By Dr Tom Foley, Dr Fergus Fairmichael.
Professor Faden is the Philip Franklin Wagley Professor of Biomedical Ethics and Andreas Dracopoulos Director of the Berman Institute of Bioethics.
Professor Kass is the Phoebe R Berman Professor of Bioethics and Public Health at Johns Hopkins, Deputy Director for Public Health of the Berman Institute of Bioethics, and Professor of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health
Faden, Kass et al. published the first ethical framework for the learning health care system in their paper “An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics”. This outlined seven obligations :
1. Respect the rights and dignity of patients
2. Respect clinician judgments
3. Provide optimal clinical care to each patient
4. Avoid imposing nonclinical risks and burdens on patients
5. Address health inequalities
6. Conduct continuous learning activities that improve the quality of clinical care and health care systems
7. Contribute to the common purpose of improving the quality and value of clinical care and health care systems
Further to this work, they have also discussed the potential use of a streamlined consent process or, in some cases, no consent process at all within a learning health care system, in their paper “Informed Consent, Comparative Effectiveness, and Learning Health Care”.
Their proposed “common purpose” framework is “a radical departure from the current relationship between research and practice” and calls for a rethinking of this relationship. It is premised on the two foundational system level principles of:
• Justice in health care; and
• Increasing quality
It is also based on the key principle of reciprocity, that patient participation in healthcare is with the understanding that knowledge learned will translate into improved service for everyone.
This framework has had a mixed reception:
• Significant enthusiasm from those supportive of learning health systems and from those in the bioethics community whose views are that multiple options for informed consent may be acceptable in different types of circumstances
• More reservation amongst those doubtful about learning health systems in general and from those wedded to the view that the traditional informed consent model is the only morally acceptable approach for clinical research
Changes to the consent process
Introducing studies without informed consent has been very controversial. This ignores the double standard that we often don’t give patients informed choice in other situations, for example in quality improvement studies. Fully informed consent can be stifling for research and impede learning. It should be acknowledged that there may be other ways in addition to, or separate from, informed consent that are worth exploring.
A large amount of research could be done ethically but in a less effortsome manner than is currently the case. Engagement with patients and the public regarding which procedures need consent and which don’t will be key to the development of this change.
Implementation of the framework
This framework could not be implemented immediately on top of our current healthcare system and would need a phased, step by step approach. Some healthcare systems are currently more suited for this development than others. To be successful, like any kind of social change, implementation of the framework will require a number of steps:
• The healthcare system leadership must have the vision and commitment to have an ethically robust LHS.
◦ There should be a culture within the institution or system to endorse this approach
◦ This may be easier in a system like NHS than in a fragmented system such as the US. Documents like the NHS constitution may be important and would be worth examining to determine whether it would need to be expanded or developed to facilitate this transformation.
• Data needs to be collected systematically
• The required digital infrastructure must be built
• The system must prioritise what studies would need to be RCTs and what could be observational
• Clinicians must be carefully involved
• Patients must be involved and play a central role in these decisions including decisions about which types of studies or projects could go forward with which different types of consent or disclosure
The “ETA” approach is important in the development of the learning health system and is relevant to the ethical foundation of such a system:
◦ Massive engagement of stakeholders, especially patients and the public, is required. It is important for them to understand the reasons for the system and that it will help to deliver current best care.
◦ Patients should help decide what sort of studies should require full informed consent, streamlined consent or no consent at all.
◦ Be open that your system is committed to learning from care.
◦ Ensure that when joining a health system, the public is aware that the aim is to learn from care and to constantly improve.
◦ Transparency about quality improvement as well
◦ Let people know when care does change as a result of learning activities. Use multiple methods including newsletters, websites etc.
◦ Accountability from the system side in making sure that care actually does change and improve as a result of learning. The justification for streamlined consent or disclosure approaches is that these will facilitate more learning which is ultimately in patients’ best interests. if the learning does not translate into changes in care, then the ethical “contract” is no longer valid
Throughout all of these steps, there is a need to create an environment that highlights the importance of learning for a common purpose. Researchers must not only be excited about the research itself but also about changing the way that care is delivered. Central to this is the idea of facilitating very low risk research that is less burdensome to conduct in an ethical way.
A true learning healthcare system requires universal access to affordable care. The common purpose framework includes an explicit obligation to reduce unjust inequalities in health outcomes and access to health care. It is possible, however, that the introduction of learning health care systems in some but not all contexts might result in inequalities in healthcare quality or provision, with those who are treated outside of such systems being at a potentially significant disadvantage. This may include those from smaller countries or smaller providers. Whilst no direct harm would be done to them as their care would be unlikely to worsen there is the potential for a widening gap in quality of care. There is a moral obligation to reduce unjust inequality of this sort as well.
• Stakeholders must understand the value of a learning healthcare system going forward. If this is not understood, then people are less likely to engage with the system
• The system should be patient oriented and start in incremental ways to increase acceptance
• There is a need to translate learning into practice and inform patients that this has happened
• Need to prioritise which questions need to be answered and which require an RCT rather than an observational study. Patients should be heavily involved
• Need to communicate with patients and involve patients in decisions about what sort of consent is required. Anxiety about removing elements of consent will persist into the future.
• This move towards learning health systems represents a huge transition for the ethics of research and clinical practice
• There is an ethical justification for implementing a LHS
• But LHS also requires having an ethical foundation whose steps must be followed and implemented as part of the process
• It needs to be a set by step process
• It is necessary to develop an understanding that learning will be translated into improved health care
• Patients should be consulted regarding changes to the consent process. This would overcome anxiety and build trust in the process
• Patients should help to guide research priorities
• Learning health systems are not just about advancing science but are about learning for a purpose and translating learning into practice in a more timely way.