Kraft Stephanie A, Rothwell Erin, Shah Seema K, Duenas Devan M, Lewis Hannah, Muessig Kristin, Opel Douglas J, Goddard Katrina A B, Wilfond Benjamin S
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington, USA
Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.
J Med Ethics. 2020 Oct 6. doi: 10.1136/medethics-2020-106440.
The ethical principle of 'respect for persons' in clinical research has traditionally focused on protecting individuals' autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals' rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English (n=30) or Spanish (n=10) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female (93%), identified as Hispanic/Latino(a) (43%) or non-Hispanic white (38%), reported annual household income under US$60 000 (70%) and did not have a Bachelor's degree (65%); 30% had limited health literacy. We identified four key domains for demonstrating respect: (1) personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; (2) study communication processes, including following up and sharing results with participants; (3) inclusion, particularly ensuring materials are understandable and procedures are accessible; and (4) consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research.
临床研究中“尊重人”的伦理原则传统上侧重于保护个人的自主权利，但对参与者的尊重还包括更广泛的伦理义务，尽管这些义务不太为人所理解，即关注个人的权利、需求、利益和感受。然而，关于如何有效地向潜在参与者和现有参与者表达尊重，几乎没有实证证据。为了填补这一空白，我们对一项临床基因组学实施研究的参与者进行了探索性的定性访谈。我们用英语（n = 30）或西班牙语（n = 10）采访了40名参与者，询问他们在研究中对尊重的体验，以及他们对假设的观察性研究中的研究人员如何表达尊重或缺乏尊重的看法。大多数受访者为女性（93%），自我认同为西班牙裔/拉丁裔（43%）或非西班牙裔白人（38%），报告的家庭年收入低于6万美元（70%），且没有学士学位（65%）；30%的人健康素养有限。我们确定了表达尊重的四个关键领域：（1）个人与研究团队的互动，重点是同理心、感激和不评判；（2）研究沟通流程，包括跟进并与参与者分享结果；（3）包容性，特别是确保材料易懂且程序可及；（4）同意和授权，包括提供中立的知情同意书并信守隐私保护承诺。虽然尊重的体验本质上是主观的，但这些发现突出了四个关键领域，这些领域可能对向潜在参与者和现有研究参与者表达尊重具有重要意义。需要进一步的实证和规范性工作来证实这些领域，并评估如何最好地将它们纳入研究实践。
