Table 1

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

Ethical principleEthical considerationHealth policy and systems researchClinical researchPublic health research
General considerationsPurposeAddress healthcare disparities
Improve health system functioning
Policy development
Answer questions related to specific disease process/interventionIdentification of population health determinants, disease levels, establishing effectiveness, safety and costs of public health interventions
MethodsVariable, often multidisciplinaryIdeally randomised controlled trial, variableVariable, may be multidisciplinary
Need for ethical review?Blurred line between research and practiceUsually required for researchBlurred 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 interventionIs study addressing a local health priority?May be very specific/detached from public health prioritiesShould address a locally relevant public health question
Is the study responsive to local health needs?
Study contextEmbedded within health system, interdependent relationships, social contextTypically controlled circumstances for study, strict inclusion/exclusion criteriaPublic health system, community, pragmatic real-life conditions
Local health system, not controllable
Ancillary careNeed to consider who is responsible, link with standards of careMay/not be relevantMay be relevant
DataMay be very large databases on whole communities/institutionsUsually strict rules governing privacy, etc.May be very large databases on whole communities
Who owns the data?Researchers often “own” dataUsually 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 risksCommunity members may not be aware that their data are being collected
Responsibility for post-study careScalability/sustainability–state responsibilityOften limited post-study obligations to study participants only — study funders, researchersPublic health programmes should be ongoing if effective
AccountabilityResearchers, state, funders?Researchers, sponsorsPublic health policy makers and practitioners
Obligation for health system strengtheningYesNot usually primary goalNot usually primary goal
Conflict of interestMinistry of Health/health agency may commission a study to evaluate its own actionsResearch versus marketingPublic health agency evaluating its own interventions
AutonomyUnits of studyCommunities, institutions, IndividualsIndividualsCommunities, institutions, individuals
ConsentGroup permission, gatekeeper
Waived (provision of information)
IndividualsWaived (provision of information), permission, gatekeeper
Individual (less common)
Community engagementNecessary to engage with and inform participantsOften not necessary, subjects informed during individual consent processGenerally necessary to engage with and inform communities
Opt-out possibilitiesSometimes not possible to opt out without imposing large burdenIntegral to informed consent processMay not be possible to opt out without imposing large burden
GatekeepersAppropriate choice of person/institutionOften not required/relevantIf required, appropriate choice of representative
Non-maleficenceRisks/harmMay not be the same recipient as beneficiaryUsually 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 definitionDefinition of ‘minimal risk’Risk to the individual participant should be acceptable relative to potential benefitDefinition of 'minimal risk'
StigmatisationOf groups selected for studyLess risk because of individual consentOf communities receiving an intervention
Institutional reputational risks, may be difficult to 'blind' data
BeneficenceBenefitsBenefits may be gained by groups not directly targeted by studyUsually 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 benefitStudy should only be undertaken if reasonable expectation of meaningful outcomesClinical equipoise should guard against 'useless' studyStudy should only be undertaken if reasonable expectation of meaningful outcomes
JusticeInclusion in studyRepresentation of vulnerable groupsEligibility and exclusion criteria clearEntire community
Fair subject selectionVulnerable groups
EquityConcern not to aggravate inequalities or even work towards more equitable careUsually 'inequity' accepted to some degree for randomisation or inclusion/exclusion criteriaJustice and fairness are key
Community/stakeholder engagementFrequently required, may depend on nature of intervention to be testedOften not necessary, subjects informed during individual consent processFrequently required, may depend on nature of intervention to be tested
Standard of careRelevant especially for control armOften clearRelevant especially if control group
EquipoiseMay be procedural or contextual equipoise, usually not clinicalClinical equipoise requiredMay be contextual and clinical
Dissemination of findingsTo policy makers to impact policy, other researchers, decision makers, communities who participatedObligation 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 relevantTo public health policy makers to impact policy, other researchers, community, health workers
  • Concepts developed from references.6 14–21 27–29