A Global Health Research Checklist for clinicians

As with any sound research project, the first step is defining the research question and objectives. Generally, the project will grow out of personal interests or, preferably in global health, the needs of the local partner. A review of the literature will help identify work already done in the specified field as well as people who have worked in the area of research and the country of interest. Many professional organizations have interest groups to connect with those working in similar areas in global health [12]. Ideally, in global health settings where the territory and the system may be unfamiliar, the investigator should identify both published and unpublished studies and learn about successes and roadblocks previous investigators faced. Most importantly, the on-site partners must be involved and invited to give feedback on the value and acceptability of the project, and a formal needs assessment can be a valuable tool.

For example, in case one, RS initially aimed to study pre-hospital care but in response to the local partner’s needs, changed to study the emergency department.

Next, the investigator, together with on-site collaborators, should formulate specific objectives from the potential broad research questions. This may be a testable hypothesis, such as a new triage system will have less over-triage than the previous system (case two), or a may be a specific aim describing the training of providers caring for children in local emergency departments (case one).

Finally, the investigator is encouraged to consider the potential impact of the study being planned. These include answers to the following questions: Why is this question worth investigating? What are the potential implications on health outcomes of individual and of the community? Is there a possible impact beyond the population studied? What are the implications for the health resource utilization for the hospital or ministry of health? Will the implementation of this study drain the system or contribute to it?

While any study design may be applied to global health research, the methodology selected will depend on the available data sources, ethical considerations, and resource limitations. A structured planning tool, such as a logic model [13], will help ensure all necessary resources and desired outputs are considered and will provide a map of the project to share with collaborators. Table 3 lists examples of study designs with special considerations for a global health setting.

One priority is defining the study population. In a global setting, the local team’s input is invaluable to help understand the population and setting the investigator will be working in and how it will impact the study population.

Finally, the outcome specifies exactly what the study will measure. For example, to evaluate a new triage system, the investigator may want to measure how well the assigned triage level compares to the eventual disposition of the patients (case two). One could also measure staff satisfaction, length of stay, or in-hospital mortality. Using mortality as a measure can potentially show the importance of an intervention, but it can be difficult to demonstrate an impact and may require a larger sample size.

Significant discussion regarding the ethics of research in developing versus developed countries has occurred in recent decades, leading to the elaboration of guidelines specific to research in international settings [14‐16]. These highlight the need to consider local cultures, economic capabilities, population needs, the local team’s right to innovation, and self-governance as well as long-term benefits and sustainability to the community studied [17, 18].

The principle of respect for persons emphasizes the individual’s right to self-determination and requires protection of those with a lower capacity for self-determination (e.g., children) [19]. Informed consent is an integral part of this principle and one that often causes complications in research implementation. For instance, in some societies, it is traditional and acceptable for the husband or another male relative to make decisions for a woman [14]. In others, the consent of community elders or senior family members must be sought before individual consent is obtained, if it is to be obtained at all [15]. Finally, illiteracy and cultural perceptions of western medicine may prove to be significant barriers to obtaining informed consent [20]. Discussions with local partners early on will be invaluable in understanding cultural implications of the proposed study and adjusting study design accordingly.

The principle of beneficence centers on non-maleficence and maximizing benefits while minimizing risk [19]. One controversy arising from the implementation of this principle for research in developing countries is the question of “standard of care,” i.e., should research studies in developing countries be required to provide the best available therapies (often standard of care in developed countries) as controls or should the standard of care in the local setting (frequently no or minimal therapy) be used? Such dilemmas have occurred frequently in published literature [20‐22].

The principle of justice is exemplified by fairness of distribution. It requires appropriate selection of subjects and requires that the population in which the research study is being performed directly reap the benefits of the study [19]. Case 2 illustrates this principle: in Botswana, the host hospital was left with a new triage system uniquely designed specifically for it [10, 11].

To protect research subjects and follow the basic ethical principles outlined above, there is a requirement that proposed research studies be reviewed by independent bodies based on ethical merit and scientific validity [14, 15]. In principle, research should be held to high standards regardless of location. Generally, studies in developing countries involving cross-national collaborations require review by Institutional Review Boards (IRBs) (or Research Ethics Committees) in both the developed and developing countries [14]. Identifying IRBs in developing countries may be difficult. If not available at the host institution, IRBs may be available at nearby large educational institutions/universities. In addition, local or national Ministries of Health could provide such services. Finally, if after a good faith effort to locate an IRB, but one does not exist at all in the country of interest, guidelines exist to assist in establishing one specifically for the study in question (Table 4).

Culture is pervasive in life, impacting every aspect of human behavior. The undertaking of a project in a different country where language, customs, religion, economic, and political climates all vary requires significant preparation [23]. A transparent relationship with a focus on humility and respect for the local partner’s culture is essential [24]. Sometimes, even a well thought out project may be affected by an unanticipated cultural misunderstanding [25‐29].

In case one, RS had a rich understanding of the local culture given that she had lived there for many years. In creating the hospital surveys, since Arabic and English are the two languages utilized by most physicians, the team decided not to translate the survey in French, another main language in Lebanon. It was during the analysis that the word “resident” was noted to mean “someone who works in the hospital” for the physicians not trained in the US (or similar) medical system. This underscores the fact that even when a researcher has extensive knowledge about a culture, he or she may be from a different social class, ethnicity, or religion and therefore have a different understanding on certain issues and may not be aware of all the cultural variations within one nation.

In another unpublished example by LM, a project investigating the understanding of child abuse in Ghana was unsuccessful in getting local IRB approval because it was deemed to be too sensitive a topic with too many cultural implications for the local community.

Partnerships with local institutions, hospitals, or academic facilities are a necessary foundation to successful global health research projects. In creating a global health project, ideally, the first priority is to identify a local partner or institution that will serve as the “Local Champion” for the proposed project. This is often done over time, building a partnership individually or with a group. This long-term partnership is key to success as evidenced in the above-illustrated cases. Secondly, the project should be mutually beneficial to all parties involved and the identified partner should be equally committed and interested in the research project. In case two, the local team approached PM, highlighting their need and commitment. In academic settings, identifying partner priorities for research and offering authorship roles can be a motivating factor. Finally, delineating clear roles and expectations of both partners involved through memorandums of agreement/understanding (MOA/MOU) (Fig. 1) will provide concrete guidance for the project partnership. This could include responsibilities such as funding, housing, teaching, and authorship. Ideally, if these three key concepts are present then a successful partnership and a global health project are feasible [8, 30‐32]. Table 5 presents priorities and pitfalls in creating durable and productive partnerships.

The successful completion of an international project depends largely on logistical planning of timelines, budget, implementation, and manuscript publishing.

Timelines should include time for local partner identification, study design and development, data collection, and manuscript writing and submission. Careful planning should account for differing cultures and potential delays, such as availability of local partners and obtaining local IRB approval.

Expenses should be projected early in the project and funding options explored. Oftentimes, the pilot study may have to be funded by personal means. However, a partial list of potential funding agencies for clinicians is available in Table 6. Recently, Hansoti et al. described the potential funding opportunities available specifically for emergency medicine physicians working in international settings. This paper helps the reader navigate the complicated world of grants from seed to federal grants [33]. In addition, gaining the support of the principal investigator’s home institution can be critical in funding time and travel expenses, as well as finding home institution global research funds.

In planning for project implementation, health and safety travel preparedness should not be ignored. Research trip requirements can be found by visiting the public domains of the Centers for Disease Control and Prevention [34], the World Health Organization [35], the home country’s embassy website in the partner country as well as the partnering country’s embassy websites. Planning for the visiting members of the team with clear roles and check-in mechanisms is critical for both the safety and functionality of the team.