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: 10677859
• 负责人: KIMBERLY A KAPHINGST
• 金额: $ 37.61万
• 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/10677859
• 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; 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; effectiveness evaluation; 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.

项目概要/摘要 为了获得资助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留住足够数量的参与者。伦理学文献 对胁迫和不当影响的担忧比比皆是，但很少有人考虑是否 采用称为“助推”的行为经济学技术是合乎道德的，它可以鼓励 参与，例如使参与者倾向于同意的筛选调查，结构化 选择同意形式的架构，某些形式的社区参与以产生 团体对参与的支持，以及招聘人员的某些积极的个人行为。此外， 之前很少有实证研究考察过招聘助推实际上被用于哪些方面。 人类受试者研究的招募及其影响。该项目旨在解决什么问题 在招募临床试验时使用招募助推的程度，是否会影响 参与、人类受试者对其使用的看法以及其使用是否符合道德 对人类受试者具有不同风险比例的研究。为了解决这些问题，本 由转化科学家、生物伦理学家和法律学者组成的跨学科研究小组 凯斯西储大学和犹他大学将首先确定使用不同的 临床试验中招募助推的类型具有不同的风险比率（最小风险与大于风险比率） 最小风险）和对人类受试者的益处（直接益处与无直接益处）。目标1将 描述临床试验中招募助推的使用，具有不同的风险/效益比 与临床试验招募人员进行访谈和调查。目标 2 将检验以下效果： 一系列关于招募健康成年志愿者进行最低风险访谈研究的推动 以及参与者对于为自己和他人使用助推的看法。目标 3 将利用 目标 1 和 2 中生成的经验数据，以确定规范、法律和道德 考虑临床试验中使用的不同招募技术并提出政策和建议 实践建议。