Page 78 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A008
SOP Title: Unfunded and Underfunded Research
Medical Director
The Medical Director is responsible for overseeing the process to insure it is carried out in a timely manner while insuring a standard and fair process.
Review Committee
The Review Committee’s responsibility is to provide non-biased feedback to applicants and other reviewers to insure the most meritorious and innovative projects are selected for funding.
5. SPECIFIC PROCEDURE
Appraising the Financial Viability of the Research Portfolio
As RA does not have access or control the budgets of the studies in its portfolio, good business acumen requires that periodically the portfolio is evaluated for unfunded or under-funded studies that pose unjustifiable burden on our staff resources. The studies identified from this inventory are posited to the referenced committee for a Mission Review where potential funding resources are considered and applied to the most meritorious and mission aligned studies. Unfunded or underfunded studies that are determined not to meet the Mission’s Vision sufficiently enough and for which funding cannot be found may be eliminated from the portfolio to reduce the opportunity cost of our coordinator staff. RA can support the navigation of the internal review and application process as outlined in the SOP titled Children’s Clinical Research Advisory Committee (CCRAC) Grants Process. For a more detailed review of the internal grants and RA support in the Mission Review, selection and application processes, please visit the RA website on Sharepoint: http://cmc- childnet/ChildNet/Departments/ClinicalResearch/ResearchGrants.asp
Unfunded Research
Unfunded research from research funding expiry or research subsumed from structural realignment can impose opportunity cost on our resources. Where research funded through internal funds, such CCRAC, service package grants (SPG), Mission Grants, or otherwise foundational resources from our institution is concerned, RA is responsible for tracking the use of resources and providing notice to the stakeholders when 75% of the awarded resources is evaluable. RA can inform what options are available for continued support and make use of the remaining funding to prepare transition of the study to a non Children’s employed resource or study team member. For unfunded studies assigned to RA staff, the Team Lead should track all effort being allocated on the Effort Justification tracker kept: N:\Team Leads\6_Work Attestations.
Underfunded Research
Underfunded research from inadequate financial feasibility, changes in the expectations from sponsors, or drift that modifies the amount of workload put on our RA coordinating staff, can impose opportunity cost and undue burden that can take away from managing priorities across other research. For this reason, RA will periodically evaluate the amount of time actually required to the amount of time budgeted to support the staff’s time on a study to determine the financial viability. This
Page 3 of 4