The reasons for implementing these new procedures are twofold. First, these updates are to keep in line with new federal regulations governing the IRB oversight of minimal risk projects. Second, the MCW/FH IRB hopes these procedures will simplify the application process for investigators as well as reduce the length of time the IRB requires to review new projects.
Registration only applies to projects which meet all of the following criteria:
- All activities are no greater than minimal risk
- No federal support for the project, present or past
- Projects with no contractual obligations or restrictions that would preclude eligibility with this policy
- Project is not subject to FDA regulation
- Project does not involve prisoners as subjects
- Project does not have an executed Inter-Institutional Reliance Agreement in place
- Project is not a local bank
- Project does not include international site(s) under the supervision of the PI
- Project is limited to activities that will occur solely at MCW, a Froedtert Health entity and/or BloodCenter of Wisconsin (BCW)
Projects which are determined to be eligible for FLEX review will undergo a streamlined review process. MCW's FLEX review process and a registration determination is an institution-specific research review process for eligible minimal risk projects. Further, registered projects will not require Continuing Progress Reports (CPRs).
If a project meets the criteria for registration, projects will be re-classified at the time of the next amendment.
The IRB will determine whether a project should be registered or approved based on the inclusion and exclusion criteria for registration.
No, Continuing Progress Reports (CPRs) are not required for registered projects and will not be accepted.
Registered projects will be subject to the same QA/QI review as approved projects.
If your registered project involves the use of any Froedtert Health resource such as, space, staff services, supplies/equipment or any ancillary services - lab, pharmacy, radiology, protected health/billing information or specimen requests, OCRICC approval is required before beginning any research activity at those sites. It is recommended that you contact OCRICC before registration with the IRB
Should you have questions regarding project registration, please contact the MCW/FH IRB Office at (414) 955-8422 or IRBOffice@mcw.edu.
Additional information can also be found on the MCW/FH IRB website