醫學研究性別考量之國際進展及我國指引建置

International Progress and National Guidelines for Sex and Gender Considerations in Medical Research

生理性別(sex)與社會性別(gender)為不同概念，皆與人體健康及疾病有密切閼係，然而過去的科學研究，往往未將性別因素納入考量，未具科學基礎之篩選與忽略，可能減損科研品質丶阻礙對不同性別健康照護的發展，亦可能加劇健康不平等之問題。自1990年代超，美國、加拿大、歐盟等科研贊助機構皆陸續發展相關因應策略；國際期刊也逐漸重視此問題並提出相關指引。我國2016年由國科會率先修正其「補助專題研究計畫作業要點」，要求涉及臨床試臉之計畫進行性別分析，2020年以降，國科會生科處、國科會人文處、與衛生福利部食品菓物管理署等，亦陸續發展促進性別考量之相鬧政策與指引。本文介紹美國和加拿大相闕政策發展、國際期刊針對性別考量之建議挂引、我國相關政策進展，最後簡介國科會生科處「促進研究中的性別考量參考指引」。

Sex and gender are different concepts, and both closely related to human health and diseases. In the scientific community, however, sex and gender have long been under-researched. To exclude and omit a particular population or demographic character without a scientific basis might hinder the development of optimal healthcare for both women and men, compromise the quality of research, and aggravate health inequity. Since 1990, principal research grants agencies in the United States, Canada, and the European Union have developed strategies responsive to the above situations. International journal editors have also paid more attention to this issue and formulated relevant guidelines. In Taiwan, the National Science and Technology Council (NSTC) has amended its project funding policies since 2016, requiring the applicant to conduct sex/gender analysis if the project involves clinical trials. Since 2020, the Department of Life Sciences of NSTC, the Department of Humanities and Social Sciences of NSTC, and the Taiwan Food and Drug Administration have all made an effort to develop policies and guidelines to promote sex/gender considerations in research. In this article, we first reviewed the history of relevant policies established in the United States and Canada, the recommendations and guidelines for sex and gender considerations in the international journals, and the current status in Taiwan. Finally, we proposed a draft guideline,“Promoting Sex and Gender Considerations in Research,”for researchers as a reference.