Learn More About These Changes
Froedtert Health OCRICC has been in place since 2008 and is responsible for providing administrative approval to conduct research in all of the Froedtert Health affiliates. This approval includes Medicare Coverage Analysis (MCA) for any services billed by a Froedtert Health Affiliate and validation of operational feasibility from the institution’s perspective. Even with IRB approval, a project requiring use of any Froedtert Health resource cannot begin activities without Froedtert Health final administrative approval granted though OCRICC.
If you are unsure whether the resources involved in your project are Froedtert Health resources, are unclear exactly what resources you will need for your project or where to direct your research-related questions, we strongly recommend you contact OCRICC prior to your IRB submission at firstname.lastname@example.org or 414-805-4082 to discuss.
Any research that will be conducted in a Froedtert Health affiliate location and/or requires a Froedtert Health resource (i.e. hospital/technical services, staff/space resources, or support from a Froedtert Health affiliate) is required to get Froedtert Health administrative approval from OCRICC. This activity is separate and distinct from MCW’s determination of whether an MCW department can support the research.
We also have several guidance documents that provide additional assistance related to the process.
- Research Pricing Guidance
- Operational Feasibility Determination Guidance
- Medicare Coverage Analysis Guidance
- Informed Consent Guidance
Fees for Industry-Sponsored Studies
A one-time fee of $1,500 is charged for all studies where the funding source is an industry sponsor. The work involved in making sure that Froedtert Health can accommodate the needs of individual research protocols in a clinical environment, and that all regulatory, compliance, and billing requirements are met for the institution, is very tedious and time-consuming work. The fee offsets this expense and supports staffing to the level required to meet the turn-around times expected by researchers and sponsors. Our methodology is modeled after the IRB’s invoicing rules.
- Studies with any other funding source, including NIH, nonprofit or internally sponsored awards such as AHW, will not be charged.
- The fee will be invoiced to the investigator/MCW at the time the study is approved by OCRICC.
- There is no fee if a study does not complete start up (if site is unable to negotiate budget, negotiate contract or enrollment ends before start up is completed).
- A formal justification letter for sponsors can be found here.
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