Enhancement of Human Subjects Research Protection

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Several recent national reports identify Institutional Review Boards (IRBs) as having failed to adequately protect subjects. In large part, this is due to significant increases in the last three decades in the amount of clinical research, without concomitant increases in the size of IRB staffs. Moreover, IRBs soon will be required to play major roles in making privacy decisions as a result of HIPAA legislative mandates. Significant efficiencies can result through the deployment of newer computer based technologies to accommodate large-scale increases in data generation. Last year Saint Louis University developed the initial phase of its own new computer based Protocol Data Management System (PDMS). The University's major investment in the system has enabled the IRB office to track investigator training, generate agendas and meeting notes, create continuing review reminder letters and other related documents. Further needed development of PDMS with partial support from the RFA will include modules for tracking serious adverse events, electronic linking of IRB protocol reviews to grant applications and development of quality improvement matrices. In addition, the RFA funding will allow us to address the absence of adequate training materials for community data collectors involved in research at our own both institution and elsewhere. In consultation with IRB members and support staff, and with investigators and community workers, creation of instructional materials will be carried out by the staff of our Health Communication Research Laboratory, a Saint Louis University Center of Excellence that is recognized as a national leader in health communication research. The final activity to be supported with funds from the Human Research Enhancements Program will be the work of an experienced physician who will serve as a Research Subject Advocate. Such an individual will work with new and currently unsupported investigators as well as with the subjects recruited to participate in studies conducted by them. The RSA will assist such investigators in the preparation of protocols with a significant identified task being that of insuring the confidentiality and physical and psychological welfare of research. In addition, the individual will be available to research subjects and staff to discuss safety issues and concerns, as well as closely monitoring adverse events on these studies. Upon the expiration of the RFA, the University is committed to support these three activities and share its experiences with other IRBs in promoting more effective human subjects protection.