The University of Florida proposes to enhance three aspects of its quality assurance program in clinical research. (1) Facilitate electronic submission and evaluation of human subject protocols. An electronic document imaging and routing system has been purchased for use by the IRB support staff. Until now this system has only been used to store and archive the applications to the IRB and it has improved the storage, access and retrieval of records. The system has much greater capability that will be explored under this enhancement program. The system has the potential to route electronic versions of documents to the reviewers, whose comments and questions for the investigator can be made electronically on the image of the document and seen by the other committee members as well as by the investigator. This should stimulate discussion and clarification prior to the convened meetings, making the reviews more thorough and the meetings more efficient. Further, the applications could be distributed to the designated reviewers when received in the IRB office, rather than waiting for the entire package of agenda items to be collated and delivered to the committee, thereby increasing the time available for review. (2) Develop a library of educational materials to provide ongoing education for investigators, administrators and committee members and to create a system to document the ethical training of all the individuals involved in human trials. The intention is not to generate new training materials, but to survey the available educational packages and maintain a library of such packages. Making the library an easily accessible resource and logging the training taken will be specific aims of the initiative. (3) Augment monitoring services to support the IRB in investigating and reporting adverse events, observing the consent process, and examining data records with the intent to educate and sensitize the individuals in closest contact with the subjects to the need for attention to subject rights and safety. A nurse-coordinator position will be added to the existing IRB Support staff to provide this audit/education capability.
