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.

项目总结/摘要 为了获得赠款并成功地进行人类受试者的生物医学研究， 研究人员必须招募和保留足够数量的参与者。伦理学文献 对胁迫和不当影响的关注比比皆是，但很少考虑是否 采用行为经济学的技术，称为“轻推”， 参与，如筛选调查，使参与者倾向于同意，结构化 同意书中的选择架构，某些形式的社区参与， 对参与的团体支持，以及招聘人员的某些积极的个人行为。此外，本发明还提供了一种方法， 此前很少有实证研究考察了招聘助推实际上被用于 招募人类受试者研究及其影响。该项目旨在 在临床试验招募中使用招募助推的程度， 参与，人类受试者对其使用的看法，以及它们的使用是否符合道德， 对人类受试者的风险比率不同的研究。为了解决这些问题， 由翻译科学家、生物伦理学家和法律的学者组成的跨学科研究小组， 凯斯西储大学和犹他州大学将首先确定使用不同的 临床试验中的招募类型具有不同的风险比（最小风险与超过 最小风险）和益处（直接益处与无直接益处）。目标1将 通过以下方式描述在具有不同风险/获益比的临床试验中使用招募轻推的特征： 与临床试验招募人员进行访谈和调查。目标2将研究 一组关于招募健康成人志愿者参加最小风险访谈研究的提示 以及参与者对自己和他人使用轻推的看法。目标3将利用 目标1和目标2中生成的经验数据，用于确定规范性、法律的和道德的 考虑临床试验中使用的不同招募技术，并提出政策和 实践建议。