Protecting our patient’s protected health information (PHI) is of utmost importance to Froedtert Health.
For all projects using Froedtert Health resources, including data collection projects using Informed Consent, OCRICC review and approval is required prior to conducting your research.
This includes all projects except those that are registered with the IRB as a Category 8 project, which no longer require OCRICC review and approval but do still require completion of an Accounting Log specific to that disclosure. Instructions are included in the IRB registration letter for applicable studies.
Any human subjects research that may use or disclose PHI for research purposes must be reviewed and approved/registered (or determined to be exempt) by an MCW/Froedtert Health IRB or MCW/Froedtert Health designated IRB under one of SIX (6) pathways prior to becoming an active protocol:
- Human subjects research or clinical trials with informed consent and HIPAA authorization;
- Waiver or alteration of the authorization requirement;
- Reviews preparatory to research;
- Research on decedents’ information;
- Limited data set; or
- De-identified data.
- Investigators who plan to use or collect PHI for anything other than treatment, payment or healthcare operations may be required to obtain authorization from the patient/subject.
- Investigators must obtain IRB approval and/or approval from the Privacy Board to access PHI for the purposes of research. The MCW/Froedtert Health IRB functions as Privacy Board for MCW and Froedtert Health.
- Investigators must follow both MCW Corporate and Froedtert Hospital Corporate Policies and Procedures with regards to authorized access to PHI and medical records.
Requesting PHI, Images and Other Data (Including Aggregate, Statistical or Feasibility Information)
The preferred Froedtert Health/MCW method for researchers to acquire Froedtert Health information is through the Medical College of Wisconsin (MCW) Clinical & Translational Science Institute (CTSI) Clinical Research Data Warehouse (CRDW). Information available through the MCW CTSI CRDW includes Froedtert Health PHI, images, patient/business financial information and other aggregate or statistical data. Current Froedtert Health data as well as some legacy Froedtert Health data can be acquired via the MCW CTSI CRDW.
- To request MCW CTSI CRDW services, please visit ctri.mcw.edu/cda/i2b2-cohort-discovery-tool.
- To request the MCW CTSI CRDW Imaging services (identifiable/de-identified), please visit: ctsi.mcw.edu/investigator/services/image-deid/request-imaging-de-identification-services.
Access to Froedtert’s Electronic Medical Record System (EPIC) is limited to persons who are employees of Froedtert Health and/or the Medical College of Wisconsin. There is an approved permitted-use pathway that exists for business vendors and research sponsors/monitors. This is access is limited and monitored through existing internal processes that meet permitted-use guidelines.
Requesting Patient Billing Information
This type of information can only be requested by the patient/participant. The patient must contact Froedtert Health Patient Financial Services at 800-466-9670.
Attestation of Electronic Health Record (EHR) and Electronic Signature / CFR Title 21, Part 11 Attestation
Froedtert & the Medical College of Wisconsin health network provides the following Electronic Health Record and Electronic Signature certifications for the Epic Electronic Health Record (EHR) System. It is recommended you provide this certification form to your sponsor before completing any additional checklists or forms regarding the EHR, as this certification should fulfill their requirements.
If your sponsor then requests further information, please forward the request directly to OCRICC at [email protected] and we will facilitate.
