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OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

The VCU HRPP would like to share this message from Mary Harmon, regarding clarifications surrounding the process to obtain data from VCUHS EMRs. 

Please direct questions regarding this process to Mary Harmon.

VCUHS and VCU would like to take this opportunity to provide clarity to recent changes and communication regarding the approved pathways to request/obtain data from the VCUHS EMR.  These pathways have been vetted and align our data access options with HIPAA regulations, etc.

Screening for Eligibility

  • A partial waiver of authorization from the IRB and Privacy Board is necessary to cover the screening for eligibility of patients entering the Health System for an active visit.  There should be a clear connection between the reason for the patient’s visit and the clinical indicators for the study, or a provider has referred the patient for screening.  Example: A patient arrives for a visit in a liver disease clinic.  The patient’s electronic medical record can be accessed to screen the patient for liver disease studies that have obtained a partial waiver form the IRB and Privacy Board.  However, the patient’s electronic medical record should not be accessed to screen for a heart failure study without a referral from a provider.

Cohort Discovery or Secondary Data Review

  • All requests for VCUHS data will be managed by VCU Informatics (https://informatics.vcu.edu/) unless the data are not available through VCU informatics
  • VCU Informatics provides:

o   Cohort discovery

o   Discrete data with an IRB and Privacy Board approval

o   Manual chart review support for any approved data elements not available through a discrete data pull by providing a patient list for the study cohort and setting up data collection forms within Redcap

o   Study participant recruitment support (e.g., identifying potentially eligible patients before they arrive for a scheduled clinic visit)

o   De-identified data

o   Limited Data Sets with a completed Data Use Agreement

We will be discussing this issue at our next Clinical Research Teams Meeting for which a meeting invite will be sent next week.  In the meantime, should you have any questions, please do not hesitate to reach out to me.

Thank you,

Mary

Mary P. Harmon, PhD
Director of Clinical Research
Virginia Commonwealth University Health System
1300 E. Marshall Street
P.O. Box 981055
Richmond, Virginia 23298-0155
Phone: 804-628-7819
Cell: 804-337-6588
mary.harmon@vcuhealth.orgCategories News and Updates
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