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Considerations for ethics review of big data health research: A scoping review.

ABSTRACT: 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.

SUBMITTER: Ienca M

PROVIDER: S-EPMC6181558 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Considerations for ethics review of big data health research: A scoping review.

Ienca Marcello M Ferretti Agata A Hurst Samia S Puhan Milo M Lovis Christian C Vayena Effy E

PloS one 20181011 10

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 bi ...[more]

PMID: 30308031

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Project description:BACKGROUND:Influenzanet was launched in several European countries to monitor influenza-like illness during flu seasons with the help of volunteering participants and Web-based technologies. As in the case of developing fields, ethical approaches are not well developed in the collection, processing, and analysis of participants' information. Existing controversies and varying national ethical regulations can, thus, hamper efficient cross-border research collaboration to the detriment of quality disease surveillance. OBJECTIVE:This scoping review characterizes current practices on how ethical, legal, and social issues (ELSIs) pertinent to research ethics are handled by different Influenzanet country groups to analyze similarities and identify the need for further harmonization of ethical approaches. METHODS:A literature search was carried out on PubMed, Web of Science, Global Digital Library on Ethics, and Bioethics Literature Database to identify ELSIs for Influenzanet country platforms. Only English-language papers were included with publication dates from 2003 to 2017. Publications were screened for the application of bioethics principles in the implementation of country platforms. Additional publications gathered from the Influenzanet Consortium website, reference screening, and conference proceeding were screened for ELSIs. RESULTS:We gathered 96 papers from our search methodology. In total, 28 papers that mentioned ELSIs were identified and included in this study. The Research Ethics Committee (REC) approvals were sought for recruiting participants and collecting their data in 8 of 11 country platforms and informed e-consent was sought from participants in 9 of 11 country platforms. Furthermore, personal data protection was ensured throughout the Consortium using data anonymization before processing and analysis and using aggregated data. CONCLUSIONS:Epidemics forecasting activities, such as Influenzanet, are beneficial; however, its benefits could be further increased through the harmonization of data gathering and ethical requirements. This objective is achievable by the Consortium. More transparency should be promoted concerning REC-approved research for Influenzanet-like systems. The validity of informed e-consent could also be increased through the provision of a user friendly and standard information sheet across the Consortium where participants agree to its terms, conditions, and privacy policies before being able to fill in the questionnaire. This will help to build trust in the general public while preventing any decline in participation.

Project description:BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Project description:INTRODUCTION:The rising popularity of social media, since their inception around 20 years ago, has been echoed in the growth of health-related research using data derived from them. This has created a demand for literature reviews to synthesise this emerging evidence base and inform future activities. Existing reviews tend to be narrow in scope, with limited consideration of the different types of data, analytical methods and ethical issues involved. There has also been a tendency for research to be siloed within different academic communities (eg, computer science, public health), hindering knowledge translation. To address these limitations, we will undertake a comprehensive scoping review, to systematically capture the broad corpus of published, health-related research based on social media data. Here, we present the review protocol and the pilot analyses used to inform it. METHODS:A version of Arksey and O'Malley's five-stage scoping review framework will be followed: (1) identifying the research question; (2) identifying the relevant literature; (3) selecting the studies; (4) charting the data and (5) collating, summarising and reporting the results. To inform the search strategy, we developed an inclusive list of keyword combinations related to social media, health and relevant methodologies. The frequency and variability of terms were charted over time and cross referenced with significant events, such as the advent of Twitter. Five leading health, informatics, business and cross-disciplinary databases will be searched: PubMed, Scopus, Association of Computer Machinery, Institute of Electrical and Electronics Engineers and Applied Social Sciences Index and Abstracts, alongside the Google search engine. There will be no restriction by date. ETHICS AND DISSEMINATION:The review focuses on published research in the public domain therefore no ethics approval is required. The completed review will be submitted for publication to a peer-reviewed, interdisciplinary open access journal, and conferences on public health and digital research.

Project description:IntroductionPublic health investigations, including research, in refugee populations are necessary to inform evidence-based interventions and care. The unique challenges refugees face (displacement, limited political protections, economic hardship) can make them especially vulnerable to harm, burden, or undue influence. Acute survival needs, fear of stigma or persecution, and history of trauma may present challenges to ensuring meaningful informed consent and establishing trust. We examined the recently published literature to understand the application of ethics principles in investigations involving refugees.MethodsWe conducted a preliminary review of refugee health literature (research and non-research data collections) published from 2015 through 2018 available in PubMed. Article inclusion criteria were: participants were refugees, topic was health-related, and methods used primary data collection. Information regarding type of investigation, methods, and reported ethics considerations was abstracted.ResultsWe examined 288 articles. Results indicated 33% of investigations were conducted before resettlement, during the displacement period (68% of these were in refugee camps). Common topics included mental health (48%) and healthcare access (8%). The majority (87%) of investigations obtained consent. Incentives were provided less frequently (23%). Most authors discussed the ways in which community stakeholders were engaged (91%), yet few noted whether refugee representatives had an opportunity to review investigational protocols (8%). Cultural considerations were generally limited to gender and religious norms, and 13% mentioned providing some form of post-investigation support.ConclusionsOur analysis is a preliminary assessment of the application of ethics principles reported within the recently published refugee health literature. From this analysis, we have proposed a list of best practices, which include stakeholder engagement, respect for cultural norms, and post-study support. Investigations conducted among refugees require additional diligence to ensure respect for and welfare of the participants. Development of a refugee-specific ethics framework with ethics and refugee health experts that addresses the need for stakeholder involvement, appropriate incentive use, protocol review, and considerations of cultural practices may help guide future investigations in this population.

Project description:BackgroundThe areas of Research Ethics (RE) and Research Integrity (RI) are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.MethodsThe search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.ResultsA total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction (45.4%), followed by exclusion from funding applications (35.5%).ConclusionsCase descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors.

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Considerations for ethics review of big data health research: A scoping review.

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Considerations for ethics review of big data health research: A scoping review.

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