Ethical Challenges for Research Extenders Responsible for the Integrity of Commun

Fordham University, Bronx NY

Investigators

Linked publications, trials & patents

Abstract

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.