Using Nudges to Recruit Human Subjects in Clinical & Translational Research

在临床中利用助推来招募人类受试者

• 批准号: 10505241
• 负责人: KIMBERLY A KAPHINGST
• 金额: $ 37.46万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10505241
• 关键词: Address; Adult; Architecture; Attitude; Awareness; Bioethics Consultants; Biomedical Research; Black race; Calories; Clinical Research; Clinical Trials; Coercion; Consent; Consent Forms; Data; Educational workshop; Effectiveness; Empirical Research; Enrollment; Ethics; Goals; Grant; Human Subject Research; Informed Consent; Institutional Review Boards; Intervention; Interview; Knowledge; Latinx; Lead; Legal; Literature; Methods; Nature; Odds Ratio; Participant; Patients; Perception; Personal Behavior; Persons; Phase; Physicians; Policies; Policy Making; Population Heterogeneity; Process; Public Health; Randomized; Recommendation; Recruitment Activity; Reporting; Research; Research Personnel; Risk; Site; Structure; Suggestion; Support Groups; Surveys; Techniques; Testing; Translational Research; Universities; Utah; arm; behavioral economics; community engagement; design; effectiveness clinical trial; fast food; human subject; insight; member; minimal risk; policy recommendation; recruit; research study; response; risk benefit ratio; screening; translational scientist; undue influence; volunteer

Project Summary/Abstract To obtain grants and successfully conduct biomedical research with human subjects, researchers must recruit and retain sufficient numbers of participants. Literature on ethical concerns with coercion and undue influence abounds, but there is little consideration of whether it is ethical to employ behavioral economics techniques called “nudges” that can encourage participation, such as screening surveys that predispose participants to consent, structured choice architecture in consent forms, certain forms of community engagement to generate group support for participation, and certain positive personal behaviors by recruiters. In addition, little prior empirical research has examined what recruitment nudges are actually being used in recruitment into human subjects research and their effects. This project addresses to what extent recruitment nudges are being used in recruitment into clinical trials, whether they impact participation, the views of human subjects about their use, and whether their use is ethical in research studies with varying ratios of risk to human subjects. To address these issues, this interdisciplinary investigator team of translational scientists, bioethicists, and legal scholars at Case Western Reserve University and the University of Utah will first identify use of different types of recruitment nudges in clinical trials with varying ratios of risk (minimal risk vs. more than minimal risk) and benefit (direct benefit vs. no direct benefit) to human subjects. Aim 1 will characterize use of recruitment nudges in clinical trials with varying risk/benefit ratios by conducting interviews and a survey with clinical trials recruiter. Aim 2 will examine the effects of a set of nudges on recruitment into a minimal risk interview study for healthy adult volunteers and views of participants on the use of nudges for themselves and others. Aim 3 will utilize the empirical data generated in Aims 1 and 2 to identify the normative, legal and ethical considerations for different recruitment techniques used in clinical trials and propose policy and practice recommendations.

项目摘要/摘要 为了获得拨款并成功地对人类受试者进行生物医学研究， 研究人员必须招募并保留足够数量的参与者。关于伦理的文学 对胁迫和不当影响的担忧比比皆是，但很少有人考虑是否 使用行为经济学的“轻推”技术是合乎道德的，这种技术可以鼓励 参与，如筛选调查，使参与者倾向于同意，有组织地 在同意书中选择架构，以生成特定形式的社区参与 团队对参与的支持，以及招聘人员的某些积极的个人行为。此外, 此前很少有实证研究检验招聘微调实际上用于哪些领域 招募到人类受试者的研究及其影响。这个项目针对的是什么 在临床试验的招募中使用的招募推动的程度，他们是否影响 参与，人类主体对它们的使用的看法，以及它们的使用是否符合道德 对人类受试者具有不同风险比率的研究。为了解决这些问题，这 由翻译科学家、生物伦理学家和法律学者组成的跨学科研究团队，位于 凯斯西储大学和犹他大学将首先确定不同的用途 在风险比率不同的临床试验中的招募轻推类型(最小风险与超过 对人类受试者的风险最小)和收益(直接收益与没有直接收益)。目标1将 在具有不同风险/收益比的临床试验中，通过以下方式描述招募提示的使用 与临床试验招聘人员进行面谈和调查。目标2将考察以下因素的影响 一组关于招募健康成年志愿者参加最低风险面试研究的建议 以及参与者对自己和他人使用轻推的看法。目标3将利用 在目标1和目标2中产生的经验数据，以确定规范、法律和道德 对临床试验中使用的不同招募技术的考虑并提出政策和建议 实践建议。