Baylor College of Medicine (BCM) has experienced tremendous growth in clinical research activities during the last five years. Although the College has remained steadfast in its commitment to the highest ethical standards in the conduct of human research, it resources have been challenged by the dramatic increase in the variety and volume of clinical investigation and in the heightened public pressures to assure ethical conduct of research. To respond to this explosion of scientific inquiry, the Office of Research at BCM developed a new approach to managing information and documentation of human research subject protections. In August 2001, BCM instituted an electronic protocol management system, the Biomedical Research Assurance Information Network (BRAIN). BRAIN permits electronic submission of protocols for initial and continuing IRB review and facilitates reporting and tracking all key actions for each protocol. The Office of Research Assurance and Compliance Services in cooperation with the IRB Chairs and members has initiated a program for measuring performance of institutional components in maintaining a clinical research environment which fosters; 1) research that minimizes all possible risks to subjects; 2) respectful informed consent; 3) knowledgeable research personnel; and 4) informed and knowledgeable research volunteers. Funding provided through RFA 02-003 has allowed BCM to significantly expand the educational components of BRAIN for clinical research personnel during protocol development, for IRB members during protocol review and for the general public. The financial resources from funding of this application would allow BCM to further expand the types of data that are collected from this electronic platform, to facilitate conflict of interest reporting, to establish data-driven performance improvement standards guided by regulatory, accreditation and best-practice criteria, and to share the educational materials already developed with IRBs in the Houston area. The specific objectives of this initiative are as follows; 1) to develop an electronic conflict of interest reporting, tracking and management system linked to BRAIN that allows more effective communication between the IRB and the Conflict of Interest Committee and that augments current human subjects protections initiatives; 2) to incorporate a common hierarchical dictionary of medical terms into the BRAIN system to provide consistency in the medical and lay language descriptions of clinical research protocols and in adverse event reports to improve process and compliance monitoring and communication among investigators, IRB and the community; 3) to develop and implement a separate service function focused on ongoing assessment of ethical, regulatory and accreditation standards; 4) to provide Assurances and Compliances consultative services and educational materials developed at BCM to Texas Medical Center and Houston area institutional IRBs that currently have either limited or no formal affiliations with Baylor College of Medicine.
