July 2013 Archives

There is a new process for obtaining clinical data for researchers at the University of Minnesota. Health researchers NOW have access to clinical data from the electronic medical records of patients seen at Fairview Health Services hospital and clinics. Visit the Data Access page to request data and for more information..

For routine requests, there is no charge for the service. Response time for most approved requests will be under 10 working days, as it was with requests made to Fairview Health Services. More complex queries will take longer.

This is a core service for researchers offered by the Clinical Translational Science Institute (CTSI) and the Office of Biomedical Health Informatics (BMHI). This arrangement and the associated services are the outcome of a recently forged partnership between the University and Fairview Health Services.

This service, will achieve key outcomes:
• Provide critical medical/health data for health-related research.
• Support efficient processes to ensure compliance with federal, state, and university regulations.
• Reduce the risk of unintended use of patient data.
• Streamline IT processes through centralizing IT server/hardware management and storage, where applicable
• Ensure standardized employment of consistent legal agreements for vendors.
• Provide free access to analytic tools.

NOTE: This process will NOT impact any active data feeds from Fairview. Regular data feeds to the Academic Health Center that populate registries and research databases will continue. This change will only affect individual research requests for retrospective analysis, feasibility planning, or subject recruitment.

If you have questions about this process, please contact the Informatics Consulting Service.

i2b2 is a cohort discovery tool - this tool assists the researchers in determining the number of patients matching key study criteria. These criteria include patient demographics, diagnoses (ICD9 codes), procedures (ICD9 and CPT codes), and clinical information.

Understanding study feasibility, early in your study design is a critical first step in the path to successful research.

The i2b2 tool searches the Academic Health Center Information Exchange clinical data repository to determine the size of the cohort that meets your study criteria of interest; including patient data from the Fairview Health Services hospitals and 40+ clinics - representing over 1.8 million patients.

Because no patient identifiers or clinical data are revealed, i2b2 is available without IRB approval.

For more information or help with i2b2 click here. Or contact the Informatics Consulting Service.

Effective July 1, 2013, the Human Research Protection Program (HRPP) will facilitate scientific assessment of new biomedical research proposals. This assessment may be used to fulfill the scientific review requirement when submitting applications for full committee medical reviews to the Institutional Review Board (IRB).

More information about the IRB's scientific review requirements, including other options for meeting these requirements, may be found here.

HRPP facilitated scientific assessment is requested through a module in the CTR Portal. Download the job aid detailing how to register your project and request assessment.

The CTSI will no longer accept new requests for scientific reviews or assessments.

Contact the Research Navigator if you have further questions.