Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research (...) “ethics preparedness” constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks. (shrink)

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

BackgroundMedical errors, unsatisfactory outcomes, or treatment complications often prompt patient complaints about healthcare providers. In response, physicians may adopt defensive practices to mitigate objections, avoid complaints, and navigate lengthy trial processes or other potential threats. However, such defensive medicine (DM) practices can carry risks, including potential harm to patients and the imposition of unnecessary costs on both patients and the healthcare system. Moreover, these practices may run counter to accepted ethical standards in medicine.MethodsThis qualitative study involved conducting semi-structured interviews with (...) 43 physicians, among whom 38 were faculty members at medical universities, 42 had administrative experience at various levels of the health system, and 23 had previously served as health system policymakers. On average, the participants had approximately 23.5 years of clinical experience. The selection of participants was based on purposive sampling. Data collection through interviews continued until data saturation was achieved.ResultsBased on the findings, DM manifests in both positive and negative forms, illustrated by instances like ordering unnecessary lab tests, imaging, or consultations, reluctance to admit high-risk patients, and avoiding high-risk procedures. The study participants identified a range of underlying and contextual factors contributing to DM, encompassing organizational-managerial, social, personal, and factors inherent to the nature of defensive medical practices. The results also highlight proposed strategies to address and prevent DM, which can be grouped into organizational-managerial, social, and those focused on modifying the medical complaints management system.ConclusionDM is a multifaceted and significant phenomenon that necessitates a comprehensive understanding of its various aspects, including interconnected and complex structures and underlying and contextual factors. While the results of this study offer a solid foundation for informing policy decisions within the healthcare system and include some explanatory policy suggestions, we encourage policymakers to complement the findings of this study with other available evidence to address any potential limitations and to gain a more comprehensive understanding of the policymaking process related to DM. (shrink)

Developing World Bioethics, Volume 22, Issue 3, Page 126-139, September 2022.