Dataset Information

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

ABSTRACT:

Background

To date there is no established consensus of assessment criteria for evaluating research ethics review.

Methods

We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.

Results

Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.

Discussion

Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

SUBMITTER: Nicholls SG

PROVIDER: S-EPMC4520456 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

Nicholls Stuart G SG Hayes Tavis P TP Brehaut Jamie C JC McDonald Michael M Weijer Charles C Saginur Raphael R Fergusson Dean D

PloS one 20150730 7

<h4>Background</h4>To date there is no established consensus of assessment criteria for evaluating research ethics review.<h4>Methods</h4>We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de ...[more]

PMID: 26225553

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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: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.

Project description:BackgroundThe COVID-19 pandemic has presented many multi-faceted challenges to the maintenance of service quality and safety, highlighting the need for resilient and responsive healthcare systems more than ever before. This review examined empirical investigations of Resilient Health Care (RHC) in response to the COVID-19 pandemic with the aim to: identify key areas of research; synthesise findings on capacities that develop RHC across system levels (micro, meso, macro); and identify reported adverse consequences of the effort of maintaining system performance on system agents (healthcare workers, patients).MethodsThree academic databases were searched (Medline, EMBASE, Scopus) from 1st January 2020 to 30th August 2022 using keywords pertaining to: systems resilience and related concepts; healthcare and healthcare settings; and COVID-19. Capacities that developed and enhanced systems resilience were synthesised using a hybrid inductive-deductive thematic analysis.ResultsFifty publications were included in this review. Consistent with previous research, studies from high-income countries and the use of qualitative methods within the context of hospitals, dominated the included studies. However, promising developments have been made, with an emergence of studies conducted at the macro-system level, including the development of quantitative tools and indicator-based modelling approaches, and the increased involvement of low- and middle-income countries in research (LMIC). Concordant with previous research, eight key resilience capacities were identified that can support, develop or enhance resilient performance, namely: structure, alignment, coordination, learning, involvement, risk awareness, leadership, and communication. The need for healthcare workers to constantly learn and make adaptations, however, had potentially adverse physical and emotional consequences for healthcare workers, in addition to adverse effects on routine patient care.ConclusionsThis review identified an upsurge in new empirical studies on health system resilience associated with COVID-19. The pandemic provided a unique opportunity to examine RHC in practice, and uncovered emerging new evidence on RHC theory and system factors that contribute to resilient performance at micro, meso and macro levels. These findings will enable leaders and other stakeholders to strengthen health system resilience when responding to future challenges and unexpected events.

Project description:ObjectiveHealth-related research in sub-Saharan Africa (SSA) has grown over the years. However, concerns have been raised about the state of research ethics committees (RECs). This scoping review examines the literature on RECs for health-related research in SSA and identifies strategies that have been applied to strengthen the RECs. It focuses on three aspects of RECs: regulatory governance and leadership, administrative and financial capacity and technical capacity of members.DesignA scoping review of published literature, including grey literature, was conducted using the Joanna Briggs Institute approach.Data sourcesBioOne, CINAHL, Embase (via Ovid), Education Abstracts, Global Health, Google Scholar, Jstor, OpenEdition (French), Philosopher's Index, PsycINFO, PubMed, Science Citation and Expanded Index (Web of Science), reference lists of included studies and specific grey literature sources.Eligibility criteriaWe included empirical studies on RECs for health-related research in SSA, covering topics on REC leadership and governance, administrative and financial capacity and the technical capacity of REC members. We included studies published between 01 January 2000 and 18 February 2022 and written in English, French, Portuguese or Swahili.Data extraction and synthesisTwo independent reviewers screened the records. Data were extracted by one reviewer and cross-checked by another. Owing to the heterogeneity of included studies, thematic analysis was used.ResultsWe included 54 studies. The findings show that most RECs in SSA work under significant administrative and financial constraints, with few opportunities for capacity building for committee members. This has an impact on the quality of reviews and the overall performance of RECs. Although most countries have national governance systems for RECs, they lack regulations on accountability, transparency and monitoring of RECs.ConclusionsThis review provides a comprehensive overview of the literature on RECs for health-related research in SSA and contributes to our understanding of how RECs can be strengthened.

Dataset Information

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

Background

Methods

Results

Discussion

Publications

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

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