School of Medicine & Public Health – Feasibility Assessment Requirement for Non-Exempt Human-Subjects Research

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Policy Number:
SMPH-7010
Old Policy Number:
70.10
Responsible Office:
Institute for Clinical and Translational Research (ICTR)

School of Medicine and Public Health (SMPH) Policy

Rationale/​Purpose:

Robust feasibility assessment promotes early identification of recruitment barriers, highlights logistical challenges, and uncovers aspects of research that may require detailed planning. The goal of this vetting process is to ensure that research is well designed, likely to achieve participant accrual goals, and that costs are adequately covered. Furthermore, evaluating the presence of suitable facilities, resources, and personnel is essential to the protection of human subjects.

The purpose of this policy is to define the minimum expectations for feasibility assessment and documentation of non-exempt human-subjects research conducted by School of Medicine and Public Health (SMPH) faculty and staff.   

Definitions:
Department
The organizational unit within SMPH where the principal investigator (PI) holds their primary academic appointment.   
Department chair
The individual (e.g., dean, chair, director) or designee from the PI’s primary organizational unit who is charged with providing research leadership. 
Feasibility assessment
An exercise to gather information from Ps, research staff, data systems, and other stakeholders to make an informed decision about the possibility of conducting a research study at a proposed location(s).  
Principal investigator (PI)
The individual who bears ultimate responsibility for all activities associated with the conduct of a research study, including compliance with federal, state and local laws, institutional policies, and ethical principles. The PI remains ultimately responsible even when some aspects of the research are delegated to other members of the research team. 
Scope:

This policy applies to most non-exempt human-subjects research conducted by UW faculty with an SMPH primary appointment, regardless of funding source or initiating entity. In the case of research studies that will be reviewed by a UW Health Sciences Institutional Review Board (IRB), this policy does not apply to applications limited to grant submissions, statistical data analysis or reading centers, emergency/one-time uses, compassionate uses of test articles, and humanitarian use devices.  

Feasibility reviews will be required for any non-exempt research ceded to an external IRB. This policy is not intended to supersede existing systematic processes for assessing feasibility by a department, but rather to set a minimum standard. 

Policy:

  1. Policy Statement

    1. Research conducted by SMPH faculty must undergo a department-level feasibility assessment prior to IRB review. 
    2. The department chair must attest to the operational feasibility of the study, the availability of necessary resources, and department acceptance of the study. (This process also serves to alert the department chair of all research under their purview.) 
    3. Departments may adjust the level of scrutiny based on the nature of the research (e.g., minimal risk vs. more than minimal risk; investigator-initiated vs. industry-initiated). 
    4. Departments have discretion to conduct feasibility or other assessments of any studies that will undergo IRB review, including exempt human-subjects research. However, the IRB will not be responsible for ensuring compliance with this policy in these cases.

  2. Responsibilities

    1. Institute for Clinical and Translational Research (ICTR): On behalf of SMPH, ICTR will assist with policy implementation and maintenance.   
    2. Health Sciences Institutional Review Boards (HS IRBs) Office: At the request of the SMPH dean, the HS IRBs Office will verify the completion of a departmental feasibility assessment for research in which it will serve as the IRB of record and for research that is ceded to an external IRB (e.g., Western IRB, Quorum, Advarra) but would otherwise have been reviewed by the HS IRBs.
    3. Principal investigator: The PI is responsible for designing and/or assessing a study to ensure it is meritorious and can logistically be conducted at the desired site(s) based on the design, access to appropriate patient populations, availability of adequate facilities and equipment, and other necessary resources. The PI is also responsible for obtaining all required institutional approvals before entering the first participant. The PI or their designee will provide documentation of feasibility review via the Application Review for Research Oversight at Wisconsin (ARROW) system.
    4. Department: The department is responsible for establishing and documenting its own processes to:
      • Collect the documentation necessary to perform feasibility assessments (e.g., protocols, consent forms, participant questionnaires).
      • Evaluate documentation to ensure the practicality of the proposed research and address areas that may need additional attention to ensure successful study implementation and completion.
      • Document feasibility assessments (or recusal) and resulting judgment to the PI and other entities, as required.
    5. Department chair: The department chair [or designee(s)] is responsible for attesting that the research feasibility assessment has occurred and committing necessary resources for the research.   
Procedure:
  1. According to the department’s established processes, appropriately qualified personnel must review the research protocol and supporting materials to evaluate required feasibility domains (Table 1). Departments may elect to assess additional feasibility elements.
    Table 1. Required Feasibility Domains
    Merit Constituent Endorsement
    Fiscal Acceptable Clinical Practice
    Personnel Recruitment
    Space and Facilities Data Security and Electronic Health Record Considerations
    Equipment and Test Articles Multi-Site Investigator-Initiated Research
  2. The department shall document feasibility review.
  3. If the feasibility assessment is not favorable, the research should not be pursued, and no further action is necessary. If the review is favorable and the research will be pursued, the department shall complete the Research Feasibility Attestation Form and obtain required signature(s).
  4. If the research is deemed feasible by the department, the Research Feasibility Attestation Form should be uploaded within the Supplemental Information section of the ARROW application. Applications submitted without the required form will be flagged during IRB administrative review.
Related UW–Madison Documents, Web Pages, or Other Resources:

Policy Administration

Approval Authority:
Dean, School of Medicine and Public Health
Policy Manager:
Associate Dean of Clinical Trials
Contact:
Associate Dean of Clinical Trials -- Nasia Safdar, ns2@medicine.wisc.edu, (608) 263-1545
ICTR Multisite Research Project Manager -- Theresa Lins, tlins@wisc.edu, (608) 262-7586
Effective Date:
10-01-2018
Date Issued:
10-01-2018
Revised Dates:

10-01-2021, 04-01-2019  

Retrieved:
04-19-2024 12:00:21