Accomplishments and Future Goals Stephen Richman, MD Assistant Provost for IRB Affairs January 17, 2006

HSRO Accomplishments in 2005 Rewriting of Policies and Procedures Rewriting of Policies and Procedures Hiring and training of support staff in pre- meeting preparation, meeting management, and minutes per regulations. Hiring and training of support staff in pre- meeting preparation, meeting management, and minutes per regulations. Modeling of committee and operations based partly on WIRB model Modeling of committee and operations based partly on WIRB model

IRB Accomplishments in 2005 Formation and convening of combined Social/Behavioral and Medical “primordial” committee for review of expedited material, review of audits, and training Formation and convening of combined Social/Behavioral and Medical “primordial” committee for review of expedited material, review of audits, and training Re-training of members and staff, including lectures, manuals, mock protocols Re-training of members and staff, including lectures, manuals, mock protocols

HSRO - Plans for 2006 Returning responsibility for full board reviews of new studies and continuing reports to UM Returning responsibility for full board reviews of new studies and continuing reports to UM Likely that we will begin reviewing locally written protocols soon; procedure for industry sponsored protocols under discussion Likely that we will begin reviewing locally written protocols soon; procedure for industry sponsored protocols under discussion Final testing and re-activation of eProst system Final testing and re-activation of eProst system Improvement of audit-compliance system conducted in conjunction with the Office of Research Improvement of audit-compliance system conducted in conjunction with the Office of Research

IRB – Plans for 2006 Separation of combined committee into separate Medical and Social/ Behavioral committees Separation of combined committee into separate Medical and Social/ Behavioral committees Additional “mitoses” of Medical committees to increase reviewing capacity Additional “mitoses” of Medical committees to increase reviewing capacity Placement of trained members with new members as committees expand Placement of trained members with new members as committees expand Implementation of an IRB member evaluation system Implementation of an IRB member evaluation system