Baylor College of Medicine, Houston, TX
Submitted by: Denise Niles Canales, MA

The following information was submitted by the applicant for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose. Institutions interested in adopting or adapting the practice would be well advised to contact the person who submitted the application and to evaluate this and any additional information for their purposes. There is no implication that this "best practice" is the only, nor necessarily the best, way to perform the function.

Description: BRAIN, Biomedical Research and Assurance Information Network, is a web-based application that supports creating, routing, reviewing, signing, amending, reporting, and auditing research protocols submitted to the Baylor College of Medicine Institutional Review Board.

Genesis: It began as an IRB focused solution to address the needs of the research enterprise as a whole and later became more integrative and broader ranging. Currently BRAIN provides web-based management of human subject studies, animal research, and the creation and management of research proposals.

Experience: The development of the system took approximately 2 years and 1.5 million dollars to complete. The success of the project is attributed to the daily, full-time working relationship of Director level users at the institution and the development team.

Compliance: Since the entire research enterprise is facilitated and managed by the BRAIN application, and IRB functioning has been radically altered by the new organizational structure and business model, there is no code, standard, or guideline that is NOT supported by this system.

Protection of human subjects: BRAIN contributes to the protection of human subjects significantly by allowing all groups within the research enterprise to accomplish their work more competently, thoroughly, and quickly.

Monitoring and evaluation/outcomes: Surveys were conducted on all user groups 3 months after going live. User feedback sessions are held during each of our 101 (beginners) and 102 (advanced) training classes. A ROI report is currently being compiled. A BRAIN email account is available to all user groups, via which they submit suggestions for enhancements to the system.

Innovation: The practice is innovative in several ways: BRAIN is completely web-based, facilitates a fully paperless compliance system, has a broad scope, was developed by users, eliminates all clerical work for the IRB and IACUC support staff, and allows management the ability to leverage the technology in new ways, thereby providing data on the process and functioning of the research enterprise as a whole. We can quickly answer questions that in the past we could not ask. The data we are receiving has been used to change our policies, procedures, our overall business model, and how we prioritize upcoming IT projects.

Replicability: Development of a web-based protocol management system is expensive and takes considerable time and high level human resources. There are several applications on the market for purchase in addition to this one. Whether an institution builds, buys, or modifies an existing system, leveraging available technology in order that an institution’s research enterprise function optimally is essential these days.

Applicant’s justification for award: This application and the resulting changes to business structure and cultural climate are innovative, progressive, and unique.

For additional information:
Denise Niles Canales, MA
Tel: 713-798-6991
Fax: 713-798-6990
Email: dcanales@bcm.tmc.edu