Take the participants through the learning objectives; put IR into the context of the spectrum of health-related research and specifically as a sub-type of HSR.

Mention the need to identify specific ethical concerns in the conduct of IR that require special consideration beyond those for biomedical (clinical) research.

Briefly touch on the components of IR that will be elaborated in subsequent modules.

Take the participants through the learning objectives; put IR into the context of the spectrum of health-related research and specifically as a sub-type of HSR.

Mention the need to identify specific ethical concerns in the conduct of IR that require special consideration beyond those for biomedical (clinical) research.

Briefly touch on the components of IR that will be elaborated in subsequent modules.

This is an introductory slide to the next few slides discussing and placing the various common forms of health-related research. Basic science does not always relate directly to humans; it may, for example, be conducted on tissue samples or animals, so, in addition to ethical obligations to humans, there may be animal ethics considerations. Emphasize that all forms of research complement our comprehensive understanding of health and disease, and how to maintain health, and prevent or treat disease in individuals and populations.

Using the diagram of WHO building blocks of the health system as one framework (not the only one) to look at the health system, illustrate how it is an overarching system that affects all aspects of health and health-care delivery, and how each component is necessary for the best functioning/effectiveness of the other components.

Using a major global public health problem, such as malaria, illustrate how understanding the pathophysiology of the disease, for example, that it is transmitted by mosquitoes, and how understanding the life-cycle of the parasite was crucial in combating the disease, and in studying the compounds that might be effective in curing the disease.

Discuss how much research in the past decades has focused on understanding medical diseases and the development of disease-specific therapies and products with the goal of improving health and minimizing associated risks in individuals. In the past, less attention had been paid to how these treatments/products reached the individuals affected on a broader scale.

Introduce the idea that when studying disease pathophysiology and developing effective treatments for the individual, it should not be assumed that all who need the treatment will receive it. Attention must be paid to understanding whether a specific disease is indeed a relevant clinical burden within a country/region (i.e. responsiveness of research to the needs of the population) as well as the prevalence of the risk factors, or specific populations at risk, in order to develop strategies for disease control and management. This requires diligent epidemiological investigation including human disease incidence and prevalence, vector surveillance, etc. In the malaria example, population surveillance assists in the identification of the population most at risk (children under 5 years and pregnant women), and helps to target treatment to those who need it the most. Understanding vector control permits development of public health strategies to reduce transmission, e.g. increase uptake and the proper use of insecticide treated nets (ITNs).

Epidemiology and surveillance provide more information and lay the foundation for research to improve health-care delivery and health systems functioning, and provide information about access to care and health needs in the population. All components of the health system need to function well and in conjunction with each other for effective management, especially of diseases affecting public health.

This slide illustrates the continuum of health-related research and the feedback loop between epidemiology and surveillance and HSR. In themselves, epidemiology and surveillance are NOT IR but they provide the data upon which IR can be developed. Once a disease is recognized as a health priority, it is the responsibility of the health system to ensure equitable access to effective treatment. HSR, including IR, is designed to test potential solutions to improve access to and uptake of treatment or preventive interventions for highly relevant local health-care needs, for example, malaria in endemic areas. Such research is conducted in real-time and under real-life conditions. After the IR is conducted and an intervention is rolled out in a community, ongoing monitoring is necessary to detect effectiveness or failures, or any changes in disease patterns or in the health-care delivery process that require feedback and optimization of intervention strategies. Therefore, a continuous flow of information must be fed back to the health system to facilitate decision-making and resource allocation.

A review article by Remme et al. (2010) depicts the positions of operational research (OR) and IR within HSR. There are various ways to depict the position of IR within HSR; emphasize to the participants that this diagram is one illustration of the domains of HSR. Given the simplicity of this diagram, this is used here for practical purposes to illustrate where IR fits along the spectrum of HSR. This slide also identifies the target users of the information generated by the various forms of research and the generalizability of the research findings.

There is a progression from OR, which studies the very local application of interventions and the feedback loop is local, to IR, which studies interventions within local contexts but has broader applicability and generalizability. It is, therefore, of interest to programme managers who can feedback to the greater health system. HSR is the overarching form of research and also includes research into policy development and policy decision-making, financing and other health systems functioning; questions that may not include direct patient involvement although patients and/or the community are always the ultimate target of the research.

Once certain therapies are known to be effective in large numbers of patients, and given the responsibility of the health system to ensure equitable access to treatment, the next question is how to deliver this treatment optimally to as many people who need it, and in an affordable way that is accepted by the target communities and health-care workers. To answer these questions, OR and IR are required; OR and IR must be conducted in real-life circumstances to gain as accurate and realistic a picture of whether an intervention works under the local conditions, what barriers are encountered, how the intervention is accepted and how the strategy can be improved. Such information is crucial prior to scale-up and the widespread roll out of effective interventions.

The health system cannot function without a continuous flow of information and it, therefore, requires research to inform its policy development, decision-making, interventions and feedback.