Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania.
Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania.
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DOI：
10.1186/s13293-017-0139-5
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发表时间：
2017
影响因子：
7.9
通讯作者：
Epperson CN
中科院分区：
文献类型：
--
作者：
Freeman A;Stanko P;Berkowitz LN;Parnell N;Zuppe A;Bale TL;Ziolek T;Epperson CN
2015年美国国立卫生研究院（NIH）将性别视为生物变量（SABV）的政策现在是NIH资助同行评审过程的重要组成部分，并在几个高影响力的科学期刊上发表。我们试图确定宾夕法尼亚大学的生物医学研究人员在研究中考虑SABV或性别的程度。我们审查了2016年1月至7月期间连续提交的宾夕法尼亚大学研究审查委员会（IRB）批准的240项研究方案。检索每个方案的术语性别、性别、男性、女性、男性和女性以及与研究人群相关的理由。进行了PubMed检索，以确定关于方案主题的潜在性别和/或性别差异的当前知识状态。使用描述性统计量总结数据。在包含其中一个检索词的165份（68.8%）方案中，仅24份（14.5%）提供了选择研究人群性别的理由。百分之六十三（n = 151）的协议集中在主题的现存文献支持至少有适度的性别/性别差异在某些方面的障碍/条件正在研究。其中，只有3例（2.0%）患者表示研究者会考虑性别或性别对其主要结局的影响。对一家主要研究机构提交的IRB方案子集进行审查，结果表明，在方案制定阶段，很少有研究者将性别或性别视为其临床研究的重要变量。IRB在鼓励研究者考虑SABV和性别方面处于非常有利的地位，以提高研究设计的严谨性，最大限度地发挥所产生知识的重要性，并确保受试者选择的公平性。这些发现作为在IRB方案制定和提交水平制定干预措施的基础，将促进考虑SABV和/或性别，这些因素对患者安全性和干预措施有效性具有重要意义。
The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research. We reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016. Each protocol was searched for the terms sex, gender, male, female, man, and woman and justifications related to the population under study. A PubMed search was conducted to determine the current state of knowledge regarding potential sex and/or gender differences with respect to protocol topic. Data were summarized using descriptive statistics. Of the 165 (68.8%) protocols that included one of the search terms, only 24 (14.5%) provided justification for the choice of the sex/gender of the population studied. Sixty-three percent (n = 151) of the protocols focused on topics for which the extant literature supports at least a moderate degree of sex/gender differences in some aspect of the disorder/condition being studied. Of these, only three (2.0%) indicated that the investigator would consider sex or gender impact on their primary outcomes. Review of a subset of IRB protocols submitted at a major research institution suggests that very few investigators are considering sex or gender as important variables in their clinical research at the stage of protocol development. IRBs are in an excellent position to encourage investigators to consider SABV and gender in order to enhance the rigor of research design, maximize the importance of the resulting knowledge, and ensure that subject selection is equitable. These findings serve as the basis for developing an intervention at the level of IRB protocol development and submission that will promote consideration of SABV and/or gender, factors with critical import to patient safety and efficacy of interventions.