Not whether but how: The ethics of reporting individual results in a pregnancy cohort.

不是是否，而是如何：报告妊娠队列中个体结果的道德规范。

• 批准号: 10594241
• 负责人: Julie Beth Herbstman
• 金额: $ 17.52万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594241
• 关键词: Address; Bioethics; Bioethics Consultants; Biological Monitoring; Blood Tests; Body Composition; Child; Child Health; Communication; Communities; Consensus; Cultural Backgrounds; Data; Data Aggregation; Development; Environmental Exposure; Environmental Health; Ethics; Feedback; Focus Groups; Genetic; Goals; Health Fairs; Individual; Knowledge; Maternal Health; Methodology; Methods; New York; New York City; Outcome; Outcome Assessment; Participant; Pilot Projects; Population Heterogeneity; Pregnancy; Reading; Reporting; Research; Research Personnel; Surveys; Techniques; Testing; United States National Institutes of Health; Urine; Work; Writing; bilingualism; clinically significant; cohort; community engagement; design; expectation; lens; member; preference; pregnant; programs; response; responsible research conduct; study population

PROJECT SUMMARY This project, entitled, “Not whether but how: the ethics of reporting individual results in a pregnancy cohort,” addresses bioethics research as it relates to ethically informed reports to a culturally diverse pregnancy cohort.The ethical considerations around whether data should be returned have been carefully assessed and characterized under the bioethics framework, with the conclusion that there is an ethical obligation to return data. Consequently, how data is returned must be carefully assessed using a similar framework. The goals of this project, specific to bioethics research, are to characterize and assess ethical considerations related to howdata is returned to individuals in a pregnancy cohort, with the hypothesis that ethically informed reports increase participant knowledge and study engagement while reducing potential harms. Building on work we have conducted within the Columbia Center for Children’s Environmental Health (CCCEH) Fair Start cohort, a member of the Environmental Influences on Child Health Outcomes (ECHO) consortium, we will evaluate the hypothesis that ethically informed reports increase participant knowledge and study engagement while reducing potential harms. We will convene an Expert Panel comprised of study participants, bioethicists, researchers, experts in responsible conduct of research, and maternal health experts, as well as representatives from ECHO program components. In Specific Aim 1, we will use the Delphi methodology, a validated technique aimed at developing consensus, the Panel will identify and assess ethical considerations associated with how data is returned. The panel will co-create a survey and focus group discussion guide, which will be used in Specific Aim 2, to evaluate the ethical return of data in a pregnancy cohort that have received individual data (n=168) or have not yet received individual data (n=63). The results from the Expert Panel and the results from the pregnancy cohort will inform Specific Aim 3, developing preliminary best practices to guide how data is returned to study participants. The research will evaluate ethical considerations around the return of data in a culturally diverse pregnancy cohort, with data that lacks clinical significance. Participant preference and expectations around how data is returned will be evaluated through surveys and focus groups. Thus, we propose to evaluate how to return data within a pregnancy cohort and identify additional important variables that may influence the return of data. The anticipated impact of this work will inform best practices for returning data to pregnant individuals but is anticipated to scale to other study populations as well and can be extended to other populations from diverse cultural backgrounds representedacross the ECHO consortium.

项目摘要 这个项目名为“不是是否而是如何：在怀孕队列中报告个人结果的伦理”， 处理生物伦理学研究，因为它涉及到对文化多样性怀孕的道德知情报告 关于是否应该返回数据的伦理考虑已经过仔细评估， 在生物伦理学框架下进行了分析，结论是， 数据因此，必须使用类似的框架仔细评估如何返回数据。的目标 本项目的一个主要目标，特别是生物伦理学研究，是确定和评估与以下方面有关的伦理考虑因素： 如何将数据返回给妊娠队列中的个体，假设道德知情的报告 增加参与者的知识和研究参与度，同时减少潜在危害。在工作的基础上， 在哥伦比亚儿童环境健康中心（CCCEH）公平起步队列中进行， 作为环境对儿童健康结果影响（ECHO）联盟的成员，我们将评估 假设道德知情的报告增加了参与者的知识和研究参与， 减少潜在危害。我们将召集一个由研究参与者、生物伦理学家、 研究人员、负责任地开展研究的专家和产妇保健专家，以及 来自ECHO计划组件的代表。在具体目标1中，我们将使用德尔菲方法， 通过一项旨在达成共识的有效技术，专家组将确定和评估伦理考虑因素 与数据返回方式相关。该小组将共同创建一个调查和焦点小组讨论指南， 这将用于具体目标2，以评估妊娠队列数据的伦理回报， 已收到个体数据（n=168）或尚未收到个体数据（n=63）。来自专家的结果 小组和妊娠队列的结果将告知具体目标3， 指导如何将数据返回给研究参与者的实践。该研究将评估伦理 在文化多样性妊娠队列中返回数据的考虑因素，数据缺乏临床 意义 将通过调查评估参与者对如何返回数据的偏好和期望 和焦点小组因此，我们建议评估如何返回妊娠队列中的数据，并确定 可能影响数据返回的其他重要变量。这项工作的预期影响将 告知向怀孕个体返回数据的最佳实践，但预计将扩展到其他研究 也可以扩展到来自不同文化背景的其他人群 代表了ECHO联盟。