How the CIOMS guidelines contribute to fair inclusion of pregnant women in research

van der Graaf Rieke; van der Zande Indira S. E.; van Delden Johannes J. M.

摘要

Abstract > As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. </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 =“Bioe12520-Abs-Abs-0001”XML：Lang =“en”> <标题类型=“main”>抽象</ title> > 早在2002年，CIOMS表示应该推定孕妇有资格参加研究。尽管有这种职位和其他公认的组织的呼唤，但研究中孕妇的健康需求仍然严重遭受了高度的研究。尽管资格的推定保持不变，但2002 CIOM的修订涉及人类受试者的生物医学研究的国际道德准则</ i> 涉及对孕妇和相关指南的研究指导，例如公平包容和脆弱性的研究。然而，密切阅读指南揭示了与公平包含孕妇和其他非代表性群体的不同途径，例如儿童和无能为准。否则CIOMS列出了儿童和青少年，除非一个良好的科学理由证明他们的排斥证明，没有这样的权利要求出现在孕妇的指导方针中出现了任何证明排除。相反，CIOM声称必须促进与孕妇健康有关的研究。本文分析了如何以及在多大程度上以及在何种范围内与文档公平纳入的其他指导不同。因此，本文评估了当前措辞的程度可能有助于公平纳入研究中的孕妇。我们将得出结论，对学习卫生系统的系统改变对于在怀孕期间分解药物使用领域的知识生成的现状至关重要，并争辩说CIOM指南允许该系统发生变化。 </ 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-14793/'>《Bioethics》</a> <b style="margin: 0 2px;">|</b><span>2019年第3期</span><b style="margin: 0 2px;">|</b><span>共7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=van der Graaf Rieke&option=202" target="_blank" rel="nofollow">van der Graaf Rieke;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=van der Zande Indira S. E.&option=202" target="_blank" rel="nofollow">van der Zande Indira S. E.;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=van Delden Johannes J. M.&option=202" target="_blank" rel="nofollow">van Delden Johannes J. M.;</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"> <p>Julius Center for Health Sciences and Primary CareUniversity Medical Center UtrechtUtrecht Netherlands;</p> <p>Julius Center for Health Sciences and Primary CareUniversity Medical Center UtrechtUtrecht Netherlands;</p> <p>Medical CentreUtrecht UniversityUtrecht Netherlands;</p> </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/15.html" title="生物科学">生物科学;</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=CIOMS guidelines&option=203" rel="nofollow">CIOMS guidelines;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=learning health systems&option=203" rel="nofollow">learning health systems;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=pregnant women&option=203" rel="nofollow">pregnant women;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=research ethics&option=203" rel="nofollow">research ethics;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=vulnerability&option=203" rel="nofollow">vulnerability;</a> </p> <div class="translation"> 机译：CIOM指南;学习卫生系统;孕妇;研究道德;脆弱性; </div> </li> </ul> </div> </div> <div class="literature cardcommon"> <div class="similarity "> <h3 class="all_title" id="enpatent66">相似文献</h3> <div class="similaritytab clearfix"> <ul> <li class="active" >外文文献</li> <li >中文文献</li> <li >专利</li> </ul> </div> <div class="similarity_details"> <ul > <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/journal-foreign-detail/0704021837671.html">How the CIOMS guidelines contribute to fair inclusion of pregnant women in research</a> <b>[J]</b> . <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=van der Graaf Rieke&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">van der Graaf Rieke,</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=van der Zande Indira S. 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