BackgroundBetween 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies.WHO-ERC reviewsWHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented.ConclusionsTo accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care.

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HighlightsThere is a general lack of psychometric assessments on existing ageism scales.None of the available ageism scales have both adequate scope and psychometric validity.Current estimates of ageism incidence and prevalence may not be accurate.

BackgroundFor 30 years, women have sought equal opportunity to be included in trials so that drugs are equitably studied in women as well as men; regulatory guidelines have changed accordingly. Pregnant women, however, continue to be excluded from trials for non-obstetric conditions, though they have been included for trials of life-threatening diseases because prospects for maternal survival outweighed potential fetal risks. Ebola virus disease is a life-threatening infection without approved treatments or vaccines. Previous Ebola virus (EBOV) outbreak data showed 89–93% maternal and 100% fetal/neonatal mortality. Early in the 2013–2016 EBOV epidemic, an expert panel pointed to these high mortality rates and the need to prioritize and preferentially allocate unregistered interventions in favor of pregnant women (and children). Despite these recommendations and multiple ethics committee requests for their inclusion on grounds of justice, equity, and medical need, pregnant women were excluded from all drug and vaccine trials in the affected countries, either without justification or on grounds of potential fetal harm. An opportunity to offer pregnant women the same access to potentially life-saving interventions as others, and to obtain data to inform their future use, was lost. Once again, pregnant women were denied autonomy and their right to decide.ConclusionWe recommend that, without clear justification for exclusion, pregnant women are included in clinical trials for EBOV and other life-threatening conditions, with lay language on risks and benefits in information documents, so that pregnant women can make their own decision to participate. Their automatic exclusion from trials for other conditions should be questioned.

Evidence shows that ageism negatively impacts the health of older adults. However, estimates of its prevalence are lacking. This study aimed to estimate the global prevalence of ageism towards older adults and to explore possible explanatory factors. Data were included from 57 countries that took part in Wave 6 of the World Values Survey. Multilevel Latent Class Analysis was performed to identify distinct classes of individuals and countries. Individuals were classified as having high, moderate or low ageist attitudes; and countries as being highly, moderately or minimally ageist, by aggregating individual responses. Individual-level (age, sex, education and wealth) and contextual-level factors (healthy life expectancy, population health status and proportion of the population aged over 60 years) were examined as potential explanatory factors in multinomial logistic regression. From the 83,034 participants included, 44%, 32% and 24% were classified as having low, moderate and high ageist attitudes, respectively. From the 57 countries, 34 were classified as moderately or highly ageist. The likelihood of an individual or a country being ageist was significantly reduced by increases in healthy life expectancy and the proportion of older people within a country. Certain personal characteristics—younger age, being male and having lower education—were significantly associated with an increased probability of an individual having high ageist attitudes. At least one in every two people included in this study had moderate or high ageist attitudes. Despite the issue’s magnitude and negative health impacts, ageism remains a neglected global health issue.