Ethical Preparedness and Performance of Gene Therapy Study Co-Ordinators

Abstract

Little is known about study co-ordinators of gene therapy clinical trials. The purposes of this study were to: (1) describe characteristics of co-ordinators of gene therapy (transfer) clinical trials; (2) assess differences between nurse and non-nurse study co-ordinators; and (3) identify factors indicative of study co-ordinators' role preparation that could affect their role performance. This exploratory correlational study employed a convenience sample of 118 co-ordinators in the USA (55 participants; 47% response rate). The researcher created the Study Coordinator Role Preparedness and Performance Survey to assess factors or correlates of study co-ordinator performance. Analysis of variance was used to compare nurses and non-nurses, and men versus women on their perceived preparedness, perceived quality of orientation, and satisfaction with educational opportunities. The findings contribute to knowledge by identifying present inadequacies in the training of study co-ordinators and in recognizing the need for more effective provision of orientation and continuing education with respect to ethical issues, knowledge of genetic science, and potential research integrity challenges.