By Bridget Pratt, Coordinator for the HSG Ethics of Health Systems Research TWG, and Joseph Ali
Funders, researchers, institutions, and research ethics committees (RECs) worldwide are struggling to interpret and apply ethical principles to the increasing number of health systems research (HSR) studies being performed globally. Available research ethics guidelines, while relevant to HSR, focus predominantly on traditional forms of health research, including biomedical, social science, and epidemiological research.
But currently, no comprehensive HSR-specific guidelines exist that lay out the relevant ethical issues to consider when conducting HSR projects and provide guidance on how to address them. That HSR-specific guidelines are needed has been recognised by bioethicists and bodies such as the Alliance for Health Policy and Systems Research. Without such guidelines, key ethical issues in HSR studies are
likely to be overlooked and (as a result) not addressed, or addressed inappropriately.
A first step to develop HSR-specific ethics guidance
We were recently part of a team funded by the Alliance for Health Policy and Systems Research to perform a scoping review of the HSR ethics literature. We set out to identify a number of factors: the key ethics issues that arise when conducting HSR, with a focus (though not exclusive) on low- and middle-income (LMIC) settings; existing guidance on these ethical issues; and any gaps in the available guidance.
What emerged from the review were a number of ethical issues and a limited amount of guidance within various categories: 1) justice, 2) identifying and balancing risks and benefits, and 3) upholding autonomy. We recently presented our findings at the International Association of Bioethics’ World Congress of Bioethics in Edinburgh in June 2016.
Ethics and social justice
Given the strong links between HSR and social justice, the review identified significant ethical challenges within HSR related to selecting research populations and research questions and to providing benefits during and after studies. Notably, the existing structure of HSR may not be optimally set up to reduce health disparities between and within countries. Where HSR does not include vulnerable and disadvantaged populations sufficiently, for instance, interventions are largely proven to work for the better-off.
A related ethical concern is that global and donor priorities may overly influence what HSR is conducted in LMICs. Furthermore, ethical responsibilities for dissemination and translation of HSR findings exist but are not well defined.
Balancing the risks and benefits
The process of identifying and balancing risks and benefits at various levels in HSR adds complexity relative to traditional biomedical research. In the context of HSR, questions we should be asking about risks and benefits include:
- Whose risks and benefits (e.g. individuals, groups, communities, health systems) should be assessed as part of risk-benefit assessments?
- What individual and collective risks and benefits, including not only medical ones but also social, economic and political ones, are experienced?
- What protections must be in place to reduce or minimize the risks of studies?
- What constitutes an acceptable balance of risks and benefits within and across various types of participants?
Who holds autonomy?
There are numerous circumstantial and design factors associated with HSR that may sometimes present challenges for ensuring research participants’ autonomy. Can individual autonomy be upheld when studies test group-level interventions or involve large research populations, perhaps, where individual consent may not be feasible?
With this in mind, obtaining gatekeepers’ consent may be necessary, but how should legitimate gatekeepers be selected? When do waivers for consent apply and what constitutes minimal risk in studies? And, where individual consent is not feasible or is waived, should participants be informed that the study is taking place and, if so, what information should they be given?
Limited existing guidance for ethics in HSR
In our review, we did not identify any formal ethics guidance documents specifically for HSR. Two ethics/regulatory advisory documents do exist for cluster trials, which is a common HSR method:
- Ottawa Statement on the ethical design and conduct of cluster randomized trials (Canada)
- US Secretary’s Advisory Committee on Human Research Protections (SACHRP) Recommendations on regulatory issues in cluster studies
The majority of scholarly and HSR-related guidance focuses on obtaining or waiving informed consent and cluster trial methods. It has been recommended that obtaining consent during studies testing group-level interventions should occur at two levels: consent to the study occurring and individual consent to receive the intervention.
When developing and reviewing research protocols, it is important to consider risks and benefits in HSR at multiple levels: individual, group, and the health system. Individual and collective risks described as occurring in HSR include:
- Social stigma and violence
- Psychological risks
- Reputational and financial harms
- Social discord
- Costs to health system
- Widening health disparities between groups.
When assessing risks and benefits, the literature highlights the need to look beyond medical harms such as social and cultural risks. However, there is limited guidance on how to balance risks and benefits in HSR, and similarly, there is very limited guidance on how to address the justice considerations discussed above.
Limits of the existing literature
The literature we identified was not reflective of the breadth or depth of potential ethics issues in HSR. Ethical issues relating to certain features of HSR were not strongly discussed; for example, ethical issues associated with community/stakeholder engagement, adaptive designs, and use of social science methods. These gaps in the literature need to be addressed and guidance on how to deal with identified issues needs to be developed for both researchers and RECs.
Notably, the literature identified by the review was largely written by high-income country authors and/or focused on high-income country contexts. Clearly, there is an urgent need for increased investment in LMIC HSR ethics capacity strengthening and LMIC-led HSR.