Nik Zeps and Tanya Symons
AHRECS Consultant
ni******@****cs.com“>
Breakthroughs in medicine often highlight the existing limitations of the frameworks established to manage the ethical responsibilities arising in healthcare. The contraceptive pill, organ transplantation, assisted reproductive technology, gene therapy and more recently gene editing are notable examples that have stimulated major debates and, in several instances, prompted changes to not only ethical guidelines but also legislation. However, there are also more subtle ethical issues that arise from doing established activities in a different context or scale. Think of so-called Big Data applied to health care or to uses of machine-based learning which promise to revolutionize practice but are really just larger scale applications of business as usual using more sophisticated technology than before. One result of these two developments is the amassing of personal data online which coupled with improvements in reidentification techniques present challenges to how we manage the privacy of individuals. These have prompted amendments in regulation that facilitate the use of personal data whilst also strengthening protections for individuals (link to GDPR).
Less well known, are changes in the way we evaluate existing healthcare practices to ensure they are truly safe, effective and economical. One such example is the increasing focus on Comparative Effectiveness Research (CER). These studies compare two or more existing practices that are in widespread use and have been found safe and efficacious. CER is an extension of audit/QI practices in that it uses clinical trial methodology and the power of randomisation to remove the biases inherent in the observed outcomes in a population of non-randomised patients receiving a particular health service. These studies generally include large numbers of patients (sometimes several thousand) so that they can detect differences between the interventions that, while relatively small, can nonetheless be clinically meaningful at a population level.
There is an over-riding ethical need to do this work constantly within what can be termed a ‘learning healthcare system’ 1. Conceptually this means that every single instance that a person interacts with the health system should be captured in a manner in which it can be evaluated to make sure that optimal care is provided. Both patients and health system leaders expect this to be happening and yet in truth, the lack of standardisation in data capture, storage and interoperability means that few do this efficiently and effectively as part of routine healthcare activity. Moreover, existing research ethics frameworks impede the integration of healthcare and research by failing to recognise the differences between studies that involve standard care treatments from studies testing novel interventions with unknown safety profiles. One example is the requirement to apply to comparative effectiveness studies informed consent processes that differ so greatly from routine consent to treatment they are impossible to integrate into routine clinical workflows.
In a recent paper, (Symons et al 2) we have considered whether approaches that utilise modified consent pathways for CER are permissible from an ethical and regulatory perspective. In an accompanying editorial 3Dr Evan Kharasch challenges the readers of the journal to consider how the existing ethical and legal frameworks can be complied with for trials where the risk of harm is small. There is a perception that as soon as a study employs randomisation it becomes more than low risk when this may not, in fact, be true. It is also important to consider the ethical issues that arise when this type of ‘public good’ trial is simply not done because using consent processes suitable for interventional trials of unapproved therapeutics makes them impracticable. If indeed a particular treatment is less effective or causes more harm and we continue to use it because we consider that currently required ethics processes render them impracticable, then those processes have led to potentially unethical outcomes.
To achieve the best healthcare outcomes, greater sophistication of thought is needed at the ethics committee level. It also seems obvious that greater engagement with consumers is a necessary and relevant pathway to designing and conducting trials that deliver on expectations. The Australian Clinical Trials Alliance (ACTA) together with the Trials Clinical Trials: Impact & Quality (CT:IQ) have developed a consumer involvement and engagement toolkit that serves this purpose [1]. By working more closely together and encouraging more flexible and contemporary approaches to research ethics compliance, we can achieve the ideal of encouraging and supporting clinicians and health services to undertake continuous improvements to health services using the best methodologies to achieve this for the benefit of the community they serve.
References
1 Faden, R. R. et al. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep Spec No, S16-27, doi:10.1002/hast.134 (2013).
2 Symons, T. J., Zeps, N., Myles, P. S., Morris, J. M. & Sessler, D. I. International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology 132, 44-54, doi:10.1097/ALN.0000000000003020 (2020).
3 Kharasch, E. D. Innovation in Clinical Research Regulation. Anesthesiology 132, 1-4, doi:10.1097/ALN.0000000000003026 (2020).
[1] https://involvementtoolkit.clinicaltrialsalliance.org.au/
This post may be cited as:
Zeps, N. (22 December 2019) Advances in Medicine often require innovation in ethical thinking too. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/advances-in-medicine-often-require-innovation-in-ethical-thinking-too-2