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 为了获得赠款并成功地与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。关于道德的文献 对胁迫和unue影响的关注很多，但是几乎没有考虑是否 对员工行为经济学技术来说，这是道德的称为“裸露”的技术，可以鼓励 参与，例如筛查调查，使参与者易于同意，结构化 以同意形式的选择体系结构，某些形式的社区参与以产生 小组支持参与，以及招聘人员的某些积极个人行为。此外， 先前几乎没有实证研究研究了实际上正在使用的招募午学 招募人类受试者研究及其影响。该项目指向什么 招募nudges的范围用于招募临床试验，它们是否影响 参与，人类对他们使用的看法以及他们的使用是否道德 风险与人类受试者的比率不同的研究。为了解决这些问题， 转化科学家，生物伦理学家和法律学者的跨学科研究员团队 凯斯西部储备大学和犹他大学将首先确定使用不同的使用 临床试验中的招聘类型的类型具有不同的风险比例（最小风险与超过 最小的风险）和对人类受试者的收益（直接利益与无直接利益）。目标1意志 在风险/福利比不同的临床试验中使用招聘轻推特的特征 对临床试验招聘人员进行访谈和调查。 AIM 2将检查 一组招募招募到健康成人志愿者的最小风险访谈研究 以及参与者对自己和他人使用午睡的看法。 AIM 3将利用 目标1和2中生成的经验数据，以确定正常，法律和道德 临床试验和提案政策中使用的不同招聘技术的考虑以及 练习建议。