Basic Requirements for All Core Utilization Requests

1. Studies requesting support must be congruent with the foci and aims of the UM-OAIC mission.
   
   
2. A faculty member who has privileges at the Baltimore VA Medical Center and UMMC is required for medical coverage of study subjects.
   
   
3. The protocol must have UMB, IRB approval and VA R&D approval before the work can be initiated. You may start the core utilization application process prior to full approval.
   
   
4. Submit a yearly progress report that includes all funding received and papers published that utilized the core services.
   
   
5. Participate in the UM-OAIC registry database.
   
   
6. All publications must credit the University of Maryland, Baltimore Claude D. Pepper Older American Independence Center (UM-OAIC); “This was supported by the University of Maryland Claude D. Pepper Older American Independence Center Grant NIH P30 AG028747.”
   
   
7. After the UM-OAIC Core Leadership Executive Committee grants full approval for a protocol, the Principal Investigator must make required reports to the UM-OAIC. These reports are used to monitor the use of the Center’s approved protocol. These reporting responsibilities are in addition to reports required by the institution, study sponsor, or federal government.
   

• Adverse Events: All serious or unanticipated adverse events associated with the research must be reported to the IRB according to the established institutional policy. Please refer to the HRPO webpage. The UM-OAIC Internal Safety Monitoring Board must be notified of these expedited reports by contacting the Program Manager at 410-605-7000 extension 4844 at the time of submission to the IRB;
  
• Data and Safety Monitoring Plan Report: Reports of all Data and Safety Monitoring Plan activity must be submitted to the Program Manager for review at the intervals approved in the DSMP. Examples include safety reports generated by the Principal Investigator, Independent Safety Monitor, Safety Monitoring Committee, and Internal or External DSMBs. Reports and compliance will be reported to and reviewed by the UM-OAIC Internal Safety Monitoring Board.