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 registration will undergo a streamlined review process. Further, registered projects will not require Continuing Progress Reports (CPRs) and cannot be modified via an amendment process.
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.
Once a project has been registered, amendments cannot be submitted via eBridge or any other pathway. Changes which may alter a project’s qualification for FLEX review cannot be made to a project via an amendment once it has been registered. There are also changes which will not disqualify the project from registration under FLEX criteria, but will still require a new submission.
Investigators must submit a new eBridge PRO application and secure IRB approval under the applicable federal regulations prior to the initiation of any new or modified project activities which would trigger the need for IRB approval. The HRPP office has developed advice for study teams and investigators provide guidance on changes which is posted on the HRPP website.
No, Continuing Progress Reports (CPRs) are not required for registered projects and will not be accepted.
If a reportable event has occurred or if you think a reportable event has occurred, please contact the IRB Office via email or (414) 955-8422, include your PRO# to allow the IRB to fully evaluate the project and IRB personnel will determine the next appropriate action.
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