Cost Recovery Program Implementation Policy

Purpose

To define the policies for cost recovery for CRS core services. These policies will evolve as needed to align requests for services with the availability of CRS resources. CRS remains committed to supporting early career investigators and creating flexible processes to support all investigators adjusting to the new funding model. View CRS Cost Recovery Principles

General Policies

Criteria for using CRS core services

Research studies using CRS services must meet the following criteria:

  • The proposed study is determined to have scientific merit by one of the CRS Scientific Advisory Committees or through an alternative review process sanctioned by the CRS Scientific Advisory Committee. Specifically, reviewers believe the proposed study will contribute to research knowledge OR the study will generate preliminary data that will be used to support a request for funding support within one year of the completion of the preliminary study.
  • Requested services can be safely provided in accordance with regulatory and sponsor guidelines as determined through review/approval by the appropriate CRS core service managers.
  • For studies other than those that are fully funded by industry sponsors, the investigator provides assurance (i) to acknowledge the role of the CTSI in all future publications resulting from the research; and (ii) to provide to CRS a list of all publications, further external funding, and intellectual property arising from CRS-supported research.
  • Investigators must provide full documentation regarding funding for investigator-initiated proposals partially supported by industry.

Review process

All protocols that utilize CRS resources must undergo review by the CRS Scientific Advisory Committee and will be evaluated for:

  1. Scientific merit
  2. Utilization of CRS resources

Recommendations for deployment of CRS resources for each protocol will be made by the CRS Scientific Advisory Committee; prioritization to receive resources will depend on the Committee’s assessment of scientific merit and the quantity of resource support required. The Committee reserves the right to adjust support at any time during a study depending on overall availability of CRS funds.

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Research Sponsored by Not-for-profit Organizations (NIH, CDC, MOD, AHA, JDFR, etc.)

New, revised and competing renewal grant applications

Effective December 1, 2011, investigators submitting new, revised and/or competing grant applications and resubmissions of originally unsuccessful proposals that plan to use CRS resources must include CRS costs in their proposal budgets. Investigators should present a utilization plan to CRS staff prior to grant submission, allowing at least 4 weeks for determination of CRS costs for the study. If requested, investigators must be prepared to submit documentation of budgets submitted and award statements or contracts describing the terms and conditions of funding.

New IRB protocols

Effective September 1, 2012 any new IRB protocol that will utilize CRS resources or any new activation of a protocol not already underway, independent of the grant submission date, must have a budget that includes CRS costs and adheres to CRS cost recovery policies.

Commitments to existing studies

CRS will prioritize available funds to support commitments made to ongoing, approved CRS studies and studies for which protocol-specific funding was secured under a CRS cost agreement prepared before 12/1/11. If modifications to a study protocol result in a need for additional CRS services (e.g., additional subject visits, higher enrollment, or added tests or procedures), including those which occur during study extensions, the investigator will be responsible for payment for those additional services at the rate applied to new protocols per cost recovery policies in effect at that time. Existing commitments are only for services approved prior to the implementation of the cost recovery program.

Shortages of CRS resources will trigger a reassessment of all supported studies and may necessitate curtailment of CRS services or subsidies and/or shortening of the duration of CRS commitment. CRS will make every effort to support existing commitments until the investigator’s grant/contract end date or until the end of the current CTSA funding cycle on June 30, 2016, whichever comes first.

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Industry-Sponsored Studies

Industry-initiated Research

Industry-initiated studies will be charged industry rates and do not qualify for CRS funding support. In instances where UCSF investigators have collaborated to design a study that is sponsored by an industry partner that will own the data, industry rates will be charged and CRS funding will likewise not be provided.

Investigator-initiated, Industry-involved Research (wherein sponsor provides drug/device and/or funding)

Assignment of CRS rates will depend on the proportion of funding from the sponsor as well as the contract language in the Clinical Trial Agreement. Investigators must provide CRS with a copy of:

  1. All relevant correspondence documenting the investigator’s and sponsor’s roles in initiating the study and creating the protocol, and
  2. The industry master contract that indicates who owns the drug or device, who owns the study data and intellectual property, and a line item budget detailing the sponsor's financial support.

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Investigator-Initiated, Unfunded Research

  • Funding should be sought through institutional, departmental, and/or divisional programs, including the RAP programs, and other institutional support opportunities. CRS resources, if and when available, may only be contributed to assist (i) early career investigators whose projects are judged to have a high likelihood of providing pilot data for outside funding or (ii) investigators whose protocols are judged to have exceptional scientific merit by the CRS Scientific Advisory Committee.

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