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Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting

BACKGROUND: Electronic approaches are becoming more widely used to obtain informed consent for research participation. Electronic consent (e-consent) provides an accessible and versatile approach to the consenting process, which can be enhanced with audio-visual and interactive features to improve p...

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Autores principales: Skelton, Emily, Drey, Nicholas, Rutherford, Mary, Ayers, Susan, Malamateniou, Christina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/
https://www.ncbi.nlm.nih.gov/pubmed/32979650
http://dx.doi.org/10.1016/j.ijmedinf.2020.104271
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author Skelton, Emily
Drey, Nicholas
Rutherford, Mary
Ayers, Susan
Malamateniou, Christina
author_facet Skelton, Emily
Drey, Nicholas
Rutherford, Mary
Ayers, Susan
Malamateniou, Christina
author_sort Skelton, Emily
collection PubMed
description BACKGROUND: Electronic approaches are becoming more widely used to obtain informed consent for research participation. Electronic consent (e-consent) provides an accessible and versatile approach to the consenting process, which can be enhanced with audio-visual and interactive features to improve participant engagement and comprehension of study procedures. Best practice guidance underpinned by ethical principles is required to ensure effective implementation of e-consent for use in research. AIM: To identify the key considerations for successful and ethical implementation of e-consent in the recruitment of participants to research projects which are conducted remotely. METHODS: Electronic database searches of CINAHL, Medline, Embase, DARE, HTA, PubMed, the Cochrane Library, Scopus, Web of Science, NHS Evidence, and hand-searches of reference lists were performed. Primary research studies of adult (≥ 18 years old) research participants using e-consent, published in English language, peer-reviewed journals between 2010−2020 were eligible for inclusion. RESULTS: Of the initial 665 identified studies, 18 met the inclusion criteria: 6 cohort studies, 5 qualitative studies, 4 randomised control trials, 2 mixed-methods studies and one case-control study. Critical appraisal of included studies using Critical Appraisal Skills Program (CASP) tools suggested a low to moderate risk of bias in most studies (n = 15). Key practice recommendations for researchers using e-consent were identified around five primary themes: 1) accessibility and user-friendliness of e-consent, 2) user engagement and comprehension, 3) customisability to participant preferences and demographics, 4) data security and 5) impact on research teams. CONCLUSION: E-consenting approaches are generally well received by participants, with most studies reporting user-friendly interfaces and sufficient participant comprehension of consenting documentation. IMPLICATIONS FOR PRACTICE: E-consent may facilitate remotely-conducted research by offering a feasible and robust alternative to face-to-face consenting approaches, however paper-based options should still be offered, based on participant preference. Customising e-consenting platforms may improve accessibility for individuals with specific needs, and increase engagement with study information. Research teams must offer prospective participants opportunities to discuss study information in real-time.
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spelling pubmed-74872052020-09-14 Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting Skelton, Emily Drey, Nicholas Rutherford, Mary Ayers, Susan Malamateniou, Christina Int J Med Inform Article BACKGROUND: Electronic approaches are becoming more widely used to obtain informed consent for research participation. Electronic consent (e-consent) provides an accessible and versatile approach to the consenting process, which can be enhanced with audio-visual and interactive features to improve participant engagement and comprehension of study procedures. Best practice guidance underpinned by ethical principles is required to ensure effective implementation of e-consent for use in research. AIM: To identify the key considerations for successful and ethical implementation of e-consent in the recruitment of participants to research projects which are conducted remotely. METHODS: Electronic database searches of CINAHL, Medline, Embase, DARE, HTA, PubMed, the Cochrane Library, Scopus, Web of Science, NHS Evidence, and hand-searches of reference lists were performed. Primary research studies of adult (≥ 18 years old) research participants using e-consent, published in English language, peer-reviewed journals between 2010−2020 were eligible for inclusion. RESULTS: Of the initial 665 identified studies, 18 met the inclusion criteria: 6 cohort studies, 5 qualitative studies, 4 randomised control trials, 2 mixed-methods studies and one case-control study. Critical appraisal of included studies using Critical Appraisal Skills Program (CASP) tools suggested a low to moderate risk of bias in most studies (n = 15). Key practice recommendations for researchers using e-consent were identified around five primary themes: 1) accessibility and user-friendliness of e-consent, 2) user engagement and comprehension, 3) customisability to participant preferences and demographics, 4) data security and 5) impact on research teams. CONCLUSION: E-consenting approaches are generally well received by participants, with most studies reporting user-friendly interfaces and sufficient participant comprehension of consenting documentation. IMPLICATIONS FOR PRACTICE: E-consent may facilitate remotely-conducted research by offering a feasible and robust alternative to face-to-face consenting approaches, however paper-based options should still be offered, based on participant preference. Customising e-consenting platforms may improve accessibility for individuals with specific needs, and increase engagement with study information. Research teams must offer prospective participants opportunities to discuss study information in real-time. Elsevier B.V. 2020-11 2020-09-13 /pmc/articles/PMC7487205/ /pubmed/32979650 http://dx.doi.org/10.1016/j.ijmedinf.2020.104271 Text en © 2020 Elsevier B.V. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Skelton, Emily
Drey, Nicholas
Rutherford, Mary
Ayers, Susan
Malamateniou, Christina
Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
title Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
title_full Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
title_fullStr Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
title_full_unstemmed Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
title_short Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting
title_sort electronic consenting for conducting research remotely: a review of current practice and key recommendations for using e-consenting
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/
https://www.ncbi.nlm.nih.gov/pubmed/32979650
http://dx.doi.org/10.1016/j.ijmedinf.2020.104271
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