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1.
Health Secur ; 20(S1): S60-S70, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1838056

ABSTRACT

Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States. A core aspect of successful initiation of research during a pandemic or epidemic is the ability to operationalize an approach for rapid ethical review of human subject research and conduct those reviews at multiple sites-without losing any of the substantive aspects of ethics review. This process must be cultivated in anticipation of a public health emergency. US guidance for operationalizing IRB review for multisite research in a public health emergency is not well studied and processes are not well established. UNMC sought to address operational gaps and identify the unique procedural needs of rapid response single IRB (RR-sIRB) review of multisite research by conducting a series of preparedness exercises to develop and test the RR-sIRB model. For decades, emergency responder, healthcare, and public health organizations have conducted emergency preparedness exercises to test requirements for emergency response. In this article, we describe 2 types of simulation exercises conducted by UNMC: workshops and tabletops. This effort represents a unique use of emergency preparedness exercises to develop, refine, and test rapid review functions for an sIRB and to validate readiness of regulatory research processes. Such processes are crucial for conducting rapid, ethical, and sound clinical research in public health emergencies.


Subject(s)
Civil Defense , Emergency Responders , Ethics Committees, Research , Humans , Pandemics , Public Health , United States
2.
Ethics Hum Res ; 44(6): 23-31, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2094165

ABSTRACT

The Covid-19 pandemic required rapid changes to research protocols, including immediate transitions to recruiting research participants and conducting the informed consent process virtually. This case study details the challenges our research team faced adapting an in-person, behavioral-intervention and survey study to virtual recruitment. We reflect on the impact of these rapid changes on recruitment and retention, discuss protocol changes we made to address these challenges and the needs of potential and enrolled participants, and propose recommendations for future work. Using computer technology to display professional return phone numbers, being flexible by contacting potential participants through various means, minimizing email communication due to added regulatory requirements, and partnering with the institutional review board to shorten and improve the consent document and process were critical to study success. This case study can offer insight to other researchers as they navigate similar processes. Virtual recruitment is likely to continue; it is important to ensure that it facilitates, rather than hinders, equitable and just recruitment practices.


Subject(s)
COVID-19 , Humans , Pandemics , Informed Consent , Ethics Committees, Research , Research Personnel
3.
Indian J Med Res ; 155(5&6): 461-471, 2022.
Article in English | MEDLINE | ID: covidwho-2080641

ABSTRACT

Background & objectives: The COVID-19 pandemic had a distinct impact on scientific research and Ethics Committees (ECs). We conducted a mixed-methods investigation to understand the issues faced and solutions identified by ECs during this pandemic in India. Methods: A quantitative online survey form (30 members) and qualitative in-depth interviews (10 members) from various ECs were conducted. Thematic content analysis for qualitative and proportion analysis for quantitative data was carried out. Results: During the online survey, an average difficulty score, which was measured using the Visual Analogue Scale, was 5.3 (SD 2.1). Pressure for expedited approvals was felt by EC members with a drastic increase in the number of submission of research projects. The scarcity of information on investigational products (IPs) and requisite consent process posed major hurdles. Ongoing non-COVID studies and post-graduate dissertations were badly hit due to the shift in attention towards COVID-related research. Non-familiarity with virtual technology and lack of face-to-face interactions were highlighted as demerits. However, a few of the EC members welcomed newer methods, being time-saving, convenient and reducing travel hassles. Site monitoring and severe adverse event-related analyses were also negatively impacted upon. Solutions included the alternate methods of consenting (virtual, abbreviated), a detailed explanation of the protocol and IPs and benefits versus risk assessment. Interpretation & conclusions: Despite various challenges posed by the COVID-19 pandemic, the ECs in India steered well through the hurdles. Moreover, adapting a hybrid mode, technical training and updating guidelines were perceived as urgent by EC members.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Pandemics , Ethics Committees, Research , Committee Membership , Surveys and Questionnaires
4.
Int J Environ Res Public Health ; 19(18)2022 Sep 16.
Article in English | MEDLINE | ID: covidwho-2055232

ABSTRACT

The struggle for information and the hasty search for answers caused by the COVID-19 pandemic threatened the possibility of lowering study quality, as well as ethical committees' review standards during the outbreak. Our investigation aimed to assess the impact of COVID-19 on the quality of clinical research studies submitted to Italian Ethics Committees in the period between April and July 2020. All 91 Italian ethics committees were contacted via email in order to collect anonymized information on the type and quality of COVID-19-related studies submitted to each committee during the study period. The present study summarizes the characteristics of the 184 study applications collected, pointing out, especially, how the quality of the study population and statistical analysis are crucial variables in determining the study approval. Nevertheless, despite the need for high-quality and open scientific information, especially exacerbated by this particular historical period, only a minority of the ethics committees (20.9%) agreed to share their data; such scarce participation, beyond biasing the representativeness of the results obtained by the present study, more importantly, hinders the broader goal of creating trust between researchers and the general public.


Subject(s)
COVID-19 , Ethics Committees, Research , COVID-19/epidemiology , Ethical Review , Humans , Pandemics , Research Design
5.
BMJ Open ; 12(6): e055208, 2022 06 17.
Article in English | MEDLINE | ID: covidwho-1901992

ABSTRACT

OBJECTIVES: The Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. The aim of this study was to identify and explore concerns that may be raised by UK research ethics committees (RECs) when reviewing clinical trials funded in this way. DESIGN: Empirical ethics combining ethical analysis and qualitative data from three focus groups held online using Frith's symbiotic approach. Data were analysed using inductive thematic approach informed by the study aims and ethical analysis. PARTICIPANTS: 22 participants were recruited: 8 research patient public involvement group members, 7 REC chairs and 7 clinical researchers. All were based in the UK. RESULTS: With one exception, participants thought the Plutocratic Proposal may be 'all things considered' acceptable, providing their concerns were met, primary of which was upholding scientific integrity. Other concerns discussed related to the acceptability of the donor securing a place on the trial including: whether this was an unfair distribution of benefits, disclosing the identity of the donor as the funder, protecting the donor from exploitation and funding a single study with multiple donors on the same terms. Some misgivings fell outside the usual REC purview: detrimental impact of donors of bad character, establishing the trustworthiness of the matching agency and its processes and optimising research funding and resources. Despite their concerns, participants recognised that because the donor funds the whole trial, others would also potentially benefit from participating. CONCLUSIONS: We identified concerns about the Plutocratic Proposal. UK RECs may be open to approving studies if these can be addressed. Existing governance processes will do some of this work, but additional REC guidance, particularly in relation to donors securing a place on the trial, may be necessary to help RECs navigate ethical concerns consistently.


Subject(s)
Ethical Review , Ethics Committees, Research , Clinical Trials as Topic , Focus Groups , Humans , Research Personnel , United Kingdom
6.
Acta Biomed ; 93(2): e2021579, 2022 05 11.
Article in English | MEDLINE | ID: covidwho-1848011

ABSTRACT

As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications' review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it).


Subject(s)
Biomedical Research , COVID-19 , Ethics Committees, Research , Humans , Pandemics , Reproducibility of Results
7.
Plast Reconstr Surg ; 149(5): 1245-1246, 2022 05 01.
Article in English | MEDLINE | ID: covidwho-1806745
8.
Clin Microbiol Infect ; 28(4): 470-471, 2022 04.
Article in English | MEDLINE | ID: covidwho-1778056
9.
PLoS One ; 17(3): e0265252, 2022.
Article in English | MEDLINE | ID: covidwho-1759952

ABSTRACT

INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND METHODS: We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. RESULTS: IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND CONCLUSIONS: This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises.


Subject(s)
COVID-19 , COVID-19/epidemiology , Ethics Committees, Research , Humans , Pandemics , Research Personnel , SARS-CoV-2
10.
Vaccine ; 40(26): 3484-3489, 2022 06 09.
Article in English | MEDLINE | ID: covidwho-1740252

ABSTRACT

This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.


Subject(s)
COVID-19 , Ethical Review , COVID-19/prevention & control , Ethics Committees, Research , Humans , Pandemics/prevention & control , World Health Organization
11.
BMJ Open ; 12(2): e054163, 2022 Feb 02.
Article in English | MEDLINE | ID: covidwho-1673436

ABSTRACT

INTRODUCTION: Poor adolescent mental health is a barrier to achieving several sustainable development goals in Tanzania, where adolescent mental health infrastructure is weak. This is compounded by a lack of community and policy maker awareness or understanding of its burden, causes and solutions. Research addressing these knowledge gaps is urgently needed. However, capacity for adolescent mental health research in Tanzania remains limited. The existence of a National Institute for Medical Research (NIMR), with a nationwide mandate for research conduct and oversight, presents an opportunity to catalyse activity in this neglected area. Rigorous research priority setting, which includes key stakeholders, can promote efficient use of limited resources and improve both quality and uptake of research by ensuring that it meets the needs of target populations and policy makers. We present a protocol for such a research priority setting study and how it informs the design of an interinstitutional adolescent mental health research capacity strengthening strategy in Tanzania. METHODS AND ANALYSIS: From May 2021, this 6 month mixed-methods study will adapt and merge the James Lind Alliance approach and validated capacity strengthening methodologies to identify priorities for research and research capacity strengthening in adolescent mental health in Tanzania. Specifically, it will use online questionnaires, face-to-face interviews, focus groups, scoping reviews and a consensus meeting to consult expert and adolescent stakeholders. Key evidence-informed priorities will be collaboratively ranked and documented and an integrated strategy to address capacity gaps will be designed to align with the nationwide infrastructure and overall strategy of NIMR. ETHICS AND DISSEMINATION: National and institutional review board approvals were sought and granted from the National Health Research Ethics Committee of the NIMR Medical Research Coordinating Committee (Tanzania) and the Liverpool School of Tropical Medicine (United Kingdom). Results will be disseminated through a national workshop involving all stakeholders, through ongoing collaborations and published commentaries, reviews, policy briefs, webinars and social media.


Subject(s)
Biomedical Research , Mental Health , Academies and Institutes , Adolescent , Ethics Committees, Research , Humans , Tanzania
12.
J Med Internet Res ; 23(12): e25414, 2021 12 22.
Article in English | MEDLINE | ID: covidwho-1591572

ABSTRACT

Digital technologies offer unique opportunities for health research. For example, Twitter posts can support public health surveillance to identify outbreaks (eg, influenza and COVID-19), and a wearable fitness tracker can provide real-time data collection to assess the effectiveness of a behavior change intervention. With these opportunities, it is necessary to consider the potential risks and benefits to research participants when using digital tools or strategies. Researchers need to be involved in the risk assessment process, as many tools in the marketplace (eg, wellness apps, fitness sensors) are underregulated. However, there is little guidance to assist researchers and institutional review boards in their evaluation of digital tools for research purposes. To address this gap, the Digital Health Checklist for Researchers (DHC-R) was developed as a decision support tool. A participatory research approach involving a group of behavioral scientists was used to inform DHC-R development. Scientists beta-tested the checklist by retrospectively evaluating the technologies they had chosen for use in their research. This paper describes the lessons learned because of their involvement in the beta-testing process and concludes with recommendations for how the DHC-R could be useful for a variety of digital health stakeholders. Recommendations focus on future research and policy development to support research ethics, including the development of best practices to advance safe and responsible digital health research.


Subject(s)
COVID-19 , Checklist , Ethics Committees, Research , Humans , Retrospective Studies , SARS-CoV-2
13.
Acad Med ; 97(1): 48-52, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1584029

ABSTRACT

By March 2020, New York City became the early epicenter of the COVID-19 pandemic in the United States. Consequently, Columbia University, with its large portfolio of human subjects research, had to address the challenges of protecting thousands of research participants and research staff from potential exposure to COVID-19 while facilitating essential biomedical research, especially pandemic-related studies. The authors describe, from the perspective of Columbia's research administration leadership, how the University and its primary teaching hospital ramped down-and later ramped up-human subjects research and reflect on lessons learned. As the pandemic unfolded, only studies offering the prospect of direct benefit to subjects were permitted to continue with in-person contact. New in-person participant enrollment ceased, except for COVID-19 prevention or treatment studies. Centralized, frequently updated communication about policies and procedures was disseminated to the Columbia research community. Procedural efficiencies were rapidly developed and implemented for review and oversight of human subjects research and contractual agreements for clinical trials. More frequent institutional review board meetings and 24-hour support markedly reduced turnaround time for COVID-19 studies, without delaying approvals of non-COVID-19 research. Research administration worked closely with relevant principal federal agencies, whose regulatory flexibility facilitated the efficient implementation of COVID-19-related research. Overall, the ramp-down and ramp-up of the majority of human subjects research, with specified priorities and accelerated processes, worked well. Adjustments were made to handle the increase in administrative tasks, the need to respond rapidly to added oversight responsibilities, and the management of the many new COVID-19-related research protocols. Timely, centralized communication, support for staff needs, prioritization, and collaboration were critical to successful research oversight at a large-scale academic setting in the midst of a pandemic. These perspectives may be useful to academic research centers addressing the current and future pandemics.


Subject(s)
COVID-19 , Pandemics , Academic Medical Centers , COVID-19/epidemiology , Ethics Committees, Research , Humans , Pandemics/prevention & control , Research Subjects
14.
J Empir Res Hum Res Ethics ; 17(1-2): 94-101, 2022.
Article in English | MEDLINE | ID: covidwho-1528663

ABSTRACT

The problem: Running an efficient institutional review board (IRB) can be challenging. The research subjects: To ensure an efficient committee, our IRB adopted several operational metrics. Methods: Analysis of retrospective data from the IRB records, database, and annual reports over 12 years. Results: The IRB roster comprises 11 members. The average medical to nonmedical member ratio is 5:6, and the male to female ratio is 4:7, which has not been consistent over the years. One thousand three hundred and twenty-four proposals were reviewed including 1077 exempt (81.3%), 126 expedited (9.5%), and 121 full board (9.2%) with a median turnaround time to approval of 4.0, 35.0, and 68.0 days, respectively. Training of the IRB members was conducted to enhance their knowledge and skills. IRB at King Hussein Cancer Center has managed to stay abreast and efficient during the COVID-19 pandemic, by working remotely. Conclusion: Running an efficient IRB mandates implementing a number of operational metrics.


Subject(s)
COVID-19 , Neoplasms , Ethics Committees, Research , Female , Humans , Male , Pandemics , Retrospective Studies , SARS-CoV-2
15.
J Int AIDS Soc ; 24 Suppl 7: e25796, 2021 11.
Article in English | MEDLINE | ID: covidwho-1525464

ABSTRACT

INTRODUCTION: A major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance. DISCUSSION: We review recommendations related to four key issues, namely standard of prevention, post-trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants. CONCLUSIONS: There have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re-certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.


Subject(s)
AIDS Vaccines , HIV Infections , Adolescent , Ethics Committees, Research , Female , HIV Infections/prevention & control , Humans , Pregnancy , Research Design , Research Personnel
16.
BMC Med Ethics ; 22(1): 147, 2021 11 06.
Article in English | MEDLINE | ID: covidwho-1506573

ABSTRACT

BACKGROUND: Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. METHODS: We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. RESULTS: 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. CONCLUSION: LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.


Subject(s)
COVID-19 , Ethics Committees, Research , Ethics, Research , Humans , Latin America , Pandemics , SARS-CoV-2
19.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1396864

ABSTRACT

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.


Subject(s)
COVID-19 , Ethics Committees, Research/standards , Ethics, Research , Biomedical Research/ethics , Biomedical Research/standards , Humans , Informed Consent
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