Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Quantitative Imaging for Evaluation of Response to Cancer Therapies (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of PAR-11-150

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 23, 2014 - Notice of Change in Expiration Date of PAR-14-116. See Notice NOT-CA-14-044.
Funding Opportunity Announcement (FOA) Number

PAR-14-116

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.394, 93.395

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites research project - cooperative agreement (U01) applications which are expected to enhance the value of quantitative imaging (QI) in clinical trials for prediction and/or measurement of response to cancer therapies.  One avenue for this enhancement is to emphasize the development, optimization and validation of state-of-the-art QI methods and software tools for potential implementation in single site phase 1 or 2 clinical trials. The second avenue to enhance QI methods is to address the challenges of integrating existing and or new QI methods as required for multicenter phase 3 clinical trials. This may involve evaluation of a range of multimodal imaging approaches, harmonization of image data collection, analysis, display and clinical workflow methods across imaging platforms, or testing their performance across different cancer sites.

Because this validation process is complex, a single research program cannot be expected to complete every detail from initial tool development to final integration into clinical trials. Therefore, it is anticipated that these research goals will require multidisciplinary efforts. Although the involvement of industrial partners in the development of the QI methods is not required, it is strongly encouraged. Awardees will also join the Quantitative Imaging Network (QIN) to share ideas and approaches in order to validate and standardize imaging data and related imaging metadata for quantitative measurements of prediction and/or response to cancer therapies.

Key Dates
Posted Date

February 26, 2014

Open Date (Earliest Submission Date)

May 5, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

Extended to May 8, 2017 per NOT-CA-14-044 (Originally February 6, 2017)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

This Funding Opportunity Announcement (FOA) invites research project - cooperative agreement (U01) applications which are expected to enhance the value of quantitative imaging (QI) in clinical trials for prediction and/or measurement of response to cancer therapies.  One avenue for this enhancement is to emphasize the development, optimization and validation of state-of-the-art QI methods and software tools for potential implementation in single site phase 1 or 2 clinical trials. The second avenue to enhance QI methods is to address the challenges of integrating existing and or new QI methods as required for multicenter phase 3 clinical trials. This may involve evaluation of a range of multimodal imaging approaches, harmonization of image data collection, analysis, display and clinical workflow methods across imaging platforms, or testing their performance across different cancer sites.

Because this validation process is complex, a single research program cannot be expected to complete every detail from initial tool development to final integration into clinical trials. Therefore, it is anticipated that these research goals will require multidisciplinary efforts. Although the involvement of industrial partners in the development of the QI methods is not required, it is strongly encouraged. Awardees will also join the Quantitative Imaging Network (QIN) to share ideas and approaches in order to validate and standardize imaging data and related imaging metadata for quantitative measurements of prediction and/or response to cancer therapies.

Scope of this FOA

Because imaging methods used in clinical trials must be commercially supported, and because the need for more sophisticated imaging grows, the use of one or more advanced multimodal imaging methods may be required. The entire process of data analysis and comparison with clinical outcomes or alternative methods is a necessary part of validating the chosen quantitative imaging method(s) to measure or predict response to therapy.

The overarching goal of this FOA is to enhance the value of quantitative imaging (QI) in clinical trials for prediction and/or measurement of response to cancer therapies. 

Projects proposed in response to this FOA are expected to focus on one of two possible ways to enhance QI methods for prediction and/or measurement of response to therapy.

1. Need for validated QI methods or imaging standards: Development, optimization, and validation of state-of-the-art QI methods that have the potential to be incorporated into future clinical trial settings.

Oncologists engaged in clinical trials are often hampered by an absence of validated QI methods or imaging standards to predict and/or measure response to therapy. Yet the increasing number of oncologic therapy strategies currently available in clinical trials has generated the urgent need to develop both reliable and reproducible methods for prediction and /or early assessment of therapeutic response. For example, addressing these translational research needs is particularly crucial in the context of adaptive clinical trial design, or identifying stable disease, where critical “go/no go decisions” are required. Therefore, there is a critical need to develop and validate new imaging techniques to meet these emerging requirements and provide an improved means to have these advanced methods adopted into single site (i.e. phase 1-2) clinical trials, and further optimized or multisite (phase 3) clinical trials.

2. Validation of QI Methods in Clinical Trials: Emphasis on the need to extend initial software tool development and optimization to analyze performance in the multisite clinical trial, where multiple platforms are used for data collection. 

Scientific consensus across clinical disciplines concerning how the relative performance of QI methods are first validated in the single site setting, and later introduced and confirmed in the multisite setting, is important in order to accelerate adoption by clinical end users. Consensus on validation with demonstration of clear clinical benefit will also improve eventual adoption by regulatory agencies (e.g. the Food and Drug Administration, FDA) and those that address reimbursement in the clinical setting (Centers for Medicare and Medicaid Services, CMS). Thus, there is a continuum of activity extending from initial concept of quantitative imaging tools to validation in a subset of single or multisite, multi-platform clinical trial data collected within the goals of this PAR.

The requirements for these QI approaches in the single and multisite research settings have been addressed at recent NCI-supported workshops and in numerous QIN-related publications, QIN progress reports and, QIN working group documents. For this FOA, the applicants need to be familiar with the published research progress to date from the QIN and other research groups - for details, see the following links:

The tools and systems developed and validated against these databases are expected to be useful across a single or multiple clinical trial sites and imaging platform(s) within the 5 year funding period.

Within the scope of this FOA, the important issues to be considered are:

Clinical Data Collection. The research requirements for data collection will depend on the proposed research plan selected by the investigators and the number of clinical sites involved. The development, optimization and initial validation of a QI software tool or method can be achieved with clinical trial data (phase 1 or 2) from a single site or ideally from multiple sites (phase 3), or from retrospective data where the data collection methods are known.

a) Collection of image data from multisite prospective trials. For advanced characterization and comparison of QI tools and methods, multisite prospective trials offer the opportunity of collecting image data from multiple imaging platforms. Research should focus on making the collected data independent of the various platforms, or that data collection methods are harmonized across platforms to reduce the potential differences in extracted features from images. One method for this is the use of imaging phantoms that emulate the spatial and temporal characteristics encountered in clinical QI measurements. Of course, if retrospective data from single or multisite clinical trials or standard of care are used, harmonization of data collection is not possible. In this case, it is important that the methods of data collection are known and accompanied by annotation, and that the methods of image analysis are robust against the different collection scenarios. While clinical outcome data are often not available in a convenient time frame, access to clinical outcomes would be particularly useful for the research proposals addressing the optimization of QI methods and tools for phase 3 clinical trials.

b) Collection of image data from NCI-funded clinical trials. For multisite clinical trial data, and relevant metadata including biopsies, access to the NCI funded NCTN or other clinical trial organizations (national or international) would be ideal, as such data will be collected using well-established protocols and standards of clinical trial practice and clinical outcome measures. However, it is understood that any request for access to such data will require meeting the clinical trial network’s data sharing criteria, and it is recognized that the timetable for access cannot be clearly defined at the time of the application.

Importance of Quality Control for QI Methods. For data collection for all cases, the development and implementation of appropriate quality control (Q/C) methods (using appropriate imaging phantoms, for example) are critical requirements for ongoing system performance assessment. For this reason, prospective data collection of specific images needed to optimize and validate the clinical decision support tools across sites in multisite trials should include appropriate Q/C, test/retest, and standardization protocols to be included in the study. This issue is being addressed by the NCI‘s CQIE (Centers of Quantitative Imaging Excellence) initiative that requires qualification of imaging sites proposing to employ advanced QI methods in clinical trials.

For this FOA all U.S. clinical sites for data collection are expected to have met these current and future CQIE requirements. Similar requirements are expected for international applications to this FOA.

Optimization of Software Tools for targeted cancer problems: This FOA is focused on the critical need to develop and validate advanced algorithms capable of processing image data to generate quantitative information of clinical value within the (a) single or (b) multisite research setting. For the former, this may involve development and optimization of algorithms, and/or modeling methods, dedicated to a specific cancer problem. For the latter, it is anticipated that research will involve the measurement and evaluation of the performance of a suite of algorithms and/ or modeling methods across more than one site and imaging platform for a the targeted cancer problem. Testing software tools against a variety of cancer presentations is also an acceptable activity.

These individual software tools typically have many interrelated parameters requiring optimization and performance evaluation. This is achieved through prospective clinical trials or from access to annotated image databases that include pathology results, expert radiologist readings, or other validation estimates. For development and optimization of new software tools, efforts are usually focused on a single organ site for a targeted cancer problem. The characteristics of the cancer at that site (heterogeneity, texture, perfuse or hypoxic, etc.) affect the final selection of parameter values for optimization. When the tool is tried at other organ sites for a range of tumor conditions, it is not surprising that optimization conditions for parameters change. Thus, for expansion of tools into the larger clinical community, there is a need to test algorithms against a number of tissue and cancer condition, and from a number of different imaging platforms.

Metrology Tools: An important task in the evaluation of QI software tools is performance comparison. While a common data set is needed when software tools are compared with one another, or an evaluation of a suite of tools is made across different research sites, it is also necessary to use common statistical or validation tools (referred to in this FOA as metrology tools). It is expected that each research team creating algorithms or software tools, will present its tools for comparison against tools from other research teams within QIN.

Development and Optimization of QI Methods and Software Tools for phase three trial data sets. The development and optimization of QI methods and software tools for multicenter phase 3 clinical trials should ideally be based on their impact, if any, on clinical outcomes, or other clinical or statistical criteria. In addition, further development is often required such as including structured reporting with the QIN results, and means to include image and other biomarker metadata into the design of the clinical workflow and final multi-parametric display to interpret all results, to ensure their timely adoption of these QI strategies in the phase 3 clinical trial setting.

Under this FOA, the NCI will NOT support:

Alternative/Related Funding Initiatives

Investigators seeking support for imaging clinical trials, as such, are referred to the following initiatives:

Investigators seeking support for related research in areas such as imaging hardware, QI methods, clinical decision-making support systems, or related informatics or image archives, that may support the goals of this FOA, are encouraged to use the following initiatives:

Research on early-stage imaging technology development and testing can be supported by the traditional NIH R01 or R21 grant mechanisms.

Working Group Participation: All QI research teams are encouraged to assign at least one team member to each of the QIN Working Groups. At present, these groups include:

This participation is important for teams working on initial development and optimization of software tools for prediction and/or measurement of therapy response, and also for teams emphasizing the transition of tools into the larger environment of multisite clinical trials.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets for direct costs up to $500,000 per year may be requested.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

Multidisciplinary Teams: The multidisciplinary teams should include both basic imaging research groups and clinical researchers (either within the same institution or from different institutions). Participants may include individuals from clinical sites such as NCI-designated Cancer Centers, Specialized Programs of Research Excellence (SPOREs), or co-operative clinical trials group(s) such as the recently formed NCTN. Team participants may include individuals from academic centers in computer science, imaging science, and medical physics or bioengineering with specific experience in advanced QI methods, and related informatics infrastructure.

It is expected that one of the PD(s)/PI(s) will be designated as the contact PD/PI. The contact PD/PI can be an imaging researcher (basic or translational), a clinical researcher, or a researcher from industry, as appropriate.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Travel. Because awardees must agree to attend two meetings annually in the Washington, DC, area, all applicants must budget for travel to two one-day meetings of the QIN Steering Committee per year.

Sharing of Software Tools. For this FOA, applicants are encouraged to submit a plan and cost basis for sharing software tools across QIN teams, and the development and/or implementation of a means for tool sharing using resources such as NCI supported CBIIT HUB, or equivalent. It is anticipated that vehicles for tool sharing, such as NCI supported CBIIT HUB or the equivalent, will be presented in the submitted application, with any related cost sharing as appropriate. This will be coordinated through participation in one or more of the QIN working groups. The intellectual property associated with the software tools related to clinical decisions will remain with the academic institution or industrial partner, but an agreement to an “open science” approach to validate tool performance is expected for this FOA.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The following issues need to be addressed in the Research Strategy with the understanding that emphasis in each area may vary depending on the specific research goals:

Each QIN team need not be strong in all of the research areas listed below.

The data collection must be in sufficient quantity to be statistically representative of the disease and its progression and to have sufficient sensitivity to the change generated by the therapy.

Research Milestones and Deliverables: For either research pathway, the proposed research plan should identify a specific cancer problem and stress the development, optimization and validation of QI methods or clinical decision support systems to predict and/or measure the response of the patient to the therapy of the chosen clinical trial(s). In addition, this FOA will support the inclusion and optimization of other molecular-based assays and metadata from other research domains, such as genomics or proteomics. However, the development of new laboratory assays is not supported by this FOA. 

A list of milestones that measure progress during the course of the project should be given in the form of a Gantt Chart and final deliverables from the QI team must be provided. 

The following issues must be addressed in the Research Strategy:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific for this FOA: Does the proposed research plan of the multi-disciplinary research team address translational research and provide quantitative imaging methods as required for the advancement of the role of quantitative imaging, as a biomarker assay for response to therapy, in the single or multi-center clinical trial setting.  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, specific for this FOA: Is there evidence that the research team members can work together effectively? Does the multi-disciplinary team have experience in quantitative imaging and in clinical trials?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, specific for this FOA: Does the application propose methods for promoting translational efforts that will move technologies toward implementation in clinical trials and eventual commercial adaptation? Does the proposed research team address innovative solutions for the translation research goal of the QIN? Are the proposed clinical trials appropriate examples to substantiate the need for these methods?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

In addition, specific for this FOA: Are the imaging methods for data acquisition, analyses, optimization, and validation well defined.  Does the proposed multi-disciplinary research plan utilize the unique skills and capabilities of the academic and clinical centers, including industry partners if proposed? How well can the participating researchers support the conduct of the translational research for the optimization and implementation of quantitative imaging methods, as applied to prediction and/or measurement of therapy response in single site or multi-site clinical trial setting?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, specific for this FOA: Do the participating research and clinical centers demonstrate adequate commitment to this project?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.    

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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 (HHS) 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:

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PDs/PIs assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U01 award in accordance with these terms and conditions of the award.

Specific rights and responsibilities will include the following:

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 HHS, PHS, and NIH policies.

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

The Chief of the Imaging Technology and Development Branch of the Cancer Imaging Program of NCI and the designated Program Director will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as Project Scientist(s) and Project Coordinator, respectively (as described below). Additionally, the Program Director serving as Project Coordinator will be responsible for the normal scientific and programmatic stewardship of the award and will serve as Program Official named in the award notice. The Program Director serving as Project Coordinator will have the responsibility for selecting which reviewed applications will be brought for consideration of funding to the Scientific Program Leaders committee. The NCI Project Scientist and Coordinator (and other substantially involved program staff members that may be designated) will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

The main NCI responsibilities pertinent to the awards under this FOA include the following activities:

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:

Additional NCI and/or NIH program staff members and/or program staff members from other federal agencies or international institutions (e.g., FDA, National Institute of Standards and Technology [NIST], Department of Defense [DoD]) may be added to the EC by majority vote of the existing voting committee members to serve in advisory capacity (without voting rights).

The EC may, by majority vote, add representatives from the imaging and pharmaceutical industries and scientific societies to act in an advisory capacity to the EC to encourage the development of consensus methods for imaging protocols and analysis methods and related standards -- This advisory group may be invited to EC meetings when appropriate.

The EC will elect one of the team investigators as its chair for a 1-year term annually during the period of the program.

The EC will have primary responsibility for the overall organizational oversight of the QIN and for reviewing the research goals among the teams. These responsibilities will include the following:

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 academic members who are not involved in the study will be convened. 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 HHS regulation 45 CFR Part 16.

Awarded teams:

Both QI Research Project teams and Research Resource teams will join the QIN. This will involve attendance at regularly scheduled teleconference meetings and annual face-to-face meetings in the Washington, D.C., area. The network is governed by an Executive Committee as described in Section VI 2.A.3 of this FOA, and the principal investigators for each awarded team are expected to be a part of this committee.

Budget and terms of the award:

The applicants for both QI Research Projects and Research Resources are required to provide a detailed itemized budget for personnel and other research equipment and sources, including a detailed appropriate justification, as needed to participate in the QIN research network. The latter includes by way of example:

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 Steering 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 HHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Robert J. Nordstrom, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5934
Email: nordstrr@mail.nih.gov

James A. Deye, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5690
Email: deyej@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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