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Last Updated: 11/19/19
Quantitative Imaging Network (QIN)

QIN Cooperative Agreement for PAR-18-248

Terms and Conditions

For PAR-18-248:

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Defining the overall research objectives and approaches;
  • Determining experimental approaches, setting milestones for tools/methods development, and overseeing the conduct of analyses of data and other steps related to tools/methods implementation;
  • Overseeing and coordinating the effort of the investigator's team and participating institutions to ensure optimal effort integration;
  • Overseeing the conduct of UG3/UH3 research projects and ensuring their scientific rigor;
  • Ensuring compliance with the applicable mandatory regulations (including protection of confidentiality of any clinical data);
  • Adhering to the NIH policies regarding intellectual property, data release, and other data/resource policies;
  • Submitting a comprehensive annual update report to the NCI Project Scientist (apart from the Non-Competing Progress Report RPPR and financial statements as required in the NIH Grants Policy Statement) for inclusion in the Annual QIN Overview Report.
  • Participate in webinars, annual meetings, and conference calls to share research findings with the research community
  • Notifying the NCI Project Staff Scientist approximately 60 days prior to the termination of the UG3 phase of the project that a review of milestones and progress must be scheduled.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NCI Project Scientist will be responsible for:

  • Providing advice to the awardees on specific scientific, analytical, and clinical issues, as appropriate;
  • Serving as a liaison between the UG3/UH3 awardees and the NCI;
  • Facilitating interactions, sharing of data, and other forms of scientific integration across the UG3/UH3 awardees;
  • Promoting collaborations/interactions with other NIH-supported initiatives or investigators and assisting with coordination of such efforts;
  • Advising awardees with regard to various regulatory and compliance issues;
  • Participating in teleconferences with PDs/PIs to monitor progress and facilitate cooperation; and
  • Monitoring progress of the projects towards meeting milestones and adherence to the strategic goals of the program.
  • Scheduling a committee to review the progress under the UG3 phase of the project. The review process is to be conducted and completed in accordance with Part 2 Section 1 of this FOA.

Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This NCI Program Official will be responsible for conducting a UG3 to UH3 transition review.

NCI reserves the right to phase out or curtail an individual award (including the UH3 phase) in the event of inability to meet milestones or insufficient progress towards meeting milestones.

Areas of Joint Responsibility include:

  • An Executive Committee (EC) will be the main governing board for the network. The EC will be jointly established by the lead PD/PIs of the awarded multi-disciplinary teams and selected NCI staff members.
  • The EC will consist of the following voting members:
  • Two representatives from each awarded team (e.g., one from the clinical center and the other from the basic science group), who will collectively have a single vote for each team; and
  • Two designated NCI Program staff members (Project Scientist[s] and Coordinator), who will collectively have one vote for the NIH.
  • The EC will elect one of the team investigators as its chair for a 1-year term annually during the period of the program.
  • Responsibilities of the EC will include:
  • Discuss progress of each team and make recommendations that encourage intra-team collaborations to enhance progress and consensus on validation methods;
  • Review and facilitate the efforts aimed at sharing of validation methods and related databases across the Network;
  • Review the efforts of the Research Resource teams during the course of their efforts;
  • Schedule and organize an annually meeting at which network members will present their scientific progress and future plans;
  • Schedule monthly telephone conference calls to coordinate the activities of the network.
  • All EC decisions and recommendations that require voting will be based on a majority vote.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Executive Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR.

QIN Non-Cooperative Agreement for PAR-18-919

For PAR-18-919:

A R01 mechanism of support is provided to research organizations interested in clinically translating already optimized quantitative imaging software tools capable of measuring or predicting the response of cancer to clinical therapies, or in translating imaging software tools for planning and validating radiation therapy treatment strategies in clinical trials. The quantitative software tools must have been developed and optimized during a performance period in the Quantitative Imaging Network (QIN) or under other separate funding. The proposed research effort should be an extension of the research that successfully completed the tasks of developing and optimizing the chosen software tools or data collection methods intended to facilitate clinical decision making during clinical trials. Consequently, this FOA is intended to support the efforts of validating those software tools in prospective multisite clinical trials to test software tool performance and to demonstrate that the software tool can be integrated into clinical workflow with a minimum of disruption. PAR-18-919 does not support the running of any clinical trials. It will, however, support the cost of obtaining imaging and metadata from existing clinical trials as needed to validate QI tools and methods. When tested in clinical trials, software tools and methods being validated can only be a secondary measure or prediction of response to therapy, and will not be used as (nor will they interfere with) standard of care in any clinical trial.

Specific Objectives for the Clinical Validation Effort

The specific objective for the research supported by PAR-18-919 is to validate and clinically test the software tools and/or methods previously developed by the applicant. The development and optimization may have been done as a member of the QIN or under separate support. Only minimal development and optimization of tools and/or methods will be permitted in this R01 effort. Such additional development and optimization activities include, but are not necessarily limited to:

  • Participation in software challenges, where tools are tested against a standard data set to determine optimized performance,
  • Transposing a tool or method optimized for one cancer problem to another type of cancer or cancer within a different organ site,
  • Inclusion of a tool or method into a pipeline of tools.

Validation of optimized software tools must be the primary goal of this research effort. During this project, investigators may initially use retrospective clinical trial data for tasks such as testing and demonstrating utility of the software tool across vendor platforms. Eventually, however, one or more prospective multisite clinical trials must be selected as the venue for clinical trial validation of tool performance. Not only will the tool(s) be validated, but the challenges of incorporating the tool(s) into a clinical workflow environment can be addressed.