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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.

Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are central to safeguarding ethical obligations in research, yet awareness and submission practices among researchers in Saudi Arabia remain inconsistent. This study explored researchers’ awareness, submission methodologies, perceived barriers, and possible improvements to the IRB process. A national electronic cross-sectional survey was distributed to 915 researchers affiliated with academic and research institutions across Saudi Arabia, yielding 870 complete and valid responses (response rate: 95.1%). The questionnaire covered demographics, awareness of ethical principles, submission practices, barriers, and recommendations. Data were examined using descriptive statistics and chi-square tests, with Cramer’s V used to indicate effect sizes. Results showed that prior submission experience was significantly associated with higher awareness of research ethics (87.3% vs. 49.4%, χ²(2) = 149.40, p  < 0.001, Cramer’s V = 0.414). Perceived institutional support was associated with greater ease of submission (χ²(16) = 195.75, p  < 0.001, Cramer’s V = 0.237), while formal ethics training was associated with higher confidence in applying ethical protocols (78.2% vs. 48.5%, χ²(1) = 80.32, p  < 0.001, Cramer’s V = 0.304). Frequently reported barriers included unclear procedures, bureaucratic delays, and limited supervisory guidance, while qualitative analysis highlighted recurring concerns regarding procedural complexity. Despite a well-established regulatory framework, practical gaps in awareness and submission practices persist. Participants recommended structured ethics training, simplified digital submission platforms, and enhanced supervisory engagement to strengthen compliance and reinforce research integrity.

Background Brazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC’s Chairs to compose their membership. Methods All 779 Brazilian RECs’ chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. Results The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. Conclusion The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC’s specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.

The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insights into U.S. institutional review boards’ (IRBs) attitudes and practices regulating social computing research. Through descriptive and inferential analysis of survey data from staff at 59 IRBs at research universities, we examine how IRBs evaluate the growing variety of studies using pervasive digital data. Findings unpack the difficulties IRB staff face evaluating increasingly technical research proposals while highlighting the belief in their ability to surmount these difficulties. They also indicate a lack of consensus among IRB staff about what should be reviewed and a willingness to work closely with researchers.

Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants' rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study's scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.

Research efforts are growing rapidly in the digital health industry, but with this growth comes increasing ethical challenges. In this viewpoint paper, we leverage over 20 years of combined experience across academia, industry, and digital health to address critical issues related to ethics, specifically privacy policies and institutional review board compliance, which are often misunderstood or misapplied. We examine the purpose of privacy policies and institutional review boards, provide brief examples where companies faced legal and ethical consequences due to shortcomings, and clarify common misconceptions. Finally, we offer recommendations on how digital health companies can improve their ethical practices and ensure compliance in a rapidly evolving landscape.

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.

Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Background The ethics committee has the responsibility to comply with the rules and guidelines regarding oversight of all human research activities, particularly when the research study involves vulnerable people. It also has the role of educating researchers on ethical issues, scientific truthfulness, preventing misconduct and conflicts of interest. In our study we evaluate and benchmark the function of the local ethical committees across the country from the researchers point-of-view. Methods We employed an online IRB-RAT survey to measure perspectives of investigators towards IRB functions dealing with fairness issues, services, bias, and competences and upholding the rights of the human participants. Two responses were recorded: first shows how important an IRB function is for the investigator in his work, second shows how researchers rate their IRBs in being descriptive in that specific function. The difference of these two scores represent the outcome. Results We had 179 participants, 166(94%) researchers/research coordinators, and 13(7.2%) IRB members, 94 (53%) participants had been working in the research field for more than 11 years, and the majority 163(90%) revealed that they had IRB contact. The largest gap between actual rating and ideal was observed for the item “An IRB that requires that its chair be an experienced investigator” with a score difference of 1.53. In contrast, the smallest score difference was for the item “Considering the protection of human participants,” which had a score of 0.51. Conclusion According’s to researchers point of view; IRBs respect researchers, view human protections as a primary role, do not allow personal bias, maintain accurate records and take timely action whenever misconduct is reported. Further collaborations are needed to enhance IRB performance and to engage researchers in more productive communication with their IRBs.