The Ohio State University currently has two separate Institutional Review Boards (IRBs) responsible for overseeing the protection of human subjects in research. They are the Biomedical IRB and the Behavioral and Social Sciences IRB. During the calendar year 2001, the Biomedical IRB which has 18 members and 14 alternates, reviewed over 433 new protocols and processed over 950 amendments and 1000 continuing reviews. The Behavioral and Social Sciences IRB, which has 16 members, reviewed 230 new protocols and processed over 130 amendments and 220 continuing reviews. In addition to these two local IRBs, The Ohio State University has contracted with a non-institutional, independent IRB, the Western IRB (WlRB) to serve as the IRB of record for industry-sponsored, industry-initiated clinical trials. The Office for Responsible Research Practices (ORRP) provides administrative support for these committees An outline for ORRP reorganization was completed in Feb. '02. This plan included a revision of processes used to fulfill the responsibilities of the office as well as changes in both the number and job descriptions of the ORRP staff. The first essential element of the reorganization plan called for an increase in the number of ORRP staff involved in supporting our IRB's. In addition, we are going to realign the staff into functional teams that work together to support the IRB rather than working apart on isolated tasks as is now the case. Each team will be responsible for handling all aspects of the IRB files including working with the Pl's to ensure complete submissions and facilitate timely responses. Another recommendation was that """"""""the OSU leadership should establish and provide resources for a uniform education program for all levels of individuals involved in human subject protections - investigators and their research teams, IRB members, ORRP staff, and senior management"""""""". Key among the elements of this part of the plan is the creation of an education branch within ORRP which is responsible for delivering and coordinating all of the initial and continuing educational requirements. Money from this grant will be used to support various education initiatives. We will also use this grant to develop an investigator handbook, SOPs for our program, gain certification of all of our staff and seek accreditation for our program. Lastly, we plan to develop front end software to our new database system to allow electronic protocol submissions.
