Informed consent is the ethical foundation of modern medical and psychiatric care, yet little is known about the ability of persons with substance dependence to consent for clinical treatment, and data are lacking concerning addiction treatment clinicians'knowledge, attitudes, and actual practices of informed consent. This R21 proposal is conceived as the first part (Period I) of a comprehensive exploration of the informed consent process as it is currently conducted in sites providing clinical treatment for persons with addictions. The proposed study will address three critical issues in the ethics of addictions treatment: clinicians'knowledge, attitudes and practice in the assessment of decisional capacity and voluntarism as core components of informed consent. The study will survey approximately 1,500 clinicians from treatment programs of the National Institute of Drug Abuse Clinical Trials Network using self-report questionnaires conducted via an Internet platform. Both licensed and unlicensed practitioners will be surveyed. Survey instruments will address (a) demographics;(b) knowledge of clinical ethics concerning the informed consent process;(c) current informed consent practices;and (d) attitudes toward particular informed consent issues and situations, as presented in clinical vignettes.
The specific aims of the proposed study are: (1) to establish measures of informed consent that are internally consistent and have a clear factor structure;(2) to describe CTN practitioners'knowledge, attitudes, and self-reported practices regarding the informed consent process in clinical addiction treatment;and (3) to investigate correlates of practitioner knowledge, attitudes, and self- reported practices regarding the informed consent process in clinical addiction treatment. The research design and methods to achieve the study's goals use the CTN framework of sixteen Nodes each linked with five to ten or more Community-based Treatment Programs (CTPs) as the platform to conduct the research. The project will survey participants from each Node to sample the geographical, demographic, educational background, and academic-clinical diversity of CTPs. Participants will be recruited through CTP program directors, and will be reimbursed for their time. The two-year study will utilize the web-based survey program QuestionPro to create and distribute project surveys.
Addiction is a significant public health problem in the United States. This study will examine the knowledge, attitudes and practices regarding informed consent of addiction professionals in clinical care. Results of this study could potentially improve informed consent processes in addiction treatment with corresponding benefits in treatment outcome.
