Part I Overview Information


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: Statistical Coordination Center for the Population-based Research Optimizing Screening through Personalized Regimens (PROSPR)(U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-CA-11-004

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.399

Key Dates
Release Date: November 12, 2010
Letters of Intent Receipt Date(s): January 9, 2011
Application Receipt Dates(s): February 9, 2011
Peer Review Date(s): May 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date: September 20, 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: February 10, 2011.

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution
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:

This funding opportunity announcement (FOA) issued by the National Cancer Institute is a component of the Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) program. PROSPR’s overall purpose is to promote coordinated, multidisciplinary research to evaluate and improve the cancer screening process (recruitment, screening, diagnosis, referral for treatment). The PROSPR program will support (under a separate FOA) 9-12 PROSPR Research Centers. Each PROSPR Research Center will have a research program, which will include collecting screening data and evaluating the entire screening process for breast, colon, and cervical cancers. (For details on the roles and functions of the PROSPR Research Centers, see RFA-CA-11-003). To facilitate the multidisciplinary research of individual Research Centers as well as facilitate integration of all findings, the activities of the individual PROSPR Research Centers need to be supported and coordinated at the Network level. To address this need, this FOA will support an additional component of the PROSPR Network, referred to as the PROSPR Statistical Coordination Center.

Roles of the PROSPR Statistical Coordinating Center

The PROSPR Statistical Coordinating Center is expected to contribute to the PROSPR program by serving in the following roles:

1.     Establishing and operating a Central Data Repository to combine cancer screening data (and associated clinical data) from all the PROSPR Research Centers and enabling data sharing across the PROSPR Network;

2.     Leading efforts to optimize and standardize terminology, data collection, processing, and exchange across all three cancers; activities will include quality control, management of pooled data for each cancer in separate but related data sets, and oversight for the analysis and sharing of the data with investigators.

3.     Functioning as a scientific hub for integrating multidisciplinary efforts across the Research Centers studying a single cancer and for reaching a comprehensive understanding of the screening process by comparing the screening processes across cancers.

4.     Establishing and operating an outreach/dissemination arm of the Central Data Repository to provide appropriate access to PROSPR data and procedures.

Key Definitions Used in the FOA:

Screening process – A series of sequential steps individuals undergo to be screened: 1) being identified as someone at risk, 2) undergoing the screening test (detection), 3) undergoing the appropriate diagnostic procedures for those with positive results (diagnosis), and 4) being treated for pre-neoplastic conditions and/or cancers that are found. The coordination of these steps is critical to its overall effectiveness so the actions that link the steps such as being offered the test (recruitment), being notified of test results, or being referred for further evaluation of a positive screening test are also fundamental to a complete and effective screening process. Performing the screening test is just one of the specific steps in the screening process. The test is used to identify people at increased risk for disease. The diagnostic evaluation includes additional testing (imaging, laboratory, and/or biopsy) and comprehensive medical assessment of the results to identify a cancer.

Clinical Provider Network (CPN) – the clinicians and their organizational structures who together deliver cancer screening, diagnosis, and treatment. CPN may function as a formal network with established business relationships such as in a Preferred Provider Organization, or Managed Care Organization, or an informal group of health care providers. For this FOA, participating CPNs must have the ability to provide complete information regarding the size of the screening-eligible population served by the CPN, screening performance and results, diagnostic testing and results, and first treatment.

Target Population – The population of individuals who are associated with a particular clinical provider network and are age-eligible for the screening test of interest under current guidelines. The nature of the association could be defined based on the geographic area of provider’s operation, insurance plan enrollment, documented clinical experience (e.g., people with at least one visit to a network office in the prior three years), or any data source that could reflect a reasonable estimator of the size of the population who are age-eligible for screening and served by the network.

Screening Reminders - a notice that a specific individual is due for screening; this term includes “outreach reminders” (i.e., notification by direct correspondence such as mail, telephone, text message to an individual due for screening) or “inreach reminders” (i.e., notification of the health care provider and/or patient during the course of a medical office visit).

Sensitivity – the likelihood a cancer will be found by the test (or process) when it is present

Specificity – the likelihood a cancer-free person will have a negative test (or process)

Positive predictive value – the likelihood a test (or process) is positive due to the condition of interest (e.g. cancer, or a pre-malignant condition)

Multidisciplinary Research – more than one scientific discipline (e.g. Medicine, health services research, economics) working side by side to conduct research.

Transdisciplinary Researchresearch efforts conducted by investigators from different disciplines working jointly to create new conceptual, theoretical, methodological, and/or translational innovations that integrate scientific approaches and move beyond discipline-specific approaches to address a common problem.

Background

Screening for cancers within the large population of people who do not have obvious cancer symptoms represents a major undertaking for health care providers in the U.S. Most medical organizations recommend screening for breast, colon, and cervical cancers based on demonstrated mortality reductions in randomized trials (breast and colon cancers) and large population cohort studies (cervical cancer). As a result, at least 82 million people in the U.S. are screened for breast, colon, and cervical cancers each year, and 8 million of these also undergo evaluations of abnormal test results to find the 350,000 people who will be diagnosed with one of these cancers.

There is evidence that the process of finding these cancers among the many screened is not done optimally. Whereas performance characteristics of individual screening tests (sensitivity, specificity, positive predictive value) are relatively well known, analogous performance characteristics of the entire process remain understudied. Two studies evaluated breakdowns in the screening process that would affect performance measures of the screening process. They examined the care of women with late-stage breast and invasive cervical cancer who had been enrolled in a managed care plan for at least 3 years. The studies showed that 50% of patients with the late-stage breast and invasive cervical cancers were women who were not screened within the 3-year period. Another 40% of the late-stage breast and invasive cervical cancers had negative test results within the same period. Finally, 10% of these women had positive test results but no diagnosis for more than a year after the positive test. Similar findings exist for colorectal cancer in a Medicare population but the effect of different settings and populations needs closer examination.

These studies in patients of managed care plans are important because they show that providing access alone will not achieve the full potential of screening; every one of the late-stage cases had access for at least 3 years, and half the late-stage cases were screened. Nationwide, population access to screening is expected to be improved by the major policy change resulting from the Patient Protection and Affordable Care Act (http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/content-detail.html). The increased access to screening should be accompanied by the systematic implementation of efforts to promote screening among people who are eligible. Such efforts may take advantage of more than 25 years of research regarding methods of promoting screening. But as more people are screened there will also be a greater need for a high quality screening process. This need to focus on the quality of screening has already been demonstrated through a growing skepticism about screening in the lay press and technical literature as screening rates have risen in general. Therefore the research proposed through this initiative is focused upon the screening process among those screened (detection, diagnosis, treatment).

Furthermore, there is a need to move beyond the documentation of problems to undertake studies that lead to improvements in screening test performance, and the diagnosis of cancer in community practice. Improving detection, diagnosis, and treatment in the screening process will contribute to optimizing the process as a whole. To make improvements, the factors affecting these steps need to be more clearly defined and the perspective of the people being screened needs to be more carefully considered. These factors include characteristics of the multiple layers of influence upon the screening process such as the characteristics and knowledge of the staff and providers (nurses, nurse practitioners, physicians, and physician assistants) involved in the steps of the screening process; the organization of the providers’ offices; the financial incentives of the provider organizations and staff; the policy and health care financing environment in which the screening process occurs; how the process is perceived by those seeking screening; and how those perceptions can influence the design and coordination of the screening process. 

Understanding factors that influence the screening process is necessary to designing interventions to improve it. The research sought through this FOA will establish a foundation for interventional work to optimize the screening process. Efforts building that foundation should also include quality metrics that have been raised as goals for health care in United States for the 21st century: making it more patient-centered), more effective, efficient , timely, equitable, and safe. An optimal screening process is therefore one that is patient-centered, efficient, safe, and effective regardless of where it is delivered.

A patient-centered efficient process is of particular concern. One consequence of a suboptimal screening process is unnecessarily high costs of screening. During the 10-year period from 1990 through 1999, the U.S. spent an estimated $166 billion on breast cancer screening, but one analysis suggests that additional quality adjusted life years and $6 billion in cost savings could have been achieved by reaching a larger proportion of the target population and eliminating over-screening (i.e., screening more frequently than is effective). Analogous data on screening for colon or cervical cancer are not available. Therefore, the need exists to conduct systematic research efforts on screening for all three cancers to gain insight into the influences upon the screening process. Those studies are also needed to identify interventions with current and emerging technologies that will maximize the detection of clinically relevant cancers while limiting the undesirable effects and assure equitable treatment across diverse screening delivery settings and geographic regions. Studies also needed to assess how the person being screened is affected by current and proposed screening processes.

Research efforts to optimize screening could address a number of areas, such as: 1) personalizing screening recommendations: risk-based screening guidelines based on biologic and other assessments of risks to determine who will benefit most from a particular screening type and/or screening schedule; 2) improving screening tests and processes to reduce the frequency of false-positive results and, consequently, reduce unnecessary follow up, including biopsies, 3) developing and implementing optimized procedures and schemes for the follow-up of abnormal screening test results; 4) improving communication among providers, between providers and patients, and between organizations involved in screening; and 5) improving the health care environment for the screening process. Each of these areas is elaborated below.

Personalizing Screening Recommendations. Applying screening less frequently in those at lowest risk would reduce the morbidity of screening (anxiety, false positive tests, unnecessary biopsies, infections, unnecessary treatment, death) in people less likely to have cancer. Several investigators have created models that identify increased cancer risk, and genetic tests are emerging as a tool for assessing risk. In the screening context, though, finding those at low risk may be even more important. For example, women who are negative for human papilloma virus and in stable monogamous relationships are at minimal risk for cervical cancer. By undergoing repeated annual Pap testing they face an increased likelihood of experiencing one or more false positive test results and unnecessary invasive follow up procedures. Efforts are needed to stratify populations more precisely in terms of risk of the disease and then identify optimal timing and/or frequency of testing. Less-intensive screening regimens for low-risk individuals could minimize adverse effects in people without cancer.

Improving Screening Tests and Processes. Optimization of screening tests in practice is one part of improving the overall process. Many factors affect how a screening test is implemented in practice: skill in the interpretation of imaging techniques (mammography, magnetic resonance imaging, virtual colonoscopy); variations in chemical compounds used for fecal occult blood testing; variations in the skills of the colonoscopists for colorectal cancer screening; and sample collection and processing procedures for cervical cytology. As a result, there are wide variations in the proportions of cancers diagnosed after an abnormal screening test result.  For example, in 3-19% of patients with abnormal mammograms, 2-29% of patients with abnormal results of stool occult blood tests, 4-11% patients with abnormal colonoscopies, and 0-5% patients with abnormal Pap smears. Cancer is also relatively infrequently detected in the screened populations, occurring, for example, among 4-6/1000 women screened for breast cancer with mammography. Therefore, it is essential to maximize the sensitivity and specificity of the screening test and the screening process in community practice and reduce the unnecessary evaluation of healthy people that may have unhealthy consequences. Factors affecting the screening test performance and implementation of the screening process need to be considered and addressed. There is, therefore, a need to evaluate current screening process and conduct comparative effectiveness studies of new screening processes against current standards in the community practice in order to maximize performance.

Developing and implementing better follow-up procedures. The evaluation of someone with a positive screening test result using diagnostic tools (additional imaging evaluations, more specific tests, or both) is an important part of the screening process. Even with better performing screens, further testing and evaluation will be needed for the diagnosis of cancer and there is marked variation in the proportion that are positive as noted above.  Still, like with the screening tests, the follow-up procedures may be optimized. The comparative effectiveness of follow-up schemes is needed to increase their accuracy, reduce associated risks or burden to patients, and/or to increase their quality, accessibility and acceptability.  The effect of new schemes on patients’ time, understanding, and adherence are also needed to move the health care system towards patient-centered care.

Improving communication: The screening process depends upon high quality recruitment, screening, diagnosis, and treatment as well as well functioning connections between these steps. Those connections involve communications between health care providers and patients, among providers at various steps, and across the primary and specialty care organizations involved in the screening process or conveying guidelines. Failures in communication may result in confusion for people in the screening process, and the community in general as illustrated, for example, by the aftermath of the publication of new screening guidelines by the US Preventive Services Task Force in November 2009. Studies are needed into messages, key communication issues, how to present risk information, and how to offer personalized screening schedules if changes in the screening process are to occur.

Improving the health care environment: People seek cancer screening in the multilayer context of a health care practice that is part of an organization, a community, and a national health care policy environment. The characteristics of those layers include factors such as the knowledge of all the staff and health care practitioners involved in the screening process, the organization and relationships among the providers and institutions involved in the screening process, the referral patterns and communication among staff members, the economic incentives, and the financing of health care. How those factors affect the screening process and influence its quality is another area of potential study and improvement.

In order to optimize the screening process, research is needed to monitor and assess current screening practices and to compare the benefits and negative consequences of alternative screening processes. In addition, methods and contextual influences that affect the screening process must be analyzed. Comparing alternative strategies and processes to well characterized current practices is at the heart of the effectiveness comparisons encouraged by this funding initiative. Such comprehensive comparisons and systematic evaluation of the screening process to maximize the detection of cancers while minimizing the negative consequences are the focal points of this PROSPR initiative.

Specific Research Objectives and Requirements for PROSPR Statistical Coordinating Center

General Requirements:

The PROSPR Statistical Coordinating Center (PSCC) will serve individual PROSPR Research Centers and the entire PROSPR initiative by establishing and operating a single, shared Central Data Repository for all the data collected by Research Centers. The Statistical Coordination Center will also lead efforts across the PROSPR Network to establish common data elements, standardize data definitions for documenting the screening process, and standardize methods for evaluating the comparative effectiveness of various screening strategies. The PSCC will also facilitate the conduct of the multidisciplinary studies within individual Research Centers and across the entire PROSPR Network, and be responsible for sharing PROSPR summary data and full datasets with all interested and qualified researchers in the scientific community.

Applicants responding to this FOA must address all these main functions of the Statistical Coordination Center and specific requirements defined below.

Required Components of the Statistical Coordination Center

The proposed Statistical Coordination Center must have the following main components:

  1. Leadership and Administrative Core;
  2. Central Data Repository/Data Management; and
  3. Dissemination/Outreach

The requirements for these components are outlined below with additional details in Section IV.6. Other Submission Requirements.

1. Leadership and Administrative Core:

Requirements for PSCC Team and Leadership. Given the strategic roles of the PSCC, applicants must have prior experience in organizing and coordinating large-scale multi-site data collection efforts, providing logistical infrastructure for scientific programs based on the collected data, and organizing related research development and dissemination efforts. The needed expertise and required institutional capabilities include (but are not limited to): operation of a large repository of clinical data, as well as knowledge of and ability to standardize and optimize data collection and processing, especially in the context of comparative effectiveness research to assess the benefits and harms of screening.

The PSCC team is expected to be knowledgeable in the area of cancer screening, in general, as well as possess direct expertise relevant to screening for the types of cancer of focus (breast, colon, and/or cervical cancer). If such direct expertise is not immediately available to the team, applicants are expected to outline specific plans for how such expertise will be developed or acquired.

To ensure valid data interpretation and updating of cancer outcomes, the expertise of the PSCC team must include strong statistical skills. The PSCC team must also have an understanding of the data collection procedures at each Research Center to aid in interpreting cancer-type specific data and creating common data elements.

Main Leadership Responsibilities for PSCC Team. Because of the central requirement for interactions across PROSPR Research Centers, PSCC must be able to assist individual PROSPR Research Centers as well as serve and coordinate trans-Network activities. This role will require strong leadership, scientific insights, knowledge of each screening test’s application in practice and capacity to bring diverse teams together. The PSCC team must plan for the following main activities:

a)   Providing scientific leadership and serving as an intellectual/scientific hub for PROSPR Research Centers including, but not limited to, establishing common data definitions for describing the screening process and the benefits and harms of screening, as well as the comparative effectiveness of screening technologies.

b)   Providing analysis of pooled data aggregated from across Research Programs studying a single cancer and advising Research Program Investigators regarding analytic issues

c)   Leading the coordination of data collection for each cancer type and across cancer types so as to minimize the impact on clinical care.

d)   Bringing together expertise from across the network of PROSPR Research Centers to help establish topical “Working Groups” (such as a comparative effectiveness methods group, or a data collection and definitions group) relevant to the funded PROSPR research and scientific needs of the entire PROSPR program.

e)   Providing logistical infrastructure for the PROSPR Research Centers and facilitating trans-PROSPR functions and activities.

f)    Organizing the semiannual meetings of PROSPR investigators (in cooperation with the NCI representatives)

To facilitate these activities, the PSCC must organize an Administrative Core as an infrastructure resource and Central Data Repository/Data Management Unit (see below) as its main scientific component.

2. Central Data Repository/Data Management Unit

The primary function of the PROSPR Statistical Coordinating Center will be to establish and maintain a Central Data Repository for the entire PROSPR initiative. The main goal of the Central Data Repository is to facilitate data collection in the course of clinical care and establish the common data elements so that data can be pooled from across PROSPR Research Centers. Therefore, applicants must propose appropriate plans to establish and operate this Central Data Repository with adequate database support and the capacity to manage all the anticipated data types and data volumes to be generated by individual PROSPR Research Centers. Central Data Repository is expected to include the following elements:

Data Collection and Management. The Coordination Center will be responsible for establishing standardized definitions for pooling data across Research Centers and establishing a standardized approach for evaluating the comparative effectiveness of screening tests, The plans must address such aspects as:

a. Understanding the data collection and quality of Research Centers and their networks

b. Management of the Pooled Database:

c. Procedures for Data Processing to include the following:

d. Procedures for data sharing among the PROSPR Research Centers:

The Statistical Coordination Center will establish the PROSPR website for use by the Research Centers, the Coordination Center (PSCC) and the NCI. The website will be use for the following purposes:

Dissemination/Outreach

The Statistical Coordination Center will serve as a resource to the scientific community. Applicants must anticipate how the data sharing process will be developed so that data and results can be shared among Research Centers, the Scientific Consulting Committee, NCI, external researchers, and the community. It is anticipated that these outreach/dissemination efforts will include establishing a generally accessible public website with the following features:

One aspect of dissemination and outreach for the Statistical Coordination Center will include a plan and appropriate procedures for promptly responding to requests for data by external investigators. The PSCC must ensure that shared data are in an appropriate format and securely transmitted to comply with the regulations pertaining to the confidentiality of the individuals, facilities, and providers as appropriate (including IRB and HIPAA requirements).

The Dissemination/Outreach arm of the PSCC is also expected to collect information on the usage of the resource and its contribution to outside research (e.g., publications and grants using PROSPR data). Finally, the Coordination Center will be responsible for enabling the external evaluation of PROSPR and collaborate with the evaluation efforts in coordination with NCI.

PROGRAM EVALUATION. PROSPR program will be subject to external evaluation (to be coordinated by the NCI Program Staff). Such evaluation is part of NIH efforts since the efficiency of the funded research is an increasing priority for NCI. The purpose of the evaluation process is to monitor and assess the progress of the PROSPR program toward achieving its goals. This component includes evaluating the quality and innovation of the research conducted by the PROSPR awardees. For the efficient evaluation of the Program, cooperation of all PROSPR awardees (but in particular Statistical Coordination Center) will be important and expected.

PROSPR GOVERNANCE

The PROSPR Network (i.e., the PROSPR Research Centers and Coordinating Center) will be governed by the PROSPR Steering Committee. The Steering Committee will also be responsible for the identification of appropriate opportunities for trans-network research and selection of specific projects.

In consultation with the NCI, the PROSPR Steering Committee will form a Scientific Consulting Committee that will advise and provide technical expertise to the PROSPR Steering Committee and the PROSPR awardees.

Details on the composition and functions of PROSPR Steering Committee and the Scientific Consulting Committee are provided in Section VI.2.A. Cooperative Agreement Terms and Conditions of Award.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH U01 Cooperative Agreement award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

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 funding opportunity will use 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 estimated amount of funds available for support of one Coordination Center awarded as a result of this announcement is $2 million for fiscal year 2011, and $10 million over 5 years.

Applicants may request a project period of up to five years, and a budget (in total cost) up to $2 million per year in total costs.

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 IC(s) 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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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://grants.nih.gov/grants/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. 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

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted 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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

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.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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.

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
Letters of Intent Receipt Date(s): January 9, 2011
Application Receipt Dates(s): February 9, 2011
Peer Review Date(s): May 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date: September 20, 2011

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 in Section IV.3.A.

The letter of intent should be sent to:

Stephen Taplin, MD, MPH
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, MSC 7344
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 402-1483
FAX: (301) 435-3710
Email: taplins@mail.nih.gov

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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service 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 (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.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 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 award.

The incurrence of pre-award costs in anticipation of an 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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

PROSPR Statistical Coordinating Center (U01) applicants must demonstrate in the application their ability to meet:

For the PROSPR Statistical Coordinating Center application submitted in response to this FOA, the standard PHS 398 Research instructions for application preparation are altered as follows:

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements: Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to replace standard sub-sections of Section 3 “Research Strategy” of the PHS 398 Research Plan with the following new sub-sections A- D:

A. Overview (6 pages)

B. Leadership and Administrative Core (6 pages)

C. Central Data Repository/Data Management Unit (12 pages)

D. Dissemination/Outreach (6 pages)

For applications submitted in response to this FOA, the standard PHS 398 Research instructions for application preparation are altered as follows:

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to replace standard sub-sections of Section 3 “Research Strategy” of the PHS 398 Research Plan with the following new sub-sections A-F:

A. Overview

B. Leadership and Administrative Core

C. Central Data Repository/Data Management Unit

D. Dissemination/Outreach

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5).

Use additional Form Pages 4 and 5 to provide detailed separate budget information (first year and cumulative budgets for the entire project period) for the individual application components. This information must include:

Budget pages for Leadership and Administrative Core;

Budget pages for Central Data Repository/Data Management ; and

Budget pages for Dissemination and Outreach.

RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:

Standard sub-sections of Section 3. Research Strategy of the PHS 398 Research Plan are replaced by the new sub-sections A-D (corresponding to individual application components, see details below); and

The PHS 398 standard page limit for Research Strategy is replaced by individual limits indicated below for the new sub-sections A-D.

Other sections of the PHS398 Research Plan remain unmodified and should be completed following standard instructions.

A. Overview (up to 6 pages)

In this section, outline the following aspects:

B. Leadership and Administrative Core (up to 6 pages)

In this section, describe the following aspects:

C. Central Data Repository/Data Management Unit (up to 12 pages)

This section must clearly address all the specific requirements for the Central Data Repository/Data Management Unit defined Under Research Objectives (Section I of this FOA).

Organize this Section in the following blocks:

D. Dissemination/Outreach Activities (up to 6 pages)

Following the specific requirements for the Dissemination/Outreach Activities defined Under Research Objectives (Section I of this FOA), describe the following:

OTHER REQUIREMENTS

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD only, and 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. 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 should 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: Investigators seeking $500,000 or more in direct costs in any year 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/.

Additional considerations specific to this FOA to address in Resource Sharing Plan

PROSPR Research Centers will be expected to share essential data for optimizing care by identifying problems in the screening process that limit screening effectiveness in community practice. It is anticipated that PROSPR awardees will be expected to share data at up to 3 levels: 1) data sharing within the PROSPR Network, and 2) data sharing with qualified investigators who are not funded through PROSPR, and 3) data sharing with the general scientific community as appropriate.

Data Sharing among the PROSPR research centers:

PROSPR Research Centers will be expected to share individual demographic information and screening process data from their clinical networks to the Statistical Coordination Center at least once/year. The Statistical Coordination Center applicants should describe the documentation it will need and its approach to ensuring the protection of individual identities of providers and patients. The Statistical Coordination Center experience with data management and analytic tools for large data sets will also be needed. The Statistical Coordination Center applicants should also describe whether or not a data-sharing agreement will be required and, if so, briefly describe 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., by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

Data Sharing with Qualified Investigators Not Funded through PROSPR:

The expected depth and breadth of data collected through PROSPR there will be opportunities to collaborate with investigators not funded by PROSPR and to share data with investigators outside of PROSPR before publications occur. Statistical Coordinating Center applicants are strongly encouraged to be prepared for such extra-Network sharing. Appropriate opportunities may be identified not only through applicants’ institutions but also through interactions with other PROSPR investigators (e.g.,  at PROSPR meetings), and the PROPSR Scientific Consulting Committee.

Data Sharing with General Public

Resource sharing plans would be expected to describe the type(s) of data/resources that may become available through the proposed center. Whenever appropriate, the proposed data types and outputs for sharing are expected to comply with data standards of the Cancer Biomedical Informatics Grid (caBIG®, https://cabig.nci.nih.gov) as a unified platform for sharing and disseminating information.

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

Review Process

Applications that are 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, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact.

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

Scored Review Criteria.

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

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

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does their literature review reflect knowledge of the issues in screening for breast, colon, and cervical cancer? Do they have demonstrated experience leading an effort of this scope? Do they have experience collaborating in an effort of such scope? Do they have the statistical and screening content expertise or a plan to acquire it for this effort?

Innovation. Will the proposed approaches shift current research, data management, or collaborative paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, for data analysis and management? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to screening research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application show evidence of knowledge of the latest in data management and security?  How well do the investigators identify areas of analytic concern in cancer screening and the use of large data sets?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Do the applicants present state-of-the-art knowledge regarding data security and the transfer of data across geographically disperse study teams?

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

Additional Review Criteria

In addition to the above review criteria, the following criteria will be applied to application components, which will receive separate merit descriptors. These component evaluations will be considered in the determination of the scientific merit of the entire application.

A. Criteria for PSCC Leadership and Administrative Core:

Has the applicant shown creativity in developing the research infrastructure, programs, collaborations and evaluation plan? Do they have expertise relevant to each cancer, screening, and data management? Have they demonstrated the ability to lead multidisciplinary and/or trans-disciplinary efforts? Is there adequate evidence for the managerial and collaborative capabilities of the proposed PROSPR leadership? How appropriate is the leadership structure of the proposed PROSPR Statistical Coordinating Center in terms of (a) the overall goals of PROSPR initiative; (b) the coordination of efforts of multiple institutions participating in a given PROSPR; and (c) the participation in and coordination of cross-PROSPR activities? Are the backgrounds, expertise, and commitments of the PI and other key personnel sufficient for the proposed scope of activities and in line with the overall goals for PROSPR initiative?

B. Criteria for Central Data Repository/Data Processing Unit:

How well are proposed cores within the PROSPR Statistical Coordinating Center meeting the goals for the overall PROSPR Center without overlaps or unaddressed needs? How well does the proposed plan address the technical requirements of the data management? Will the cores allow the proposed coordination center to be responsive to the technical and scientific challenges that each of the individual PROSPR Research Centers may face? Are the functions of the cores appropriately described? How will the shared resources help the PROSPR meet requirements for the scientific research objectives and scope?

C. Criteria for Dissemination/Outreach Activities:

How well do the applicants articulate their plans and capabilities to collaborate with the PROSPR Research Centers and NCI program staff on critical evaluation of scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships? Has the applicant provided a thorough plan for sharing limited data sets with external investigators?

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

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

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Additional Review Considerations

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

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the 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

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.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of PROSPR research in accordance with terms and conditions of the award.

The Principal Investigator(s) will have the primary responsibility for:

The PD/PI responsible for the PROSPR Statistical Coordinating Center will have, as appropriate, the following additional responsibilities:

The PROSPR Statistical Coordinating Center will be subject to periodic self-evaluation and external evaluation (coordinated by the NIH). The PROSPR Statistical Coordinating Center Awardee will be expected to participate in such evaluations.

All PROSPR awardee institutions/organizations will be expected to share with other PROSPR awardees knowledge, data, research materials, and any other resources necessary and relevant to the PROSPR Program.

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 and is described below. The NCI Project Scientist may invite, as needed, additional NCI scientific staff as members with relevant expertise to have substantial involvement in the conduct of the PROSPR’s scientific activities.

NCI staff members who are substantially involved in the scientific activities of PROSPR, including the Project Scientist, will not attend peer review meetings of renewal and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict interest.

In addition, 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. If this individual becomes substantially involved in the PROSPR activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NCI waiver if such participation is essential.

The NCI Project Scientist and other substantially involved Program staff members will assist PROSPR Network in the following ways:

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those PROSPR awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

The NCI Staff members will coordinate an external evaluation of the PROSPR Program.

2.A.3. Collaborative Responsibilities

The collaborative scientific activities of the PROSPR investigators will include interactions within and across PROSPR centers. In addition to regular steering committee calls as described below, it is expected that PROSPR investigators will form the appropriate scientific groups to address cancer specific and trans-cancer projects, and will meet 2/year in face-to-face meetings to discuss scientific progress.

The PROSPR Steering Committee will serve as the main governing board for the PROSPR Initiative. The committee will consist of the following voting members:

Additional NIH and PRC staff members may participate in Steering Committee meetings as non-voting members when their presence is needed.

The PROSPR Steering Committee will meet two times per year (in person at semiannual scientific PD/PI meetings). The PI co-chair of the PROSPR Steering Committee will be selected for every 12 months by the NCI Project director with approval by the Steering Committee to coordinate its operation. The PROSPR Steering Committee co-chairs will meet with NCI Project Scientists – members of PROSPR, one to two times per month by telephone conference.

In addition, designated NCI Program staff members and Scientific Consulting Committee members will participate in activities of the PROSPR Steering Committee as non-voting member (s) when needed. These additional non-voting members serve in an advisory capacity and may be added to the PROSPR Steering Committee as need by a decision of the existing voting committee members. These additional non-voting members may include other extramural scientists, NCI and NIH Program Staff members and/or Program Staff members from other Federal Agencies (e.g., Centers for Disease Control and Prevention), and/or members of the Scientific Consulting Committee.

The PROSPR Steering Committee will have primary responsibility for:

The PROSPR Steering Committee will establish a Scientific Consulting Committee (in consultation with the NCI Program Director) during the first year of the program. The Scientific Consulting Committee will advise the PROSPR Steering Committee and will provide technical expertise to the PROSPR awardees.

The Scientific Consulting Committee will comprise scientific experts from outside the PROSPR initiative, with relevant expertise (including extramural scientists and clinicians as well as NCI staff members). The Scientific Consulting Committee will be charged with the following activities:

Note: The NCI will cover the associated travel and consultation costs (where applicable) for the members of the Scientific Consulting Committee.

Members of the PROSPR network (i.e., PROSPR Research Center awardees and PROSPR Coordinating Center awardee) will be required to accept and implement policies approved by the PROSPR Steering Committee to the extent consistent with the applicable grant regulations.

Semi-Annual Scientific meetings:

PROSPR investigators and other key personnel (e.g., data managers), NCI program staff members will meet at least twice per year to discuss scientific progress and address scientific issues. These meetings will include discussions of common terminology, scientific progress, and relevant Trans-Network, and cancer type-specific scientific and operational issues. The members of the Scientific Consulting Committee may also be involved in these discussions.

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardees 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.

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

Section VII. Agency Contacts


We encourage 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:

Stephen Taplin, MD, MPH
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, MSC 7344
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 402-1483
FAX: (301) 435-3710
Email: taplins@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:

Carol Perry
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd, Suite 243, MSC 7150
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7205
FAX: (301) 496-8601
Email: perryc@mail.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.

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 Statistical Coordination Centers 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-09-116.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.

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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