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: Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium (Limited Competition) [U01]
Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-01-013.
Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394,
93.395, 93.396, 93.397, 93.398, 93.399
Key Dates
Release Date: October 17, 2008
Letters of Intent Receipt Date: Not applicable
Application Receipt Date: December
16, 2008
Peer Review Date: February 26, 2009
Council Review Date: May
2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: December
17, 2008
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
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, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D.
Application Assignment
4. Intergovernmental
Review
5. Funding Restrictions
6. Other Submission
Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection
Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Resource Sharing Plan(s)
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
Purpose
The purpose of this limited competition cooperative agreement (U01) funding opportunity announcement (FOA) is to continue support for the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium. The CanCORS Consortium, originally established in 2001, was designed to collect information on approximately 10,000 newly diagnosed lung and colorectal cancer patients. The Consortium has collected extensive information about medical care received by these cancer patients and the clinical and patient-reported outcomes experienced by them over the initial acute treatment phase. The next step (and the main objective of this FOA) is to obtain a detailed assessment of the quality of follow-up care and the health outcomes among longer-term survivors using the same two CanCORS cohorts of lung and colorectal cancer patients. In addition, to maximize the benefits from the investment in CanCORS, this FOA also includes the dissemination of CanCORS data and data collection instruments as a distinct objective.
To enhance CanCORS ability to address its scientific goals and the dissemination objective, this FOA also seeks to streamline the organization of CanCORS. The currently funded CanCORS Consortium consists of separate awards for a Statistical Coordinating Center (SCC) and seven Primary Data Collection and Research Sites (PDCRs). This FOA solicits a single, joint application from the current SCC and the PDCR awardee institutions that will consolidate these components under a single organizational entity.
Background
The NCI established the CanCORS Consortium (http://healthservices.cancer.gov/cancors/) in 2001 to address the growing need for targeted information about the quality of cancer care in diverse care delivery settings in the United States (U.S.). In regards to the scope of the targeted information sought, the CanCORS effort markedly exceeded the existing limited treatment and outcomes data available from either population-based cancer registries or integrated health care delivery systems.
During the initial funding period, the CanCORS Consortium collected standardized data from two large, population-based prospective cohorts consisting of approximately 10,000 newly diagnosed lung and colorectal cancer patients, approximately 5,000 each. Baseline and follow-up patient surveys were conducted at approximately 4 and 12 months, post-diagnosis, respectively. In addition, standardized data from 4,400 health care providers (including cancer specialists and primary care physicians such as internists) and 1,600 informal caregivers, as well as salient clinical data (from medical records), have been collected. Ongoing analyses of these data permit a comprehensive evaluation of: (a) the quality of cancer care delivered to the patients in the two CanCORS cohorts; (b) the links between quality of care and patient outcomes (both clinical and psychosocial); and (c) disparities in both cancer care and patient outcomes.
CanCORS represents a novel collaborative model for studying cancer care: a large, distributed, multidisciplinary team of investigators collecting shared, standardized data. The initial set of CanCORS awards was funded in 2001 as individual cooperative agreements. These original awards included six Primary Data Collection and Research Sites (PDCRs) and one Statistical Coordinating Center (SCC). In 2003, the Department of Veterans Affairs (VA) sponsored an additional PDCR consisting of more than 12 Veterans Administration Medical Centers. This structure permitted the investigators to address a much broader array of important clinical and policy questions than would typically be feasible at a single site, or via smaller, investigator-initiated grant projects. Importantly, this approach was designed to complement multi-regional, randomized clinical trials of specific treatments that are typically conducted among more selected patients and providers.
Priority areas for cancer research identified in the 2007 NCI Strategic Plan include the following items pertinent to CanCORS:
The NCI strategic plan also underscores that the patterns of care and patient outcomes can be more rigorously examined if multiple, linked data sources are used to track patient information. CanCORS provides the unique capability to integrate data from patients, medical records, physicians, caregivers, and administrative databases to address these priority areas. Moreover, CanCORS is the only NCI effort to conduct collaborative community-based cancer care delivery research across the entire spectrum of the health care delivery system including: (a) NCI comprehensive cancer centers; (b) community cancer centers; (c) cancer registries; and (d) healthcare provider organizations such as the VA. The continued support for the CanCORS Program under this limited competition FOA will take maximal advantage of the research resources already created during the initial funding period. The CanCORS Program addresses several priorities related to cancer care delivery, which would not be easily addressed in a cost-effective manner by other existing initiatives or research infrastructures.
In the long run, it is anticipated that the CanCORS-generated data and analyses will aid efforts to create practical and cost-effective systems to monitor the quality of healthcare for cancer patients in diverse healthcare delivery settings. Such systems are expected to be applicable to the initial treatment phase as well as post-treatment survivorship and end-of-life phases of care.
Specific Objectives and Requirements
As the overarching goal of this FOA is to continue support for CanCORS as a unique resource, only the current CanCORS awardees may apply to this FOA. This limited competition, however, is also an opportunity to enhance the program. Therefore, all interested current CanCORS awardees must work together and submit a joint application. This consolidated application must propose appropriate subcontractual arrangements to provide the following required components:
To allow for proper recognition of program leaders at the individual participating institutions, the applicants are encouraged to take advantage of the multiple Principal Investigators (PIs) option. If the multiple PDs/PIs option is used, it is expected that the SCC PI and one of the PDCR PDs/PIs will jointly oversee and coordinate the entire program. To reflect their roles, such individuals may be designated as lead PDs/PIs .
Applicants must describe detailed plans addressing the two primary research objectives and the dissemination objective for CanCORS as outlined below. All the participating institutions must agree to work jointly toward these goals. Beyond these mandatory aspects, applicants may also propose other elements that may additionally enhance the CanCORS program.
A. Research Objectives
Both clinical and patient-centered aspects of the quality of care should be examined. Disparities in quality of care and factors that are likely to mediate such disparities, should also be evaluated. These topics have rarely been investigated systematically because of the traditionally greater emphasis of quality of care research on establishing reasons for under use of proven, curative therapies during the acute phase(s) of care.
These two main research objectives are also consistent with the recommendations of the Institute of Medicine’s report, From Cancer Patient to Cancer Survivor: Lost in Transition (2005). This report calls for a substantial expansion of the NCI’s commitment to survivorship studies in large ongoing cohorts, such as the CanCORS Consortium.
The comprehensive detailed data collected on quality
of care and patient outcomes during both initial treatment and follow-up care,
should allow for the identification of key attributes of care delivery
(clinical and patient-centered), which are likely to drive short-term and/or
longer-term patient health outcomes. Such analyses that take advantage of
the data collected as part of the initial FOA and this re-issuance, would lay
the foundation for future intervention-based studies aimed primarily at
improving the quality of care delivered to, and health outcomes of, survivors
of lung and colorectal cancer.
B. Dissemination Objective
This FOA also includes a dissemination objective that is geared towards maximizing the benefits from the investment in CanCORS. CanCORS as a research resource may be used to facilitate: (a) new ancillary studies that may be funded through separate, competitive grant mechanisms; and (b) studies that use existing CanCORS data to address additional important questions in care delivery and outcomes. To address these goals, applicants must plan the creation of a shared, open data resource accessible to investigators outside of CanCORS. Plans must also be described to encourage collaboration of CanCORS investigators with other non-CanCORS investigators with the goal to promote CanCORS data and related data collection instruments as a shared resource and facilitate researchers access to this resource. The long-term goal behind expanding access of the larger extramural community to the CanCORS database should be to facilitate initiation of novel projects in understudied areas that are relevant to the overarching goals of CanCORS. Some examples of pertinent areas in which CanCORS data may aid or inspire new investigator-initiated studies, include:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the U01 award mechanism. The multiple Principal Investigators (MPIs) will be solely responsible for planning, directing, and executing the proposed project with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains 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 Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."
2. Funds
Available
The
total amount of funding that NCI expects to award through this announcement is
approximately $11 million for 3 years starting FY2009; the first year budget is
expected to be approximately $3.7 million (total costs). The total project period for applications submitted in
response to the present FOA may not exceed 3 years. The earliest
anticipated award date is July, 2009
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).
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
The following organizations/institutions are eligible to apply:
Only those organizations funded under RFA-CA-01-013 are eligible to apply, but all the eligible (and interested) institutions must jointly submit a single application.
1.B. Eligible Individuals
Eligible individuals include the current PDs/PIs of the CanCORS Consortium funded under RFA-CA-01-013 or other qualified individuals designated by the current awardee institutions. Within the framework of the existing CanCORS Consortium, any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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 support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH 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 grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills, and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI 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 required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Renewal applications will be permitted for this FOA.
Resubmission applications are not permitted in response to this FOA.
Only one application may be submitted in response to this FOA.
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: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the 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 in item (box) 2 only of the
face page of the application form and the YES box must be checked.
In this FOA, the NCI solicits a single consolidated application from all the current CanCORS awardees seeking funding continuation. The applicant must demonstrate in the application the ability to meet the scientific objectives (both research and dissemination objectives) outlined in Section I Funding Opportunity Description of the FOA and meet the investigator responsibilities described in Section VI.2 Cooperative Agreement Terms and Conditions of Award.
Applicants are strongly encouraged to take advantage of the multiple PD/PI option and designate separate PDs/PIs for the SCC and PDCRs. If this option is used, it is expected that the SCC PI and one of the PDCR PDs/PIs will assume jointly the roles of lead PDs/PIs to coordinate the entire program.
The application must contain appropriate budget pages for each participating institution under subcontractual arrangements with the institutions submitting the application. Follow PHS 398 instructions to include other required information about key personnel, their biosketches, and resources at each participating institution.
Research Plan
For the CanCORS application submitted in response to this FOA, the standard PHS398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as Sections A-D ) is altered as follows:
New sections of the Research Plan include the following:
A. Background and Significance;
B. Progress Report/Past Performance;
C. Research Aims and Methods;
D. Project Operations and Administration; and
E. Open Data Resource.
Section A. Background and Significance: This section should briefly outline: (a) the significance of the research conducted in the previous funding cycle along with the main accomplishments to date of the CanCORS Consortium; and (b) the significance of the research proposed in the current application for the next funding period in terms of the program’s overall objectives.
Section B. Progress Report/Past Performance: This section should describe the work conducted and productivity of the CanCORS Consortium to date. Include information on activities conducted by the Consortium as a whole during the previous funding cycle, as well as specific information on the work conducted by individual CanCORS Consortium member institutions (i.e., the SCC and the seven PDCRs). Specifically address the following aspects:
a. Number of patients accrued by cancer type, total for the Consortium and by each PDCR along with associated response rates;
b. Number of physicians surveyed by specialty, total and by each PDCR along with associated response rates (similar information should also be provided for the caregiver survey that was conducted);
c. Percentage of patients for whom medical record data were abstracted by cancer type, total for the Consortium and by each PDCR along with any pertinent information on the quality of information that was abstracted.
d. Manuscripts planned, submitted, and published, including representation of different Consortium institutions (lead and co-author);
e. Research presentations made to date along with a distribution of lead presenter by Consortium institution; and
f. Efforts made, if any, to disseminate the tools developed (e.g., data collection instruments) may be presented.
g. The evolution and operations of the Consortium: describe the roles and responsibilities of the SCC and the different PDCRs in collecting, managing, and analyzing the data. Identify the key challenges encountered and how they were overcome. Describe efforts made for quality improvement and how these efforts enhance the functioning of the Consortium. Provide any additional information that could be helpful in assessing the performance of the SCC and/or the individual PDCRs.
Section C. Research Aims and Methods: This section should include details on how the research objectives identified in Section I of this FOA will be addressed by the applicants. Specifically, the following information should be provided:
a. Specific research questions and hypotheses related to quality of follow-up care, patient health outcomes, and potential links between quality of care and patient outcomes should be presented.
b. Data collection: It is expected that the research objectives of this FOA will be addressed by utilizing more than one data collection approach. The applicants should propose to conduct a comprehensive follow-up survey of patients in the two CanCORS cohorts. Patient survey data may be complemented by relevant clinical data abstracted from medical records. Medical record data may also be abstracted to provide information on the end-of-life care for patients who are no longer alive. Provider perceptions, attitudes, and beliefs about issues related to quality of follow-up care may also be assessed by conducting a focused survey of health care providers. The applicants may also propose collecting data from any additional sources within the CanCORS institutions as deemed necessary, to address the scientific objectives of this FOA. The rationale for and specific focus of all data collection modalities should be clearly stated. This FOA does not require a follow-up caregiver survey to be conducted.
Information in this section should include, but may not be limited to, the following:
c. Core data elements to assess the quality of follow-up care and associated patient outcomes should be proposed. A potential list of instruments that might be used to measure these data elements should also be presented. This should be done for all data collection instruments that might be used (e.g., surveys, medical record abstraction forms) to address the research questions and hypotheses outlined in the application. Procedures for selection of final core data elements and associated measures should be outlined.
d. Analytic approach: An analysis plan and statistical methods for evaluating key research hypotheses should be proposed.
e. Any additional information on the technical strengths deemed important by the applicants may also be provided.
Section D. Project Operations and Administration: This section should address recommendations to streamline CanCORS operations that were made by the evaluation committee that evaluated the performance of the Consortium in the initial phase. Include the following elements in this section:
a. Describe specific roles and responsibilities of the Statistical Coordinating Center (SCC) and the PDCRs in conducting follow-up activities identified under the research aims and methods section of the application. Include a timeline for conducting the various activities over the 3-year funding period.
b. Present a detailed break down of how the various tasks will be allocated across the participating organizations along with plans for ensuring coordination among all the Consortium members. Budget allocations for the Consortium members should be consistent with the tasks assigned to them.
c. Discuss quality control and assurance procedures for all phases of the research proposed from data collection, storage, transfer, and analysis.
d. Discuss functioning of the SCC, including plans for:
e. Describe the administrative/governance structure of the Consortium (must be consistent with the Terms and Conditions of Award section). Provide appropriate plans (including a budget for travel expenses as needed) for participation in all required meetings of the CanCORS Consortium including the annual in-person meeting of the Consortium and regular CanCORS Steering Committee (CSC) teleconferences. Describe the process for the identification of CanCORS scientific leadership. If desired, the function of a lead scientific PI could rotate among the PDs/PIs of CanCORS sites. Describe other working groups (besides CSC) that may be necessary.
f. Outline plans for monitoring the performance of participating institutions along with a discussion of procedures that would be taken to respond to inadequate performance at individual institutions.
Section E. Open Data Resource: This section should address the dissemination objective of the FOA by providing specifics on the procedures for the development, maintenance, and dissemination of the open data resource. The applicants should present efficient methods by which non-CanCORS investigators might be engaged to conduct new ancillary studies that would build upon CanCORS capabilities and resources.
The application should include plans to develop appropriate procedures and policies regarding the access to and use of CanCORS data and related data collection instruments by outside investigators. Institutional Review Board (IRB) approvals and Health Insurance Portability and Accountability Act (HIPAA) considerations at the awardee institutions must be addressed as needed. Plans for the development and maintenance of the collaborative open-access data resource, as well as its dissemination to outside investigators, especially new investigators should be presented in sufficient detail. As part of the development and expansion of the data resource, CanCORS applicants should also outline plans for interacting with NCI’s Center for Biomedical Informatics and Information Technology (CBIIT) to ensure data compatibility with NCI’s Cancer Biomedical Informatics Grid (caBIG). The applicants must also agree to participate in any efforts by the U.S. Department of Health & Human Services to develop privacy standards, thereby protecting the confidentiality of all participants in population-based research on the quality of cancer care delivery systems.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project (Section 14 in the PHS 398 Table of Content).
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Additional information is available in the PHS 398 grant application instructions.
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
Application Receipt Date: December 16, 2008
Peer Review Date: February/March
2009
Council Review Date: May 2009
Earliest
Anticipated Start Date: July
2009
3.B. Sending an
Application to the NIH
Applications
must be prepared using the 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 non-USPS delivery)
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 regular or express mail)
Rockville,
MD 20852 (for non-USPS delivery)
Telephone:
(301) 496-3428
Fax: (301)
402-0275
Email: ncirefof@dea.nci.nih.gov
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above Their previous application would have
had to be funded(Section IV.3.A.). If an application
is received after that date, the application may be delayed in the review
process or not reviewed. Upon receipt, applications will be evaluated for
completeness by the CSR and for responsiveness by the reviewing Institute
Incomplete and/or non-responsive applications will not be reviewed.
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 NIH Grants
Policy Statement.
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 renewal award if such costs: 1) are necessary to conduct the
project, and 2) 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
renewal 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 and Information
Applicants must plan for and budget appropriate travel funds for the participation in the annual CanCORS meetings. From each CanCORS site, at least two investigators, including the site PI, (but no more than four investigators) must attend these meetings. See additional information on annual meetings in the section on Terms and Conditions of Award .
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information, see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088 and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
It is anticipated that only one application will be submitted
in response to this limited competition (U01) FOA. An application that is
complete and
responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, the application 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. Each of these criteria will be addressed and considered in assigning the overall score, and weighted 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 meritorious 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.
The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the Consortium will be able to meet the responsibilities described in Section VI.2A.1 and will be successful in meeting NCI’s goal of supporting a group of experienced investigators from highly capable institutions to conduct follow-up of the CanCORS cohort.
Review Criteria:
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, specific to this FOA:
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PD/PIs?
In addition, specific to this FOA:
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
In addition, specific to this FOA:
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do the PD/PIs and the investigative team bring complementary and integrated expertise to the project (if applicable)?
In addition, specific to this FOA:
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
In addition, specific to this FOA:
Additional Review Criterion Specific to This FOA:
Past Performance/Progress: Have the applicants achieved the goals for the current funding period of CanCORS? How well did the individual CanCORS awardees perform, particularly in terms of coordinating and participating in a large data collection effort and conducting pooled data analysis? Is the performance of the CanCORS investigators in the current funding cycle sufficient to ensure the likelihood of success in the next phase?
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
rating:
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 on Human Subjects in the PHS 398 instructions).
Inclusion of Women, Minorities, and Children in Research: The adequacy of plans to include subjects of 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 on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan 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. All the PD/PIs and other key
personnel at all the proposed CanCORS sites are expected to devote sufficient
amount of time (effort) to accomplish the research and dissemination goals of
the FOA. The
priority score should not be affected by the evaluation of the budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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.
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 Principal Investigator 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 OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients' activities
by involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.
Throughout these Terms and Conditions of Award, the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium refers to all individual CanCORS components including Statistical Coordinating Center (SCC) and Primary Data Collection and Research Sites (PDCRs). All the awardee institutions, principal investigators (PI/PDs) and other key personnel must agree to collaborate on the goals of the CanCORS Consortium.
2. A.1. Awardees and Principal Investigator Rights and
Responsibilities
The PD/PI(s) has (have) primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the CanCORS research in accordance with these terms and conditions of the award.
1. Responsibilities of the lead PD/PIs will include:
Lead PDs/PIs responsible for the SCC and PDCRs will have, as appropriate, the following responsibilities:
2. Responsibilities of all Consortium PD/PIs (including the lead PDs/PIs) will include:
3. Responsibilities specific to the Statistical Coordinating Center (SCC).
SCC and its PI(s) will be responsible for the following activities:
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.
2. A.2.
NIH Responsibilities
A designated NCI Program Director acting as a Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NCI Project Scientist may invite, as needed, additional NCI scientific staff members with relevant expertise to have substantial involvement in the conduct of the Consortium’s scientific activities. All NCI staff members who may be involved in the scientific activities of the Consortium, including the Project Scientist, will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.
Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official may occasionally serve as a second or substitute Project Scientist. If this is the case, this individual will not participate in the peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, this individual will seek NCI waiver according to the NCI procedures for management of conflict of interest.
The main NCI responsibilities pertinent to CanCORS include the following activities:
2.A.3.
Collaborative Responsibilities
The main governing body of the CanCORS Consortium will be the
CanCORS Steering Committee (CSC).
The CSC will have the following organization and functions:
The inability of an awardee to meet the performance requirements set forth in these Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award.
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 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Neeraj K. Arora, Ph.D.
Program Director
Division of Cancer
Control and Population Sciences
National Cancer
Institute
6130 Executive
Boulevard, EPN Room 4092, MSC
7344
Bethesda, MD 20892 (for US Postal Service Express or regular mail)
Rockville,
MD 20852 (for non-USPS delivery)
Telephone: 301-594-6653
Email: aroran@mail.nih.gov
Anita Ambs, M.P.H.
Program Director
Division of Cancer
Control and Population Sciences
National Cancer
Institute
6130 Executive
Boulevard, EPN Room 4106, MSC
7344
Bethesda, MD 20892 (for US Postal Service Express or regular mail)
Rockville,
MD 20852 (for non-USPS delivery)
Telephone: 301-451-6051
Email:
ambsa@mail.nih.gov
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 regular or express mail)
Rockville,
MD 20852 (for non-USPS delivery)
Telephone:
(301) 496-3428
Fax: (301)
402-0275
Email: ncirefof@dea.nci.nih.gov
3. Financial or Grants Management
Contacts:
Crystal
Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, Suite 243,
MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville,
MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
Fax: 301-496-8601
Email: crystal.wolfrey@nih.gov
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);
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 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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA 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.
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 two years to the research. For further
information, please see: http://www.lrp.nih.gov.
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NIH Funding Opportunities and Notices
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