Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs.
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ABSTRACT:
SUBMITTER: Ferretti A
PROVIDER: S-EPMC7814666 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Big data trends in biomedical and health research enable large-scale and multi-dimensional aggregation and analysis of heterogeneous data sources, which could ultimately result in preventive, diagnostic and therapeutic benefit. The methodological novelty and computational complexity of big data health research raises novel challenges for ethics review. In this study, we conducted a scoping review of the literature using five databases to identify and map the major challenges of health-related big data for Ethics Review Committees (ERCs) or analogous institutional review boards. A total of 1093 publications were initially identified, 263 of which were included in the final synthesis after abstract and full-text screening performed independently by two researchers. Both a descriptive numerical summary and a thematic analysis were performed on the full-texts of all articles included in the synthesis. Our findings suggest that while big data trends in biomedicine hold the potential for advancing clinical research, improving prevention and optimizing healthcare delivery, yet several epistemic, scientific and normative challenges need careful consideration. These challenges have relevance for both the composition of ERCs and the evaluation criteria that should be employed by ERC members when assessing the methodological and ethical viability of health-related big data studies. Based on this analysis, we provide some preliminary recommendations on how ERCs could adaptively respond to those challenges. This exploration is designed to synthesize useful information for researchers, ERCs and relevant institutional bodies involved in the conduction and/or assessment of health-related big data research.
| S-EPMC6181558 | biostudies-literature
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| S-EPMC4838154 | biostudies-literature
Project description:Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.
| S-EPMC8083817 | biostudies-literature
Project description:There is potential value in incorporating biomedical big data (BBD)-observational real-world patient-level genomic and clinical data in multiple sub-populations-into economic evaluations of precision medicine. However, health economists face practical and methodological challenges when using BBD in this context. We conducted a literature review to identify and summarise these challenges. Relevant articles were identified in MEDLINE, EMBASE, EconLit, University of York Centre for Reviews and Dissemination and Cochrane Library from 2000 to 2018. Articles were included if they studied issues relevant to the interconnectedness of biomedical big data, precision medicine, and health economic evaluation. Nineteen articles were included in the review. Challenges identified related to data management, data quality and data analysis. The availability of large volumes of data from multiple sources, the need to conduct data linkages within an environment of opaque data access and sharing procedures, and other data management challenges are primarily practical and may not be long-term obstacles if procedures for data sharing and access are improved. However, the existence of missing data across linked datasets, the need to accommodate dynamic data, and other data quality and analysis challenges may require an evolution in economic evaluation methods. Health economists face challenges when using BBD in economic evaluations of technologies that facilitate precision medicine. Potential solutions to some of these challenges do, however, exist. Going forward, health economists who present work that uses BBD should document challenges and the solutions they have applied to the challenges to support future researcher endeavours.
| S-EPMC6647451 | biostudies-literature
Project description:BackgroundIn recent years, tensions between IRBs and principal investigators (PIs) have risen, posing the needs to understand these conflicts, their underlying causes, and possible solutions. Researchers frequently complain about IRBs, but how IRBs perceive and respond to these criticisms is unclear.MethodsI conducted in-depth, semi-structured interviews of two hours each with 46 chairs, administrators, and members. I contacted the leadership of 60 IRBs around the country (every fourth one in the list of the top 240 institutions by NIH funding) and interviewed IRB leaders from 34 of these institutions (response rate = 55%).ResultsInterviewees suggest that IRBs and PIs may view the nature and causes of these conflicts very differently and misunderstand each other, exacerbating tensions. Interviewees often recognized that they were seen by PIs as having power, but many IRBs saw themselves as not having it (e.g., because they are "merely following the regulations," and their process is "open," impersonal and unbiased, and they are themselves subject to higher administrative agencies), or as having it, but feeling it is small, and/or justified (e.g., because it is based on overriding goals and "the community values," and IRBs are trying to help PIs). Questions emerge as to whether IRBs do or should have power, and if so, what kind, how much, and when. Several factors may affect these tensions.ConclusionsThis study, the first to explore how IRBs perceive and understand conflicts and power relationships with PIs, suggests how IRBs and PIs may differ in viewing their respective roles and relationships, exacerbating tensions. These issues have critical implications for IRBs and PIs--to enhance their awareness and understanding of these conflicts (e.g., that IRBs may have discretionary power) and the underlying causes involved, and for increasing attention to research, practice, and policy concerning these areas of IRB functioning and interactions with PIs.
| S-EPMC3236766 | biostudies-literature
Project description:Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.
| S-EPMC4928761 | biostudies-literature
Project description:The worldwide adoption of electronic health records (EHR) promises to accelerate clinical research, which lies at the heart of medical advances. However, the interrogation of such Big Data by clinical researchers can be laborious and error-prone, involving iterative and ineffective communication of data requests to data analysts. Research on this communication process is rare. There also exists no contemporary system that offers intelligent solutions to assist clinical researchers in their quest for clinical data. In this article, we first provide a detailed characterization of the challenges encountered in this communication space. Second, we identify promising synergies between fields studying human-to-human and human-machine communication that can shed light on biomedical data query mediation. We propose a mixed-initiative dialog-based approach to support autonomous clinical data access and recommend needed technology development and communication study for accelerating clinical research.
| S-EPMC5875984 | biostudies-literature
Project description:BackgroundData provenance refers to the origin, processing, and movement of data. Reliable and precise knowledge about data provenance has great potential to improve reproducibility as well as quality in biomedical research and, therefore, to foster good scientific practice. However, despite the increasing interest on data provenance technologies in the literature and their implementation in other disciplines, these technologies have not yet been widely adopted in biomedical research.ObjectiveThe aim of this scoping review was to provide a structured overview of the body of knowledge on provenance methods in biomedical research by systematizing articles covering data provenance technologies developed for or used in this application area; describing and comparing the functionalities as well as the design of the provenance technologies used; and identifying gaps in the literature, which could provide opportunities for future research on technologies that could receive more widespread adoption.MethodsFollowing a methodological framework for scoping studies and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, articles were identified by searching the PubMed, IEEE Xplore, and Web of Science databases and subsequently screened for eligibility. We included original articles covering software-based provenance management for scientific research published between 2010 and 2021. A set of data items was defined along the following five axes: publication metadata, application scope, provenance aspects covered, data representation, and functionalities. The data items were extracted from the articles, stored in a charting spreadsheet, and summarized in tables and figures.ResultsWe identified 44 original articles published between 2010 and 2021. We found that the solutions described were heterogeneous along all axes. We also identified relationships among motivations for the use of provenance information, feature sets (capture, storage, retrieval, visualization, and analysis), and implementation details such as the data models and technologies used. The important gap that we identified is that only a few publications address the analysis of provenance data or use established provenance standards, such as PROV.ConclusionsThe heterogeneity of provenance methods, models, and implementations found in the literature points to the lack of a unified understanding of provenance concepts for biomedical data. Providing a common framework, a biomedical reference, and benchmarking data sets could foster the development of more comprehensive provenance solutions.
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