Respect for Persons in the Genomics Research Enrollment Process: Incorporating Diverse Experiences and Attitudes

项目摘要/摘要 候选人：斯蒂芬妮·克拉夫特，JD，儿科生物伦理学系代理讲师， 华盛顿大学医学院。她拥有法律和经济学背景，并已完成 斯坦福生物医学伦理学中心和特鲁曼·卡茨中心生物伦理学博士后奖学金 西雅图儿童医院和研究所的儿科生命伦理学。她之前的工作包括混合 方法与知情同意和遗传学的伦理、法律和社会影响(ELSI)相关的研究 和基因组学。在这个职业发展奖中，她将在定性研究方面进一步发展专业知识， 包括深思熟虑的利益相关者参与技巧，并加强她的干预技能 发展和评估，包括生物统计分析。她还将在以下方面积累主题专业知识 研究伦理和知情同意，特别是在涉及基因组学研究日益多样化的情况下。 她的长期职业目标是成为一名独立调查员，建立支持纳入的实用工具 在研究中对不同的患者群体进行研究，以最终减少健康差距。到年底的时候 在获奖期内，她计划已成功获得R01资金，以继续该项目的工作。 环境：克拉夫特得到了西雅图儿童中心特鲁曼·卡茨中心的机构支持 华盛顿大学和翻译健康科学研究所，所有这些都提供了重要的 学术和研究资源，将支持她的职业发展和研究成功。在……里面 此外，她强大的导师和咨询团队包括研究伦理和知情同意方面的专家， 以及一系列的方法技能和观点，将在计划的所有阶段支持她 研究。克拉夫特的主要导师是医学博士本杰明·威尔方德，他在 研究伦理、知情同意和混合方法研究。她的共同导师是Erin Rothwell博士和 ELSI基因组学和定性研究方面的专家，以及研究伦理学和 知情同意理论。项目顾问道格拉斯·欧佩尔，医学博士，公共卫生硕士和卡特里娜·戈达德博士将提供 在干预措施的制定和评估方面的其他专门知识和指导。 研究：这项拟议的项目将确定和评估尊重潜在客户的方式 来自不同背景的研究参与者。目标1将定性地检查以下背景和价值观 告知参与者对注册的尊重和决定。目标2将使用深思熟虑 确定具体方式以显示对潜在参与者的尊重的技术。AIM 3将选择一个 干预和评估其对嵌入在正在进行的临床中的可行性研究的尊重和信任的效果 审判。该项目的结果将为后续的R01提案提供信息，以进一步测试干预措施的效果 在研究中历史上代表性不足的不同患者群体中的尊重，这将 为确保基因组研究的多样性反映普通患者群体的多样性做出贡献。

PROJECT SUMMARY/ABSTRACT Candidate: Stephanie Kraft, JD, is an Acting Instructor in the Division of Bioethics, Department of Pediatrics, University of Washington School of Medicine. She has a background in law and economics and has completed postdoctoral fellowships in bioethics at the Stanford Center for Biomedical Ethics and the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Hospital and Research Institute. Her prior work includes mixed methods studies related to informed consent and the ethical, legal, and social implications (ELSI) of genetics and genomics. In this career development award, she will develop further expertise in qualitative research, including deliberative stakeholder engagement techniques, and strengthen her skills in intervention development and evaluation, including biostatistical analysis. She will also build subject matter expertise in research ethics and informed consent, particularly as they relate to increasing diversity in genomics research. Her long-term career goal is to be an independent investigator building practical tools to support the inclusion of diverse patient populations in research, in order to ultimately reduce health disparities. By the end of the award period, she plans to have successfully obtained R01 funding to continue this project’s line of work. Environment: Ms. Kraft has the institutional support of the Treuman Katz Center at Seattle Children’s, the University of Washington, and the Institute of Translational Health Sciences, all of which offer significant academic and research resources that will support her in her career development and research success. In addition, her strong mentorship and advisory teams include experts in research ethics and informed consent, as well as a range of methodological skills and perspectives that will support her at all stages of the planned research. Ms. Kraft’s primary mentor is Benjamin Wilfond, MD, who offers nationally recognized expertise in research ethics, informed consent, and mixed methods research. Her co-mentors are Erin Rothwell, PhD, an expert in ELSI genomics and qualitative research, and Seema Shah, JD, an expert in research ethics and informed consent theory. Project advisors Douglas Opel, MD, MPH, and Katrina Goddard, PhD, will provide additional expertise and guidance on intervention development and evaluation. Research: This proposed project will identify and evaluate ways of demonstrating respect to prospective research participants from diverse backgrounds. Aim 1 will qualitatively examine the context and values that inform participants’ perceptions of respect and decisions about enrollment. Aim 2 will use deliberative techniques to identify specific ways to demonstrate respect to prospective participants. Aim 3 will select an intervention and evaluate its effects on respect and trust in a feasibility study embedded in an ongoing clinical trial. This project’s outcomes will inform a subsequent R01 proposal to further test the intervention’s effects on respect in different populations of patients who are historically underrepresented in research, which will contribute to efforts to ensure that diversity in genomics research mirrors that of the general patient population.