The support of the National Institutes of Health through RFA OD-02-003 allowed the Office of Research at University of Massachusetts Medical School (UMMS) to enhance the capacity for human subjects protection through the development of education, training and quality improvement initiatives. Through Good Clinical Practice (GCP) training, web enhancements and internal inspections for quality improvement, these efforts have collectively identified future needs for educational reinforcements. Independent of future funding, the UMMS is fully committed to the continuation of all the education and training efforts that have been initiated this year. The availability of an additional year of NIH support through RFA OD-03-007, however, will allow us to enhance our capacity for system improvements through electronic tools, a necessary next step to keep current with trends in research administration. Primary among the technology that could facilitate better tracking, management and follow-up of submissions to the Institutional Review Board is an automated web-based system known as Webridge. This automated compliance system would facilitate collaboration between the IRB and principal investigators through electronic submission of new protocol applications and ensure compliance by automating amendments, adverse events and continuing reviews. Other technology detailed in this application to assist in enhancement of human subjects protections are readability software programs for consent documents and Standard Operating Procedure templates for the IRB. The inclusion of a training coordinator to facilitate the implementation of these efforts will be key to their successful utilization. Two of the affiliate hospitals to our clinical system partner, UMass Memorial Health Care, will be included in these expanded efforts for human subjects protections. The combined strength of our existing human resources and these new technologies will allow UMMS and our clinical system partners to enhance human subjects protections as we monitor our metrics systematically for continuous quality improvement.
