INFORMED CONSENT IN THE RECRUITING OF SUBJECTS INTO PHARMACOLOGIC RESEARCH.
Contributors: Catholic University of America.
Published: 1986
Number of pages: 312
Subjects: Health Sciences, Pharmacology.; Health Sciences, Nursing.
Description: Although informed consent is understood as a process of focused interaction between researcher and potential subject, research in informed consent has focused on particular elements of informed consent, neglecting the human interaction. The purpose of this study was to provide a description and analysis of subjects' consent to participate in pharmacologic research. The focus was the interaction between researcher and prospective subject during the formal consent interview. While studying this interaction, factors: client, researcher, and environmental, were identified which influenced the process. A grounded theory approach to data collection and analysis was used. The study sample consisted of sixteen researcher-patient dyads. The investigator observed these interviews and tape recorded them. Following this, researchers were interviewed using a structured interview guide. The data collected yielded qualitative information. The taped interviews were transcribed verbatim andcontent a++

lyzed. The theory generated, which accounted for the process between researcher and subject, is described as a process of induction, a process by which a person is recruited and enrolled as a subject of research. Induction defines and describes a process consisting of four phases. Each phase contains one or more tasks to be accomplished and corresponding behaviors which operationalize the task. In phase one, the interaction is defined. During phase two, the screening and selecting of subjects occurs and the research is defined. In phase three, subjects and researchers establish and maintain their interaction. Phase four tasks are to define the outcome of the interaction, and to revise the definition of the interaction based on interview content. Time, setting, and power were found to be overriding conditions of the process. The data indicate that there is a poor fit between the elements of informed consent (disclosure, comprehension, voluntariness, and competence) and the interactive++

ta. The investigator concludes that these are not the elements that drive the induction interview. Induction and informed consent differ in their goals and activities. Implications of this study derive from both the knowledge of what transpires for subjects and researchers in formal consent interviews and an understanding that what occurs is in fact different from what is said should occur.
Notes: Source: Dissertation Abstracts International, Volume: 47-01, Section: B, page: 0147.

Thesis (D.N.SC.)--THE CATHOLIC UNIVERSITY OF AMERICA, 1986.

School code: 0043.