A framework for research ethics review during public emergencies.
Ontology highlight
ABSTRACT:
SUBMITTER: Tansey CM
PROVIDER: S-EPMC2950185 | biostudies-literature | 2010 Oct
REPOSITORIES: biostudies-literature
Publications
A framework for research ethics review during public emergencies.
Tansey Catherine M CM Herridge Margaret S MS Heslegrave Ronald J RJ Lavery James V JV
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20100607 14
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Project description:Between 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 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.To 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.
| S-EPMC5485606 | biostudies-literature
Project description: Not available
| S-EPMC4838154 | biostudies-literature
Project description:The identification of the factors underlying the willingness or lack thereof to respond to public health emergencies is paramount to informing more capable health services. The interest in this topic appears renewed with each surge of threat, either referring to natural disasters, man-made violence, or epidemic and pandemics. However, there is no systematic approach to the research patterns and related main findings concerning individual and contextual determinants. The present article contributes to this theme through a systematic literature review of a sample of 150 articles published in the last 30 years on the subject of willingness and preparedness of health professionals to deal with public health threats. Our findings show that the research is mainly phenomena and contextual driven, responding to whichever emergency threat is more salient in a given period. Geographically, research on this topic is led by USA and China, mostly solely, while European countries invest in collaborations that are more international. Universities, including health institutes and schools, and researchers at hospitals conduct most of the research on the topic. The main research areas are medicine, psychology, and psychiatry. Pandemics, including COVID-19, influenza, and natural disasters, are the phenomena gauging more attention as opposed to terrorism events and biological accidents. The specific role of health professionals within the institution, their belief in ethical duties, preparation training, and concerns regarding infection of self and family are the main variables influencing the willingness and ability to report to work in public health emergencies.
| S-EPMC9408569 | biostudies-literature
Project description:BackgroundDisasters and public health emergencies increasingly affect populations around the world, posing significant wide-ranging challenges for societies as well as for effective public health and suicide prevention. Intervention research is essential to inform evidence-based responses. Yet, despite evident public concern and growing research interest in heightened suicide risks and impacts, little is known about effective suicide prevention interventions in these contexts. We conducted a systematic review to examine the outcomes of suicide prevention strategies implemented in disasters and public health emergencies.MethodsWe searched five databases (Medline, Embase, PsycINFO, Web of Science, PTSDpubs) from inception to December 2022 for peer-reviewed quantitative studies that reported relevant intervention outcomes (changes in the frequency of suicide, suicide attempts, self-harm) for populations affected by disasters and public health emergencies. We assessed the quality of eligible studies using the Quality Assessment Tool for Quantitative Studies, and distilled review findings through narrative synthesis. The study protocol was registered with PROSPERO (CRD42021276195).ResultsTen eligible and mostly observational studies were included in this review, which examined a range of universal, selective, and indicated interventions. Three of five studies of interventions in public health emergencies indicated the potential effectiveness and buffering effects of generic disaster related mental health support, access to urban parks, as well as the beneficial role of video-enabled tablets in facilitating treatment access and outcomes. Similarly, three of five studies of interventions in disaster contexts provided evidence of the beneficial role of universal economic security measures, national gun laws and buy back schemes, and volunteer-delivered mental health support. Overall, four of six studies with favorable outcomes examined interventions specifically deployed in disaster or public health emergency contexts, whereas two studies examined ongoing existing interventions. Three studies, respectively, of suicide prevention focused interventions or generic interventions reported favorable outcomes. The quality of included studies was variable, with two studies being rated as 'strong', four studies rated as 'moderate', and four studies rated as 'weak'.ConclusionNotwithstanding the limited scope and variable quality of published evidence, our review findings highlight the breadth of interventions that have been applied in such contexts with some success. There is a need for further research on effective interventions and intervention adaptations to inform evidence-based suicide prevention responses to disasters and public health emergencies.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021276195, PROSPERO ID CRD42021276195.
| S-EPMC10876787 | biostudies-literature
Project description:This systematic review aimed to explore the monitoring and evaluation (M&E) and operational research (OR) practices during public health emergencies (PHE) in the southeast Asian region (SEAR) over the last decade. We searched electronic databases and grey literature sources for studies published between 2012 and 2022. The studies written in English were included, and a narrative synthesis was undertaken. A total of 29 studies were included in this review. Among these 25 studies documented M&E and four studies documented OR practices. The majority of the studies were from India and Bangladesh, with no evidence found from Sri Lanka, Bhutan, Myanmar, and Timor-Leste. M&E of surveillance programs were identified among which PHE due to COVID-19 was most prevalent. M&E was conducted in response to COVID-19, cholera, Nipah, Ebola, Candida auris, and hepatitis A. OR practice was minimal and reported from India and Indonesia. India conducted OR on COVID-19 and malaria, whereas Indonesia focused on COVID-19 and influenza. While most SEAR countries have mechanisms for conducting M&E, there is a noticeable limitation in OR practices. There is a compelling need to develop a standard framework for M&E. Additionally, enhancing private sector engagement is crucial for strengthening preparedness against PHE. Furthermore, there is a necessity to increase awareness about the importance of conducting M&E and OR during PHE.
| S-EPMC10866922 | biostudies-literature
Project description:BackgroundEthics review preparedness is a major foundation for national effective response to public health emergencies, because it promotes pertinent research and enhances the protection of research participants and communities. In low-income countries, it can also promote equitable research partnership. However, most relevant literature is in English and not easily accessible for the members of research ethics committees in French-speaking African countries.MethodsA training module in French, addressing the issue of research ethics review during outbreaks and other public health emergencies, was designed based on a non-systematic literature review, and in order to be complementary to the Democratic Republic of Congo (DRC) national guidelines for ethics review. The module was administered to 42 members of the five ethics committees in DRC that expressed their interest for the training.ResultThis training, co-designed with local stakeholders, in the local working language and taking into account local circumstances and regulation, provided participants with up-to-date insights of research ethics (and research ethics preparedness) in public health emergencies. It resulted in rich reflection and knowledge-sharing on good practices across the ethics committees.ConclusionAs most participating ethics committees do not have yet explicit standard operating procedures for expedited review of protocols submitted in emergency situations, this would be a next important step to facilitate emergency reviews in the most efficient way.
| S-EPMC9826200 | biostudies-literature
Project description:The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes.We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise.Our analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises.ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.
| S-EPMC5704399 | biostudies-other
Project description: Not available
| S-EPMC8649484 | biostudies-literature
Project description:Researchers in areas as diverse as computer science and political science must increasingly navigate the possible risks of their research to society. However, the history of medical experiments on vulnerable individuals influenced many research ethics reviews to focus exclusively on risks to human subjects rather than risks to human society. We describe an Ethics and Society Review board (ESR), which fills this moral gap by facilitating ethical and societal reflection as a requirement to access grant funding: Researchers cannot receive grant funding from participating programs until the researchers complete the ESR process for their proposal. Researchers author an initial statement describing their proposed research's risks to society, subgroups within society, and globally and commit to mitigation strategies for these risks. An interdisciplinary faculty panel iterates with the researchers to refine these risks and mitigation strategies. We describe a mixed-method evaluation of the ESR over 1 y, in partnership with a large artificial intelligence grant program at our university. Surveys and interviews of researchers who interacted with the ESR found 100% (95% CI: 87 to 100%) were willing to continue submitting future projects to the ESR, and 58% (95% CI: 37 to 77%) felt that it had influenced the design of their research project. The ESR panel most commonly identified issues of harms to minority groups, inclusion of diverse stakeholders in the research plan, dual use, and representation in datasets. These principles, paired with possible mitigation strategies, offer scaffolding for future research designs.
| S-EPMC8719852 | biostudies-literature
Project description:ObjectiveTo explore the different processes of the themes and emotional evolution of various stakeholders in the network public opinion of sudden public health emergencies at different stages of the public opinion evolution lifecycle.MethodsThis paper proposes a cross-platform analysis method for online public opinion during the public health emergencies based on stakeholders. Firstly, data from multiple platforms are collected and integrated. Secondly, stakeholders are categorized and the stages of public opinion evolution are determined based on stakeholder theory and lifecycle theory. Finally, the Latent Dirichlet Allocation (LDA)+Word2vec model and Convolutional Neural Network (CNN) model are used to analyze the themes and emotional evolution of stakeholders during different stages of public opinion evolution.ResultsThere are differences in the evolution patterns of different types of stakeholders. The evolution process of stakeholders' focus points exhibits a two-stage transition from concentration to divergence. The focus points of stakeholders are closely associated with their respective social domains. The emotions of the public undergo a three-stage process of positive-negative-positive change.ConclusionsThis study can provide a reference for the government to have a more comprehensive understanding of the development trend of public opinion and reduce the negative impact of public opinion.
| S-EPMC11198828 | biostudies-literature