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235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms
OBJECTIVES/GOALS: To evaluate the clarity of plain-language informed consent forms (ICF) created using a browser-based tool called the ICF Navigator, we solicited feedback from two community review boards (CRB) to ensure the resulting ICF met the informational needs of all potential participants, in...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10129636/ http://dx.doi.org/10.1017/cts.2023.304 |
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author | Spencer, Nicola Bona, Jonathan Brochhausen, Mathias Caballero, Alison Gan, Jennifer M. Kemp, Aaron S. Miner, Skye Utecht, Joseph Whorton, Justin James, Laura |
author_facet | Spencer, Nicola Bona, Jonathan Brochhausen, Mathias Caballero, Alison Gan, Jennifer M. Kemp, Aaron S. Miner, Skye Utecht, Joseph Whorton, Justin James, Laura |
author_sort | Spencer, Nicola |
collection | PubMed |
description | OBJECTIVES/GOALS: To evaluate the clarity of plain-language informed consent forms (ICF) created using a browser-based tool called the ICF Navigator, we solicited feedback from two community review boards (CRB) to ensure the resulting ICF met the informational needs of all potential participants, including those with limited health literacy skills. METHODS/STUDY POPULATION: Community-engaged research highlights the importance of involving community members in the planning and execution of translational research projects. Virtual discussions were held to elicit feedback from two separate CRBs on the understandability of an ICF that was generated using an online, browser-based tool that we designed to aid researchers in the creation of plain-language ICFs. CRBs included representation of diverse communities from across the state of Arkansas, including individuals who may have limited health literacy skills, those with and without prior experience participating in clinical research projects, members living in rural and urban settings, and those whose race or ethnicity have been traditionally underrepresented among clinical research participants. RESULTS/ANTICIPATED RESULTS: CRB feedback was used to inform actionable improvements to the tool, such as removing content redundancies and embedding tips to guide researchers on how best to optimize the clarity and understandability of resulting ICFs. Program refinements in response to the feedback have been implemented and will be evaluated in another round of CRB discussions in early 2023. Feedback from this follow-up CRB session will also be presented in addition to a discussion of how the feedback was used to improve the online tool, which will ultimately be available for free use by other institutions. DISCUSSION/SIGNIFICANCE: The use of community feedback to optimize the functionality of the ICF Navigator demonstrates the value of CRBs for ensuring that ICFs are culturally salient and readily understandable by all potential research participants, particularly those who may have limited health literacy skills, thereby promoting more equitable opportunities for all. |
format | Online Article Text |
id | pubmed-10129636 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-101296362023-04-26 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms Spencer, Nicola Bona, Jonathan Brochhausen, Mathias Caballero, Alison Gan, Jennifer M. Kemp, Aaron S. Miner, Skye Utecht, Joseph Whorton, Justin James, Laura J Clin Transl Sci Health Equity and Community Engagement OBJECTIVES/GOALS: To evaluate the clarity of plain-language informed consent forms (ICF) created using a browser-based tool called the ICF Navigator, we solicited feedback from two community review boards (CRB) to ensure the resulting ICF met the informational needs of all potential participants, including those with limited health literacy skills. METHODS/STUDY POPULATION: Community-engaged research highlights the importance of involving community members in the planning and execution of translational research projects. Virtual discussions were held to elicit feedback from two separate CRBs on the understandability of an ICF that was generated using an online, browser-based tool that we designed to aid researchers in the creation of plain-language ICFs. CRBs included representation of diverse communities from across the state of Arkansas, including individuals who may have limited health literacy skills, those with and without prior experience participating in clinical research projects, members living in rural and urban settings, and those whose race or ethnicity have been traditionally underrepresented among clinical research participants. RESULTS/ANTICIPATED RESULTS: CRB feedback was used to inform actionable improvements to the tool, such as removing content redundancies and embedding tips to guide researchers on how best to optimize the clarity and understandability of resulting ICFs. Program refinements in response to the feedback have been implemented and will be evaluated in another round of CRB discussions in early 2023. Feedback from this follow-up CRB session will also be presented in addition to a discussion of how the feedback was used to improve the online tool, which will ultimately be available for free use by other institutions. DISCUSSION/SIGNIFICANCE: The use of community feedback to optimize the functionality of the ICF Navigator demonstrates the value of CRBs for ensuring that ICFs are culturally salient and readily understandable by all potential research participants, particularly those who may have limited health literacy skills, thereby promoting more equitable opportunities for all. Cambridge University Press 2023-04-24 /pmc/articles/PMC10129636/ http://dx.doi.org/10.1017/cts.2023.304 Text en © The Association for Clinical and Translational Science 2023 https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work. |
spellingShingle | Health Equity and Community Engagement Spencer, Nicola Bona, Jonathan Brochhausen, Mathias Caballero, Alison Gan, Jennifer M. Kemp, Aaron S. Miner, Skye Utecht, Joseph Whorton, Justin James, Laura 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms |
title | 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms |
title_full | 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms |
title_fullStr | 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms |
title_full_unstemmed | 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms |
title_short | 235 Use of Community Review Boards to Evaluate the Utility of the ICF Navigator - A Browser-based Tool to Create Plain-Language Informed Consent Forms |
title_sort | 235 use of community review boards to evaluate the utility of the icf navigator - a browser-based tool to create plain-language informed consent forms |
topic | Health Equity and Community Engagement |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10129636/ http://dx.doi.org/10.1017/cts.2023.304 |
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