Applying the new SABV (sex as a biological variable) policy to research and clinical care

Applying the new SABV (sex as a biological variable) policy to research and clinical care
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DOI:
10.1016/j.physbeh.2017.08.012
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发表时间:
2018-04-01
影响因子:
2.9
通讯作者:
Clayton, Janine Austin
Clayton, Janine Austin
中科院分区:
医学3区
文献类型:
--
作者:
Clayton, Janine Austin

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性别作为生物变量(SABV)是美国国立卫生研究院(NIH)新倡议的关键部分,旨在通过严格和透明来提高可重复性。SABV政策要求研究人员将性别因素纳入脊椎动物和人类研究的设计、分析和报告中。这项政策的实施是因为越来越明显的是,男女之间的差异远远超出了生殖和荷尔蒙问题。执行这项政策也是为了解决生物医学研究中不重视性别影响的问题。性别影响:细胞生理学、代谢和许多其他生物功能;疾病的症状和表现;以及对治疗的反应。例如,性在神经科学中有着深远的影响,从电路到生理学到疼痛感知。除了NIH为确保女性被纳入临床试验所做的努力之外,SABV政策还包括为临床研究提供信息的严格的临床前实验设计。此外,NIH还聘请期刊编辑和出版商,通过科学上适当的性别特异性研究结果报告来解决严谨性和提高透明度,以促进可重复性。研究中的性别和性别平等(SAGER)指南的制定是为了帮助研究人员和期刊编辑在出版物中报告性别和性别信息。
Sex as a biological variable (SABV) is a key part of the new National Institutes of Health (NIH) initiative to enhance reproducibility through rigor and transparency. The SABV policy requires researchers to factor sex into the design, analysis, and reporting of vertebrate animal and human studies. The policy was implemented as it has become increasingly clear that male/female differences extend well beyond reproductive and hormonal issues. Implementation of the policy is also meant to address inattention to sex influences in biomedical research. Sex affects: cell physiology, metabolism, and many other biological functions; symptoms and manifestations of disease; and responses to treatment. For example, sex has profound influences in neuroscience, from circuitry to physiology to pain perception. Extending beyond the robust efforts of NIH to ensure that women are included in clinical trials, the SABV policy also includes rigorous preclinical experimental designs that inform clinical research. Additionally, the NIH has engaged journal editors and publishers to facilitate reproducibility by addressing rigor and promoting transparency through scientifically appropriate sex-specific study results reporting. The Sex And Gender Equity in Research (SAGER) guidelines were developed to assist researchers and journal editors in reporting sex and gender information in publications [1].