Research and Global Health Emergencies: On the Essential Role of Best Practice

Sethi, Nayha

doi:10.1093/phe/phy014

Cited by 15 publications

(17 citation statements)

References 64 publications

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“…The focus of such regulation should not be on minimizing harm that is unpredictable, rather, it should be about maximizing data use and increasing benefits for study populations. In the absence of harmonized regulation, an alternative will be to develop a governance model that are informed both by the principles of solidarity, reciprocity, and equity (Sethi, 2018).…”

Section: Resultsmentioning

confidence: 99%

Establishing a Multi-Country Sickle Cell Disease Registry in Africa: Ethical Considerations

et al. 2019

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Sickle cell disease (SCD) is one of the most prevalent genetic conditions in sub-Saharan Africa. It is a chronic, lifelong disease often characterized by severe pain. However, SCD has received little investment terms of health research, though there is currently a growing pool of SCD data from health and research facilities in different countries. To facilitate research on SCD in Africa, the SickleInAfrica consortium has established a SickleInAfrica registry. The registry will store a systematic collection of longitudinal data from persons with SCD across sub-Saharan Africa, and currently, participants are being enrolled in Ghana, Nigeria, and Tanzania. In establishing this registry, the SickleInAfrica consortium decided to actively identify and anticipate possible ethical issues that may arise in the development and management of the registry. This was motivated, in part, by the near absence of well documented ethical issues for registry research in Africa, more-so for registries enrolling participants across multiple countries and for a genetic condition. The consortium aims to establish standards for the equitable use of data stored in the registry. This paper presents a comprehensive report on the ethical considerations that came up in setting up a genetic disease registry across multiple African countries and how they were addressed by the SickleInAfrica consortium. Major issues included: active involvement of patients in the initiation and management of the registry; questions of assent and re-consent; the importance of ensuring that fears of exploitation are not replicated in African–African research collaborations; and the importance of public engagement in the management of registries. Drawing on this experience, SickleInAfrica plans to set up an ethics helpdesk for genetic disease registries and research in Africa.

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Section: Resultsmentioning

confidence: 99%

Establishing a Multi-Country Sickle Cell Disease Registry in Africa: Ethical Considerations

et al. 2019

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“…Ethical issues arise from allocating scarce resources on data collection during a crisis as well as retrospectively researching a disaster overcome. More transparent and continuous reporting by aid agencies have been suggested feasible solutions 22 60. Evaluations might run the risk of lending too little agency to the frontline workers involved in the EVD response.…”

Section: Discussionmentioning

confidence: 99%

”For this one, let me take the risk”: why surgical staff continued to perform caesarean sections during the 2014–2016 Ebola epidemic in Sierra Leone

et al. 2019

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IntroductionRoutine health service provision decreased during the 2014–2016 Ebola virus disease (EVD) outbreak in Sierra Leone, while caesarean section (CS) rates at public hospitals did not. It is unknown what made staff provide CS despite the risks of contracting EVD. This study explores Sierra Leonean health worker perspectives of why they continued to provide CS.MethodsThis qualitative study documents the experiences of 15 CS providers who worked during the EVD outbreak. We interviewed surgical and non-surgical CS providers who worked at public hospitals that either increased or decreased CS volumes during the outbreak. Hospitals in all four administrative areas of Sierra Leone were included. Semistructured interviews averaged 97 min and healthcare experience 21 years. Transcripts were analysed by modified framework analysis in the NVivo V.11.4.1 software.ResultsWe identified two themes that may explain why providers performed CS despite EVD risks: (1) clinical adaptability and (2) overcoming the moral dilemmas. CS providers reported being overworked and exposed to infection hazards. However, they developed clinical workarounds to the lack of surgical materials, protective equipment and standard operating procedures until the broader international response introduced formal personal protective equipment and infection prevention and control practices. CS providers reported that dutifulness and sense of responsibility for one’s community increased during EVD, which helped them justify taking the risk of being infected. Although most surgical activities were reduced to minimise staff exposure to EVD, staff at public hospitals tended to prioritise performing CS surgery for women with acute obstetric complications.ConclusionThis study found that CS surgery during EVD in Sierra Leone may be explained by remarkable decisions by individual CS providers at public hospitals. They adapted practically to material limitations exacerbated by the outbreak and overcame the moral dilemmas of performing CS despite the risk of being infected with EVD.

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“…This relationship was described as essential in order to achieve regulatory efficiency and in the identification of, and reaching consensus on, instances of best practice. One respondent explained that such collaboration between regulators and experienced researchers could provide the context-sensitivity necessary to develop best practice (24, regulator), an important function of best practice which has been considered elsewhere [28].…”

Section: Roles and Responsibilities Of Key Actors In Shaping The Regumentioning

confidence: 99%

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

et al. 2019

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European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos-that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders-researchers and regulators alike-who attempt to navigate these landscapes. This Delphi study was undertaken in order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders-including researchers, regulators, publics and research sponsors-can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to coproduce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation-including the public interest and public engagement-our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty-both as a human practice and a regulatory objective-may represent the brighter future for health research.

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Research and Global Health Emergencies: On the Essential Role of Best Practice

Cited by 15 publications

References 64 publications

Establishing a Multi-Country Sickle Cell Disease Registry in Africa: Ethical Considerations

Establishing a Multi-Country Sickle Cell Disease Registry in Africa: Ethical Considerations

”For this one, let me take the risk”: why surgical staff continued to perform caesarean sections during the 2014–2016 Ebola epidemic in Sierra Leone

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

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