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