The Marshfield Clinic Health System IRB participates in a variety of IRB reliance partnerships, all designed to streamline the IRB review process for multisite and collaborative research studies.  The status, scope and process for each reliance partnership differ.  Please see below for additional information on each partnership. 

Single IRB of Record Submission Process

A Central (or Single) IRB of Record is a single board that reviews research studies for multiple sites.  A Central (or Single) IRB of Record can be any registered IRB that functions to review multiple sites.  Regardless of the IRB providing it, centralized IRB review is one review for a number of sites.  Commonly, the sponsor determines which sites are to participate and suggests or requires those sites to use a Central IRB selected to perform the centralized review.  In this model, MCHS may serve as either the IRB of Record or relying role.

When relying on a external or centralized IRB of Record, it is the Principal Investigator's responsibility to adhere to policies and procedures of the IRB of Record.  In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail.  However the institutional policies as well as the state and local laws governing human subjects research also need to be adhered to.  The MCHS IRB Reliance Request form is designed to capture the majority of the information necessary to identify the Human Research Protection Program review requirements and various institutional policies.  See also IRB policies - "Deferring, Ceding and Review to an External IRB" and "MCRI IRB as IRB of Record"

All CITI and COI Training/disclosures will need to be completed for all key personnel before any Reliance requests will be reviewed by the IRB.

Wisconsin IRB Consortium (WIC)

The primary purpose of the Wisconsin IRB Consortium (WIC) is to facilitate collaboration among member institutions' Institutional Review Boards (IRBs) in order to provide more effective and efficient oversight of multi-site human subject research protocols in Wisconsin and reduce costs and duplication of effort among the Member institutions and affiliated investigators. WIC has established one agreement that allows any member institution to serve as the IRB of record for another, eliminating the need to draft individual, study-specific IRB authorization agreements for each study reviewed.

The following are participants of WIC:

  • Aurora Health Care IRB, Milwaukee
  • Marshfield Clinic Health System IRB, Marshfield
  • Medical College of Wisconsin IRB, Milwaukee
  • University of Wisconsin-Madison Health Sciences IRB, Madison

If you are an investigator from one of the institutions listed above who is collaborating on a research project with an investigator from another of the participating institutions, your project may be eligible for review through the WIC process. MCHS investigators, please contact the IRB Administrator to discuss this process and fill out the  IRB Reliance Request form.  The collaborating investigator will also likely need to contact their local IRB reliance point of contact and complete a form. 

SMART IRB

MCHS is a participating institution of SMART IRB along with approximately 360 other institutions across the country including most major academic medical centers.  SMART IRB is a flexible, national IRB reliance agreement that is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.  SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status.   

How Does it Work?

      The Overall Principal Investigator (PI) of a multisite study works with the Points of Contact (POCs) for each participating institution involved in the study to determine an appropriate reliance arrangement.  Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research.  SMART IRB website link - https://smartirb.org/

MCHS investigators, please contact the IRB Administrator at ext. 93022 for additional details.

Greater Plains Collaborative (GPC)

The GPC is a network of medical centers focused on improving healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination.  The GPC has an IRB reliance agreement that has been finalized between the following: Children's Mercy Hospital, University Of Kansas Medical Center, Medical College of Wisconsin, University of Nebraska Medical Center, University of Texas Southwestern Medical Center, University of Iowa, Marshfield Clinic Health System, University of Minnesota, University of Texas Health Sciences Center at San Antonio, University of Wisconsin-Madison, and University of Missouri.

GPC under PCORI

Marshfield Clinic Health System (MCHS) is part of PCORI Greater Plains Collaborative (GPC) focusing on three primary areas of patient centered outcomes research.  However use of the GPC IRB Reliance model does not require research to be centered under these three primary areas of focus.  The research proposal should include a Patient Centered Outcome focus and involve one or more the participating institutions working under the GPC reliance model.  If Marshfield Clinic Health System (MCHS) IRB is named as the IRB of Record under a GPC endorsed study, the MCHS Investigator will submit the project to the MCHS IRB. 

MCHS investigators, please contact the IRB Administrator to discuss this process and fill out the  IRB Reliance Request form. 

Health Care Services Research Network (HCSRN)

The HCSRN brings together the research departments of some of the nation's best and most innovative non-profit health care systems.  Collectively, the HCSRN represents more than 1,900 scientists and research staff with methodological and content expertise from an array of disciplines such as epidemiology, economics, disparities, outcomes and quality assessment, trials, and genomics.

MCHS is a current member of this network along with these other organizations: Center for Applied Health Research - Baylor Scott & White, Center for Research & Evaluation – Kaiser Permanente Georgia, Center for Health Research, Hawaii – Kaiser Permanente Hawaii, Center for Health Research, Northwest – Kaiser Permanente Northwest, Department of Research & Evaluation - Kaiser Permanente Southern California, Division of Research - Kaiser Permanente Northern California, Essentia Institute of Rural Health - Essentia Health, Center for Health Research - Geisinger Health System, Harvard Pilgrim Health Care Institute - Harvard Pilgrim Health Care, HealthPartners Institute - HealthPartners, Henry Ford Research Centers & Institutes - Henry Ford Health System, Institute for Health Research - Kaiser Permanente Colorado, Kaiser Permanente Washington Research Institute - Kaiser Permanente Washington, Maccabi Institute for Health Services Research - Maccabi Healthcare Services, Marshfield Clinic Research Institute - Marshfield Clinic Health System, Meyers Primary Care Institute - Fallon Community Health Plan | Reliant Medical Group, Mid-Atlantic Permanente Research Institute - Mid-Atlantic Permanente Medical Group, Palo Alto Medical Foundation Research Institute - Palo Alto Medical Foundation

For additional details on the HCSRN please view the website at http://www.hcsrn.org/en/

MCHS investigators, please contact the IRB Administrator to discuss this process and fill out the  IRB Reliance Request form.

National Cancer Institute Central IRB (NCI CIRB)

MCHS IRB has an IRB reliance agreement with the NCI CIRB, which provides centralized IRB oversight for institutions conducting certain types of oncology trials.  Eligible studies must obtain institutional sign-off through the submission to the IRB to cede review.

MCHS Investigators will need to provide the IRB with the IRB Institutional Certification for IRB Deferred Studies and if applicable the Waiver of HIPAA Authorization.  

Western Institutional Review Board (WIRB)

MCHS IRB has contracted with Western Institutional Review Board (WIRB) for the option of review and oversight of new industry initiated and industry sponsored protocols that meet certain criteria.  MCHS IRB will have the option to elect to allow the study to remain with the MCHS IRB upon the request from the MCHS investigator.

MCHS investigators, please contact the IRB Administrator to discuss this process and fill out the  IRB Reliance Request form.