A Scoping Study on the Ethics of Health Systems Research

Abstract

Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic.

Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions

“…The plurality and situation-specific perceptions of informed consent requirements for HPEs by IPs resonate with findings of a recent scoping review (Bachani, Rattani, & Hyder, 2016), which demonstrated that at present no clear ethics requirements exist for HPEs. While requirements for health system studies and HPEs have so far been largely based on consent requirements for clinical research (MacKay & Chakrabarti, 2019), there are no generally accepted guidelines as to whether informed consent is needed or can be waived for implementation or health system studies including HPEs (Bachani et al, 2016; Gopichandran et al, 2016; MacKay & Chakrabarti, 2019).…”

“…The plurality and situation-specific perceptions of informed consent requirements for HPEs by IPs resonate with findings of a recent scoping review (Bachani, Rattani, & Hyder, 2016), which demonstrated that at present no clear ethics requirements exist for HPEs. While requirements for health system studies and HPEs have so far been largely based on consent requirements for clinical research (MacKay & Chakrabarti, 2019), there are no generally accepted guidelines as to whether informed consent is needed or can be waived for implementation or health system studies including HPEs (Bachani et al, 2016; Gopichandran et al, 2016; MacKay & Chakrabarti, 2019). While many authors uphold individual informed consent requirements as a crucial requirement across a range of research trials (Brown et al, 2014; Essack et al, 2010; McRae, Taljaard, & Weijer, 2016; Taljaard et al, 2017), some prefer community consent or consultations with communities (Blom & De Vries, 2011; Weijer & Emanuel, 2000) while others argue for a possibility of no consent in less risky research studies, e.g.…”

Letter to the Editor

“…As we have previously shown, most research ethics review committees (RECs) are not adequately equipped to review, appraise, or identify the salient ethical challenges for LMIC HPSR. 4 However, given that there are current ethical review mechanisms in place -albeit for clinical/human-subjects researchwe suggest that perhaps these mechanisms may be an appropriate starting point and could be modified in the short-term to accommodate the ethical review of HPSR. We agree, and repeatedly state throughout our paper, that each component/section of our checklist should not be taken as definitive, but subject to deliberation.…”

Emergency care research ethics in low-income and middle-income countries

“…For example, registry research that looks at patients admitted through emergency departments will generally be eligible for a waiver of informed consent for the use of de-identified data under the same conditions as other registry research. Health systems research may have its own challenges relating to informed consent 23. For example, cluster-randomised designs in which patients cannot opt out of the research remain hard to justify from the perspective of individual informed consent 24.…”