The objective of this 4-year qualitative sociological study is to build on and add to knowledge of the socially dynamic informed consent process through the identification of its occurrence in HCV clinical trials and through an analysis of how it is affected by social contingencies (interpretations of research-related clinical and social risk and patient experience with clinical trials) as well as how it is affected by the local organization and wider context of clinical research. The study has six specific aims: 1) to uncover the activities of referring providers related to patient participation on clinical trials; 2) to specify the actions of research professionals (physician-investigators, nurse trial coordinators, trial personnel) with regards to informing, consenting, and overseeing patients on clinical trials; 3) to establish how two groups of adult patients (those who have never participated on a clinical trial, """"""""initiates,"""""""" and those who have previously participated on trials, """"""""repeaters"""""""") learn about, consent to, and withdraw from clinical trials; 4) to ascertain how the actions of research professionals and referring providers are impacted by perceptions of risk and the context of clinical research; 5) to discover how the actions of patient-subjects are influenced by previous experience (or lack thereof) with clinical research, perceptions of risk, and the context of clinical research; and 6) to develop a robust """"""""social process"""""""" model of informed consent. Ethnographic methods of data collection - participant observation, interviews, and documents review - will be used in the study. Data analysis will involve: 1) multiple operationalism, to validate interview accounts with source materials and observations in the field; 2) cross- case event comparison, to compare how the informed consent process comes about and is impacted by contingencies within specific cases; and 3) quantification of events, to document the repetition of patterns, themes, and categories of phenomena. The goal of the study is to produce empirically-based analyses and interpretations of the informed consent process which can be applied to medical and nursing practice and to the development of social policies related to the care of patients in human subject research.
| Instone, Susan L; Mueller, Mary-Rose; Gilbert, Tari L (2008) Therapeutic discourse among nurses and physicians in controlled clinical trials. Nurs Ethics 15:803-12 |
| Mueller, Mary-Rose; Instone, Susan (2008) Beyond the informed consent procedure: continuing consent in human research. Cien Saude Colet 13:381-9 |
| Mueller, Mary-Rose (2004) Clinical, technical, and social contingencies and the decisions of adults with HIV/AIDS to enroll in clinical trials. Qual Health Res 14:704-13 |
| Mueller, Mary-Rose (2004) Involvement and (potential) influence of care providers in the enlistment phase of the informed consent process: the case of AIDS clinical trials. Nurs Ethics 11:42-52 |
