Ethical Challenges for Research Extenders Responsible for the Integrity of Commun

描述（由申请人提供）：联邦旨在解决基于社区的成瘾干预研究中的健康差异的倡议鼓励雇用社区成员，称为“研究扩展者”（RE），作为招募者和数据收集者，以形成研究者和目标人群之间的重要合作联系。当RE在翻译研究中发挥作用时，他们与边缘化成瘾社区成员分享的价值观，经验和问题可以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）引用了3起涉及捏造和伪造数据的RE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潜力并减轻研究完整性的风险，并提供一种可用于评估RE研究完整性培训计划的有效性的工具。该项目的具体目标1是提供一个定性的知识基础，以加强对RE对成瘾研究伦理的共同社区态度与其对研究诚信的承诺之间联系的理解。目标1将通过与纽约市、费城、哈特福德、纽黑文和特拉华州纽瓦克参与成瘾研究的RE开展焦点小组活动来实现。焦点小组讨论将通过在社区咨询委员会（CAB）的协助下创建的视频进行刺激，并使用专业演员，详细说明安慰剂对照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之间的联系，共同的社区信仰和RE动机，影响研究诚信的承诺。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 扩展器（ARIS-RE）可以评估可能促进或阻碍可再生能源招聘和数据收集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的信念和动机的子量表项目将从RE声明中提取，这些声明被确定为焦点小组内容分析中最具代表性的主题。在试点和CAB反馈之后，大量RE样本将完成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可靠性的迭代过程进行评估，然后通过ARIS-RE分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的相关性来确认结构效度。最近，ORI发表了一份声明，提醒调查人员，管理人类受试者保护的法规适用于所有参与PHS研究的人。该提案旨在生成信息和工具，以帮助ORI和主要研究者为RE提供所需的培训和技能，以满足基于社区的成瘾试验中的研究完整性标准。 公共卫生相关性（由申请人提供）：联邦健康差距倡议，以实现基于社区的成瘾治疗研究的公平性，增加了土著研究扩展者（RE）作为招聘人员，数据收集者和同行访谈者的就业。虽然他们有助于形成成瘾科学家和边缘化人群之间的重要合作联系，最近研究诚信办公室（ORI）发现了涉及REs的科学不端行为。拟议的研究是理解和衡量道德相关的信念和动机促进和阻碍RE对成瘾试验的贡献的重要一步。

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.