and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov/)
Title: In Vivo Cellular and Molecular Imaging Centers (ICMICs)[P50]
Announcement Type
This is a reissue of PAR-04-069, which was previously released February 27, 2004.
Update: The following update relating to this notice has been issued:
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
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
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
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the progress in molecular imaging as the basis for the extraordinary, non-invasive and quantitative analytical tools useful in the diagnosis and treatment of cancer as well as in the laboratory environment to interrogate biological pathways relevant to cancer. The Cancer Imaging Program of the NCI solicits new or competing applications for P50 Research Center Grants for In Vivo Cellular and Molecular Imaging Centers (ICMICs). The program will fund the 5-year P50 ICMIC grants to support interdisciplinary scientific teams conducting cutting-edge cancer molecular imaging research with clinical relevance. ICMIC funding is designed to: (1) support unique core facilities; (2) enable the awardees to initiate pilot research in new promising directions; and (3) provide interdisciplinary career development opportunities for investigators new to the field of molecular cancer imaging. The P50 funding mechanism and the intended ICMIC structure promote integration of resources and expertise to facilitate synergistic and creative scientific interactions, while allowing each center to define research objectives that would maximize individual unique scientific strengths of each research team. Collectively, the formation of multidisciplinary ICMICs is expected to stimulate cancer imaging research and streamline the implementation of the imaging technologies in patient care.
Background
Molecular imaging now has an impact on every aspect of clinical cancer management, both directly and indirectly. Examples of direct clinical applications include, but are not limited to, the continued development and testing of targeted molecular imaging agents for the detection and diagnosis of cancer as well as for guiding and monitoring therapeutic interventions. There is also an increasing demand for pre-clinical molecular imaging tools. These pre-clinical tools include, but are not limited to, model systems for the discovery and in vivo testing of novel cancer therapeutics and systems to validate emerging biomarkers. Even though these tools will not be intended for direct use in the clinic, they are expected to have a definite positive impact on the availability of new and more efficacious treatments in the clinic.
Since the initiation of the ICMIC Program in 1999, the field of molecular imaging has made significant and rapid advances. The formation of multidisciplinary research teams has stimulated and streamlined cancer imaging research from inception to use in patient care. The flexibility of the P50 ICMIC structure allows each Institution to capitalize on its own unique scientific strengths, and to define the structure and research objectives that create the most synergistic and creative scientific interactions. In general, an ICMIC will provide researchers with the following critical resources.
Special Features and Research Objectives of the ICMIC Program
1. Multidisciplinary Expertise of ICMIC Teams. The ICMICs will provide an organizational structure specifically designed to facilitate multi-disciplinary interactions among investigators focused on the ultimate goal of discovering, developing, and translating molecular imaging technologies that will have eventual impact in the clinic. The structure of the ICMIC is designed to provide investigators with the means of conducting multidisciplinary research in a highly collaborative atmosphere and consistent access to expertise, with minimal wasted time and effort. Key personnel of ICMICs may comprise scientists from a variety of fields including, but not limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cell and molecular biology, pathology, pharmacology, computational sciences, and biomedical engineering. Other specialists, for example in fields such as MRI physics, immunology, or neuroscience, may also be involved. Most importantly, ICMIC personnel must demonstrate an eagerness to collaborate outside of their own disciplines. The nature of these interactions will be determined by the applicants, and emphasis will be placed on establishing creative, productive, and synergistic interactions with eventual clinical impact.
2. Research Components. The ICMICs will provide funding for a minimum of three Research Components. Research Components will apply multidisciplinary approaches based on molecular imaging that are either: (a) directly applicable to the clinic; or (b) reflect the pre-clinical development of molecular imaging reagents or technologies that will ultimately support clinically-relevant research. Individual research projects will be structured in order to maximize appropriate scientific interactions between the projects, and coordinated utilization of the Specialized Resources (see below). Each Research Component will be similar in size and scope to a typical R01 or subproject of a P01, and will be expected to meet the same standards of preliminary data in support of the hypotheses.
3. Specialized Resources. The ICMICs will provide Specialized Resource Facilities and Services. The lack of available facilities for cross-disciplinary experiments is often a barrier to productive scientific interactions. Demands on equipment, resources, and reagents in every scientific area are extremely high, and this demand prohibits ready access to investigators interested in expanding their studies into new areas of research. The establishment of Specialized Resources dedicated to ICMIC-related research will enable this access. The Specialized Resource(s) will be determined by the requirements of the Institution, the defined scientific goals of the Research Components of the ICMIC, and budgetary limits. Prioritization of the research projects supported through ICMIC Specialized Resources will be an essential function of the ICMIC’s leadership, and the mechanism to be employed for prioritization must be delineated by the applicants. Resource facilities may be utilized by active members of the ICMIC and will also be available to investigators supported through Developmental Funds (see below).
4. Developmental Funds for Pilot Projects. ICMICs will provide Developmental Funds for feasibility testing of new projects. A high priority of each ICMIC will be the solicitation and selection for support of innovative pilot projects that would stimulate interdisciplinary collaborations, while addressing promising emerging research opportunities. The selection of projects will be through a review process established by the ICMIC’s leadership. This fund is not to be used to support traditional, ongoing projects that could readily be supported through R01s; it is not appropriate for projects that utilize single areas of expertise or to support the continuation of previously funded research projects.
Developmental Projects may not be supported for more than 2 years. Necessary equipment should be provided through the appropriate Specialized Resource. These projects are to be monitored closely by the ICMIC leadership. Investigators working on projects supported through the Development Fund must understand that they will be expected to compete for independent R01 funding when the projects become sufficiently mature. Alternatively, if it becomes obvious that the project will not provide the expected results, a plan should be in place for terminating a development project.
5. Career Development Opportunities. ICMICs will provide career development opportunities for new and established investigators. Current graduate programs are generally focused on single disciplines and may be inadequate to train the needed cadre of inter-disciplinary imaging scientists. The ICMICs will provide support for a limited number of pre-and post-doctoral trainees in a program to be defined by the applicants. Career development opportunities through the ICMIC will be expected to be highly cross-disciplinary.
See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the P50 award mechanism.
As an applicant, you will be 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 (additional instructions below).
2. Funds Available
The NCI anticipates awarding two new or competing P50 ICMICs each year. The total project period for a P50 application submitted in response to this PAR may not exceed 5 years. Based on the past awards, each of the two projected ICMIC awards are anticipated to amount to approximately $1,800,000-$2,000,000 total costs per year. The total costs requested (direct costs plus Facilities and Administrative costs) for a new or competing renewal P50 ICMIC application may not exceed a maximum of $2,000,000 per year. Applications that exceed a total cost of $2,000,000 per year will be returned to the investigator as non-responsive to the PAR.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Foreign institutions and organizations may participate only as collaborators or subcontractors (and are therefore not eligible to submit applications in connection with this FOA).
1.B. Eligible Individuals
Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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).
The decision of whether to apply for a single PI or multiple PI grant is the responsibility of the applicant organization and should be determined by the scientific goals of the project. Applications for multiple PI grants will require additional information, as outlined in the instructions below, and the NIH review criteria for approach, investigator and environment will be modified as indicated below. For example, a weak or inappropriate PI can have a negative effect on the review. If the multiple PI grant option is elected, a contact PI must be named, as described in the instructions below. Multiple principal investigators on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each principal investigator is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports.
Multiple PIs may be located at the same institution or at different institutions and may request budget apportionment between the PIs (see supplementary instructions below). For multiple organizations, a subcontract or consortium arrangement must be agreed on by the participating organizations, as described in special instructions below.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
An institution may only have one funded ICMIC.
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.
SUPPLEMENTARY INSTRUCTIONS:
1) Inclusion of Multiple PIs (if appropriate):
Face page. Name of Principal Investigator (PI)
The PI is the individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating institution, for the proper conduct of the project or program, including submission of all required reports.
When multiple PIs are proposed, use Face Page (Continued) page to provide items 3a-3h for all PIs. NIH requires one PI be designated as the contact PI for all communications between the PIs and the agency. The contact PI must meet the eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PI may be changed during the project period. The contact PI should be listed in block 3 of Form Page 1 (the Face Page), with additional PIs listed on the Face Page (Continued). 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).
Format Page 2. Key Personnel
When multiple PIs are proposed, list the Contact PI first, then all additional PIs in alphabetical order. Then, list all Key Personnel, giving name and organization.
2) Budget(s):
The budget(s) should be presented in logical, discrete units for each section of the application using the standard PHS-398 form pages 4-5.
The budgets to be submitted should include:
a) A detailed composite budget for the entire ICMIC;
b) A separate budget for Administrative and Organizational activities;
c) A separate budget for each individual Research Component;
d) A separate budget for each Specialized Resource;
e) A single separate budget section for the Developmental Component; and
f) A single separate budget for the Career Development Component.
Additional pages for budget justification are to be used when necessary.
3) Research Plan
The following format is suggested for completing the Research Plan section (see pages 19 through 23 of the PHS 398 application brochure.) The application should be as concise as possible to ensure a thorough review.
a) ICMIC Description (not to exceed 10 pages)
This section should be used to present the overall vision for the ICMIC. This summary should contain the long and short-term scientific objectives, specifically addressing how the molecular imaging research supported through the ICMIC will impact clinical cancer care. Summarize the organizational structure for the ICMIC, concisely defining Research Components, Specialized Resources, the Developmental Fund, and the Career Development Component, and their relationships to each other. In addition, relationships between the ICMIC and other research, academic, and administrative units of the institution(s) (such as centers, institutes, departments) and the central administration should be described in this section. The ICMIC description should serve as an overview of the ICMIC, with a more detailed description of each component to be presented in a later section.
Competing applications should include a progress report for the previous funding period. Specifically address any significant scientific changes, including addition/deletion of Research Components or Specialized Resources.
Revised applications may include a 1-page introductory statement addressing concerns of the previous review.
b) Organization and Administration (not to exceed 20 pages, including any organizational charts). A separate budget should be prepared and included for centralized administrative and organizational activities. The Organizational and Administrative Component should describe all of the infrastructure and decision-making needs of the ICMIC.
Appropriate for inclusion in this component would be (not necessarily in the following order):
Competing applications should include a progress report for the previous funding period. Specifically address any significant organizational changes. Include relevant information about oversight committee activities during the previous funding period, and their impact on the functioning of the ICMIC and provide summaries of the activities of the Developmental Project and Career Development Programs.
Revised applications may include a 2-page introductory statement addressing concerns of the previous review.
c) Research Components (not to exceed 25 pages each)
Research Components will define the scientific projects supporting the long-term goals of the ICMIC, and are to be presented using the format of a traditional research project [Research Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)]. The leader(s) of each Research Component will be responsible for ensuring that ongoing research project(s) are relevant to the ICMIC goals, and that the investigators and projects remain highly integrated with other ongoing ICMIC research. Research Components may rely on the support of the Specialized Resources. To ensure a sufficient level of multidisciplinary interaction, no fewer than three Research Components should be included in the application; the maximum number will be determined by the identified needs of the investigators and budgetary constraints. The total number of pages for each Research Component is not to exceed 25. Describe each Research Component in sufficient detail to enable reviewers to judge the scientific merit from the written application. Do not present separate "subprojects." All projects are to have a single theme and budget.
More than one PI, or multiple PIs, may be designated on each Research Component (see Eligibility Criteria [above] and Review Criteria [below]). If a Research Component PI is not a PI for the ICMIC application, he/she should be listed on the Key Personnel page as a Research Component PI with the name of the component provided. Research Component PIs should not be listed on the Principal Investigator expansion page. The Leadership Plan (Section I) for the ICMIC application should address the governance and organizational structure for Research Components with more than one PI.
Following the description of the scientific goals, each Research Component should summarize exactly how the project integrates with the goals of the ICMIC, how it will directly support or impact clinical cancer care, how it will communicate and complement the other Research Components, and how it will utilize the Specialized Resources. Describe in this section the relevance of the project to the primary theme of the ICMIC and the collaborations with investigators within the ICMIC. Explicitly state which Specialized Resources will be used by this Research Component, and, if possible, quantitate the anticipated usage of Specialized Resources in tabular format. This summary should not exceed 1-2 pages, which are included in the 25-page limit for each Research Component section.
Competing applications must provide a Progress Report on the previously funded Research Component (Section C). Summarize the previous application’s specific aims and the importance of the findings. Discuss any changes in the specific aims as a result of advances in the field of molecular imaging. Include the complete references to appropriate publications and manuscripts accepted for publication (not part of the page limitations). For all new projects, include justification of how this Research Component contributes to the overall ICMIC scientific vision.
Revised applications may include a 3-page introductory statement addressing concerns of the previous review.
d) Specialized Resources (not to exceed 15 pages each)
Specialized Resources may include laboratory and clinical facilities, equipment, and services. For each Specialized Resource, describe in detail the resource(s) that it will provide to the ICMIC. In addition, describe its role in the overall functioning of the ICMIC, including how each resource will enhance multidisciplinary research, and a description of the projects that will be supported by the Specialized Resource.
1. Using a Form PHS 398 Continuation Page, denote "Specialized Resource" and the Specialized Resource director's name. If there is to be more than one core component, prepare a separate section for each core (i.e., Specialized Resource A, Specialized Resource B, etc.).
2. For each Specialized Resource, describe the role of the Specialized Resource as a core to the ICMIC as a whole. Clearly present the facilities, resources, services, and professional skills that the core component provides.
3. To aid in the review, it is suggested that a table to show the estimated or actual proportional use of this Specialized Resource by each project, be included in the application. Justify this core component by discussing ways in which these centralized services improve quality control, produce an economy of effort, and/or save overall costs compared to their inclusion as part of each project in the P50 ICMIC.
Competing applications must provide a Progress Report on the previously funded Specialized Resource. Summarize the activities of the previous Specialized Resource specifically in relation to the services and resources provided to the funded Research Components and Developmental Projects and describe the importance of the findings. Discuss any planned changes in the resource as a result of advances in the field of molecular imaging. For all new Specialized Resources, include justification of how it will contribute to the overall ICMIC scientific vision.
Revised applications may include a 3-page introductory statement addressing concerns of the previous review.
e) Developmental Fund (not to exceed 20 pages)
This section should include a description of the Developmental Project(s) that will be initiated during the first year of ICMIC funding, including a summary of which Specialized Resources will support the projects, and to what level that support will occur. The description of decision-making and oversight responsibilities, including the process for selecting, monitoring, and terminating the Developmental Projects should be included in the "Organization and Administration" Section of the application. This section should include only the scientific portion of the Developmental Projects. The Developmental Projects should provide an avenue for introducing and integrating new investigators and innovative technologies and/or methodologies into the ICMIC infrastructure (in specific) and molecular imaging (in general). It should not be viewed as a supplemental source of funding for investigators that are already integrally invested in the success of the ICMIC. Since the Developmental Projects will be flexible, only the first year of projects should be included in the application. However, applicants should include in their budgets appropriate funds to also support Developmental Projects in years 2-5 of the award. The Developmental Fund projects must be multidisciplinary, and each is to be presented using the format of a traditional research project [Research Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)]. The number of Developmental Projects to be initiated will be determined by the ICMIC applicants.
Competing applications must provide a concise Progress Report on the Developmental Projects selected in the previous funding period. For each Developmental Project include title, description, Principal Investigator, summary of results and outcomes (5 additional pages are allowed for this Progress Report).
Revised applications may include a 3-page introductory statement addressing concerns of the previous review.
f) Career Development Component (not to exceed 15 pages)
Career Development opportunities sponsored by ICMICs will provide a limited number of trainees with access to a highly cross-disciplinary experience. The extent of the Career Development Component is to be defined by the applicant, based on the needs and capabilities of the ICMIC participants. Applicants for career development support may be new investigators or established investigators who wish to change research directions. Candidates should be scientists who have demonstrated outstanding research potential but who need additional time in a productive scientific environment to establish an independent, multidisciplinary research program. Recruitment must include qualified women and minorities. To this end, each applicant should propose a clear policy and plan for recruitment of career development candidates. The ICMIC application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process. Also, the application should indicate prospective mentors who are already in place at the proposed ICMIC, briefly describe their research programs, and describe complementary activities that contribute to the environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs).
Competing applications must provide a concise Progress Report on the activities of each investigator selected for funding through the Career Development Component. For each investigator, include title, description, Principal Investigator, summary of results and outcomes. (Five additional pages are allowed for this Progress Report.)
Revised applications may include a 3-page introductory statement addressing concerns of the previous review.
4) Section I. Multiple PI Leadership Plan.
For applications designating multiple PIs, a new section titled Leadership Plan should be included. The governance and organizational structure of the overall research project (ICMIC) should be described, including communication plans, 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, including responsibilities for human subjects and animal studies as appropriate. For competing continuation applications, the application should state how the research will be enhanced by employing a multiple PI approach. This section should also address the governance and organizational structure for Research Components that have designated more than one PI.
5. Section J. Consortium/Contractual Arrangements: If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): July 16, 2006; July 16, 2007
Application Receipt Date(s): August 16, 2006; August 16, 2007
Peer Review Date(s): October/November, 2006; October/November, 2007
Council Review Date(s): January/February, 2007; January/February, 2008
Earliest Anticipated Start Date(s): March/April 2007; March/April 2008.
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 IC 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:
Anne E. Menkens, Ph.D.
Cancer Imaging Program
National Cancer Institute
6130 Executive Boulevard, EPN Room 6068
Bethesda, MD 20892-8329 (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. Appendix material should not be sent with the application, but applicants should await specific instructions in a later contact from the Scientific Review Administrator. 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)
At the time of submission, two additional copies of the application 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
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be received on or before the application receipt/submission date(s) 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 CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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.
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 NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.
6. Other Submission Requirements
ICMIC investigators will be expected to participate in ICMIC workshops and investigator meetings as necessary to share results with other ICMICs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations. Travel funds for the Principal Investigator(s) and selected ICMIC investigators and collaborators should be budgeted for this purpose.
For those projects that involve clinical trials, investigators must include a general description of the Data and Safety Monitoring Plan (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) in the application. All clinical trials supported or performed by NIH require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the Principal Investigator/project manager or NIH program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the Data and Safety Monitoring of Clinical Trials see, http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
Plan for Sharing Research Data
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 NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.
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 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.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the NIH ICs on the basis of established U.S. Public Health Service (PHS) referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the National Cancer Institute in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
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 ICMIC address an important cancer-related imaging research problem? Will the research have an impact (either direct or indirect) on clinical cancer care? Are the scientific objective(s) of the Research Components, Specialized Resources, Developmental Projects and Career Development Plans appropriate and adequate to achieve the long-term goals of the ICMIC?
APPROACH: Is the conceptual framework and the experimental design, methods and analyses proposed for each of the ICMIC components sound and feasible? Do the individual Research Components interact appropriately with the other Research Components and Specialized Resources? For applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs? Are the administrative plans for the management of the research appropriate, including plans to resolving conflicts?
INNOVATION: Are the experimental designs of the proposed research focused on cellular and molecular imaging of cancer, and are they original, novel, and innovative?
INVESTIGATOR(S): Are the ICMIC Director(s) and leadership appropriately trained and well suited to the organizational and scientific responsibilities of the ICMIC? Is there evidence that ICMIC participants are committed to productive, multidisciplinary interactions? Are the principal investigator(s) and key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the principal investigator(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?
ENVIRONMENT: Is there evidence of significant commitment of the institution(s) to fulfilling the objectives of the ICMIC? Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features in the scientific environment?
In addition, each ICMIC component will be reviewed using the following criteria:
1) Organization and Administration
Is the organizational, scientific, and operational framework reasonable, well-integrated, and appropriate to the aims of the ICMIC? Does the ICMIC employ novel approaches or methods for facilitating scientific interaction? Are the ICMIC Director(s) and leadership appropriately trained and well suited to the organizational and scientific responsibilities associated with this project Is there sufficient oversight and monitoring of Research Components, Specialized Resources, Developmental Funds and Career Development Programs? Is there evidence of significant commitment of the institution(s) to fulfilling the objectives of the ICMIC? If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the ICMIC? For applications designating multiple PIs, does the ICMIC governance plan ensure that there will be sufficient coordination and communication among the PIs?
2) Research Components
The five criteria to be used to evaluate individual Research Components in ICMIC applications are listed below.
SIGNIFICANCE: Does the Research Component address an important research problem related to cancer imaging? Will the research have a direct or indirect impact on clinical cancer care? Does the scientific merit and experimental design of the Research Project(s) adequately address issues of substantive importance?
APPROACH: Are the conceptual research framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative translational approaches? Is there clear evidence of significant multidisciplinary basic and clinical interactions in the conception, design, and proposed implementation of the project? For Research Components designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs?
INNOVATION: Does the Research Project(s) develop new methodologies or technologies? Is the experimental design of sufficient originality, novelty, and innovativeness to make it highly relevant to the overall goals and objectives of the ICMIC?
INVESTIGATORS: Are the investigator(s) appropriately qualified with demonstrated competence to conduct the proposed research? Is the proposed work appropriate to the experience level of the investigators? Are the proposed time commitments for all key laboratory and clinical researchers reasonable and adequately associated with the project?
ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features in the scientific environment or reach out to useful collaborative arrangements? Is there evidence of adequate institutional support?
2) Specialized Resources
Is each Specialized Resource essential for the conduct of ICMIC? Is the Specialized Resource utilized by more than one Research Component? Is the access to, and distribution of, Specialized Resources focused on meeting the goals of the ICMIC? Are the proposed managers of Specialized Resources adequately qualified to conduct high quality, reliable resource operations? Are the requested budgets appropriate to conduct each resource operation?
3) Developmental Projects
The Developmental Projects will be reviewed as a cluster, reflecting the cumulative scientific strength of the projects and the process, rather than assigning each project an independent merit rating. Do the Developmental Projects demonstrate innovative approaches that integrate multiple scientific disciplines? Do these projects reflect a careful selection process focused on scientific quality and innovation? Do the Developmental Projects establish new, multidisciplinary collaborations focused on cellular and molecular imaging of cancer, and are the projects original and innovative?
4) Career Development Program
Is the Career Development Program well justified, and does it describe a program that will successfully train investigators capable of establishing independent multidisciplinary imaging research programs? Are the proposed mentors in the Career Development Program experienced in the types of training proposed? Is the process for selecting candidates for training adequate, and does it seek out and include qualified minorities and women?
The initial review group will also examine the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment.
2.A. Additional Review Criteria
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 will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
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://ott.od.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
Section VI. Award Administration Information
1. Award Notices
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.
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).
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.
The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.
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:
Anne E. Menkens, Ph.D.
Cancer Imaging Program
National Cancer Institute
6130 Executive Boulevard, EPN Room 6068
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9531
FAX: (301) 480-3507
Email: [email protected]
2. Peer Review Contacts:
Not applicable
3. Financial or Grants Management Contacts:
Amy Connolly
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8786
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 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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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% 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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