Accomplishments Accomplishments and Future Goalsand Future Goals

Stephen Richman, MDStephen Richman, MD

Assistant Provost for IRB Assistant Provost for IRB AffairsAffairs

January 17, 2006January 17, 2006

HSRO Accomplishments HSRO Accomplishments in 2005in 2005

Rewriting of Policies and ProceduresRewriting of Policies and Procedures Hiring and training of support staff Hiring and training of support staff

in pre-meeting preparation, meeting in pre-meeting preparation, meeting management, and minutes per management, and minutes per regulations.regulations.

Modeling of committee and Modeling of committee and operations based partly on WIRB operations based partly on WIRB modelmodel

IRB Accomplishments in IRB Accomplishments in 20052005

Formation and convening of Formation and convening of combined Social/Behavioral and combined Social/Behavioral and Medical “primordial” committee for Medical “primordial” committee for review of expedited material, review review of expedited material, review of audits, and trainingof audits, and training

Re-training of members and staff, Re-training of members and staff, including lectures, manuals, mock including lectures, manuals, mock protocolsprotocols

HSRO - Plans for 2006HSRO - Plans for 2006

Returning responsibility for full board Returning responsibility for full board reviews of new studies and continuing reviews of new studies and continuing reports to UMreports to UM

Likely that we will begin reviewing locally Likely that we will begin reviewing locally written protocols soon; procedure for written protocols soon; procedure for industry sponsored protocols under industry sponsored protocols under discussiondiscussion

Final testing and re-activation of eProst Final testing and re-activation of eProst systemsystem

Improvement of audit-compliance system Improvement of audit-compliance system conducted in conjunction with the Office of conducted in conjunction with the Office of ResearchResearch

IRB – Plans for 2006IRB – Plans for 2006

Separation of combined committee Separation of combined committee into separate Medical and Social/ into separate Medical and Social/ Behavioral committeesBehavioral committees

Additional “mitoses” of Medical Additional “mitoses” of Medical committees to increase reviewing committees to increase reviewing capacitycapacity

Placement of trained members with Placement of trained members with new members as committees expandnew members as committees expand

Implementation of an IRB member Implementation of an IRB member evaluation systemevaluation system