Cottingham Marci D, Fisher Jill A
University of Amsterdam.
University of North Carolina - Chapel Hill.
Soc Probl. 2022 May;69(2):492-509. doi: 10.1093/socpro/spaa035. Epub 2020 Oct 11.
Despite the importance of including diverse populations in biomedical research, women remain underrepresented as healthy volunteers in the testing of investigational drugs in Phase I trials. Contributing significantly to this are restrictions that pharmaceutical companies place on the participation of women of so-called childbearing potential. These restrictions have far-reaching effects on biomedical science and the public health of women. Using 191 interviews collected over 3 years, this article explores the experiences of 47 women who navigate restrictions on their participation in U.S. Phase I trials. Women in this context face a number of contradictory criteria when trying to enroll, which can curtail their participation, justify additional surveillance, and deny pregnant women reproductive agency. The pharmaceutical industry's putative protections for hypothetical fetuses exacerbate inequalities and attenuate a thorough investigation of the safety of their drugs for public consumption. We use the framework of "anticipatory motherhood" within a gendered organizations approach to make sense of women's experiences in this context.
尽管在生物医学研究中纳入多样化人群很重要,但在一期试验中,女性作为健康志愿者参与研究性药物测试的比例仍然很低。制药公司对所谓具有生育潜力的女性参与试验的限制是造成这一现象的重要原因。这些限制对生物医学科学和女性公共健康产生了深远影响。本文通过对三年间收集的191份访谈进行分析,探讨了47名女性在美国一期试验中突破参与限制的经历。在这种情况下,女性在尝试报名时面临许多相互矛盾的标准,这可能会减少她们的参与机会,为额外的监测提供理由,并剥夺孕妇的生育自主权。制药行业对假设中的胎儿的所谓保护加剧了不平等,并削弱了对其供公众消费的药物安全性的全面调查。我们运用性别化组织方法中的“预期母亲身份”框架来理解女性在这种情况下的经历。