Concerns regarding the protection of human subjects in clinical research have escalated in recent months, with reports of inadequate policies and procedures at some of the nation's premier research universities. Many of the clinical studies conducted in these centers are managed by clinical research nurse coordinators (CRNCs), who, in collaboration with principal investigators, coordinate the day-to-day operations involved with the research and are the main resource and contact persons for research subjects. This group of nurses, while ubiquitous in clinical research, is relatively invisible and has had little, if any, formal preparation in research ethics. Current certification courses for clinical research coordinators (sponsored through the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP)) do not cover ethical issues arising in the practical management of clinical research studies in any depth. Focus groups conducted with CRNCs in two university teaching hospitals reveal that these nurses deal with a variety of complex problems for which they have little to no formal preparation. Therefore, the objective of this grant is to conduct and evaluate a series of short-term courses on ethical issues in human subjects research specifically designed and targeted to address commonly occurring ethical problems experienced by CRNCs. The template course is designed as a six-module series with four of the six modules available via web-based instructional methodologies, enabling participants to access the course from their home sites. Courses will be offered twice in each General Clinical Research Center (GCRC) Region to enable CRNCs from around the country to participate. Evaluation methods include participant evaluation of content and process, interviews of selected participants three months after course completion, and pre- and post-course assessments of participants' ethical knowledge, ethical behaviors and ethics environment within the research team. A secondary goal is enhanced knowledge of the clinical research nurse coordinator role and the ethical issues these nurses confront, and development of resources to assist CRNCs in ethical problem solving, in dialogue with research ethics experts at the University of Virginia.
