Ethics of randomized trials in a public health emergency.
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ABSTRACT:
SUBMITTER: London AJ
PROVIDER: S-EPMC5957337 | biostudies-literature | 2018 May
REPOSITORIES: biostudies-literature
Publications
Ethics of randomized trials in a public health emergency.
London Alex John AJ Omotade Olayemi O OO Mello Michelle M MM Keusch Gerald T GT
PLoS neglected tropical diseases 20180517 5
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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:Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in-depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.
| S-EPMC10739783 | biostudies-literature
Project description:Newborn screening was established over 50 years ago to identify cases of disorders that were serious, urgent, and treatable, mirroring the criteria of Wilson and Jungner. In the last decade, conditions have been added to newborn screening that do not strictly meet these criteria, and genomic newborn screening is beginning to be discussed. Some of these new and proposed additions to newborn screening entail serious public health ethical issues that need to be explored.
| S-EPMC9590071 | biostudies-literature
Project description:ImportanceIncentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals.ObjectiveTo determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements.Design, setting, and participantsTwo RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020.InterventionsPatients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial.Main outcomes and measuresThe primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes.ResultsThere were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions.Conclusions and relevanceIn these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial.Trial registrationClinicalTrials.gov Identifier: NCT02697799.
| S-EPMC8453363 | biostudies-literature
Project description: Not available
| S-EPMC7322772 | biostudies-literature
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:INTRODUCTION:Nine events have been assessed for potential declaration of a Public Health Emergency of International Concern (PHEIC). A PHEIC is defined as an extraordinary event that constitutes a public health risk to other states through international spread and requires a coordinated international response. The WHO Director-General convenes Emergency Committees (ECs) to provide their advice on whether an event constitutes a PHEIC. The EC rationales have been criticised for being non-transparent and contradictory to the International Health Regulations (IHR). This first comprehensive analysis of EC rationale provides recommendations to increase clarity of EC decisions which will strengthen the IHR and WHO's legitimacy in future outbreaks. METHODS:66 EC statements were reviewed from nine public health outbreaks of influenza A, Middle East respiratory syndrome coronavirus, polio, Ebola virus disease, Zika, yellow fever and coronavirus disease-2019. Statements were analysed to determine which of the three IHR criteria were noted as contributing towards the EC's justification on whether to declare a PHEIC and what language was used to explain the decision. RESULTS:Interpretation of the criteria were often vague and applied inconsistently. ECs often failed to describe and justify which criteria had been satisfied. DISCUSSION:Guidelines must be developed for the standardised interpretation of IHR core criteria. The ECs must clearly identify and justify which criteria have contributed to their rationale for or against PHEIC declaration. CONCLUSION:Striving for more consistency and transparency in EC justifications would benefit future deliberations and provide more understanding and support for the process.
| S-EPMC7299007 | biostudies-literature
Project description: Not available
| S-EPMC1126736 | biostudies-literature
Project description:Coronavirus disease 2019(COVID-19) has brought great disasters to humanity, and its influence continues to intensify. In response to the public health emergencies, prompt relief supplies are key to reduce the damage. This paper presents a method of emergency medical logistics to quick response to emergency epidemics. The methodology includes two recursive mechanisms: (1) the time-varying forecasting of medical relief demand according to a modified susceptible-exposed-infected- Asymptomatic- recovered (SEIAR) epidemic diffusion model, (2) the relief supplies distribution based on a multi-objective dynamic stochastic programming model. Specially, the distribution model addresses a hypothetical network of emergency medical logistics with considering emergency medical reserve centers (EMRCs), epidemic areas and e-commerce warehousing centers as the rescue points. Numerical studies are conducted. The results show that with the cooperation of different epidemic areas and e-commerce warehousing centers, the total cost is 6% lower than without considering cooperation of different epidemic areas, and 9.7% lower than without considering cooperation of e-commerce warehousing centers. Particularly, the total cost is 20% lower than without considering any cooperation. This study demonstrates the importance of cooperation in epidemic prevention, and provides the government with a new idea of emergency relief supplies dispatching, that the rescue efficiency can be improved by mutual rescue between epidemic areas in public health emergency.
| S-EPMC8312947 | biostudies-literature
Project description:BackgroundEmergencies and disasters impact population health. Despite the importance of upstream readiness, a persistent challenge for public health practitioners is defining what it means to be prepared. There is a knowledge gap in that existing frameworks lack consideration for complexity relevant to health systems and the emergency context. The objective of this study is to describe the essential elements of a resilient public health system and how the elements interact as a complex adaptive system.MethodsThis study used a qualitative design employing the Structured Interview Matrix facilitation technique in six focus groups across Canada. Focus group participants were practitioners from public health and related sectors. Data collection generated qualitative data on the essential elements, and interactions between elements, for a resilient public health system. Data analysis employed qualitative content analysis and the lens of complexity theory to account for the complex nature of public health emergency preparedness (PHEP). The unit of study was the local/regional public health agency. Ethics and values were considered in the development of the framework.ResultsA total of 130 participants attended the six focus groups. Urban, urban-rural and rural regions from across Canada participated and focus group size ranged from 15 to 33 across the six sites. Eleven elements emerged from the data; these included one cross-cutting element (Governance and leadership) and 10 distinct but interlinked elements. The essential elements define a conceptual framework for PHEP. The framework was refined to ensure practice and policy relevance for local/regional public health agencies; the framework has ethics and values at its core.ConclusionsThis framework describes the complexity of the system yet moves beyond description to use tenets of complexity to support building resilience. This applied public health framework for local/regional public health agencies is empirically-derived and theoretically-informed and represents a complex adaptive systems approach to upstream readiness for PHEP.
| S-EPMC6280369 | biostudies-literature