Perceived challenges in the informed consent process: Mismatches between enrollers and researchers at a South African clinical research site

Scott Megan; Watermeyer Jennifer; Nolle Samantha; Penn Claire

摘要

Abstract > Enrollers play a critical yet often overlooked role in clinical research, particularly in informed consent processes. Study retention may depend in part on how complex information is conveyed to potential participants. This?qualitative study aimed?to assess communicative barriers during consent and enrolment in two South African <fc>TB</fc> / <fc>HIV</fc> clinical studies. In particular, we compared our own perceptions of potential challenges to consent with that of thirteen enrollers, gained via reflective journaling and focus group discussions. Some overlap of identified challenges was evident, including terminology, jargon and consent document format. However there were mismatches to identified challenges. Enrollers provided further insights into potential challenges to consent, in particular, blood withdrawal, discussion of sexual issues and misunderstanding of study participation. Enrollers also reported feeling ill‐equipped to provide counselling when participants became distressed. We offer several recommendations for strengthening the inclusion of enrollers in the development of clinical research protocols and consent documents. </abstract> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> <div class="translation abstracttxt"> <span class="zhankaihshouqi fivelineshidden" id="abstract"> <span>机译：</span><Abstract Type =“Main”XML：ID =“DEWB12218-ABS-ABS-0001”XML：LANG =“EN”> <标题类型=“main”>抽象</ title> > 注册在临床研究中发挥着批判性，但在临床研究中，特别是在知情同意过程中的作用。研究保留可能部分取决于复杂信息如何传达给潜在参与者。这个定性研究旨在瞄准？在两个南非的同意和入学期间评估交际障碍 <FC> TB </ FC> / <FC> HIV </ FC> 临床研究。特别是，我们通过反思日记和焦点小组讨论获得了三十名注册所获得的十三名入学潜在挑战的看法。识别挑战的一些重叠是明显的，包括术语，术语和同意文件格式。然而，识别挑战存在不匹配。注册提供了进一步了解同意的潜在挑战，特别是血液撤离，对性问题讨论和研究参与的误解。报名者还报告了在参与者变得苦恼时提供咨询的感觉不佳。我们提供了若干建议，以加强在临床研究协议和同意文件发展中纳入入学人员。 </ p> </摘要> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> </div> <div class="record"> <h2 class="all_title" id="enpatent33" >著录项</h2> <ul> <li> <span class="lefttit">来源</span> <div style="width: 86%;vertical-align: text-top;display: inline-block;"> <a href='/journal-foreign-32947/'>《Developing world bioethics》</a> <b style="margin: 0 2px;">|</b><span>2019年第4期</span><b style="margin: 0 2px;">|</b><span>共9页</span> </div> </li> <li> <div class="author"> <span class="lefttit">作者</span> <p id="fAuthorthree" class="threelineshidden zhankaihshouqi"> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Scott Megan&option=202" target="_blank" rel="nofollow">Scott Megan;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Watermeyer Jennifer&option=202" target="_blank" rel="nofollow">Watermeyer Jennifer;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Nolle Samantha&option=202" target="_blank" rel="nofollow">Nolle Samantha;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Penn Claire&option=202" target="_blank" rel="nofollow">Penn Claire;</a> </p> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zkzz" style="display: none;">展开▼</span> </div> </li> <li> <div style="display: flex;"> <span class="lefttit">作者单位</span> <div style="position: relative;margin-left: 3px;max-width: 639px;"> <div class="threelineshidden zhankaihshouqi" id="fOrgthree"> </div> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zhdw" style="display: none;">展开▼</span> </div> </div> </li> <li > <span class="lefttit">收录信息</span> <span style="width: 86%;vertical-align: text-top;display: inline-block;"></span> </li> <li> <span class="lefttit">原文格式</span> <span>PDF</span> </li> <li> <span class="lefttit">正文语种</span> <span>eng</span> </li> <li> <span class="lefttit">中图分类</span> <span><a href="https://www.zhangqiaokeyan.com/clc/5696.html" title="医学伦理学">医学伦理学;</a></span> </li> <li class="antistop"> <span class="lefttit">关键词</span> <p style="width: 86%;vertical-align: text-top;"> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=clinical study&option=203" rel="nofollow">clinical study;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=clinical trial&option=203" rel="nofollow">clinical trial;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=enroller&option=203" rel="nofollow">enroller;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=informed consent&option=203" rel="nofollow">informed consent;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=qualitative research&option=203" rel="nofollow">qualitative research;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=South Africa&option=203" rel="nofollow">South Africa;</a> </p> <div class="translation"> 机译：临床研究;临床试验;注册;知情同意;定性研究;南非; </div> </li> </ul> </div> </div> <div class="literature cardcommon"> <div class="similarity "> <h3 class="all_title" 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Nyehn，Joyce Olenja，Leslie Swartz，Nora Groce Doi：10.19088 / 1968-2019.106 Abstract Pdfonline文章分层和链接研究合作伙伴关系：从您的世界研究中学习在埃塞俄比亚和尼泊尔Vicky Johnson，Anannia Admassu，安德鲁教堂的世界研究， JILL HEALELY，SUJETA MATHEMA DOI：10.19088 / 1968-2019.107抽象PDFONLINE文章在学术界政府伙伴关系中的基本挑战在冲突研究中埃塞俄比亚牧场的牧区牧场地区牧羊犬MULUGETA，宇瓦·塔利克（Ekal Nettir Doi：10.19088 / 1968-2019.108摘要PDFONLINE文章区域研究 - 健康股权和包容性发展的政策伙伴关系：关于南部非洲观点的机遇和挑战的思考</span> </p> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06130501148760.html">Method and system for managing electronic informed consent process in clinical trials</a> <b>[P]</b> . <span> 外国专利：  JP6976093B2 </span> <span> . 2021-12-08</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：在临床试验中管理电子知情知情同意过程的方法和系统 </span> </p> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" 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