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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.

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.

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 . . .

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.

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.

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.

As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.

Research studies that leverage emerging technologies, such as passive sensing devices and mobile apps, have demonstrated encouraging potential with respect to favorably influencing the human condition. As a result, the nascent fields of mHealth and digital medicine have gained traction over the past decade as demonstrated in the United States by increased federal funding for research that cuts across a broad spectrum of health conditions. The existence of mHealth and digital medicine also introduced new ethical and regulatory challenges that both institutional review boards (IRBs) and researchers are struggling to navigate. In response, the Connected and Open Research Ethics (CORE) initiative was launched. The CORE initiative has employed a participatory research approach, whereby researchers and IRB affiliates are involved in identifying the priorities and functionality of a shared resource. The overarching goal of CORE is to develop dynamic and relevant ethical practices to guide mHealth and digital medicine research. In this Viewpoint paper, we describe the CORE initiative and call for readers to join the CORE Network and contribute to the bigger conversation on ethics in the digital age.

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.

Background The increasing use of geographic data about individuals in health and social research raises ethical challenges that extend beyond existing legal frameworks. While regulations such as data protection laws define boundaries, they rarely provide researchers with sufficient practical guidance for addressing geoprivacy risks. Methods We developed a structured, reflexive ethical framework tailored for research involving human-centered geographic data. The framework was designed using a lifecycle approach and informed by both a review of existing literature and the expertise of the multidisciplinary author team. It organizes ethical considerations into five research phases: data collection, storage, sharing, analysis, and results dissemination. To enhance usability, we translated these considerations into 60 guiding questions, each assigned an importance level (high, moderate, or low). An ethical review applicability matrix was also introduced to help determine the level of ethical scrutiny required, based on study characteristics such as data type, granularity, linkage potential, and participant vulnerability. Results The framework offers a practical and scalable tool for embedding ethical reflection into research processes. It supports proportionate ethical review by aligning the sensitivity of specific research practices with the corresponding importance of guiding questions. To demonstrate its adaptability, we provide two case studies in the supplementary materials that apply the framework to different research scenarios with varying levels of geoprivacy sensitivity. Conclusions By encouraging early and context-aware engagement with ethical risks, this framework safeguards participant dignity, fosters transparency, and advances ethically responsible research involving geographic data. It equips both researchers and ethics committees with a systematic approach for addressing geoprivacy challenges across diverse health and social science contexts.