MCW as an institution has chosen to limit the scope of its Federal Wide Assurance (FWA) to apply to federally funded and/or FDA-regulated research. Since January 2017, certain MCW local research projects not funded by federal sources, and/or not regulated by the FDA, and so fall outside of the scope of the FWA, may qualify to be reviewed under institutional equivalent protections consistent with the Belmont Report.
Registration Projects and FLEX Review
Under no circumstances will federally funded or FDA regulated research projects qualify for FLEX review
FLEX Review is limited to projects which meet the following criteria:
- All project activities are no greater than minimal risk.
- There is no/ has never been federal support for this project or study team members including: projects where a student/fellow is supported via a federal training grant or other federal funding including support from Faculty Advisor’s federal funding
- Projects with contractual obligations or restrictions that preclude eligibility with this policy. For example: the sponsor’s contract requires the project to be reviewed under FDA or HHS regulations.
- 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 may 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 Versiti Blood Center of Wisconsin (BCW)
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 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.
Projects which qualify for registration will be reviewed under newly defined MCW-specific registration categories which have been modeled from the currently defined federal categories of activities for exempt and minimal risk research projects.
These categories will only be applied to research projects which qualify for FLEX review and are considered registration projects.
- Category 1: Evaluation or comparison of educational techniques or instructional curriculum
- Category 2: Conducting surveys, questionnaires, focus groups, or interviews
- Category 3: Use of specimens that has been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)
- Category 4: Taste and Food Quality evaluations
- Category 5: Blood draws via venipuncture, finger, heel or ear stick
- This category has specific criteria which must be met to qualify under this category such as limits on amount of blood collected depending upon the subject population to be included
- Category 6: Prospective collection of biospecimens via non-invasive procedures
- Category 7: Prospective collection of data via non-invasive procedure
- Category 8: Research involving materials (i.e. data, documents, or records) that has been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
- Category 9: Collection of images, video or recordings for solely for research
- Category 10: Psychosocial interventions
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 be required to submit Continuing Progress Reports (CPRs).