Protocol Feasibility

Inefficiencies in clinical research challenge the effective translation of basic discovery research into improvements in health. These inefficiencies often include an inadequate assessment of local capacity to support research projects via access to data systems, patient cohorts and other key services. When our clinical research workforce is unable to comprehensively assess protocol requirements, otherwise promising projects may be stalled in the initial stages of implementation.

In response to this need, ICTR and School of Medicine and Public Health (SMPH) leadership partnered to develop a standard for assessing clinical research project needs before Institutional Review Board (IRB) commences.  As outlined in SMPH policy 70.10, Feasibility Assessment Requirement for Non-exempt Human Subjects Research, departments are obligated to institute a multi-pronged approach to protocol assessment, to ensure the necessary resources are available, and systems and processes to support protocol implementation are in place.

The below resources and guidance are intended to assist departments with policy compliance.

Forms

Research Feasibility Attestation Form

This form must be included with the initial IRB application.  ARROW will prohibit submissions that fail to upload this form.

Research Feasibility Checklist Template

This is an optional template that provides details to consider when assessing operational feasibility. Researchers and departments can edit this form to suit their needs if they choose.

Frequently Asked Questions

Policy

This is an accordion element with a series of buttons that open and close related content panels.

Are departments required to use the SMPH Research Feasibility Attestation Form?

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.

Are departments required to use the Research Feasibility Checklist?

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

Does the policy apply to studies ceded to an external IRB?

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

Which UW SMPH departments are required to conduct and document feasibility assessments?

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.

Can feasibility assessment occur simultaneous to IRB review?

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.

Does this policy apply to studies reviewed by the UW Carbone Cancer Center Protocol Review Monitoring Committee (PRMC)?

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)

Will there be any exemptions to completing the Feasibility Assessment Attestation Form?

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.

Is there opportunity for appeal by the investigator should the department’s review be unfavorable?

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.

Are all departments impacted by a particular study required to conduct a feasibility assessment?

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.

Can the Department Chair designate more than one designee?

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.

Process

This is an accordion element with a series of buttons that open and close related content panels.

What strategies are departments using to comply with the policy?

  • 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.

Are there other formats for documenting research feasibility assessment?

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:

Is ARROW access necessary to determine a study’s feasibility?

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.

The policy requires feasibility assessment of non-exempt human subjects research, but according to UW policy, only the IRB office (not the investigator) can make such determination. How do I know if feasibility assessment is required prior to IRB review?

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.

Are there any tools to estimate the number of UW patients from which to recruit?

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.

How can competing studies be identified?

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.

What technology resources and data security infrastructure is available within my department?

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

Is there a list of common resources that should be consulted to determine constituent endorsement?

Signatory Designees & Contacts

Some SMPH department chairs have elected to appoint designees to sign the Research Feasibility Attestation Form on their behalf.  Point(s) of Contact represent feasibility experts within a department or operational unit.  If a POC is not listed, please contact the individual(s) listed in the Signatory Designee column for assistance or questions related to your department’s feasibility process.

Note: the University of Wisconsin Carbone Cancer Center Protocol Review and Monitoring Committee (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)
wdt_ID Department | Division Chair | Chief Divisions PRMC Additional Signatory Designee(s) Point(s) of Contact
1 Anesthesiology Joshua Sebranek,  MD NA Laura Zitur, MS
2 Dermatology Beth Drolet, MD NA John Roy, MSHA; Heather Neils
3 Emergency Medicine Azita Hamedani, MD, MPH, MBA NA Manish Shah, MD; Mike Pulia, MD, MS Jessie Libber
4 Family Medicine & Community Health Valerie Gilchrist, MD NA Larry Hanrahan, PhD; David Rabago, MD; Lisa Sampson, MBA
5 Human Oncology Paul Harari, MD X N/A prmc@uwcarbone.wisc.edu
6 Medicine Betsy Trowbridge, MD Shari Zeldin
7 Neurological Surgery Robert Dempsey, MD NA Stephanie Wilbrand, PhD; Greg Zalesak, MPA
8 Neurology Kathleen Shannon, MD NA Kimberly Janko, RN, BSN; Greg Zalesak, MPA
9 Obstetrics & Gynecology Laurel Rice, MD Jennifer Stevens, MPA Jenny Poetter
10 Ophthalmology & Visual Sciences Terri Young, MD, MBA NA Jennie Perry-Raymond; Christina Thomas-Virnig, PhD
Department | Division Chair | Chief Divisions PRMC Additional Signatory Designee(s) Point(s) of Contact