Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Department of Global Health, University of Washington, Seattle, Washington, USA.
Reprod Health. 2017 Dec 14;14(Suppl 3):160. doi: 10.1186/s12978-017-0424-0.
The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women's access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women's continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman's decision; however, many reported that they deferred to their male partner's opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner's permission, while a few men believed participation was ultimately a woman's decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women's autonomy while accommodating partner engagement.
将孕妇排除在健康研究之外仍然是一个全球性的重大挑战。在那些文化传统和性别规范普遍支持限制妇女决策角色的环境中，人们对男性伴侣在怀孕期间对将妇女纳入研究的态度知之甚少。了解这种文化背景下男性和女性的期望，为参与和解决当地的伦理问题提供了机会，以改善妇女在怀孕期间参与研究的机会，并加强干预措施的制定。本文介绍了一项定性研究伦理案例研究，该研究来自肯尼亚的暴露前预防 (PrEP) 合作伙伴示范项目，涉及男性伴侣在怀孕期间继续使用 PrEP 的决策中的作用。PrEP 是一种有效的艾滋病毒预防工具；然而，由于孕妇被排除在早期 PrEP 临床试验之外，因此怀孕期间的安全性和有效性数据有限。鉴于艾滋病毒感染率持续居高不下，一些孕妇现在正在接受 PrEP 或参与 PrEP 研究。我们研究中的男性和女性同样担心 PrEP 对胎儿的健康风险，并依赖医疗保健提供者的指导来了解这些风险。由于示范项目招募了夫妇，因此许多女性在怀孕期间继续使用 PrEP 的隐含社会期望是与男性伴侣协商。一些女性报告说，同意参与完全是女性的决定；然而，许多女性报告说，她们在决策过程中听从了男性伴侣的意见和支持。大多数男性伴侣认为，没有伴侣的许可，妇女不应该参与研究；然而，也有少数男性认为，参与最终是妇女的决定。我们认为，关系自主权可以为知情同意提供一个中间立场，既促进妇女的自主权，又能兼顾伴侣的参与。
