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Table 2 A case study illustrating the multiple ethical challenges arising in implementation research

From: Developing the ethics of implementation research in health

Implementation research of strategies to improve vaccine coverage in children in nomadic populations

Study description. Country X had a low rate of vaccine coverage largely because a significant group of nomadic populations were not reached by the routine vaccination strategies. A basic needs assessment was performed among the nomadic populations and found their vaccine coverage rate to be very low. In addition, the assessment found that insufficient knowledge of the location of the nomadic populations, lack of logistical support and lack of community engagement in the vaccination drives were important reasons for poor coverage. In order to overcome these problems, an implementation research study was planned. Special Outreach Teams (SOTs) were trained and deployed to a selected sample of known nomadic groups. These SOTs were provided with all logistical requirements such as vehicles, ice boxes, vaccine stocks, and temperature logs. They were also trained to engage with the communities, to deliver the vaccinations to the children under five according to schedule and also to collect data on the existing level of vaccine coverage, numbers vaccinated, documentation of feasibility challenges, and costs. The SOTs coordinated their work with the routine health care workers in the communities where these nomadic groups were stationed at the time of contact. In addition, a small subsample of the nomadic groups were invited to participate in a mobile phone-based GPS tracking study to assess the feasibility and utility of locating the nomadic groups in real-time. Solar powered battery packs were provided to the key members of the community who held the GPS tracking mobile phone. Their GPS coordinates were relayed to the SOTs so that they can deliver their services effectively.

Ethical issues. This implementation research study brings out several important ethical considerations. There is an ethical imperative to engage and work with this special marginalized group in order to increase coverage of vaccination as it is the duty of the health system to protect and promote their health and also in order to more effectively protect the rest of the community with whom the nomadic groups will come in contact. Equipoise to justify the conduct of the study lies primarily in the uncertainty of how the intervention will be taken up and effective within this context as it is known that the vaccinations are effective from other populations. Despite this fact, however, effectiveness of the vaccine should be tracked in this new population as there may be modifiers of the effect, e.g., nutritional status etc. that may also require ancillary care. The findings of the study will help understand the feasibility and acceptability of the intervention among nomadic communities thus facilitating the implementation of the vaccination coverage campaign. Community engagement is a key ethical consideration in this context. Marginalized communities like these have inherent mistrust in health systems and community engagement helps build trust. Identification of appropriate gatekeepers of the community by appropriate selection process will facilitate both the informed consent process as well as representation of long-term voices of the communities. The tracking of the position of the nomadic groups for the sake of facilitating the vaccination process using the GPS tracking system is a significant intrusion into the privacy of the communities. This needs to be carefully weighed and balanced against the benefits of enhanced vaccine coverage and reduced child mortality because of that. Moreover, confidentiality of the GPS tracking data should be clearly maintained. Issues of sharing the GPS tracking position with local health system, other parties who may be interested to track them for other purposes etc. needs to be carefully deliberated. In addition, it is likely that many other health needs would be identified in these communities, raising the ethical issues associated with ancillary care responsibilities.