Ethical Challenges for Research Extenders Responsible for the Integrity of Commun

负责社区诚信的研究扩展者面临的道德挑战

• 批准号: 7936984
• 负责人: Celia B Fisher
• 金额: $ 18.85万
• 依托单位: FORDHAM UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-23 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7936984
• 关键词: Address; Affect; Attitude; Belief; Clinical Trials; Communities; Data; Data Collection; Drug user; Economically Deprived Population; Educational Background; Employment; Environment; Ethics; Evidence based practice; Factor Analysis; Family history of; Feedback; Focus Groups; Fostering; Funding; Goals; Healthcare; Indigenous; Institution; Intervention Studies; Interviewer; Life; Life Experience; Link; Measures; Medical Research; Methods; Motivation; National Institute of Drug Abuse; New York City; Philadelphia; Placebo Control; Plant Roots; Play; Population; Principal Investigator; Process; Property; Psychometrics; Publishing; Randomized; Randomized Clinical Trials; Recruitment Activity; Regulation; Reporting; Research; Research Ethics; Research Personnel; Research Project Grants; Risk; Role; Sampling; Scientific Misconduct; Scientist; Social Class; Street Drugs; Substance Addiction; Target Populations; Training; Training Programs; Translational Research; Trust; Underserved Population; United States Agency for Healthcare Research and Quality; United States Office of Research Integrity; Work; addiction; base; efficacy research; experience; health disparity; human subject protection; instrument; knowledge base; meetings; member; outreach; peer; public health relevance; responsible research conduct; skills training; standardize measure; success; tool

DESCRIPTION (provided by applicant): Federal initiatives to address health disparities in community-based addiction intervention research, has encouraged the employment of community members, called "research extenders" (REs), as recruiters and data gatherers to form the essential collaborative link between the investigator and target population. When REs play a role in translational research, the values, experiences and problems they share with marginalized addicted community members can affect research integrity in both positive and negative ways. In 2004, the Office of Research Integrity (ORI) cited 3 cases of RE's involved in fabrication and falsification of data; however studies on research integrity have not focused on this unique set of research workers. The broad and long term goals of this application is to strengthen the research integrity of community-based addiction trials, help investigative teams maximize RE potential and mitigate risks to research integrity, and provide a tool that can be used to assess the efficacy of RE research integrity training programs. Specific Aim 1 of this project is to provide a qualitative knowledge base to enhance understanding of the linkages between REs' shared community attitudes toward addiction research ethics and their commitment to research integrity. Aim 1 will be achieved through the implementation of focus groups conducted with REs who are involved in addiction research in New York City, Philadelphia, Hartford, New Haven and Newark DE. Focus group discussion will be stimulated by a video created with the assistance of a community advisory board (CAB) and using professional actors, that illustrates in detail the different facets of placebo-controlled randomized addiction trials. Content analysis will provide a rich base of information for identifying linkages among addiction trial domains, shared community beliefs and RE motives that influence commitment to research integrity. Specific Aim 2 is to construct and psychometrically validate an instrument, the Addiction Research Integrity Scale-Research Extenders (ARIS-RE) that can assess multiple components of beliefs and motives that may facilitate or impede the integrity of RE recruitment and data collection. Subscale items representing beliefs and motives specific to different addiction research domains will be drawn from RE statements identified as best representing themes in the content analysis of the focus groups. After piloting and CAB feedback, a large sample of REs will complete the ARIS-RE. Psychometric properties of the scale will be evaluated through an iterative process of item analysis, exploratory factor analysis, and internal reliability followed by correlations between ARIS-RE subscales and standardized measures of medical research trust, health care distrust, and addiction beliefs to confirm construct validity. Recently ORI published a statement alerting investigators that regulations governing human subjects protections pertain to all who are involved in PHS research. This proposal seeks to generate information and tools that can assist ORI and principal investigators to provide REs with the training and skills they need to meet standards of research integrity in community-based addiction trials. PUBLIC HEALTH RELEVANCE (provided by applicant): Federal health disparity initiatives to achieve equity in community-based addiction treatment research have increased employment of indigenous research extenders (REs) as recruiters, data gatherers, and peer interviewers. While they help to form the essential collaborative link between addiction scientists and marginalized populations, recently the Office of Research Integrity (ORI) has uncovered scientific misconduct involving REs. The proposed study is an important step toward understanding and measuring the ethics-related beliefs and motivation facilitating and impeding the RE's contribution to addiction trials.

描述(由申请人提供)：为解决基于社区的成瘾干预研究中的健康差距，联邦倡议鼓励雇用社区成员，称为“研究延伸者”(Res)，作为招聘人员和数据收集者，在调查者和目标人口之间形成必要的协作联系。当RE在翻译研究中发挥作用时，他们与边缘化的成瘾社区成员分享的价值观、经验和问题可能会以积极和消极的方式影响研究的完整性。2004年，研究诚信办公室(ORI)列举了3个RE涉及伪造和伪造数据的案例；然而，关于研究诚信的研究并没有集中在这组独特的研究工作者身上。该应用程序的广泛和长期目标是加强基于社区的成瘾试验的研究完整性，帮助调查团队最大限度地发挥RE潜力并降低研究完整性的风险，并提供一个可用于评估RE研究诚信培训计划有效性的工具。这个项目的具体目标1是提供一个定性的知识库，以加强对Res对成瘾研究伦理的共同社区态度与他们对研究诚信的承诺之间的联系的理解。目标1将通过实施与参与纽约市、费城、哈特福德、纽黑文和纽瓦克DE成瘾研究的Res进行的焦点小组来实现。在社区咨询委员会(CAB)的帮助下，使用专业演员制作的一段视频将刺激焦点小组讨论，该视频详细说明了安慰剂对照的随机成瘾试验的不同方面。内容分析将提供丰富的信息基础，以确定成瘾试验领域、共同的社区信念和影响研究完整性承诺的RE动机之间的联系。具体目标2是构建和心理测量学验证的工具，成瘾研究诚信量表-研究 (ARIS-RE)，可以评估可能促进或阻碍RE招募和数据收集的完整性的信念和动机的多个组成部分。代表不同成瘾研究领域具体信念和动机的子量表条目将从被确定为在焦点小组内容分析中最能代表主题的RE陈述中提取。经过试飞和驾驶室反馈，一大批RE将完成ARIS-RE。量表的心理测量学特性将通过项目分析、探索性因素分析和内部信度的迭代过程进行评估，然后在ARIS-RE子量表与医学研究信任、医疗保健不信任和成瘾信念的标准化测量之间建立相关性，以确认结构效度。最近，ORI发布了一份声明，提醒调查人员，管理人类受试者保护的法规涉及所有参与PHS研究的人。这项建议寻求生成信息和工具，以帮助ORI和主要调查人员为RES提供他们所需的培训和技能，以满足基于社区的成瘾试验的研究诚信标准。 公共卫生相关性(由申请者提供)：联邦健康差距倡议为实现基于社区的成瘾治疗研究的公平，增加了对土著研究推广者(RE)的雇用，作为招聘者、数据收集者和同行面试者。虽然它们有助于在成瘾科学家和被边缘化的人群之间形成必要的合作联系，但最近研究诚信办公室(ORI)发现了涉及RE的科学不当行为。这项拟议的研究是理解和衡量道德相关信念和动机的重要一步，这些信念和动机促进和阻碍了RE在成瘾试验中的贡献。