Table 1 Differences between clinical and implementation research which impact application of ethical principlesa
From: Developing the ethics of implementation research in health
Domain | Clinical research | Implementation research |
|---|---|---|
Research participants | Individuals | Countries, institutions, communities, and individuals |
Informed consent | Informed consent by competent individuals, assent by minors and consent by legally authorized representatives | Consent may be difficult to obtain in cluster randomized trial design. There may be a need for a two level consent—consent for randomization from gatekeepers and consent for participation at the individual level. Sometimes individual consent may not be feasible. However, gatekeeper consent does not replace the need for individual consent. Ethical committee should oversee the informed consent requirement and process |
Equipoise | Clinical equipoise | Clinical as well as contextual equipoise (genuine uncertainty that the implementation will work in a new context as well as whether the implementation package will work at all) |
Pre-requisites | Understanding of disease pathophysiology Intervention aimed at disease-specific management | Identification of population health needs Understanding relative priority of need for intervention within local context Community engagement to understand community needs, ensure scalability, and sustainability |
Research conditions | Generally controlled research environment | Real-life or pragmatic research environment |
Research designs | Cross-sectional, case-control studies, Cohort studies, randomized clinical trials | Cluster randomized trials Pragmatic, mixed methods, effectiveness implementation hybrid designs, participatory action research, quasi-experimental design, realist review |
Integration within health system | Often, there is no a priori plan for health system integration. Findings of clinical research go through IR before integration into health system | IR has a strong health system strengthening focus. It creates horizontal integration into the health system. There is an ethical imperative for health system integration |
Predominant research disciplines | Physiology, genetics, biochemistry, and other basic sciences, epidemiology, clinical medicine | Anthropology Economics Epidemiology Political science Public health Sociology |
Control groups | In most epidemiological designs, control groups are required. But some phase 1 clinical trials and observational studies may not require control groups | Having a no intervention control group may not be acceptable. Alternative designs of quasi-experimental studies do not require a control group |
Boundary between research and clinical care | This boundary is usually clear, but may be unclear in case of therapeutic misconception especially in cancer trials | Is often unclear, because the intervention is of proven efficacy |
Types of research question | Efficacy and safety of a therapeutic strategy in the individual | Operationalization of an intervention in local context Implementation of an intervention in local context prior to scale-up Policy analysis Health system functioning at multiple levels |
Anticipated outcomes | Well-defined hypothesis at the beginning of the clinical research. Expected outcomes clearly stated. | Multifaceted holistic impact on health systems functioning with regard to intervention tested. Sometimes outcomes may be unexpected |
Risks assumed by: | Mostly, the risks are for the study participants. However, families and communities may also be affected in specific contexts | Usually population level risks. Moreover, the people getting the benefits and people suffering the risks may be different. |
Benefits accrued by: | Benefits accrue to the participants, the community. The research finding may be a common good | Individuals, communities, health system, institutions may benefit. The research findings may be common good. The people accruing benefits may be different from those who suffer risks |
Generalizability | Generalizability is sometimes possible in multicentric and well sampled studies, however most studies are specific to the target populations. | Generalizability may be limited by contextual factors. However, findings may be generalizable to similar contexts |
Social justice implications | Social justice is usually not a primary consideration. However, justice considerations are required in selection of research participants. Research on vulnerable participants is often contentious because of compromised autonomy and other logistics | Social justice considerations are primary. Working with vulnerable groups essential to understand implementation issues in these groups so that the intervention can reach them |