Table 3 Ethical issues relating to examples of implementation research designsa
From: Developing the ethics of implementation research in health
IR design | Features | Example | Ethical concerns |
|---|---|---|---|
Cluster randomized trials (group randomized, place-based, community wide intervention trials) | -Random allocation of groups or “clusters” to study arms and outcomes are measured in individual subjects and at community level | -Randomization of clusters of obstetrics unit staff to education on hand washing or usual practice, measurement of rates of puerperal sepsis in women delivering at study clinics | -Different units of intervention and outcomes measurement -Consent before and after randomization, whom to consent? -Choice of gatekeepers -No opt-out option within cluster -Risk: benefit balance -Ethics of randomization to known intervention, equipoise, -Identification of vulnerable groups |
Effectiveness-implementation hybrid trials | -Assess both effectiveness and implementation strategy simultaneously -Identify intervention—implementation interactions | -Evaluate impact of ITN on reduction of malaria and assess robustness of availability and uptake of ITNs in the community | -The trade-off between the scientific rigor required for effectiveness assessment and the realistic contextual considerations required for implementation is an important ethical consideration |
Mixed-methods research | -Use of both qualitative and quantitative methods -Understands various perspectives -Rationales: “participant enrichment”, “instrument validity”, implementation validity”, “meaning enhancement” | -Integration of HIV and TB management in single clinics—patient experience (qualitative) and adherence (quantitative) | -The trade-off between the scientific rigor required for quantitative methods and the realistic contextual considerations required for the qualitative component |
Participatory action research | -Research question, design, and data collection in a participative manner by the research participants -“Bottom-up” approach | -Peer support groups to improve adherence to ARV in HIV + subjects | -There is a need for community engagement to ensure responsiveness, sustainability, and scalability |
Pragmatic trials | -Effects of intervention in routine practice -Maximize variability of settings, practitioners, patients | -Introduction of community health workers for home management of malaria | -There may be concerns of standards of care and ancillary care, which in pragmatic conditions may be ethically debatable. |
Quasi-experimental study | -Real-life conditions -With or without control group No randomization | -Open label demonstration project of effectiveness of self-reported use of pre-exposure prophylaxis for HIV | -There is a concern regarding scientific rigor of the research |
Realist view | -Analysis of how and why an intervention works in a context combining theory and empirical evidence. | -Integration of traditional healers into home management of malaria strategies | -Community engagement is of utmost importance to retain cultural and contextual sensitivity |