The objectives of this proposal are to further strengthen the human subjects protections environment throughout the Health System by hosting a Chairs' Roundtable and a retreat for IRB members and clinical researchers, and to enhance our program for research compliance oversight. Appropriate high-level individuals from all the hospitals within our health system, including some with independent IRBs, will be convened for a Chair's Roundtable to outline their responsibilities in further enriching the program for human subjects protections. Following this event, a two-day retreat will be held for all IRB members and clinical researchers to expose them to the knowledge and tools necessary to properly review and conduct research with human subjects. The retreat will feature separate tracks for researchers and IRB members, with emphasis placed on the utilization of the GCRC. The tools developed for this event will then be used for future training and education as part of an ongoing effort to assist the researchers throughout our health system in refining their skills and knowledge in human subjects protections and protocol development. A """"""""Research Road Show"""""""" to be debuted at the Research Retreat will feature a number of booths that depict the life of a research protocol from the conception of an idea to the birth of a research plan. These booths will include individuals who are specialists in the areas crucial to the proper development of a research protocol, including the appropriate scientific/medical specialties, proper protocol design, GCRC utilization and the role of the research subject advocate (RSA), IRB submission and process, statistical design, regulations, ethics, etc. One of the community hospitals within our health system that operates a separate IRB will have their program enhanced through the purchase of computer and audiovisual equipment, which will allow their human subjects protections program to meet the demands of their growing research program. Additionally, the current program for research compliance will be evaluated and, if necessary, a consultant will be hired to help determine the areas where the program can be improved. Per diem staff will be hired to assist in the conduct of audits while this program is being evaluated and improved. The purchase of computer equipment will provide the compliance staff with the mobility that is necessary for efficiently conducting on-site audits and for writing compliance reports.
