Ethical considerations for health policy and systems research
A publication from the Alliance for Health Policy and Systems Research (WHO) with the Global Health Ethics Unit (WHO)
Overview
The field of HPSR and its conduct pose important challenges for both researchers and research ethics committees (RECs) about the interpretation and application of the principles for ethical conduct of health research to policy and systems research. For
instance, when is a project health research and when is it health practice? Is research ethics review required for studies of existing policy decisions?
This document provides researchers and RECs with a series of “points to consider” for clear identification, consideration and communication of ethical issues in HPSR.
It is intended that, after reading this document, researchers will better understand relevant ethical issues in their HPSR study protocols and respond effectively to REC comments and questions; and REC members will be better able to identify aspects of an HPSR project that fall within its purview, identify ethical issues raised by the study and better communicate comments and questions to researchers.
Considerations about the ethics of HPSR
| Point to consider | Challenges in HPSR | Specific questions |
|---|---|---|
| 1. Is it research? | Studies are complex, and research and practice may be intertwined. Quality improvement is the primary goal of most HPSR. A distinction between research and quality improvement is not helpful. | In the study protocol, are practice and research elements clearly identified? Is the project as a whole rightly classified as programme evaluation? Is there uncertainty? If yes, a written determination from an REC may be required. |
| 2. Which aspects are research? | Research and practice are intertwined, and it may be difficult to clearly identify research and practice elements. | Are practice elements (activities that are part of routine delivery of care) clearly identified? One way of identifying practice elements might be to determine whether activities are under the control and direction of the ministry of health, health administrators or a health organization and whether they preserve the role of provider judgement in providing care. Are research elements clearly identified? |
| 3. Is research ethics committee review required? | Studies may have multiple levels, complicating identification of participants. Research involving human participants must be reviewed by an REC. | If the project involves research, does it involve human participants (see point to consider 7)? Is there uncertainty about whether an REC review is required? A written determination from an REC may be required |
| 4. Are there adequate plans to manage any conflicts of interest? | Conflicts of interest may occur when an agency or institution evaluates its own performance. | Are there adequate plans in place to ensure the independence of the study and disclosure of results? |
| 5. Where relevant, what is the study intervention ? | Study interventions are diverse. The study may be administered at different levels. | What action is to be evaluated in the study? Actions may involve policy change, educational interventions or reorganization of care delivery. Is the action administered at the level of the community or organization, health professional or citizen? |
| 6. What are the procedures for data collection? | A single study may involve various types of data collection, including desk reviews, primary data collection and use of routinely collected data. Data may be collected at various levels (e.g. individual, aggregated). | By what means is information collected for research purposes? s it collected at the level of the cluster, health professional or patient? |
| 7. Who are the research participants? | Studies commonly involve stakeholders at various levels, including the health system, hospital, health provider and citizen. Within one study, an intervention may target one group but the outcomes may be measured in a different group. | In the context of the study, who is manipulated, intervened upon, observed or otherwise interacted with by researchers or whose private health information is collected? Are policy-makers, decision-makers or health providers research participants? Is there uncertainty about the identifiability of samples or data that would require a written determination from an REC? |
| 8. From whom is informed consent required, or is a waiver of consent appropriate? | Different groups of participants may be exposed in different aspects of the study. Policy-makers, decision-makers and health providers may have a prima facie ethical duty to continually improve the delivery and outcomes of health care. Intervention at cluster level may be difficult or impossible to avoid, making refusal of consent meaningless. | Will research participants provide informed consent? Will research participants be provided with information relevant to their involvement in the study? If policy-makers, decision-makers or health providers are research participants, will their informed consent be obtained? Do the conditions for a waiver of consent apply? If consent is waived, will staff, patients or members of the public be notified that a research study is being conducted? |
| 9. Is permission from a “gatekeeper” required? | Studies commonly involve groups as well as individuals, and there may be an impact on group or institutional interests. A variety of gatekeepers may be involved, including the ministry of health, hospital administrator or data custodians. The authority of the gatekeeper to give permission may be unclear. | Does the conduct of the study substantially implicate group or institutional interests? Does the gatekeeper have the legitimacy to give permission? For what aspects of the study is the gatekeeper giving permission? |
| 10. Is group or community engagement required? | Engagement with communities in activities that involve them is good practice. Some studies may substantially affect the interests of groups or communities. | Are there adequate plans to engage with relevant groups or communities before initiation of the study? |
| 11. Are there adequate plans for protection of privacy and confidentiality? | Data collection procedures may include use of routinely collected data and individual and aggregated data. Data may be collected on patients, health providers or institutions. | Has use of identifiable data been adequately justified? Are adequate procedures in place to protect the confidentiality of patients and health providers? Are institutions or communities identifiable, and, if so, is there risk to their reputations? |
| 12. Are the potential benefits and risks of the study acceptable? | Benefit–risk analysis is complicated by potential impacts on group and individual interests. Application of clinical equipoise to studies involving policy or care delivery is not straightforward. Different groups of participants may be exposed in different aspects of the study, and separate benefit–risk analyses may be required. Improvement of the health system or human and material capacity building are not necessarily benefits but the central aims of the HPSR. | Is the study intervention consistent with competent practice in the relevant field? Will the control condition deprive participants of effective care or programmes to which they would have access? Are the risks of data collection minimized and reasonable in relation to the importance of the knowledge to be gained? |
| 13. Are concerns about justice and equity adequately addressed? | The research question must address a local health priority in context. Studies may be conducted to evaluate interventions in people who are socially disadvantaged or to explore differences in the effects of interventions in subgroups with different levels of social disadvantage. Health providers and employees may be exposed to social risks, including reputational or professional harm. | Does the research project address a local health priority? Does the study protocol ensure the participation of hard-to-reach and “hidden” groups and those that are often left out? Are any groups unfairly excluded? Are some participants vulnerable and at increased likelihood of incurring additional or greater wrongs? If the study involves employees, are procedures in place to promote free and informed participation? Are procedures in place to protect the interests of participating groups, health facilities or organizations? |
| 14. Where relevant, are there satisfactory plans for access to interventions after the study, and roll-out of successful interventions on a wider scale? | The aim of HPSR is to strengthen health systems through research. It therefore has a greater responsibility to ensure that when interventions are studied, they are sustainable, and efforts are made to develop plans for wider roll-out of the successful interventions. Multiple actors are commonly involved, and it may be unclear where the researcher’s obligation ends and that of others, including the State, begins. | Who is funding the study, and who is responsible for implementing its results? Are there adequate plans to ensure that the intervention is sustainable and the government is committed to incorporate the successful interventions into the health systems programmes and policies? |
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