The Ethics of Teaching Science and Ethics: A Collaborative Proposal. Journal of Microbiology & Biology Education, 15(2), 135–138. https://doi.org/10.1128/jmbe.v15i2.841

Kelder, J.-A., Carr, A. R. and Walls, J. (2017). Evidence-based Transformation of Curriculum: a Research and Evaluation Framework. Paper presented at the 40th Annual Conference of the Higher Education Research and Development Society of Australasia (HERDSA), Sydney.

Keiler, K. C., Jackson, K. L., Jaworski, L., Lopatto, D. and Ades, S. E. (2017). Teaching broader impacts of science with undergraduate research. PLoS biology, 15(3), e2001318.

Loughlin, W. (2013). Good Practice Guide (Science) Threshold Learning Outcome 5: Personal and professional responsibility. http://www.acds-tlcc.edu.au/science-threshold-learning-outcomes-tlos/science-threshold-learning-outcomes-tlosscience-tlo-good-practice-guides/

McGowan, A. H. (2013). Teaching Science and Ethics to Undergraduates: A Multidisciplinary Approach. Science and Engineering Ethics, 19, 535–543.

National Statement on Ethical Conduct in Human Research. https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

TEQSA (12 December 2018). “Guidance Note – Scholarship” Version 2.5. https://www.teqsa.gov.au/latest-news/publications/guidance-note-scholarship

van Leeuwen, B., Lamberts, R., Newitt, P. and Errington, S. (2012, October). Ethics, issues and consequences: conceptual challenges in science education. In Proceedings of The Australian Conference on Science and Mathematics Education.

This post may be cited as:

Kelder, J., Jones, S., Johnson, E & Botwright-Acuna, T. (18 June 2020) The ethical petri-dish: recommendations for the design of university science curricula Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/the-ethical-petri-dish-recommendations-for-the-design-of-university-science-curricula

When Research is the treatment: why the research/clinical care divide doesn’t always work0

 

Nik Zeps
AHRECS Consultant

Health services are often operated by people who strive to improve the way they deliver care. In the public imagination improvements arise from ‘breakthroughs’ such as the discovery of new disease mechanisms and drugs or devices to address these. However, it is not just novel treatments that lead to better outcomes. Sadly, it is not widely recognised that eliminating sub-optimal practices or variations in healthcare practices play a major role in improving clinical outcomes. Indeed, I don’t recall a headline announcing an increase in operational efficiency in any health service as this is hardly exciting news regardless of its value. Funders of healthcare are interested though, and in a report entitled Exploring HealthCare Variation in Australia: Analyses resulting from an OECD Study, published by the Australian Commission on Safety and Quality in Health Care in 2014, the authors stated that:

Unwarranted variation may also mean that scarce health resources are not being put to best use. As countries face increasing pressure on health budgets, there is growing interest in reducing unwarranted variation in order to improve equity of access to appropriate services, the health outcomes of populations, and the value derived from investment in health care.

All consumers of health care should therefore be interested in this and support those working toward improving health services. Unfortunately doing this work is difficult and often unrewarding. The ethical imperative to do this work is also often thwarted by the ‘ethics’ and governance framework that too often encumbers those doing it {Clay-Williams, 2018 #516}. It is also largely left to the NHMRC to fund Health Services Research (HSR) and the Comparative Effectiveness Research (CER) studies that generate evidence to reduce wasteful practice. In contrast, very little funding from health services themselves go to these activities despite them being the direct beneficiaries of the research.[1] Importantly, those engaged in HSR and CER are becoming an increasingly larger proportion of the total medical research endeavour in Australia, and by classification constituted almost one third of NHMRC competitive funding in 2019[2]. This is despite the fact that the studies undertaken often take several years to complete and therefore the number of publications is smaller than for life sciences. For HSR, publication is rarely in the ‘higher impact’ journals, whereas for some CER Trials the outcomes are so profound that they are of international significance and will be published in widely read international journals. Pleasingly this suggests that the criteria for assessment do not necessarily disadvantage such research in terms of competitiveness for funding, but also reflects the fact that clinical trial funding from the NHMRC supports a great deal of CER studies.

Those doing HSR and CER are also often involved in working in health services as clinicians which reduces the amount of time they can devote to academic research and to build a competitive personal research portfolio. The NHMRC has implemented a “Relative to opportunity” process in an attempt to address the almost impossible task of taking into account personal circumstances, but I doubt anyone is truly comfortable in applying it across the breadth of candidates and disciplines. Indeed, it could be argued that it is a surprisingly unscientific and subjective approach to use in schemes that are rewarding the quality of scientific approaches to address major societal issues. In 2019, only 7% of investigator grants went to applicants identified as HSR researchers.

It is difficult to think of what could replace this system across all areas of scientific endeavour but there is a possibility of rethinking how we fund and manage HSR and CER clinical trials. In both types of activity the end points are focussed on providing evidence to inform changes to clinical practice and health service delivery. As such the end users are health care providers and their funders. It would therefore seem much more appropriate that the end users play a much greater role in judging what kind of research should be done as well as the value of the outcomes of existing projects. The problem with this is that Health Services do not have the internal infrastructure and capability to manage research and have no incentive or means to do so.

What is particularly important to reflect on here is that publication metrics and university-based career milestones are largely irrelevant to the health services and arguably should not be the drivers of why the work is done. It would be more appropriate to have a regular employment relationship between the health services researchers and the health services in a manner that does not differ to clinical safety and quality activities. Sadly, health services have not seen the need to invest in this out of their operating budget and one can see why they would not if universities will do so. The problem though is that health service managers inevitably regard them as academic exercises with no direct relevance to routine health practice and when budgets are tight any support rapidly evaporates.

Like other industries that are reliant on R&D, it could be argued that a defined proportion of all health funding should go to HSR and CER that is conducted and run within the health services themselves. In the UK the National Institute for Health Research (NIHR) was established in 2016 with £1 billion to do just this, representing just under 1% of the total National Health Service Budget at the time (£126 billion[3]). The current public expenditure on health in Australia is $81.8 billion AUD, however, the total health spend, including private and personal (out of pocket) expenditure was $185 billion in 2017/2018[4]. The combined NHMRC and MRFF expenditure on all HSR and clinical research is estimated to be around $800million in 2019, less than 0.5% of the total health expenditure. The difference with the UK is that the Australian funding is largely administered through universities and not by the health services as in the UK.

I would propose that researchers engaged in HSR and CER should be employed by the health services themselves and be regarded as intrinsic to the operations of the health service. In addition, I propose that these staff would not publish papers under their own names but instead publish under the health service banners, either singly or as collaborations of organisations. In this way individual career progression would be based upon demonstration of outcomes in the same way that other activities in the health service are evaluated. Staff who do their job well would continue in their employment and be eligible for ongoing employment. Career progression would be through building a demonstrated portfolio of achievement that is attested to by their employers in a similar way that professional references are provided. Success for individuals would therefore be entirely based on being able to show how they had contributed to productive activity within the organisation.

If this major change to operating this type of research was made then it might also change one of the other major barriers that currently exists, the disproportionately burdensome ethical and governance requirements for such ‘research’ which is mostly treated as having the same risk profile as novel interventional studies. The aims of research are stated to differ from those of providing clinical care to patients, and this is at the heart of the Declaration of Helsinki’s ethical principles as well as those known as The Belmont Report published in 1979. In the Australian National Statement on Ethical Conduct in Human Research, such a distinction between clinical care and research is no longer identified and not commented on so explicitly.

For HSR and CER the distinction between what is routine practice and what is research is extremely blurred, particularly within the context of a self-improving/self-learning healthcare system in which a constant cycle of analysis of the current status of clinical activity informs the delivery of healthcare into the future. The robust methodologies employed to do the analysis and to test potential alternative practices aimed at improving care are indistinguishable to those used for researching novel and potentially more risky interventions. However, the risk profile is completely different, particularly where the research involves one or more practices already in widespread use. A more embedded framework that ensures that ethical issues are addressed at a systemic level rather than through the existing ethics and governance system that treats such work as ‘other’ is needed. The 2019 draft Clinical Trial Governance Framework developed by the ACSQHC goes some way toward creating a culture in which this can be delivered although it will likely require significant cultural change at most health services engaged in research.

We need a system that values those doing this work as core employees and is directly vested in the outcomes of the work and their implementation into improved practice as the prime demonstration of productivity. Such a cultural change will provide the drive to streamline the overly burdensome regulatory framework that currently exists. Such a framework would deliver its own efficiency dividends in a positive cycle enabling more of this work to be done and an acceleration in avoiding wasteful practice and generation of data that brings real improvements to people’s lives. It would seem that this is the very definition of an ethical outcome.

[1] ACSQHC/ACTA report on clinical trial benefits https://www.safetyandquality.gov.au/publications-and-resources/resource-library/economic-evaluation-investigator-initiated-clinical-trials-conducted-networks-final-report

[2] https://www.nhmrc.gov.au/file/14808/download?token=GAkwLHj0

[3] https://fullfact.org/health/spending-english-nhs/

[4] https://www.aihw.gov.au/reports/health-welfare-expenditure/health-expenditure-australia-2017-18/contents/summary

This post may be cited as:

Zeps, N. (04 June 2020) HWhen Research is the treatment: why the research/clinical care divide doesn’t always work Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/when-research-is-the-treatment-why-the-research-clinical-care-divide-doesnt-always-work

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