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Background Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. Methods We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. Results Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries. Conclusions Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Integration of genomic technology into healthcare settings establishes new capabilities to predict disease susceptibility and optimize treatment regimes. Yet, Indigenous peoples remain starkly underrepresented in genetic and clinical health research and are unlikely to benefit from such efforts. To foster collaboration with Indigenous communities, we propose six principles for ethical engagement in genomic research: understand existing regulations, foster collaboration, build cultural competency, improve research transparency, support capacity building, and disseminate research findings. Inclusion of underrepresented communities in genomic research has the potential to expand our understanding of genomic influences on health and improve clinical approaches for all populations. Indigenous peoples are still underrepresented in genetic research. Here, the authors propose an ethical framework consisting of six major principles that encourages researchers and Indigenous communities to build strong and equal partnerships to increase trust, engagement and diversity in genomic studies.

Clinical Ethics Committees (CECs), as distinct from Research Ethics Committees, were originally established with the aim of supporting healthcare professionals in managing controversial clinical ethical issues. However, it is still unclear whether they manage to accomplish this task and what is their impact on clinical practice. This systematic review aims to collect available assessments of CECs’ performance as reported in literature, in order to evaluate CECs’ effectiveness. We retrieved all literature published up to November 2019 in six databases (PubMed, Ovid MEDLINE, Scopus, Philosopher’s Index, Embase and Web of Science), following PRISMA guidelines. We included only articles specifically addressing CECs and providing any form of CECs performance assessment. Twenty-nine articles were included. Ethics consultation was the most evaluated of CECs’ functions. We did not find standardized tools for measuring CECs’ efficacy, but 33% of studies considered “user satisfaction” as an indicator, with 94% of them reporting an average positive perception of CECs’ impact. Changes in patient treatment and a decrease of moral distress in health personnel were reported as additional outcomes of ethics consultation. The highly diverse ways by which CECs carry out their activities make CECs’ evaluation difficult. The adoption of shared criteria would be desirable to provide a reliable answer to the question about their effectiveness. Nonetheless, in general both users and providers consider CECs as helpful, relevant to their work, able to improve the quality of care. Their main function is ethics consultation, while less attention seems to be devoted to bioethics education and policy formation.

The new National Institutes of Health policy on review of multicenter studies by a single institutional review board ushers in new responsibilities for investigators. Public comments have highlighted several challenges to streamlining ethics review in this way. Review of the ethics of multicenter clinical studies is typically conducted by the institutional review board (IRB) of each participating center. Extensive evidence suggests that the current practice is costly, is unnecessarily duplicative, and delays commencement of research. 1 The U.S. government has permitted single-IRB review and other streamlined review models since 1991, but few investigators have taken advantage of those options. 2 In June 2016, the National Institutes of Health (NIH) issued new guidance on single-IRB review of multicenter studies. 3 The policy was introduced as a means to increase the efficiency of multicenter studies, reduce the time to study initiation, promote . . .

Background‘The Clinical Ethics Advisory Group’ (CEAG) is the clinical ethics support body for Newcastle upon Tyne Hospitals National Health Service Foundation Trust. A significant change in CEAG’s way of working occurred over the past 5 years as a result of Court decisions, increasing public expectations and an increase in CEAG’s paediatric case flow.PurposeReview historical data: (a) as a useful benchmark to look for the early impact of significant service changes and (b) to seek possible reference (‘sentinel’) cases for use with a posited practical (casuistic) case-based reasoning model.MethodsAudit of the minutes of the first 22 years’ meetings was undertaken by the two chairs of CEAG over that period of time.Results223 matters discussed: 86 Trust policy issues; 117 clinical cases (84 adult (32 urgent), 33 child (8 urgent)); 12 CEAG procedural issues and 8 UK Clinical Ethics Network ‘round robin’ cases. The range of topic areas was wide. A broad range of ethical structures were deployed, principlism predominated. Quality was subjectively assessed by each reviewer, but different methods were used. This proved highly concordant between the two reviewers. 47% (105/223) of discussions were ‘excellent’ (*A4C4–A4C4) and 70% (156.5/223) ‘good’ or better (*A4C4–A3C3). By meeting the criteria of ‘excellent’ and ‘prospective’, 92/223 (41%) of matters were deemed potentially suitable as sentinel cases.ConclusionsThe audit provides a rich vein of information. There is demand for CEAG’s services, workload is becoming more complex. Formal funding for such services seems justified.

Background: Regular evaluation of the performance of research ethics committees is vital to ensure their effectiveness in protecting the rights of research subjects and increasing public trust in biomedical research. Aim: To evaluate the performance of research ethics committees (RECs) at Tehran University of Medical Sciences and identify key challenges in carrying out their functions. Methods: Using the WHO ethics oversight benchmarking tool, we interviewed 18 secretaries of research ethics committees, 7 bioethics experts and 14 researchers at Tehran University of Medical Sciences and reviewed relevant documents. We performed a content analysis of the text and interview transcripts to identify key operational mechanisms and challenges. Results: Of the 26 indicators for structure and composition, resources, procedures, mechanisms to promote transparency and accountability, and mechanisms to monitor self-performance, only 8 were fully implemented, 8 were partially implemented, and 4 were not implemented by all the 18 RECs. There were variations in implementation of the remaining 6 indicators. The most prominent challenges in implementation were absence of post-approval monitoring of research, inadequate conflict of interest management and inconsistent adherence to procedures. The RECs had limited ethics training and there were no policy and procedures for managing conflict of interest. Conclusion: The WHO tool effectively identified strengths and weaknesses in the performance of RECs at Tehran University of Medical Sciences. A tiered oversight system is recommended to enhance support for, and harmonization among, RECs. Key improvements should focus on post-approval monitoring, conflict of interest management, and institutional accountability. Addressing these gaps will strengthen ethics oversight and increase trust in biomedical research.

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.

The preparation of a randomized controlled trial (RCT) requires substantial resources and the administrative processes can be burdensome. To facilitate the conduct of RCTs it is important to better understand cost drivers. In January 2014 the enactment of the new Swiss Legislation on Human Research (LHR) considerably changed the regulatory framework in Switzerland. We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethics committees (RECs) and the regulatory authority Swissmedic. We surveyed investigators of RCTs which were approved by RECs in 2012 or in 2016 and asked for RCT preparation costs using a pre-specified item list. Additionally, we collected approval times from RECs and Swissmedic. The response rates of the investigator survey were 8.3% (19/228) for 2012 and 16.5% (47/285) in 2016. The median preparation cost of an RCT was USD 72,400 (interquartile range [IQR]: USD 59,500-87,700; n = 18) in 2012 and USD 72,600 (IQR: USD 42,800-169,600; n = 35) in 2016. For single centre RCTs a median REC approval time of 82 (IQR: 49-107; n = 38) days in 2012 and 92 (IQR: 65-131; n = 63) days in 2016 was observed. The median Swissmedic approval time for any clinical trial was 27 (IQR: 19-51; n = 213) days in 2012 and 49 (IQR: 36-67; n = 179) days in 2016. The total duration for achieving RCT approval from both authorities (REC and Swissmedic) in the parallel submission procedure applied in 2016 could not be assessed. Based on limited data the costs to plan and prepare RCTs in Switzerland were approximately USD 72,000 in 2012 and 2016. For effective and valid research on costs and approval times of RCTs a greater willingness to share cost information among investigators and more collaboration between stakeholders with data linkage is necessary.

Early trial termination remains frequent. Research ethics committees (RECs) could play a role in reducing the probability of early termination. Their review process provides a window for both identifying trials at high risk of terminating prematurely and imposing preventive measures, such as design modifications. This study aimed to explore whether characteristics of ethics review, alongside trial characteristics, are related to subsequent early trial termination. This meta-epidemiological cohort study assessed 198 clinical trials approved by a Dutch REC between 2015 and 2018. Data from archived trial protocols, related study documents, and correspondence between the REC and investigators were analysed to identify predictors of early termination during ethics review. Of the 198 trials, 69 (34.8%) terminated early, most often due to recruitment failure (n = 31, 35.2%). Several characteristics were associated with early termination, such as multicentre design (vs single centre, risk ratio [RR]: 1.89, 95% CI: 1.24–3.14), number of comments raised during ethics review (per comment, RR: 1.02, 95% CI: 1.00–1.05), and specific comments regarding privacy and confidentiality (RR: 1.21, 95% CI: 1.05–1.41) and participant information sheets (RR: 1.05, 95% CI: 1.02–1.08). Investigator sponsorship, longer review durations, and comments raised regarding privacy and confidentiality and subject selection were associated with an increased likelihood of recruitment failure, specifically. This exploratory study showed that various characteristics of ethics review have the potential to predict early trial termination. Further studies are needed to validate and expand upon these findings. Clinical trials sometimes end earlier than planned, often due to difficulties recruiting enough participants. When trials stop too soon, their results become less reliable. Research ethics committees (RECs) review trial plans before they begin to make sure they meet legal and ethical standards. RECs may also be able to help prevent early termination by identifying trials at high risk and recommending improvements. This study looked at 198 clinical trials approved by a Dutch REC to see if the characteristics of the ethics review process could predict which trials might stop early. The study found that about one-third of the trials ended early, most often due to recruitment problems. Trials were more likely to stop early if they involved multiple centres, received more comments from the REC, or received comments specifically about issues related to privacy, confidentiality, or the information given to participants. Recruitment problems were more common in trials that had longer review times, received comments about who was eligible to take part or issues related to privacy and confidentiality, or were run by researchers without commercial sponsorship. Overall, the findings suggest that by examining the ethics review process more closely, RECs might be able to identify and support trials at higher risk of stopping early. More research is needed to confirm these results and explore how RECs might help improve trial success. •Around one-third of clinical trials stop early, often due to recruitment failure.•Research ethics committees may help reduce the risk of early termination.•This study showed that aspects of ethics review can help predict early termination.•Review time, number and type of comments were linked to early trial termination.•Multicenter design was linked to termination and sponsorship to recruitment failure.