Rapid Review of Therapy Protocols for Public Health Emergencies.

How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid-response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid-Response IRB's subsequent transition to a multisite single IRB model during the current Covid-19 pandemic. The rapid-response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.

The Ethics of Using News Stories concerning Minors as Empirical Material in Health Research: Reflections on a Swedish Case.

In 2021, we were designing a research study in Sweden in which we planned to use newspaper articles focusing on children and adolescents under the age of eighteen during the Covid-19 pandemic as empirical material. As we developed this study, an ethical question arose: do studies using journalistic articles that may contain health information about individuals as empirical material have to be approved by an ethics review committee? Sweden, in contrast to other countries, requires the approval of an ethics review committee for the use of publicly available material in research when such material might include sensitive personal data such as health-related information. This case study calls for harmonized laws and policies that support global research by clarifying what kinds of empirical material and what types of research must be assessed by national ethics review committees, including with consideration for children's safety and rights.

Exploring Online Health Information Seeking Behaviour (OHISB) among young adults: A scoping review protocol.

INTRODUCTION: In recent years, information technology and social media have experienced unprecedented growth, particularly in the Nordic countries. However, there is a noticeable lack of comprehensive understanding regarding the latest research findings on online health information seeking behaviour (OHISB) among young adults (18 to >30). There is a need to conduct an updated review to identify knowledge gaps in where young adults find health information and their user interface preferences and to provide research-based guidance and recommendations to governments, health organisations and social media platforms on how to facilitate this prominent pattern. The scoping review protocol outlines a study that will systematically map the existing literature on young adults' preferences for digital platforms and platform characteristics in relation to OHISB, enabling the identification of promising areas for further research and the development of more effective interventions to promote healthy and informed choices. Conducting a scoping review is imperative to gain a comprehensive understanding of young adults' OHISB and support the next generation of dissemination that promotes accurate and reliable digital health information. METHODS AND ANALYSIS: The scoping review will use Arksey and O'Malley's methodological framework (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR)) and employ the citation pearl method and the Sample, Phenomenon of Interest, Design, Evaluation, Research type model to design the search strategy. To identify relevant literature, three databases will undergo a search: Scopus, Web of Science and EMBASE. Additionally, a subsidiarily grey literature search will be conducted in Google Scholar. The data charting process will conform to the PRISMA-ScR standard and will be further structured with EndNote. Qualitative and quantitative analyses of the extracted data will be developed using EndNote and Excel. ETHICS AND DISSEMINATION: Conducting a scoping review involves secondary data analysis of publicly available sources and does not require an ethical review. The protocol will be published to ensure transparency. The scoping review results will be disseminated through open-access peer-reviewed publications, national and international conferences, social media platforms, newspapers and YouTube to service users and stakeholders.

Preparing ethical review systems for emergencies: next steps.

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

Ethical considerations surrounding health-related big data research.

As health-related big data research (HRBDR) has drastically increased over the last years due to the rapid development of big data analytics, a range of important ethical issues are raised. In this study, a systematic literature review was conducted. Several and interesting results emerged from this review. The term ″big data″ has not yet been clearly defined. The already existing ethical principles and concepts need to be revisited in the new HRBDR context. Traditional research ethics notions like privacy and informed consent are to be reconsidered. HRBDR creates new ethical issues such those related to trust / trustworthiness and public values such as reciprocity, transparency, inclusivity and common good. The implementation of dynamic consent rather than broad consent is currently highlighted as the more satisfying solution. Ethical review committees in their current form are ill-suited to provide exclusive ethical oversight on HRBDR projects. Expanding Ethical Review Committees' purview and members' expertise, as well as creating novel oversight bodies by promoting a co-governance system including public and all the stakeholders involved are strongly recommended. The mechanism of ″social licence″, that is, informal permissions granted to researchers by society, can serve as a guideline. High-stakes decisions are often made under uncertainty. Machine learning algorithms are highly complex and in some cases opaque, and may yield biased decisions or discrimination. Improved interdisciplinary dialogue along with considering aspects like auditing, benchmarking, confidence / trust and explainability /interpretability may address concerns about HRBDR ethics. Finally and most importantly, research ethics shifts towards a population-based model of ethics.

Structured Ethical Review for Wastewater-Based Testing in Support of Public Health.

Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of WBT measured biomarkers for research activities and for the pursuit of public health goals, both areas with well-established ethical frameworks. Currently, WBT practitioners do not employ a standardized ethical review process, introducing the potential for adverse outcomes for WBT professionals and community members. To address this deficiency, an interdisciplinary workshop developed a framework for a structured ethical review of WBT. The workshop employed a consensus approach to create this framework as a set of 11 questions derived from primarily public health guidance. This study retrospectively applied these questions to SARS-CoV-2 monitoring programs covering the emergent phase of the pandemic (3/2020-2/2022 (n = 53)). Of note, 43% of answers highlight a lack of reported information to assess. Therefore, a systematic framework would at a minimum structure the communication of ethical considerations for applications of WBT. Consistent application of an ethical review will also assist in developing a practice of updating approaches and techniques to reflect the concerns held by both those practicing and those being monitored by WBT supported programs.

Should infectious disease modelling research be subject to ethics review?

Should research projects involving epidemiological modelling be subject to ethical scrutiny and peer review prior to publication? Mathematical modelling had considerable impacts during the COVID-19 pandemic, leading to social distancing and lockdowns. Imperial College conducted research leading to the website publication of a paper, Report 9, on non-pharmaceutical interventions (NPIs) and COVID-19 mortality demand dated 16th March 2020, arguing for a Government policy of non-pharmaceutical interventions (e.g. lockdowns, social distancing, mask wearing, working from home, furlough, school closures, reduced family interaction etc.) to counter COVID 19. Enquiries and Freedom of Information requests to the institution indicate that there was no formal ethical committee review of this specific research, nor was there any peer review prior to their online publication of Report 9. This paper considers the duties placed upon researchers, institutions and research funders under the UK 'Concordat to Support Research Integrity' (CSRI), across various bioethical domains, and whether ethical committee scrutiny should be required for this research.

Situation analysis of research ethics governance in Pakistan.

Background: Mapping of ethical governance structures is very useful in identifying strengths and weaknesses in order to uphold integrity and ensure standardization. However, reliable countrywide data about ethical review committees (ERCs) is unavailable in Pakistan. Aims: To evaluate the research ethics governance mechanisms at national level and at key healthcare institutions in Pakistan. Methods: This pilot mapping exercise used a mixed-methods approach, involving a cross-sectional survey of 19 key healthcare research institutions, and structured in-depth interviews with the chairs of the National Bioethics Committee and the Drug Regulatory Authority of Pakistan. Results: Eighteen institutions responded to the ethics mapping survey. Twelve public sector ERCs had a permanent structure and 17 had formal terms of reference. Seven ERCs claimed accreditation, although no central accreditation agency exists in Pakistan. Eight ERCs were chaired by the heads of the institutions. There was no fixed tenure for the heads in 13 committees, and 14 committees allowed multiple terms. Six ERCs had follow-up mechanisms for ethical approvals, and 6 took punitive actions in response to any deviation from an approved protocol, or to a scientific misconduct. Two respondents recalled situations where applicants pressured committee members for favourable approvals. Survey respondents mentioned the lack of central research ethics guidelines as a weakness of the national governance system. Structured interviews revealed the need for formal training of committee members and capacity strengthening, particularly for administrative staff. Conclusion: There is a need to develop guidelines for local ethics governance in Pakistan, and ensure accreditation of ERCs through the National Bioethics Committee to uphold the integrity of the ethics governance structure.

Artificial intelligence and medical research databases: ethical review by data access committees.

BACKGROUND: It has been argued that ethics review committees-e.g., Research Ethics Committees, Institutional Review Boards, etc.- have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data. MAIN BODY: Focusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work. CONCLUSION: Data access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise.

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study.

INTRODUCTION: Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain. METHODS: Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse-Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach. RESULTS: Four main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites. DISCUSSION: The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.

The reporting of ethical review and ethical considerations in articles published in medical education journals: A literature review.

BACKGROUND: Health professions education research (HPE-R) must be ethically sound. Ethical review decisions and other ethical considerations should be clearly reported in journal articles to allow readers to assess the ethical soundness of the research. We explored and evaluated how ethical review decisions and ethical considerations for HPE-R are reported in health professions education (HPE) journal articles. METHODS: We identified a 1-year sample, for 2020, of eight HPE journals. We systematically assessed the reporting of ethical review and key ethical considerations in the articles in the sample. RESULTS: The search yielded 2004 articles, of which 955 articles (47.7%) were eligible and were thus assessed. Most (83.4%) of the assessed articles mentioned a review by an ethical review board (ERB). In the category 'research articles', 92% articles reported the outcome of the ethical review. In the category 'other articles' (e.g. educational case reports), reporting of ethical processes was less common (32%). Overall, the reporting of key ethical considerations was limited, although these considerations were more reported in 'research articles' compared with 'other articles'. CONCLUSIONS: ERB assessments and HPE-R approval was reported in most research articles. This finding is an improvement compared with previous evaluations of ethical research practice in HPE-R. All studies, particularly those that are exempted or not fully reviewed, should describe their key ethical considerations clearly to enable the HPE community to assess the ethical soundness. Our review revealed that the reporting of ethical considerations was limited and deserves attention from the research community.

[Time of ethics review of research proposals: results of an observational study]. / Tiempos de evaluación ética de protocolos de investigación: resultados de un estudio observacional.

The review of research protocols by Research Ethics Committees (RECs), essential to ensure the protection of participants, has been managed in the City of Buenos Aires through the PRIISA.BA electronic platform since January 2020. The aim of the present study was to describe ethical review times, their temporal evolution, and predictors of their duration. We conducted an observational study that included all the protocols reviewed between January 2020 and September 2021. Times to approval and to first observation were calculated. Temporal trends in times, and the multivariate association between these and protocol and IRB characteristics were evaluated. 2,781 protocols reviewed in 62 RECs were included. The median time to approval was 29.11 (RIQ 11.29 to 63.35) days, and time to first observation was 8.92 (RIQ 2.05 to 18.18) days. The times were significantly reduced throughout the study period. We detected as variables independently associated with shorter time to approval to be a COVID proposal, having funding and the number of centers to perform the study and having been reviewed by an RECs with more than 10 members. Making observations to the protocol was associated with more time. The results of the present work suggest that ethical review times were reduced during study period. In addition, variables associated with time were identified that could be the object of interventions to improve the process.

Catalyzing Ethical Research in Emergencies: Recommendations for Research Ethics Committees

This technical note presents the recommendations for research ethics committees included in the Pan American Health Organization publication entitled 'Catalyzing Ethical Research in Emergencies. Ethics Guidance, Lessons Learned from the COVID-19 Pandemic, and Pending Agenda', which provides direction for strategies and guidelines on modifying ethical oversight processes in emergency situations, ethically monitoring ongoing research in the face of new evidence, and overcoming other ethical challenges that arise when doing research in public health emergencies. It also provides guidance so that the emergency use of unproven interventions outside of a research setting is carried out in an ethical manner. Finally, it includes the lessons learned in the Region of the Americas during the COVID-19 pandemic and recommendations resulting from a regional reflection exercise aimed at improving ethical preparation for conducting research during future health emergencies.

Tiempos de evaluación ética de protocolos de investigación: resultados de un estudio observacional / Time of ethics review of research proposals: results of an observational study

La evaluación de protocolos de investigación por Comités de Ética en Investigación (CEI), esencialpara garantizar la protección de los participantes, se gestiona en la Ciudad de Buenos Aires a través laplataforma electrónica PRIISA.BA desde enero del 2020. El objetivo del presente estudio fue describirlos tiempos de evaluación ética, su evolución temporal, y los predictores de su duración. Se realizóun estudio observacional que incluyó todos los protocolos evaluados entre enero de 2020 y septiem-bre de 2021. Se calcularon los tiempos al dictamen final y a la primera observación. Se evaluaron lastendencias temporales de los tiempos, y la asociación multivariada entre éstos y características de losprotocolos y de los CEI. Se incluyeron 2781 protocolos evaluados en 62 CEI. La mediana de tiempo aldictamen final fue de 29.11 (RIQ 11.29 a 63.35) días, y del tiempo a la primera observación de 8.92(RIQ 2.05 a 18.18) días. Los tiempos se redujeron significativamente a lo largo del período de estudio.Detectamos como variables independientemente asociadas a menor tiempo a la temática COVID, tenerfinanciamiento y el número de centros a realizarse el estudio y haber sido evaluado en un CEI con másde 10 miembros. La realización de observaciones al protocolo se asoció a mayor tiempo. Los resultadosdel presente trabajo sugieren que los tiempos de evaluación ética se redujeron durante el período deestudio. Además, se identificaron variables asociadas con los tiempos, que podrían ser objeto de inter-venciones para mejorar el proceso.(AU)

The review of research protocols by Research Ethics Committees (RECs), essential to ensure theprotection of participants, has been managed in the City of Buenos Aires through the PRIISA.BA elec-tronic platform since January 2020. The aim of the present study was to describe ethical review times,their temporal evolution, and predictors of their duration. We conducted an observational study thatincluded all the protocols reviewed between January 2020 and September 2021. Times to approvaland to first observation were calculated. Temporal trends in times, and the multivariate associationbetween these and protocol and IRB characteristics were evaluated. 2,781 protocols reviewed in 62RECs were included. The median time to approval was 29.11 (RIQ 11.29 to 63.35) days, and time to firstobservation was 8.92 (RIQ 2.05 to 18.18) days. The times were significantly reduced throughout thestudy period. We detected as variables independently associated with shorter time to approval to bea COVID proposal, having funding and the number of centers to perform the study and having beenreviewed by an RECs with more than 10 members. Making observations to the protocol was associatedwith more time. The results of the present work suggest that ethical review times were reduced duringstudy period. In addition, variables associated with time were identified that could be the object ofinterventions to improve the process.(AU)

Beyond regulatory approaches to ethics: making space for ethical preparedness in healthcare research.

Centralised, compliance-focused approaches to research ethics have been normalised in practice. In this paper, we argue that the dominance of such systems has been driven by neoliberal approaches to governance, where the focus on controlling and individualising risk has led to an overemphasis of decontextualised ethical principles and the conflation of ethical requirements with the documentation of 'informed consent'. Using a UK-based case study, involving a point-of-care-genetic test as an illustration, we argue that rather than ensuring ethical practice such compliance-focused approaches may obstruct valuable research. We call for an approach that encourages researchers and research communities-including regulators, ethics committees, funders and publishers of academic research-to acquire skills to make morally appropriate decisions, and not base decision-making solely on compliance with prescriptive regulations. We call this 'ethical preparedness' and outline how a research ethics system might make space for this approach.

What are We Asking Patients to Do? A Critical Ethical Review of the Limits of Patient Self-Advocacy in the Oncology Setting.

Increasing emphasis on patient self-management, including having patients advocate for their needs and priorities, is generally a good thing, but it is not always wanted or attainable by patients. The aim of this critical ethical review is to deepen the current discourse in patient self-advocacy by exposing various situations in which patients struggle to self-advocate. Using examples from oncology patient populations, we disambiguate different notions of self-advocacy and then present limits to the more demanding varieties (i.e., health-related, trust-based, and psychological); we argue that these limits create ethical dilemmas with respect to whether it is always desirable to encourage patients to self-advocate. We conclude that self-advocacy can be both under and overrated with respect to how much it benefits the patient with cancer, with many instances being indeterminate. Ultimately, providers must understand the patient's perspective relative to the challenges they are experiencing and work with them to meet their needs.

The creation of the Belmont Report and its effect on ethical principles: a historical study.

The Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report's creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report's features. Additionally, we analyze the effect of unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials-which were at first expected to be applicable to research involving children-in addition to implementing policies regarding the public review of protocols that passed ethical review, this report's principles are clearly reflected in the key notes that should have been referred to when the report was created.