scholarly journals Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Evelien De Sutter ◽  
Drieda Zaçe ◽  
Stefania Boccia ◽  
Maria Luisa Di Pietro ◽  
David Geerts ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mixed Methods ◽  
User Interface ◽  
Informed Consent ◽  
Systematic Reviews ◽  
Biomedical Research ◽  
Cross Sectional ◽  
Research Participants ◽  
Stakeholder Groups ◽  
Multiple Stakeholder

BACKGROUND Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. OBJECTIVE We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. METHODS We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. RESULTS A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. CONCLUSIONS Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

scholarly journals Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

10.2196/19129 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e19129
Author(s):  
Evelien De Sutter ◽  
Drieda Zaçe ◽  
Stefania Boccia ◽  
Maria Luisa Di Pietro ◽  
David Geerts ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mixed Methods ◽  
User Interface ◽  
Informed Consent ◽  
Systematic Reviews ◽  
Biomedical Research ◽  
Cross Sectional ◽  
Research Participants ◽  
Stakeholder Groups ◽  
Multiple Stakeholder

Background Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. Objective We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. Methods We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. Results A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. Conclusions Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

scholarly journals Barriers and facilitators to implementing clinical imaging guidelines by healthcare professionals using theoretical domains framework: a mixed-methods systematic review protocol

BJR|Open ◽  
2021 ◽  
Vol 3 (1) ◽  
pp. 20210004
Author(s):  
Harriet Nalubega Kisembo ◽  
Ritah Nassanga ◽  
Faith Ameda Ameda ◽  
Moses Ocan ◽  
Alison A Kinengyere ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mixed Methods ◽  
Systematic Reviews ◽  
Financial Incentives ◽  
Healthcare Professionals ◽  
Information Source ◽  
Theoretical Domains Framework ◽  
Barriers And Facilitators ◽  
Cochrane Library ◽  
Clinical Imaging

Objectives: To identify, categorize, and develop an aggregated synthesis of evidence using the theoretical domains framework (TDF) on barriers and facilitators that influence implementation of clinical imaging guidelines (CIGs) by healthcare professionals (HCPs) in diagnostic imaging Methods: The protocol will be guided by the Joanna Briggs Institute Reviewers’ Manual 2014. Methodology for JBI Mixed Methods Systematic Reviews and will adhere to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA-P). Information source will include databases (MEDLINE, EMBASE and The Cochrane Library), internet search (https://www.google.com/scholar), experts’ opinion, professional societies/organizations websites and government bodies strategies/recommendations, and reference lists of included studies. Articles of any study design published in English from 1990 to date, having investigated factors operating as barriers and/or facilitators to the implementation CIGs by HCPs will be eligible. Selecting, appraising, and extracting data from the included studies will be independently performed by at least two reviewers using validated tools and Rayyan – Systematic Review web application. Disagreements will be resolved by consensus and a third reviewer as a tie breaker. The aggregated studies will be synthesized using thematic analysis guided by TDF. Results: Identified barriers will be defined a priori and mapped into 7 TDF domains including knowledge, awareness, effectiveness, time, litigationand financial incentives Conclusion: The results will provide an insight into a theory-based approach to predict behavior-related determinants for implementing CIGs and develop strategies/interventions to target the elicited behaviors. Recommendations will be made if the level of evidence is sufficient Advances in knowledge: Resource-constrained settings that are in the process of adopting CIGs may opt for this strategy to predict in advance likely impediments to achieving the goal of CIG implementation and develop tailored interventions during the planning phase. Systematic review Registration: PROSPERO ID = CRD42020136372 (https://www.crd.york.ac.uk/PROSPERO).

scholarly journals Methods of conduct and reporting of living systematic reviews: a protocol for a living methodological survey

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 221 ◽  
Author(s):  
Assem M. Khamis ◽  
Lara A. Kahale ◽  
Hector Pardo-Hernandez ◽  
Holger J. Schünemann ◽  
Elie A. Akl
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Evidence Synthesis ◽  
Cochrane Library ◽  
Cross Sectional Survey ◽  
Systematic Review Methodology ◽  
Cross Sectional ◽  
Prospective Longitudinal ◽  
Over Time

Background: The living systematic review (LSR) is an emerging approach for improved evidence synthesis that uses continual updating to include relevant new evidence as soon as it is published. The objectives of this study are to: 1) assess the methods of conduct and reporting of living systematic reviews using a living study approach; and 2) describe the life cycle of living systematic reviews, i.e., describe the changes over time to their methods and findings. Methods: For objective 1, we will begin by conducting a cross-sectional survey and then update its findings every 6 months by including newly published LSRs. For objective 2, we will conduct a prospective longitudinal follow-up of the cohort of included LSRs. To identify LSRs, we will continually search the following electronic databases: Medline, EMBASE and the Cochrane library. We will also contact groups conducting LSRs to identify eligible studies that we might have missed. We will follow the standard systematic review methodology for study selection and data abstraction. For each LSR update, we will abstract information on the following: 1) general characteristics, 2) systematic review methodology, 3) living approach methodology, 4) results, and 5) editorial and publication processes. We will update the findings of both the surveys and the longitudinal follow-up of included LSRs every 6 months. In addition, we will identify articles addressing LSR methods to be included in an ‘LSR methods repository’. Conclusion: The proposed living methodological survey will allow us to monitor how the methods of conduct, and reporting as well as the findings of LSRs change over time. Ultimately this should help with ensuring the quality and transparency of LSRs.

scholarly journals Binge drinking in young people: protocol for a systematic review of neuropsychological, neurophysiological and neuroimaging studies

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e023629 ◽  
Author(s):  
Briana Lees ◽  
Louise Mewton ◽  
Lexine Stapinski ◽  
Lindsay M Squeglia ◽  
Caroline Rae ◽  
...  
Keyword(s):  
Systematic Review ◽  
Alcohol Use ◽  
Young People ◽  
Binge Drinking ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Primary Data ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
The Impact

IntroductionBinge drinking is the most common pattern of alcohol use among young people in Western countries. Adolescence and young adulthood is a vulnerable developmental period and binge drinking during this time has a higher potential for neurotoxicity and interference with ongoing neural and cognitive development. The purpose of this systematic review will be to assess and integrate evidence of the impact of binge drinking on cognition, brain structure and function in youth aged 10–24 years. Cross-sectional studies will synthesise the aberrations associated with binge drinking, while longitudinal studies will distinguish the cognitive and neural antecedents from the cognitive and neural effects that are a consequence of binge drinking.Methods and analysisA total of five peer-reviewed databases (PubMed, EMBASE, Medline, PsychINFO, ProQuest) will be systematically searched and the search period will include all studies published prior to 1 April 2018. The search terms will be a combination of MeSH keywords that are based on previous relevant reviews. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and study quality will be assessed using The Grades of Recommendation, Assessment, Development and Evaluation approach. All studies will be screened against eligibility criteria designed to synthesise studies that examined a young binge drinking sample and used neuropsychological, neurophysiological or neuroimaging assessment techniques. Studies will be excluded if participants were significantly involved in other substances or if they had been clinically diagnosed with an alcohol use disorder, or any psychiatric, neurological or pharmacological condition. If available data permits, a meta-analysis will be conducted.Ethics and disseminationFormal ethics approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, conference presentations and social media.Trial registration numberInternational Prospective Register for Systematic Reviews (PROSPERO) number: CRD42018086856.

In Defense of Broad Consent

2011 ◽  
Vol 21 (1) ◽  
pp. 40-50 ◽  
Author(s):  
GERT HELGESSON
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Broad Consent ◽  
Human Beings ◽  
Personal Integrity ◽  
Research Participants ◽  
Ethical Requirement

Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants.

scholarly journals Epidemiology and Reporting Characteristics of Systematic Reviews of Biomedical Research: A Cross-Sectional Study

PLoS Medicine ◽  
2016 ◽  
Vol 13 (5) ◽  
pp. e1002028 ◽  
Author(s):  
Matthew J. Page ◽  
Larissa Shamseer ◽  
Douglas G. Altman ◽  
Jennifer Tetzlaff ◽  
Margaret Sampson ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Biomedical Research ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional

scholarly journals Social Outcomes Contracting (SOC) in Social Programmes and Public Services: A Mixed-Methods Systematic Review Protocol

2021 ◽  
Vol 4 ◽  
pp. 1-21
Author(s):  
Vanessa Picker ◽  
Eleanor Carter ◽  
Mara Airoldi ◽  
James Ronicle ◽  
Rachel Wooldridge ◽  
...  
Keyword(s):  
Social Sciences ◽  
Systematic Review ◽  
Mixed Methods ◽  
Systematic Reviews ◽  
Population Characteristics ◽  
Social Outcomes ◽  
Synthesis Process ◽  
Systematic Review Protocol ◽  
Starting Point ◽  
Review Protocol

Background: Across a range of policy areas and geographies, governments and philanthropists are increasingly looking to adopt a social outcomes contracting (SOC) approach. Under this model, an agreement is made that a provider of services must achieve specific, measurable social and/or environmental outcomes and payments are only made when these outcomes have been achieved. Despite this growing interest, there is currently a paucity of evidence in relation to the tangible improvement in outcomes associated with the implementation of these approaches. Although promising, evidence suggests that there are risks (especially around managing perverse incentives).[1] The growing interest in SOC has been accompanied by research of specific programmes, policy domains or geographies, but there has not been a systematic attempt to synthetise this emerging evidence. To address this gap, this systematic review aims to surface the best evidence on when and where effects have been associated with SOC.  Methods: This mixed-methods systematic review protocol has been prepared using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines (Additional File 2) (Shamseer et al., 2010). The review aims to consult policymakers throughout the evidence synthesis process, by adopting a user-involved research process. This will include the establishment and involvement of a Policy Advisory Group (PAG). The PAG will consist of a large, diverse, international group of policy makers who are or have been actively involved in funding and shaping social outcomes contracts (Additional File 3). The following electronic databases will be searched: ABI/INFORM Global, Applied Social Sciences Index & Abstracts (ASSIA), Scopus, International Bibliography of the Social Sciences (IBSS), PAIS Index, PolicyFile Index, Proquest Dissertations and Theses, ProQuest Social Science, Social Services Abstracts, Web of Science, Worldwide Political Science Abstracts and PsycINFO. We will also conduct a comprehensive search of grey literature sources. Studies will be imported into Covidence and screened (after de-duplication) independently by two reviewers, using explicit inclusion/exclusion criteria. We will conduct risk of bias and quality assessment using recommended tools and we will extract data using a pre-piloted, standardised data extraction form. If meta-synthesis cannot be conducted for the effectiveness component, we will carry out a descriptive narrative synthesis of the quantitative evidence, categorised by type of intervention, type of outcome/s, population characteristics and/or policy sector. The qualitative studies will be synthesised using thematic content analysis (Thomas and Harden 2008). If possible, we will also analyse the available economic data to understand the costs and benefits associated with SOC. Finally, we will conduct a cross-study synthesis, which will involve bringing together the findings from the effectiveness review, economic review and qualitative review. We recognise that the proposed conventional effectiveness review method may lead to inconclusive or partial findings given the complexity of the intervention, the likely degree of heterogeneity and the under-developed evidence base. We see a traditional systematic review as an important foundation to describe the evidence landscape. We will use this formal review as a starting point and then explore more contextually rooted review work in future. Discussion: We will use the systematic review findings to produce accessible and reliable empirical insights on whether, when, and where (and if possible, how) SOC approaches deliver improved impact when compared to more conventional funding arrangements. The outputs will support policymakers to make informed decisions in relation to commissioning and funding approaches. Systematic   review   registration: This   systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO), on 20th November 2020 and was last updated on 21 January 2021: (registration number PROSPERO CRD42020215207). [1] A perverse incentive in an outcomes-based contract is an incentive that has unintended and undesirable results. For instance, a poorly designed welfare-to-work scheme could create incentives for service providers to prioritise clients who are easier to help and to ‘park’ those who are harder to assist (NAO 2015).

scholarly journals Primary care integration of sexual and reproductive health services for chlamydia testing across WHO-Europe: a systematic review

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031644 ◽  
Author(s):  
Harumi Quezada-Yamamoto ◽  
Elizabeth Dubois ◽  
Nikolaos Mastellos ◽  
Salman Rawaf
Keyword(s):  
Systematic Review ◽  
Primary Care ◽  
Mixed Methods ◽  
Reproductive Health ◽  
The Netherlands ◽  
Sexual And Reproductive Health ◽  
Critical Appraisal ◽  
Case Control ◽  
Cross Sectional ◽  
Chlamydia Testing

ObjectiveTo identify current uptake of chlamydia testing (UCT) as a sexual and reproductive health service (SRHS) integrated in primary care settings of the WHO European region, with the aim to shape policy and quality of care.DesignSystematic review for studies published from January 2001 to May 2018 in any European language.Data sourcesOVID Medline, EMBASE, Maternal and Infant Care and Global Health.Eligibility criteriaPublished studies, which involved women or men, adolescents or adults, reporting a UCT indicator in a primary care within a WHO European region country. Study designs considered were: randomised control trials (RCTs), quasi-experimental, observational (eg, cohort, case–control, cross-sectional) and mixed-methods studies as well as case reports.Data extraction and synthesisTwo independent reviewers screened the sources and validated the selection process. The BRIGGS Critical Appraisal Checklist for Analytical Cross-Sectional Studies, the Mixed Methods Appraisal Tool 2011 and Critical Appraisal Skills Programme (CASP) checklists were considered for quality and risk of bias assessment.Results24 studies were finally included, of which 15 were cross-sectional, 4 cohort, 2 RCTs, 2 case–control studies and 1 mixed-methods study. A majority of the evidence cites the UK model, followed by the Netherlands, Denmark, Norway and Belgium only. Acceptability if offered test in primary healthcare (PHC) ranged from 55% to 81.4% in women and from 9.5% to 70.6% when both genders were reported together. Men may have a lower UCT compared with women. When both genders were reported together, the lowest acceptability was 9.5% in the Netherlands. Denmark presented the highest percentage of eligible people who tested in a PHC setting (87.3%).ConclusionsDifferent health systems may influence UCT in PHC. The regional use of a common testing rate indicator is suggested to homogenise reporting. There is very little evidence on integration of SRHS such as chlamydia testing in PHC and there are gaps between European countries.

scholarly journals Heritability of glaucoma and glaucoma-related endophenotypes: systematic review and meta-analysis protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e019049 ◽  
Author(s):  
Nigus Gebrmedhin Asefa ◽  
Anna Neustaeter ◽  
Nomdo M Jansonius ◽  
Harold Snieder
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Vision Loss ◽  
Assessment Tool ◽  
Open Angle Glaucoma ◽  
Meta Analysis ◽  
Scientific Journal ◽  
Secondary Data ◽  
Cross Sectional ◽  
Age Related

IntroductionGlaucoma is the second leading cause of age-related vision loss worldwide; it is an umbrella term that is used to describe a set of complex ocular disorders with a multifactorial aetiology. Both genetic and lifestyle risk factors for glaucoma are well established. Thus far, however, systematic reviews on the heritability of glaucoma have focused on the heritability of primary open-angle glaucoma only. No systematic review has comprehensively reviewed or meta-analysed the heritability of other types of glaucoma, including glaucoma-related endophenotypes. The aim of this study will be to identify relevant scientific literature regarding the heritability of both glaucoma and related endophenotypes and summarise the evidence by performing a systematic review and meta-analysis.Methods and analysisThis systematic review will follow the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols 2015 checklist, which provides a standardised approach for carrying out systematic reviews. To capture as much literature as possible, a comprehensive step-by-step systematic search will be undertaken in MEDLINE (PubMed), EMBASE, Web of Science and ScienceDirect, and studies published until 31 December 2017 will be included. Two reviewers will independently search the articles for eligibility according to predefined selection criteria. A database will be used for screening of eligible articles. The quality of the included studies will be rated independently by two reviewers, using the National Health Institute Quality Assessment tool for Observational Cohort and Cross-Sectional Studies. A random-effects model will be used for the meta-analysis. This systematic review is registered with the International Prospective Register of Systematic Reviews with a registration number: CRD42017064504.Ethics and disseminationWe will use secondary data from peer-reviewed published articles, and hence there is no requirement for ethics approval. The results of this systematic review will be disseminated through publication in a peer-reviewed scientific journal.

Editorial

2006 ◽  
Vol 3 (5) ◽  
Author(s):  
Tade M Spranger
Keyword(s):  
Informed Consent ◽  
Case Studies ◽  
Biomedical Research ◽  
Genetic Research ◽  
Research Participants ◽  
Legal Questions

AbstractBiomedical research raises manifold ethical and legal questions. Matthew Rimmer's article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. He focuses upon several case studies like

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