Table 1.

Relevance of ethical considerations in health policy and systems research versus clinical research

Ethical principle	Ethical consideration	Health policy and systems research	Clinical research	Public health research
General considerations	Purpose	Address healthcare disparities Improve health system functioning Policy development	Answer questions related to specific disease process/intervention	Identification of population health determinants, disease levels, establishing effectiveness, safety and costs of public health interventions
	Methods	Variable, often multidisciplinary	Ideally randomised controlled trial, variable	Variable, may be multidisciplinary
	Need for ethical review?	Blurred line between research and practice	Usually required for research	Blurred line between public health interventions and research
		Research versus quality improvement, Monitoring and Evaluation (which may not require review)		Nature of public health interventions, observational studies, programme evaluation (which may not require review)
		Data review (no human subjects)
	Type of intervention	Is study addressing a local health priority?	May be very specific/detached from public health priorities	Should address a locally relevant public health question
		Is the study responsive to local health needs?
	Study context	Embedded within health system, interdependent relationships, social context	Typically controlled circumstances for study, strict inclusion/exclusion criteria	Public health system, community, pragmatic real-life conditions
		Local health system, not controllable
	Ancillary care	Need to consider who is responsible, link with standards of care	May/not be relevant	May be relevant
	Data	May be very large databases on whole communities/institutions	Usually strict rules governing privacy, etc.	May be very large databases on whole communities
		Who owns the data?	Researchers often “own” data	Usually public health system
		How to ensure privacy? Community members may not be aware that their data exist/are being shared	Subject de-identification, individual consent accept risks	Community members may not be aware that their data are being collected
	Responsibility for post-study care	Scalability/sustainability–state responsibility	Often limited post-study obligations to study participants only — study funders, researchers	Public health programmes should be ongoing if effective
	Accountability	Researchers, state, funders?	Researchers, sponsors	Public health policy makers and practitioners
	Obligation for health system strengthening	Yes	Not usually primary goal	Not usually primary goal
	Conflict of interest	Ministry of Health/health agency may commission a study to evaluate its own actions	Research versus marketing	Public health agency evaluating its own interventions
Autonomy	Units of study	Communities, institutions, Individuals	Individuals	Communities, institutions, individuals
	Consent	Group permission, gatekeeper Waived (provision of information) Individual	Individuals	Waived (provision of information), permission, gatekeeper Individual (less common)
	Community engagement	Necessary to engage with and inform participants	Often not necessary, subjects informed during individual consent process	Generally necessary to engage with and inform communities
	Opt-out possibilities	Sometimes not possible to opt out without imposing large burden	Integral to informed consent process	May not be possible to opt out without imposing large burden
	Gatekeepers	Appropriate choice of person/institution	Often not required/relevant	If required, appropriate choice of representative
Non-maleficence	Risks/harm	May not be the same recipient as beneficiary	Usually risk taken by beneficiary (phase III, IV clinical trials)	Risks may apply to individuals while benefits may accrue to communities
		Broader risks may not be obvious upfront
		How to balance benefits gained by one group and risks taken by another?		May infringe on individual autonomy for common good
		Long term risks may not be initially apparent/recognised
	Minimal risk definition	Definition of ‘minimal risk’	Risk to the individual participant should be acceptable relative to potential benefit	Definition of 'minimal risk'
	Stigmatisation	Of groups selected for study	Less risk because of individual consent	Of communities receiving an intervention
		Institutional reputational risks, may be difficult to 'blind' data
Beneficence	Benefits	Benefits may be gained by groups not directly targeted by study	Usually gained by individual who takes the risk Common good	Usually common good, extend to broader local population
		How to balance benefits gained by one group and risks taken by another?		Balance cost-effectiveness versus priority of need
	Minimal benefit	Study should only be undertaken if reasonable expectation of meaningful outcomes	Clinical equipoise should guard against 'useless' study	Study should only be undertaken if reasonable expectation of meaningful outcomes
Justice	Inclusion in study	Representation of vulnerable groups	Eligibility and exclusion criteria clear	Entire community
		Fair subject selection		Vulnerable groups
	Equity	Concern not to aggravate inequalities or even work towards more equitable care	Usually 'inequity' accepted to some degree for randomisation or inclusion/exclusion criteria	Justice and fairness are key
	Community/stakeholder engagement	Frequently required, may depend on nature of intervention to be tested	Often not necessary, subjects informed during individual consent process	Frequently required, may depend on nature of intervention to be tested
	Standard of care	Relevant especially for control arm	Often clear	Relevant especially if control group
	Equipoise	May be procedural or contextual equipoise, usually not clinical	Clinical equipoise required	May be contextual and clinical
	Dissemination of findings	To policy makers to impact policy, other researchers, decision makers, communities who participated	Obligation to report both positive and negative results of clinical trials, at the very least in a publicly available clinical trials registry. Outcome of all clinical research to be reported back to research participants where relevant	To public health policy makers to impact policy, other researchers, community, health workers

Concepts developed from references.6 14–21 27–29