Table 2

Current challenges in research ethics committees review of health policy and systems research

ChallengeRelevant considerationsExamples
What to review
  • Is the study research or not?

  • Does the study require full review, expedited review, waiver of review?

  • ‘Piggy-backing’ problem: as a project evolves an unanticipated research component may develop requiring further/additional review

Debate exists whether quality improvement or monitoring and evaluation exercises are indeed research.
The research—practice continuum is often blurred in health policy and systems research.
Research components
  • What is the intervention and why (ie, prioritisation)?

  • Define who/what subject of research is (ie, justice, equity considerations)

  • What level of consent is required/feasible?

  • What methods are used? Are they appropriate for research question?

  • Does the study increase risk/burden/compromise interests in any way that would not have occurred if learning activity were not present?

  • Identify possible consequences or problems?

  • Who assumes ancillary care responsibilities?

  • Have all stakeholders been meaningfully engaged in planning phase?

In an intervention providing taxi vouchers to pregnant women as incentives to increase institutional deliveries, performance at local clinics will be monitored to determine impact of voucher intervention on outcomes.
In this case, the intervention is directed at pregnant women but could benefit taxi drivers or destabilise the local taxi economy and impact on local clinic capacity, which may become rapidly overwhelmed unless adequate planning occurred. Should informed consent be obtained from pregnant women, taxi drivers or clinic staff? Should the care provided by the clinic staff be considered a research activity or is it practice?
Women living in areas without taxi facilities may be marginalised.
Individuals with other urgent conditions, although not pregnant, would not have access to the intervention. How sustainable is the intervention? Has the community/stakeholders been engaged with in study design?
Potential conflict of interest
  • Role of those commissioning or funding the research?

The state may commission a study to evaluate its own interventions/programmes
How to deal with individual risk/autonomy
  • Balance risk and benefits for individuals versus community or health system

  • Is ‘minimal benefit’ a form of potential harm (ie, is the study worth doing?)

  • ‘Reputational risk’ to researchers, states, stakeholders

  • The risks of health policy and systems research are experienced at different levels; therefore, more comprehensive global risk assessment must be required.

  • Redefine concept of an ‘adverse event’ outside of clinical research, as the perspective is far broader in health policy and systems research

In health policy and systems research, those exposed to the risks of an intervention may be different from those who benefit from the intervention. For example, an intervention testing a vaccine to prevent transmission of malaria from an infected individual to others would expose the vaccinated individual to the risk of vaccination but only protect other individuals from malaria.
Study and reporting of institutional/district performance, although anonymous, may still permit identification of institutions/districts and may lead to stigmatisation. Such stigmatisation could be classified as an adverse event/unintended consequence of a health policy and systems research study.
Use of incentives
  • Unclear if incentives are moral in any form in a poor country (size and nature of incentive)

  • If questionable sustainability of incentives for the long term, they may not be ethical to study

Incentives used in studies conducted in communities/regions where poverty is high may induce participation that would otherwise have been against the will of a participant for example, payment for blood sampling.
Is a taxi voucher scheme to increase institutional deliveries sustainable over the long term?
Justice
  • Ethical value of repeating an intervention known to be valid elsewhere (clinical versus contextual equipoise)

  • Is randomisation justified?

  • What is an acceptable standard of care for control groups?

  • Research may be a tool to introduce an intervention into a country but this may exacerbate regional inequalities at least initially

A stepped-wedge trial evaluating delivery of a new vaccine, known to be highly effective in prevention of diarrhoeal illness, in a community with historical reluctance to vaccination may be justifiable to evaluate acceptability of the vaccine in the community, but given the known effectiveness of the vaccine, leaving ‘control’ communities unvaccinated especially in the early stages of the study could be interpreted as permitting harm.
Introduction of piped water and soap to schools in poor overcrowded urban communities may improve hand hygiene practices and reduce diarrhoeal illness in children but would further exacerbate inequities between urban and rural children
Legal concerns
  • Implementation of interventions outside the law may be tolerated (eg, testing an unapproved medication or task shifting), but where does the accountability lie for adverse events?

Study of the effectiveness of using community health workers to diagnose and empirically treat pneumonia in young children in rural areas goes beyond the usual scope of practice of the community health workers. If a child is misdiagnosed or incorrectly treated by a community health worker, where does the responsibility lie?
Post-study
  • Must there be assurance of sustainability post-study?

  • Does the study enhance local infrastructure/research capacity?

The use of incentives to induce changes in health behaviour may not be sustainable long term.
Studies conducted by research groups based outside of the country may bring their own experts/tools and not strengthen local capacity
Role of research ethics committee
  • Distinguish ethical risks inherent to the public health practice being studied versus those intrinsic to the research study itself

  • What is the research ethics committee's role (if any) in ensuring appropriate post-study activities?

Randomisation to intervention versus control itself may constitute a risk if an intervention is known to be effective
Research may more clearly identify risk groups as compared with public health practice and thereby increase the risk of stigmatisation of the risk groups
Strategies to improve quality of ethical review
  • Research ethics committees must be familiar enough with specific relevance of ethical issues to health policy and systems research to reduce variability across sites

  • Research ethics committees should include representatives of variety of stakeholder groups to enhance appropriateness of the review process and anticipation of challenges

  • Research ethics committees must be independent bodies and not tools of external stakeholders.

  • Engagement between research ethics committees and researchers and establishment of a guidance tool with ethical practice expectations to reduce perceived ‘rubber stamping’ role of research ethics committees

Research committees reviewing the same health policy and systems research protocol at various sites may issue different reports which may cause important delays in study initiation and create difficulties for researchers conducting studies in multiple sites.
Accelerated research ethics review during the recent Ebola outbreak facilitated conduct of time-sensitive research but identified many challenges that must be addressed to optimise this process.26 30