The ethical implications of gender bias in clinical research: a Narrative Review

dc.creatorQuinn, Quinceyen_US
dc.creatorTucker, Zacharyen_US
dc.creatorYockey, Andrewen_US
dc.creatorFulda, Kimberlyen_US
dc.description.abstractIntroduction: Sex bias in clinical research emerged in the 1960s after the 'thalidomide babies' incident, causing ethical concerns and a culture of abundance of caution. This led to the systematic exclusion of females, contributing to the exclusion of women as a gender identity. While sex bias has been extensively explored, gender bias merits separate consideration as gender bias affects the healthcare of an expanded group of individuals. Purpose: The purpose of this study was to conduct a narrative review on the ethical implications of gender bias in research with the following questions in mind: What are the implications of sex and gender bias in clinical research? What is the current landscape of gender bias in clinical research? Where can we improve consideration of sex and gender in clinical research to increase healthcare outcomes for women and those assigned female at birth? What are the participation differences in research by gender? What are barriers (social, economic, practical) to research by gender? Are there ethical implications to the inclusion/exclusion criteria for research participants by gender identity? Methods: A narrative review utilizing 8 databases (PUBMED, Scopus, CINAHL Complete, EBSCO host, APA Psych Info, Families Studies Abstract, MEDLINE Complete) from 2013 to August 2023 was performed. Search terms: “women OR woman OR female,” “research OR clinical research,” “sex bias or gender bias” and “underrepresent OR ethic OR equity.” 90 articles were reviewed by 3 researchers and evaluated for inclusion. A total of 45 articles were utilized for the final review. Results: In the analysis of five key questions, gender-related discussions were limited. The ethical implications of sex and gender bias in clinical research were acknowledged, emphasizing the need for ethical considerations related to sex bias, including varied safe doses, potential risks to pregnant individuals, and the impact on patient outcomes. The current landscape of gender bias in clinical research remained largely unaddressed, but insights into sex bias were provided, highlighting recent guidelines, disparities in representation, and the pervasive issue of sex bias across different specialties. Participation differences and barriers in research by gender were explored, with a focus on social, economic, and practical aspects. Barriers included education, economic stability, practical challenges, and researcher-imposed biases, affecting recruitment and retention. In addressing the ethical implications of inclusion/exclusion criteria based on gender identity, the study touched on the utility of studying transgender individuals due to hormone profiles, with one author recognizing the importance of the question. Conclusion: There is a need for education of the scientific community on the difference between gender and sex. The dataset gathered yielded limited information due to the inconsistent use of gendered and sex terms. More women need to be included in research both as participants and as authors to address gaps in professional development in academia and address the underpinnings of bias in the workforce. Further strategies to work towards equity include enforcing pre-existing guidelines, utilizing the participation-to-prevalence ratio, combating misinformation, and modifying inclusion criteria for greater inclusivity.en_US
dc.titleThe ethical implications of gender bias in clinical research: a Narrative Reviewen_US