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Guidance on the the UnityPoint Health - Meriter & UW IRB Partnership
What is the UnityPoint Health - Meriter/University of Wisconsin-Madison (UW) IRB Partnership?
Several UW investigators conduct research that involves patients, samples, or records from Meriter Hospital. In the past, IRB review and approval from both the Meriter Hospital and a UW IRB was required for these studies. In order to assist our researchers and streamline IRB review, the UW and Meriter Hospital have entered into a joint agreement to allow for a single IRB of record (i.e., one institution can defer IRB review to another) between these institutions. This agreement means that for most research conducted by UW employees or students involving Meriter Hospital patients (or their records or samples) will now be reviewed by a single IRB (i.e., Meriter or a UW Health Sciences IRB). There will still be some cases when both the Meriter IRB and a UW IRB will need to retain oversight of a research study and researchers will then need to submit their proposals to both IRBs or cases where researchers will need to obtain approval from other IRBs in addition to a UW or Meriter IRB.
Which UW IRBs are covered by this agreement?
Currently, only studies submitted to the UW Health Sciences IRB and Health Sciences Minimal Risk IRB are covered by the agreement with Meriter Hospital. The UW Education and Social/Behavioral Science IRB is not part of this initiative.
Which studies fall under this agreement?
Any non-exempt human subjects research conducted by employees and students under UW purview that has not yet undergone IRB review and involves Meriter Hospital patients (or their records or samples) may qualify for review by a single IRB. The following projects do not qualify for consideration of IRB deferral between UW and Meriter because they are likely to qualify for exemption and are best handled internally by each institution:
- projects that do not constitute research (e.g., quality assurance initiatives)
- projects that do not involve human subjects
Which IRB is likely to serve as the IRB of record?
The table below provides an overview of which IRB would be expected to review and maintain oversight of a research project and identifies situations when dual IRB review may still be necessary. Decisions will be made on a case-by-case basis and both institutions reserve the right to retain IRB review of a project even if listed in the chart below as one likely to be deferred to another institution.
|Characteristics of Study||UnityPoint Health - Meriter Review||UW HS-IRBs Reivew||Both Institutions||Notes|
|All subjects recruited, medical records used, or study activities occur at Meriter
|Retrospective chart review, including Meriter records, UW/UWHC/UWMF records
||X||Access to UWHC records and HealthLink Records may be reviewed by the Meriter IRB only when the PI is a UW health sciences faculty member and the same access is being granted to Meriter records as to UWHC and HealthLink records
|Studies limited to the use of discarded specimens collected for clinical purposes from Meriter and UW/UWHC/UWMF patients, except tissues collected for creation of Induced Pluripotent Stem (IPS) cell lines and gametes
||X||Use of discarded specimens from UWHC
patients must also be approved by the
UWHC Pathology department, unless
exempt under UWHC Policy #7.01(IV)
|Studies limited to collection of biological specimens through
venipuncture or noninvasive means for research purposes from Meriter and UW/UWHC/UWMF patients
unless for the creation of embryonic stem cell lines or IPS cell lines
|Studies involving collection of data through noninvasive procedures routinely employed in clinical practice (except x-rays, microwaves, or devices not cleared/approved for marketing) that involve Meriter and UW/UWHC/UWMF patients||X|
|Research involving subjects drawn from Meriter Child & Adolescent Psychiatry Unit, or Meriter Addiction Medicine and no drug or device is involved||X||If study involves investigational drugs or devices, deferral to Meriter by UW unlikely|
|Studies involving the testing of investigational drugs or devices||X||Decision as to whether deferral would be granted depends on where drugs are administered or devices implanted; IRB of record likely to be the committee that has purview over the site at which theadministration or implantation occurs|
|Studies, other than those noted above, that involve
UW/UWHC/UWMF patients, records, or facilities
|Donations of embryos for research purposes involving Meriter and UW/UWHC/UWMF patients or research involving embryonic stem cells||X|
|Collection of tissues for the creation of IPS cell lines||X|
|Creation and maintenance of tissue banks or databases for research purposes that involves samples and/or data from both Meriter and UW/UWHC/UWMF patients||X|
|Epidemiological research that includes subjects from Meriter and UW/UWHC/UWMF||X|
|Multi-site research that involves institutions or clinical practices beyond those that fall under UW or Meriter purview||X||Unless UW’s involvement in the research|
|Research involving prisoners||X|
|Research involving the Madison VA||X|
How do I initiate a request for consideration under the Meriter Hospital/University of Wisconsin-Madison (UW) IRB Partnership?
After reviewing the table above to determine the IRB most likely to serve as the reviewing IRB for a study, the principal investigator submits a formal request to that IRB Office. Please see the Instructions for Using the UnityPoint Health - Meriter & UW IRB Partnership . These instructions will walk you through the process.
Before the IRB Office from the relying institution finalizes approval of the deferral request, it will ensure that relevant institutional requirements are met, such as conflict of interest and other institutional approvals.
If the UW cedes IRB review to Meriter Hospital, is the project excused from scientific review?
If the project would otherwise be required by the UW Health Sciences IRBs to undergo scientific review by the Institute for Clinical & Translational Research (ICTR) Scientific Review Committees (SRCs) or UW Comprehensive Cancer Center Protocol Review & Monitoring Committee this requirement will not be waived if the UW agrees to cede IRB review to Meriter Hospital. The ICTR SRCs have agreed to review appropriate studies on Meriter Hospital’s behalf.
Which consent form template should I use?
Consent documents should be created based on the template provided by the expected IRB of record. In future, a joint consent document may be developed. The UW requires certain wording to be included in consent forms, particularly specific compensation for injury language.
Which HIPAA authorization form template should I use?
If the research falls under the HIPAA Privacy Rule requirements and an authorization form separate from a consent form is used, the HIPAA documents should be created based on the template provided by the expected IRB of record. The UW has a program that assists research teams in creating HIPAA authorization forms available at Authorization Form Wizard.
Which human subjects training is required?
Both UW and Meriter require personnel engaged in human subjects research complete training modules within the CITI system. The institutions differ, however, in their specific training requirements. Currently, UW employees and students are required to complete the Document 34045 is unavailable at this time..
Who do I contact if I have questions about this process?
- UW-Madison Health Sciences IRBs
- Reliance Team: email@example.com