Table 3.

Key features to be considered in development of a guidance tool/ethical framework for health policy and systems research

Feature	Comments
What is health policy and systems research?	Definitions outlined by Alliance for Health Policy and Systems Research2 31 Range of study methods and types with examples Develop a matrix with links to database of cases as examples Health policy and systems research does not always involve an intervention, may be policy analysis, strategy study
Identify key areas of difference between health policy and systems research and clinical research	Scoping review findings7 Existing documents outlining methods/codes of conduct2 24 Ottawa Statement9 Secretary's Advisory Committee on Human Research Protections8 WHO guidelines on patient safety research10
Identify target audience for document	Research ethics committee members Researchers Public health practitioners Non-governmental organisations Policy makers Research funders Healthcare workers
Goal of document	Structured tool highlighting ethical domains where consideration and elaboration are required as a guide design and conduct of health policy and systems research and ethical review of health policy and systems research Living document, with integration of ongoing feedback and evaluation of the review process by the research ethics committee and researchers
Does ethics review always need to be done?	Does health policy and systems research increase risk/burden/compromise interests in way that would not have occurred if learning activity were not present? If yes, review likely required. How to enhance review? Identify ethical issues that need additional attention Avoid additional burden for the research ethics committee (emphasise that health policy and systems research review is not an additional review, it is a different approach to the review)
Identify study participants at multiple levels	Individual: for example, definition of a participant in Ottawa statement9 An intended recipient of an experimental or control intervention; A person who is the target of an experimental or control manipulation of their environment A person with whom an investigator interacts for purpose of collecting data about that individual A person about whom an investigator obtains identifiable information for purpose of collecting data about that individual) Communities Districts Institutions Policies
Emphasis on respect for researchers and their perspective	Ensure good understanding of researcher's purpose/meaning Importance of written communication between researcher and the research ethics committee
Highlight challenges particular to ethical review of health policy and systems research	Responsiveness to local needs Blurring boundary between research and clinical practice Balance need for ethical guidance versus need for more/better empirical evidence to understand issues/challenges and improve health system functioning Question of equipoise should be clearly answered, how a given health policy and systems research project achieves equipoise Distinguish between ethics review, scientific review and funding review Evolving research field Units of analysis Autonomy and risk/benefit of research in groups, imbalance between risk and benefit accrued by different groups/individuals Ancillary care responsibilities What are the ethical duties of all stakeholders? Who owns responsibility for study and outcomes? What is the appropriate response after a project is complete? When other forms of oversight might be needed, even if activities are not research?