Research Ethics Governance in Times of Ebola

Abstract

The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.

Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic

“…The sensitivity of IgG for SARS-CoV-2 reached 96.1% and specificity was 92.4%. 3 Results | On January 28, 2020, a 29-year-old primiparous woman (34 weeks 2 days of gestation) suspected of being exposed to SARS-CoV-2 developed a temperature of 37.9°C and nasal congestion, which progressed to respiratory difficulties. On January 31, a chest CT showed patchy groundglass opacities in the periphery of both lungs.…”

Novel technology for storage and distribution of live vaccines and other biological medicines at ambient temperature

“…To date, the vaccine requisites of developing countries have not been adequately met for a variety of reasons, including issues associated with fragile health care systems, conflict resolution, policy making, program management, financing, supply chain, and distribution across large urban areas and to the most remote locations (5). Each of these issues contributed in some part to the delay in the distribution of experimental vaccines and therapeutics against Ebola during the 2014-2016 outbreak (6,7). The ramifications of these roadblocks were also seen in the 2016-2017 meningitis outbreak in Nigeria, where the cost and limited supply of a vaccine contributed to the mortality and spread of disease (8).…”

Panic prescribing has become omnipresent during the COVID-19 pandemic

“…Moreover, the research was conducted according to good clinical practice standards, was approved by local and international ethics committees, and met agreed-upon standards for the protection of human subjects. In this case, the science and ethics worked well together, and a noteworthy result occurred (5).…”