Quality Improvement in Human Subjects Research

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The safety and welfare of participants in human subjects research has always been the foundation of clinical research at the University of Massachusetts Medical School (UMMS). Whether funded by federal agencies, pharmaceutical industry or investigator-initiated, research involving human subjects receives careful review and consideration by the Institutional Review Board staff and committees. In the last few years the scale of the research enterprise at UMMS has grown dramatically, evidenced by the increased funding from the NIH and the growth in clinical studies, which now total 852 active human protocols. These increases, coupled with the national acknowledgement of the necessity for increased oversight for human subjects research, have prompted UMMS to reevaluate and strengthen our existing focus on human subjects protection. In particular, the two areas of education and quality improvement will be enhanced. This will be accomplished by expanding and formalizing the education and training of both IRB members, clinical research investigators and their key personnel, along with a cycle of internal auditing to promote quality improvement in study conduct. On-site programs, conducted by professional trainers, will be enhanced through participation in a web-based education program through the Collaborative IRB Training Initiative, offering more depth and breadth of understanding of human subjects protection. A seminar series, conducted by the Office of Research staff, will incorporate issues identified through the internal auditing cycle, thus ensuring that the day-to-day conduct of studies is carried out under Good Clinical Practice (GCP) standards. Acknowledging that UMMS is dedicated to expanding our capacity for human subjects protection, there is a strong institutional commitment to continue these efforts beyond this one-year IRB enhancement funding.