OCRICC is charged with the administrative responsibility to review compliance risks and facilitate Froedtert Health (FH) system commitment to research projects conducted in any FH entity (Froedtert Hospital, Community Memorial Hospital, St. Joseph’s Hospital) or clinic/program.
Our program’s primary role is to be the link between the investigators and/or their designees and the health system clinical business leaders for research projects using FH resources.
Does Your Project Require Review and Approval through OCRICC?
You must obtain Froedtert Health administrative approval (granted through OCRICC) if your project is using any FH resource, including but not limited to:
- Clinical services (i.e., radiology imaging – requests for phantom studies or site verification/qualification of equipment)
- Surgical/interventional services
- Staff time
- Space (i.e., inpatient, FH clinics, FH ancillary services, etc.)
- Lab services (except for services provided by Wisconsin Diagnostic Laboratories that are set up as external clients)
- Specimens, including “discard” tissue from any FH or OR procedure area
- Pharmacy services
- Patient Health Information (PHI)
- Forms Completion – If sponsor requires any forms to be completed specific to any FH service or source (i.e., Legal Health Record (EMR), surveys, Grant Application documents, Letters of Support, DoD Certificates of Compliance)
If you are unsure whether the resources involved in your project are FH resources, or are unclear exactly what resources you will need for your project or where to direct your research-related questions, please contact OCRICC. Recommendation: contact us prior to your IRB submission.
A Few Facts — Fees for Industry-Sponsored Studies
Starting July 1, 2018, we will charge a one-time fee of $1,500 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 will offset this expense and staff to the level required to meet the turn-around times expected by researchers and sponsors.
Studies with any other funding source, including NIH, nonprofit or internally sponsored awards such as AHW, will not be charged. Our methodology is modeled after the IRB’s invoicing rules.
We will charge the fee 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). The fee will not be charged directly to sponsors, but will instead be invoiced to the investigator/MCW like all other research services. It will be a pass-through cost just like IRB fees so the costs will not be subject to F&A.