and Human Services (HHS)
EXPIRED
Department of Health and Human Services (DHHS)
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Cancer Institute (NCI), (http://cancer.gov)
Title: Small Animal Imaging Resource Program (U24)
Announcement Type
This funding opportunity announcement is a renewal of RFA-CA-04-011, which was previously released October 2, 2003.
Request For Applications (RFA) Number: RFA-CA-07-004
Catalog of Federal Domestic Assistance Number(s)
93.394
Key Dates
Release Date: February 10, 2006
Letters of Intent Receipt Date(s): April 18, 2006
Application Receipt Dates(s): May 18, 2006
Peer Review Date(s): September/October 2006
Council Review Date(s): January/February 2007
Earliest Anticipated Start Date: March 1, 2007
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: May 19, 2006
Due Dates for E.O. 12372
Not Applicable.
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
2. Description of SAIRs
3. Consortium Activities and Administrative Structure
A. Consortium Activities and Responsibilities
B. Executive Steering Committee
4. Program Income
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Imaging of small animals, especially genetically engineered mice, has become an essential tool for oncology investigators. Animal models of cancer formation and treatment allow identification of tumor biology and provide tumor-bearing animals for testing therapeutics. Imaging allows the animals to be used as their own experimental controls, and permits acquisition of molecular data from tumors in their usual microenvironments. The expression of genes in tumors and their surrounding tissues is different in situ than it is in excised or cultured preparations. In vivo molecular imaging is a form of in vivo assay which allows investigators to obtain physiological and/or biochemical information from tumors in their usual milieu. Furthermore, anatomic and functional imaging are valuable in population studies of genetically engineered mice to indicate which mice are expressing tumors, how many tumors are present in a given animal, and where they are located. In experiments for which temporal change is a variable of interest, without imaging data one would need a cohort of mice for each data point. In most genetically engineered mouse models, the penetrance of tumor is less than 100 percent in a population of mice. Therefore, many mice would have to be killed and analyzed at each time point in order to find those with tumors and provide sufficient statistical power. This issue is particularly important in studies of cancer pre-emption, for example with chemopreventive agents.
Many imaging techniques are applied to small animals. There are strengths and weaknesses of various imaging modalities for different questions, just as is true with many other types of laboratory tests. Previously funded Small Animal Imaging Resources (SAIRs) were required to provide at least two different imaging modalities and most provided three or four modalities. In the past year alone, oncology investigators used several million mice for such studies.
The characterization and use of genetically engineered mice, stimulated by the activities of the Mouse Models of Human Cancer Consortium (MMHCC), is entering a new era with emphasis on utilization of mouse models. Small animal imaging is essential to gain full knowledge about the models and their behavior under experimental conditions.
A research resource is much more than just a core facility and it allows imaging scientists to interact with molecular biologists and other investigators to understand the biologic questions that are being asked, and to develop, modify, or optimize imaging methods to provide the answers. These are not turnkey situations where simple imaging can be done by a technologist or the molecular biology investigators themselves. Identifying, developing, and implementing the most appropriate imaging methods to address the biologic questions require true scientific collaborations with the imaging scientists. Furthermore, many of these biologic questions require imaging methods for cellular constructs as well as for small animals, and strategies to translate methods from cell-based experiments to small animals. The SAIRs have been instrumental in moving technologies and solutions from cell culture to multi-cell approaches to in vivo animal imaging.
The use of animal imaging has increased in all facets of cancer research. The technology required for animal imaging, often more demanding than that for human imaging because of the resolution required, has advanced considerably. The techniques of animal imaging have been disseminated widely. There is continuing and increasing need for small animal imaging resources in the oncology research community.
The NCI recognizes the importance, synergy, and innovation that often evolve from research crossing disciplines, approaches, and levels of analysis. The SAIR Program (SAIRP) award enhances such multidisciplinary activities by supporting coordinated shared research resources for NIH-funded investigators performing cancer research. The use of such shared resources can increase efficiencies in an area of research by eliminating unnecessary duplications of effort and/or the support of research resources (e.g., costly equipment) that might be needed in, but not fully utilized by, the activities of any one research grant. Shared-resource laboratories can stimulate new research directions by providing access to equipment, services, and other resources that might not otherwise be available. Finally, shared research resources that are properly coordinated will promote cross-disciplinary research interactions and collaborations, technical and theoretical approaches, and levels of analysis, including interactions across basic and clinical cancer research. Such interactions often have results that exceed the sum of the contributing activities. For this reason, interactions and collaborations between SAIRs and investigators associated with scientifically diverse base grants are strongly encouraged; all else being equal, applications for SAIRs that exhibit such characteristics in meritorious ways will be given higher priority for funding consideration.
Information about the current SAIRs, including a catalog of services, policies and guidelines, can be found at http://imaging.cancer.gov/programsandresources/specializedinitiatives/SAIRP.
Each application may request funds for only one Small Animal Imaging Resource (SAIR).
2. Description of SAIRs
SAIRs are multidisciplinary teams within the cancer research community to address critical cancer research questions:
SAIRs should provide:
Structure
The structure of the SAIR must reflect the need to ensure that the small animal imaging technologies available for access or under development through this mechanism are pushing the state-of-the-art in cancer research. In addition, the SAIR should explore the broadest range of cancer research.
The primary purpose of each SAIR is to support coordinated shared research resources and related research to enhance the capabilities of NIH-supported investigators to pursue cancer research relevant to the mission of the NCI.
A SAIR is characterized as follows:
Collaborations with Cancer-Related Research Projects (including Those Supported by Base Grants)
The SAIR should use approximately one-half to two-thirds of its resources and time (i.e., efforts of associated personnel) to provide imaging services and collaboration to cancer-related research projects. As part of the initial application, there must be letters of commitment from at least four cancer-related research projects that will use the small animal imaging resource by the beginning of year 2. Base grants may include NIH R01, R21, R21/R33, P01 (program project), U01 (relevant consortia), and/or R37 (MERIT) grants, and/or R01-equivalent cancer-related awards from other agencies. After implementation, the applicants will be expected to form similar collaborations with at least four additional cancer-related research projects by the beginning of the 3rd year of the SAIR award. At the time of application, applicants must give evidence of potential to form these additional collaborations. These collaborations with at least eight other cancer-related research projects using small animals within 2 years after the award are a MINIMUM requirement. Collaborations of each SAIR with more than eight cancer-related research projects are strongly encouraged.
Initial Capacity for Imaging Small Animals
Applicants must demonstrate at the time of application that they have available at least two state-of-the-art imaging technologies optimized for small animals. In addition, they must show evidence of experience with in vivo imaging of small animals using the available technologies.
Imaging Technology Research
The SAIR should use approximately one-third to one-half of its resources and time for research and development of cancer-related small animal imaging technology. This could be further development and optimization of existing technologies or exploration of novel technologies. Methods to produce valid quantitative results would be particularly encouraged. Funds for small animal imaging technology research may be included in the application budget for all years of the award.
Research Support
The following are examples of ancillary research capabilities for which funding could be requested in a SAIR application; this list of examples is not meant to be comprehensive or exclusive of other possibilities.
Training
A plan for training of individuals including basic scientists, clinicians, technologists, and support personnel interested in learning the techniques and science of small animal imaging must be included. Some of the trainees must come from institutions other than the awardee institution. The training should include both didactic and hands-on instruction. Examples include a formal week-long class in a given technology with classroom and practical components, or the ability for an individual to spend several days in the laboratory learning imaging protocols and techniques from SAIR-funded investigators.
SAIR Web Site
Each SAIR will maintain a web site with description of capabilities and services, contact information for SAIR personnel, lists of tests, detailed descriptions of all protocols, fees, etc. The main web site at http://imaging.cancer.gov/programsandresources/specializedinitiatives/SAIRP has links to all existing individual SAIR web sites.
SAIR Institutional Governance
The Director (Principal Investigator), or Directors for multiple PI applications (see Section III.1.B Eligible Individuals), of the SAIR must have a demonstrated capability to organize, administer, and direct the shared resource. Applicants must describe their plan for governance as well as the methods to be used to evaluate and select protocols to support with the SAIR. It is suggested that a scientific advisory board of collaborators and other cancer investigators would be established for this purpose. The expertise of the scientific advisors and the structure of the board should be discussed, but the potential advisors should not be chosen or named at the time the application is submitted.
A plan for regular and systematic review of workflow and utilization of laboratories and instruments should be provided, with mechanisms put in place to facilitate redistribution and reallocation of resources as deemed appropriate by the Executive (i.e., external) Steering Committee. Recompeting SAIRs should show evidence of consistent evaluation and evolution of SAIR services during the prior funding period (in their type 2 [competing renewal] grant applications).
Activities Supported
An overall budget for the SAIR should be provided. Direct costs may be requested that are essential for the support of the SAIRs and must be fully documented and justified; salary support for administrative costs should be kept at a minimum.
3. SAIR Cooperative Group Governance, Activities, and Administrative Structure
The U24 mechanism is being used to help facilitate coordination among SAIRs and to assist in bringing the small animal resources and expertise to bear on NCI priorities. The cooperative group will participate in joint projects chosen by the Executive Steering Committee to aid in the wider NCI efforts of drug and imaging methods development. Approximately 10 percent of the SAIR resources should be dedicated to cooperative group projects. There is the possibility of supplemental funding for the cooperative group efforts.
The SAIR Consortium will consist of 12 to 14 cooperating SAIRs, with guidance provided by the Executive Steering Committee. Individual SAIRs will have a Director (i.e., the principal investigator [PI]) and an Associate Director, who would become the SAIR Director if the Director is unable to continue for any reason. For applications involving more than one PI, a Leadership Plan should be included in PHS398 application. Section H. Consortium/Contractual Arrangements and/or Multiple Principal Investigator Leadership Plan (see Section IV.6. below).
Each SAIR will be overseen by an institutional SAIR (i.e., internal) Steering Committee. These activities are described in Section VI.2. below.
3.A. Consortium Activities and Responsibilities
The PI(s) must agree to be active participants in consortium-wide activities as deemed necessary by appropriate oversight committees. Examples of such activities are cooperation with the NCI-funded Mouse Models of Human Cancer Consortium (MMHCC) in the development of imaging methods and protocols for use with mouse models characterization and drug evaluation efforts, cooperation with NCI scientists in animal imaging efforts, creation of standardized imaging protocols to match efforts to develop standardized protocols for the use of imaging as a biomarker, creation of common data sharing and storage methods, organization of and participation in workshops and symposia on small animal imaging, and participation in joint projects chosen by the Executive Steering Committee to aid in the wider NCI efforts of drug and imaging methods development.
3.B. Executive Steering Committee
The PI(s) must agree to participate in an Executive Steering Committee that will meet periodically by teleconference and once each year in person to encourage the exchange of information among participating SAIR consortium sites.
The Executive Steering Committee will consist of the SAIR Directors and the NCI Project Scientist. If voting is necessary for an action item, individual SAIRs and the NCI hold one vote each. The Chairperson will be chosen from among the SAIR Directors (PIs). Non-voting members will include an Associate Director (if single PI) from each SAIR and two NCI representatives from the NCI Cancer Imaging Program combined with two representatives from the MMHCC, other NCI Cancer Imaging Program scientists, and a representative each from the NCI Developmental Therapeutics Program and the NCI Division of Cancer Biology. The Executive Steering Committee will conduct most of its business by telephone conference.
The purpose of the Executive Steering Committee will be to discuss and evaluate concerns and cooperative activities of the SAIRs in general, and to provide a forum for sharing skills, ideas, technology, data, and biological reagents among participating SAIR sites. At the meetings and during the telephone conferences, participants will also discuss quality assurance, bioinformatics, project coordination, protocol consistency, test comparisons across background strains or across SAIRs, and training. It is expected that there will be one annual meeting and periodic telephone conferences on which most of the business will be conducted. Travel support for two attendees (or all multiple PIs if more than two) to the annual meeting should be requested. The cooperative group will participate in joint projects chosen by the Executive Steering Committee to aid in the wider NCI efforts of drug and imaging methods development.
The Executive Steering Committee may form and charge subcommittees as needed (for example in the areas of administration, bioinformatics, new technologies, or training efforts). If voting is necessary for an action item, individual SAIRs and the NCI hold one vote each. The Executive Steering Committee will discuss and evaluate SAIR Subcommittee activities and provide feedback to Subcommittee leaders at least bi-annually, implement changes in subcommittee membership or direction if needed, and discuss and evaluate collaborative projects as well as the pilot and feasibility programs.
4. Business Plan and Program Income
Plans for partial or complete cost recovery for services and collaborative efforts must be discussed in the application, because cost-recovery for on-going service projects represents the standard for shared resources. It is expected that there might be a sliding scale of charges, starting from new investigators who need developmental funds to prove a concept, to Cancer Center members, to other university investigators, and finally to commercial investigators. SAIRs may have exemption programs where permission to waive fees is requested from the Institutional SAIR (i.e., internal) Steering Committee, and this should be addressed in the application. These might cover new investigators, small pilot studies, and consortium projects. SAIR personnel are expected to advise applicants for services regarding the best set of tests, and there should be no charge for planning and advice.
Certain services may not be easily adapted to the fee-for-service model, either because they are particularly expensive in time or supplies, or because they require specialized SAIR expertise to optimize experimental design for each animal model, or to interpret data using sophisticated mathematical models, etc. Such services may be particularly valuable and therefore appropriate for a SAIR. Such services may be exempted from the requirement for a fee-for-service by the Institutional SAIR (i.e., internal) Steering Committee.
Program income should be used to improve and expand the SAIR. Appropriate uses would be for new equipment, new services, additional lab staff, training, etc. Program income will be considered as one indication of success of the SAIR.
If the applicant is located at an institution that already has a funded small animal core facility as part of an NCI cancer center support grant or other NCI grant (e.g., a P50 SPORE or P01 program project), the fee-for-service structure and any overlap should be discussed.
1. Mechanism(s) of Support
This funding opportunity will use the U24 research resource grant award mechanism. Applicants are solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
The NIH U24 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PI(s), as described under the Section VI.2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award. Plans for any future related funding opportunity are indefinite.
2. Funds Available
The NCI intends to commit approximately $3.6 million dollars in FY 2006 to fund eight new and/or competing continuation awards for SAIRs in response to this funding opportunity. An applicant for SAIR funding may request a project period of 5 years and up to $300,000 in direct costs per year.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.
Section III. Eligibility Information
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Applicants for SAIRs may request support for a period of up to 5 years. By the beginning of the 3rd year of the SAIR (U24) award, each application for a SAIR must serve a minimum of eight cancer-related research projects (R01, R21/R33 or R33), program projects (P01), relevant consortia (U01), and/or MERIT (R37) grants (known as the base grants). Training grants (T32) and individual and institutional fellowship grants are not eligible for inclusion as base grants. R01-equivalent cancer-related awards from other agencies may be included as base grants. Only one SAIR (U24) grant will be awarded to any single applicant organization, but base grants may be housed in multiple institutions. In general, each cancer-related research project grant should serve as a base grant for only one SAIR. If well justified, activities and research may be located at sites and institutions other than that/those of the base grants and the SAIR. For example, research related to a program might exist at a transgenic facility, supercomputer center, imaging facility, etc., which is neither at nor part of the institution applying for the SAIR, nor at or part of any of the institutions housing the base grants.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.
More than one PI, or multiple PIs, may be designated on the application. Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research awards can be found at http://grants.nih.gov/grants/multi_pi. All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
2. Cost Sharing or Matching
Cost-sharing or matching is not required.
The most current Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Each investigator and institution may submit only one application for this funding opportunity.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo, Telephone: (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
The research plan for SAIR can be up to 40 (43 for competing continuation applications) pages in length. See Section IV.6. for instructions regarding the contents of the research plan.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): April 18, 2006
Application Receipt Dates(s): May 18, 2006
Peer Review Date(s): September/October 2006
Council Review Date(s): January/February 2007
Earliest Anticipated Start Date: March 1, 2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Barbara Y. Croft, Ph.D.
Cancer Imaging Program
National Cancer Institute
6130 Executive Boulevard, EPS Room 6064, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9531
FAX: (301) 480-3507
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-3428
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NCI. Incomplete and non-responsive applications will not be reviewed and will be returned.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.
4. Intergovernmental Review
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Content and order of information to be provided in applications (presented within page limits indicated in above) is described below. Failure to comply with these instructions will result in return of the application without review.
TITLE: Applicants should indicate in the title that the application is for a Small Animal Imaging Resource.
Additional Specific Instructions for Preparing SAIR Applications
Face page. Item 3a. Name of Principal Investigator (PI)
The PI is any individual judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. Each PI is responsible and accountable to the grantee organization for the proper conduct of the project or program and submission of required reports. Each named PI is equally responsible and accountable for the research project.
When multiple PIs are proposed, NIH requires one PI to be designated as the "contact PI, who is responsible for all communication between the PIs and the NIH. In addition, the contact PI must meet all eligibility requirements for PI status in the same way as other PIs, but has no other special roles or responsibilities within the project team. The contact PI may be changed during the project period. This individual should be listed in block 3 of the Face Page, with all additional PIs listed under Key Personnel. All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
New Form Page for Additional PIs: Note this page does not currently exist. A new form page for information on additional PIs will be provided prior to award on a just-in-time basis.
Format Page 2. Key Personnel
When multiple PIs are proposed, list the Contact PI first, then all additional PIs in alphabetical order.
Format Page 4. Budget: Travel support for attendance at the annual meeting should be included.
Resources and Research Plan
For this funding opportunity, the format for the Resources and "Research Plan" of the PHS 398 grant application is changed. The Resources and Sections a. through d. of the Research Plan should be replaced with the following sections: 1) Small Animal Imaging Environment; 2) Experience with Small Animal Imaging, Data Processing, and Animal Handling Techniques; 3) Personnel; 4) Base Grants; 5) Imaging Technology Research; 6) Training; 7) Institutional SAIR Governance; and 8) Compliance with terms of SAIRP Cooperative Agreement.
Competing continuation SAIR applications should include a Progress Report at the start of this section describing their accomplishments and structure in all these areas; an extra 3 pages above the 40 pages should be allotted to this discussion. A summary should be provided demonstrating growth or progress in the following areas:
The remainder of the Research Plan, Sections e through j, remains the same. However, the suggested format and page recommendations should be noted. The applicant should indicate the sections in the Table of Contents using the following titles:
1. Small Animal Imaging Environment (maximum 10 pages): Briefly describe how the facilities and equipment for small animal imaging are appropriate to support the SAIR and the scientific environment in which the work will be done. Describe the institutional support for computer services, including Internet access, and conference calls. Describe how the proposed environment contributes to the research and encourages collaborative and service arrangements. Provide health and safety plans.
2. Experience with Small Animal Imaging, Data Processing, and Animal Handling Techniques (maximum 6 pages): Briefly describe previous and current research experience and accomplishments in dealing with small animal imaging, validation studies, quality control, and excellence in protocol development and refinement.
3. Personnel (maximum 4 pages): Applicants should concisely describe what expertise the group encompasses, and that is available to support their participation in the SAIR’s operations and collaborative studies. The roles of all key personnel, collaborators, and consultants who are associated with the application should be described, including even those with no requested salary support.
4. Base Grants (maximum 1 page per base grant, plus 1 page for discussion of collaborative efforts): Applicants should describe the base grants and the imaging methods appropriate to each. Applicants should also describe the relationship of the SAIR to the base grant.
Applicants should also describe the experience of their group in collaborative programs and activities with partners in academia and industry. The SAIR specifically requires development of new collaborations; plans for these should be described. Some examples of collaborations that may be provided in support of the application are listed below, but are not limited to:
In the Progress Report, competing renewal applicants should provide documented evidence of:
5. Imaging Technology Research (maximum 5 pages): Applicants should describe their plans for research into the technology of small animal imaging and their plans for its support. Describe the process of development and research oversight.
6. Training (maximum 1 page): Applicants should describe their plans for training in the techniques and science of small animal imaging, for basic scientists, clinicians, technologists, and support personnel, both inside and outside the institution. Training should include both didactic and hands-on instruction. Applicants should specifically address (and distinguish) the plans for the training of individuals from the awardee institution and of individuals from other institutions throughout the country.
7. Institutional SAIR Governance (maximum 2 pages): Applicants should describe the plan for institutional SAIR governance, to include membership on leadership groups and required expertise for membership, process of protocol selection and evaluation, contingency plans in case of incapacitation of key personnel, and appointment and function of internal and external advisory boards, some of whom should be from outside the SAIR group. The required expertise of the advisory boards should be discussed, but the members should not be named.
Plans for application for SAIR imaging studies and instrument scheduling should be given. Applicants should present a plan for regular and systematic review of workflow and utilization of laboratories and instruments by the institutional SAIR (i.e., internal) Steering Committee, with mechanisms put in place to facilitate redistribution and reallocation of resources as deemed appropriate. If there is a web site, state the URL and describe the purpose of the site.
8. Compliance with terms of SAIRP Cooperative Agreement (maximum 1 page): There should be a STATEMENT OF INTENT to abide by SAIR Project Income, and Terms and Agreements guidelines as described under Sections I.3 and I.4.
Section H. Consortium/Contractual Arrangements and/or Multiple Principal Investigator Leadership Plan.
Leadership Plan: For applications designating multiple PIs, a new section titled Leadership Plan should be included. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocating resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and shared administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs.
If multiple institutions are involved, the project will be administered through a traditional consortium/ contractual arrangement.
Plan for Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
SAIR applications will be reviewed using criteria in Section V.2. below.
The following will be considered in making funding decisions:
2. Review and Selection Process
Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed.
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does the proposed SAIR address an important problem? Do the proposed services fill a need that is present or unmet in the cancer research community? If the aims of the application are achieved, how will the needs of the research community be addressed and how will scientific knowledge and/or clinical practice be advanced? What will be the effect of these resources and studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the likelihood that the proposed SAIR will increase efficiency, promote new research directions, facilitate interactions across disciplines and levels of analysis, and/or across theoretical and technological approaches? Will the SAIR significantly enhance the capabilities of the base grants to pursue cancer research relevant to the NCI?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the proposed SAIR? What are the plans for acquiring data and for record-keeping? What plans are proposed or in place for evaluating requests to use the resource? What plans are described to assure quality control and equitable access to the resource? Does the applicant acknowledge potential problem areas and consider alternative tactics? How will the effectiveness of the SAIR in achieving its goals be judged? Are interactions and collaborations proposed and/or already occurring between investigators associated with the SAIR and with scientifically diverse base grants? Is the evidence of collaboration with the base grants and other investigators strong? Is the number of base grants adequate? Will the SAIR participate in and support the SAIR consortium activities? Are the plans to provide comprehensive and balanced didactic and hands-on training experiences adequate? Does any such training-related proposal include a plan for the training of individuals from the awardee institution as well as from other institutions throughout the country in the science of small animal imaging? Is the governance plan adequate? Does the SAIR governance plan allow for balanced decisions about resource use and for ease of scheduling and use? Does the SAIR show clear evidence of intent to implement a charge-back structure to support expanded and/or evolving SAIR activities? Are plans for the charge-back system adequate? For applications designating multiple PIs, does the institutional SAIR governance plan ensure that there will be sufficient coordination and communication among the PIs? Are the administrative plans for the management of the research projects appropriate, including plans for resolving conflicts?
Innovation: Does the application propose a new and useful type of resource that was not previously available or effective? Is the proposed SAIR original (novel) and innovative? For example: Does the proposed SAIR challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Will the SAIR develop and/or employ novel concepts, approaches, methodologies, tools, and/or technologies for small animal imaging research and practice?
Investigators: Is the necessary scientific, technical, and analytic expertise available? Are the PI(s) and other key investigators appropriately trained and well suited to organize and manage the SAIR, to conduct and maintain quality control and equitable access, and to create and maintain all appropriate records? In addition, are the key personnel qualified to provide all proposed resources and/or to carry out proposed research? Do the multiple principal investigators, if proposed, and investigative team bring complementary and integrated expertise to the project?
Environment: Do the research infrastructure and scientific environment in which the work will be done contribute to the probability of success? Are the existing and/or proposed facilities and equipment adequate for the services and goals of the resource? Does the institution have the capacity to handle, house, and care for an adequate number of small animals? Can the SAIR benefit from unique features of the scientific environment? Are the scientific and administrative expertise and experience in the proposed surrounding environment adequate and how might they impact the governance, management, and functioning of the resource? Does the application demonstrate potential for in-house development of important new services and technologies that will expand the scope and quality of the available tests? Is there evidence of adequate capacity to address the needs of the base grants? Is the computer and animal handling support adequate? Does the quality of the training environment contribute to the success of the training program?
2.A. Additional Review Criteria
The following evaluation criteria will be used to assess the progress of competing continuation SAIR applications. Competing applications should show growth or development in the following areas:
These criteria may be weighted differently for different types of projects. For instance, some services have high demand and are relatively high throughput, and generate a considerable number of publications that do not have SAIR-funded investigators as authors. Other services may be very novel but potentially powerful, may have a small user group, may be difficult and low throughput but provide important results, may deliver rare technology to a wider circle of researchers than would otherwise have access to it, or be able to uncover subtle effects. Such service may require much more time and staff input, and it may be more appropriate for SAIR staff to be represented as coauthors on resultant publications.
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score.
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities, and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (see http://grants.nih.gov/grants/policy/data_sharing).
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
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. See also Section IV.5. Funding Restrictions.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Contact PI as well as to the appropriate institutional official, at the time of award.
2.A. 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 (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 DHHS, U.S. Public Health Service (PHS), and NIH grant administration policies.
The administrative and funding instrument used for this program will be the U24 cooperative agreement (research resource grant), 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.
2.A.1. Principal Investigator Rights and Responsibilities
The PI(s) of a SAIR will have the primary responsibility for all activities, including the planning, organizing and administering the SAIR, a research and development program, and an Institutional SAIR (i.e., internal) Steering Committee. He/She will participate as a voting member of the Executive Steering Committee with NIH staff and other SAIR Directors; however, it must be noted that there is only one vote per SAIR, even if it has multiple PIs.
An individual SAIR will have a Director(s) (i.e., a PI or multiple PIs) and an Associate Director (if single PI), who would become the Director if the Director is unable to continue for any reason. The SAIR will be overseen by an Institutional SAIR (i.e., internal) Steering Committee.
Awardees will retain custody of and have primary rights to the data and software developed under these awards that are not assigned to the base grant investigators that use the SAIR, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
2.A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
He/She will participate as a voting member of the Executive Steering Committee. The NIH Project Scientist will help plan and carry out SAIR consortium activities, and will participate in all reports. He/She will act as a liaison between the SAIR and the NIH.
Additionally, a Federal agency program official or NIH/NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI Program Official is the NCI staff person responsible for reviewing annual progress of the SAIR, normal programmatic stewardship, and signing off on Grant Progress Reports.
The NIH will have only one vote on the Executive Steering Committee, even if more than one NIH staff person is attending and participating in discussions and activities of that committee.
2.A.3. Collaborative Responsibilities
The SAIR Consortium will consist of 12-14 centers (SAIRs), with guidance provided by an Executive Steering Committee.
Consortium Activities and Responsibilities
The PIs agree to be active participants in consortium-wide activities as deemed necessary by the appropriate oversight committees. Examples of such activities are cooperation with the NCI-funded Mouse Models of Human Cancer Consortium (MMHCC) in the development of imaging methods and protocols for use with mouse models characterization and drug evaluation efforts, cooperation with NCI scientists in animal imaging efforts, creation of standardized imaging protocols to match efforts to develop standardized protocols for the use of imaging as a biomarker, creation of common data sharing and storage methods, organization of and participation in workshops and symposia on small animal imaging and participation in joint projects chosen by the Executive Steering Committee to aid in the wider NCI efforts of drug and imaging methods development.
Executive Steering Committee
The PIs must agree to participate in an Executive Steering Committee that will meet periodically by teleconference and once each year in person to encourage the exchange of information among participating SAIR Consortium sites.
The Executive Steering Committee will consist of the SAIR Directors and the NCI Project Scientist. If voting is necessary for an action item, individual SAIRs and the NCI hold one vote each. The Chairperson will be chosen from among the SAIR Directors (PIs). Non-voting members will include an Associate Director (if single PI) from each SAIR and two NCI representatives from the NCI Cancer Imaging Program combined with two representatives from the MMHCC, other NCI Cancer Imaging Program scientists, and a representative each from the NCI Developmental Therapeutics Program and the NCI Division of Cancer Biology. The Executive Steering Committee will conduct most of its business by telephone conference. The Executive Steering Committee may form and charge other subcommittees as needed (for example in the areas of administration, bioinformatics, new technologies, or training efforts). It is expected that there will be one annual meeting and periodic telephone conferences on which most of the business will be conducted.
The purpose of the Executive Steering Committee will be to discuss and evaluate concerns and cooperative activities of the SAIR in general. A major goal of Executive Steering Committee meetings is to facilitate progress by providing a forum for sharing skills, ideas, technology, data, and biological reagents among participating SAIR sites. At the meetings, participants will also discuss quality assurance, bioinformatics, project coordination, protocol consistency, test comparisons across background strains or across SAIRs, and training. The Executive Committee will discuss and evaluate SAIR Subcommittee activities and provide feedback to Subcommittee leaders at least bi-annually, implement changes in subcommittee membership or direction if needed, discuss and evaluate new projects, collaborative projects, and the pilot and feasibility program. The Executive Steering Committee will decide in those rare instances if new tests should be exempted from the fee-for-service model, or should be allowed to be conducted routinely as collaborative research.
Awardee members of the Executive Steering Committee will be required to accept and implement policies approved by the Executive Steering Committee and to participate in joint consortium projects chosen by the Executive Steering Committee.
2.A.4. Arbitration Process
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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Executive 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. In the case of awards with multiple PIs, a single Non-Competing Grant Progress Report will be required.
In addition to normal elements of PHS form 2590, noncompeting continuation SAIR applications should include the following:
1. Prior Year Budget (actual expenditures and income, salaries) and
Upcoming Year Budget (projected expenditures and income, salaries);
2. List of personnel, including biosketches for new personnel;
3. Description of governance activities;
4. List of services and progress toward new services, etc.;
5. How many animals imaged using each modality;
6. Research Projects progress;
7. Publications that acknowledge the U24 award;
a. authored by SAIR investigators;
b. authored by external investigators using U24 as service;
8. Summaries of Pilot and Feasibility projects funded and brief summaries of progress; and
9. Future plans.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues.
1. Scientific/Research Contacts:
Barbara Y. Croft, Ph.D.
Cancer Imaging Program
National Cancer Institute
6130 Executive Boulevard, EPS Room 6064, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9531
FAX: (301) 480-3507
Email: [email protected]
2. Peer Review Contacts:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]
3. Financial or Grants Management Contacts:
Eileen Natoli
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8791
FAX: (301) 496-8601
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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