Baylor College of Medicine (BCM) has experienced tremendous growth during the last five years. The total research budget of the school has doubled to more than $320 million. 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. In anticipation of ever growing and changing demands in response to 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 since begun to develop a more formalized 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. The financial resources from a funded application would allow BCM to expand the types of data that are collected from this electronic platform, to establish data-driven performance improvement standards guided by regulatory, accreditation and bestpractice criteria, and to develop enduring products for ongoing education of the community, research participants, research personnel and IRB members and staff. The specific objectives of this initiative are as follows; 1) develop local programming and educational enhancements to the BRAIN system to provide additional online guidance and education to investigators at the time of protocol development and submission via BRAIN; 2) develop education resources utilizing a variety of media to enhance the community's understanding of the ethical issues as well as the protections programs in place to assure the highest possible standards; 3) expand the BRAIN system to provide more in depth analysis of data for all active human protocols as part of a performance improvement and safety monitoring plan (examples include assessment of protections for vulnerable populations, categorization of all adverse events, specific study designs, etc.); 4) develop educational and reporting tools to enhance IRB continuing review; 5) analyze the data reporting and educational enhancements to BRAIN to determine if they meet performance goals related to the support of an ethical institution-wide research environment.
