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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

基本信息

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
项目类别：
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

项目摘要

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/文摘