Protocol Feasibility

Yes. Departments must complete the Research Feasibility Assessment Attestation Form and upload it within ARROW.  Indicate “not applicable” for feasibility criteria not relevant to the study.

No. The Research Feasibility Checklist is optional. Departments may development their own processes and forms for conducting operational feasibility assessment.

Yes, the policy applies to applications to “Request to Cede IRB Review.”

The requirement for operational feasibility assessment is based on the nature of the proposed research and the principal investigator’s primary academic appointment within UW SMPH. The policy applies to both clinical and basic science departments. UW SMPH faculty that conduct research subject to this policy must develop and document a process for feasibility assessment.

No. Feasibility assessment must occur prior to IRB review. ARROW will prevent submission of applications that do not have the “Research Feasibility Attestation Form” uploaded.

Yes. The policy applies to studies reviewed by PRMC.

PRMC will fulfill the requirement for conducting and documenting protocol feasibility assessment of non-exempt human subjects research in which the study’s principal investigator has a primary appointment within:

• A532820 (Gynecologic Oncology)
• A533300 (Human Oncology-gen)
• A534260 (Hematology-Oncology)
• A536755 (Peds Hematology/Oncology)

No. All research studies that fall under the scope of the policy are required to complete the attestation form. This includes non-exempt human subjects research conducted in a non-clinical setting. Feasibility domains can be marked “Not Applicable” if they do not apply to a study.

At the request of the SMPH Dean, only studies that obtain department approval (as indicated by the attestation form) may proceed to IRB review. Departments may create their own appeal processes or take steps to remedy a study’s feasibility.

No. Only the department in which the principal investigator holds a primary appointment. The support of other departments potentially affected by a study should be captured on the attestation form under the “Constituent Endorsement” section.

Yes. A department chair may designate more than one individual to sign the attestation form on his or her behalf. Additionally, the department chair may choose to delegate responsibilities to division chiefs.

• Committee Approach

Many departments use committees to evaluate operational feasibility.  Committee members often include Department Chairs, Division Chiefs, Research Administrators, Study Coordinators, Fiscal Managers, and Data Coordinators.

• Iterative Approach

Departments may elect to charge individuals with the requisite expertise to independently but simultaneously evaluate each of the required feasibility domains.  For example, a financial specialist might be tasked with assessing the budgetary aspects while an IT professional evaluates data security and a research manager estimates staffing needs.

• Office of Clinical Trials (OCT)

At the request of a SMPH department, OCT will conduct operational feasibility assessment for studies that use its fiscal, regulatory and coordinator services.

Departments have liberty to document the research feasibility process in a manner most convenient for their workflows.

Alternatives to the SMPH Research Feasibility Checklist include:

• Adapting a document from a peer institution.  For example:
  • University of Alabama at Birmingham
  • University of California San Francisco
  • Indiana University
  • University Hospitals Cleveland Medical Center
• Developing a database in REDCap.
• Using meeting minutes to capture discussion that might occur at convened meetings of a “feasibility committee.”

No, ARROW access is not necessary to fulfill the obligation of feasibility assessment.  A study’s feasibility should be confirmed prior to preparation of an initial IRB application (i.e., time and effort should not be devoted to completing an ARROW application for studies that are not feasible).

The department chair or designee should return the signed Research Feasibility Attestation Form to the principal investigator or study team for inclusion with the initial IRB application.

Refer to Knowledgebase Document 79052 “Guidance on Exemption Categories under the Revised Common Rule.  It contains an interactive tool to assist research teams in identifying whether their study may qualify as exempt.

ICTR offers three informatics tools to assist researchers in determining the number of patients matching key study criteria.

• i2b2 Cohort Discovery Tool.  This self-service tool allows researchers to determine the approximate number of patients within the UW Health Enterprise Data Warehouse who meet eligibility criteria.  i2b2 does not provide any patient identifiers or additional clinical data.
• Clinical Research Data Services (CRDS).  The CRDS team assists investigators with developing queries and securely delivering both de-identified data and patient-specific data from the UW Health Enterprise Data Warehouse.  CRDS can be used to assess feasibility when cohort criteria are too complex for i2b2 or identify potential participants when a study is open to accrual.

Implementation of this policy should help raise awareness of competing studies proposed by faculty within the same SMPH department.

Given the depth and breath of research at UW SMPH, it can be challenging to identify competing studies across departments.  A couple of strategies to consider:

• Review ClinicalTrials.gov.  The advanced search feature enables query by condition, recruitment status, basic eligibility criteria, location and more.
• In summer 2019, ICTR and UW Health will launch Study Information Portal (SIP), a web-based repository of active clinical research studies at UW-Madison.

Information Technology contacts for each SMPH department can be located at https://it.med.wisc.edu/departmental-it-resources.

Contact your department representative to:

• Inform them of research that involves electronic data of any kind. Even if a study does not entail protected health information (PHI), other sensitive information may require special technology considerations or detailed planning.  Additionally, your local IT team can help identify services and resources that may benefit your study.
• Request assistance developing a Data Security Plan
• Inquire about the need for a Technology Usage Plan

• Clinical Research Unit
• Emergency Department
• Pharmaceutical Research Center
• UW Department of Radiology Medical Imaging Research Support
• UW Health Nursing Resources