and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)
Components of Participating Organizations
National Cancer Institute (NCI) (http://www.cancer.gov/)
Title: Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) (U54)
Related Announcements
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-CA-11-003
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: January 9, 2011
Application
Receipt Date: February 9, 2011
Peer Review Date: May 2011
Council Review Date: August 2011
Earliest Anticipated Start Date: September,
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 solicits applications for multidisciplinary Research Centers to serve as a main 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). PROSPR Research Centers (and their research programs) must be focused on screening in community settings for breast, colon, and cervical cancers. The ultimate goal of the work is to advance knowledge that leads to improvements in the screening process by making it more consistent with the Institute of Medicine’s Goals for health care: more satisfying and coordinated for the person being screened (patient-centered), more effective (reduces morbidity and mortality), efficient (finding the most cancer with the least use of resources (time, testing, and money)), timely (occurs when it should), equitable (equal access to equivalent care) and safe (has few adverse consequences such as anxiety, false positive tests, unnecessary biopsies, infections, unnecessary treatment, death).
NOTE: Research on screening for cancers other than breast, cervical, and colon cancer is nonresponsive to this FOA.
In addition to Research Centers, the PROSPR network will also include one Statistical Coordination Center (to be funded through a companion FOA, RFA-CA-11-004).
Roles of PROSPR Research Centers:
To pursue the long-term objective of optimizing the screening process(-es) for one of the eligible types of cancer in community practice, PROSPR Research Centers are expected to include investigators and clinical networks of health care providers. These centers will document the entire screening process in community practice, and conduct research relevant to improving that process. The proposed research programs must be based on access to comprehensive cancer screening data for populations in the U.S. and must have high potential for optimizing the screening process for the cancer type of focus.
Each research program must consist of 3 connected Individual Research Projects. Two of these required research projects are to be fully defined by applicants. The third project, however, must address (within the context of the scientific theme of the Center): (i) comparative effectiveness of established and emerging screening processes in community practice; and (ii) the benefits and harms of screening across recognized cancer risk profiles.
Investigators at Research Centers will be expected not only to manage the data at their institutions but also to upload their data into a single shared data repository (maintained by the Statistical Coordinating Center). In addition, the awardees will be expected to collaborate across the PROSPR Network on joint research activities.
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 Research research 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 screening test performance and implementation of the screening process need to be considered and addressed. There is, therefore, a need to evaluate current screening processes 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, as with the screening tests, follow-up procedures may be optimized. Assessment of 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 by the aftermath of the publication of new screening guidelines by the US Preventive Services Task Force in November 2009. Studies are needed of 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 focal points of PROSPR.
General Objectives and Requirements for PROSPR Research Centers
A. SCIENTIFIC REQUIREMENTS AND SCOPE
The overall objective for the proposed PROSPR Research Centers and their research programs must be improving the screening process for the selected cancer type. The key scientific requirements include the following.
1. Cancer Type Selection. Each proposed PROSPR Research Center (PRC) must be capable of documenting and evaluating the entire screening process for one of three cancer types: breast, colorectal, or cervical. Thus, PRC applicants must be able to estimate the size of the target population served by the clinical network that offers screening, diagnosis, and treatment. Applicant teams must also be able to measure the progress of that population through the screening process for that cancer.
Note: It is expected that some institutions (or consortia of institutions) may be fully capable of studying screening processes for more than one of the eligible cancer types. In such situations, applicant institutions may consider submitting more than one PRC application (as long as each application is focused on a different eligible cancer type).
2. Requirements for Cancer Screening Data and Collaborating Clinical Providers Networks. To be able to conduct the required comprehensive characterizations of the screening process(es) for the cancer type of choice, PRC applicants must secure access to appropriate cancer screening data. It is expected that this access will involve collaborations with a network of screening and diagnostic services providers (further referred to as Clinical Providers Network or CPN). It is recognized that to ensure the required breadth of research, PROSPR Research Centers may need to combine data from several sources, including cancer registries.
For each participating CPN/data source, applicants must be capable of providing the following estimates: the size of the population potentially served by the network; the method of offering screening (outreach reminders, inreach reminders, other, neither); and the proportion of the target population that is actually screened; the proportion of patients with positive test results; the proportion of patients with positive test results who undergo diagnostic testing; the proportion of patients diagnosed with cancer; and the proportion of patients that are treated for that cancer
Among the population screened, the network investigators must also be able to provide data documenting individual indications for a test, the type(s) of test used, the results of the screening test and follow-up diagnostic testing, whether a given individual was seen for a diagnostic workup, whether the individual was diagnosed with cancer, whether treatment occurred, and, if so, of what type (surgical, radiation, chemo, and/or hormonal) These individual level data also need to include demographic characteristics such as age, race, and socioeconomic status and they must be linked to detailed cancer information from a geographically defined cancer registry (SEER - http://seer.cancer.gov; or a North American Association of Central Cancer Registry gold-certified State Cancer Registry http://www.cdc.gov/cancer/npcr/about.htm; http://www.naaccr.org/Certification/CertificationLevels.aspx ).
Applicants must also be able to extract appropriate aggregated data for the entire population. The ability to provide reports with data stratified by race and socio-economic status is also needed. Of particular value to the PROSPR program will be those groups that have access to complete data, including cancer risk, demographics, and other characteristics of the screened and unscreened populations in their dataset(s).
The emphasis will be on evaluating the screening process in the average risk population, but an investigator group could choose particular subpopulations of interest, such as those served by Federally Qualified Health Centers or who are long-term survivors of another cancer.
NOTE 1: All screening data to be used by the PROSPR network must be for the populations in the U.S.
NOTE 2: A letter from the leadership/administrative official of the participating Clinical Provider Network must clearly state the commitment to provide data for the proposed PRC and the entire PROSPR Network (including data uploading/processing by the PROSPR Statistical Coordinating Center).
3. Scope of Research. Individual PRCs must develop a research program theme addressing specific factors affecting the screening process for their cancer type of focus. Applicants must explain how their theme offers an opportunity to optimize the screening process. New information from this research is expected to serve public health and the general public by informing screening guidelines and the decisions of many parties involved in the process of cancer screening, including patients making personal decisions about screening, providers offering screening tests, policy makers deciding about screening recommendations, and investigators who may develop subsequent intervention trials.
Within a selected theme, applicants must propose 3 connected research projects with clearly defined specific aims. Individual research projects are expected to explore in an innovative way factors relevant to the screening processes at, e.g., biologic, epidemiologic, health services, or behavioral factors. All these 3 projects are expected to be connected and mutually reinforcing the theme of the proposed PRC. The scope of 2 of these projects is fully up to the discretion of the applicants. The third project, however, must be oriented on measuring the benefits and harms of screening processes across risk profiles within a given cancer type and the comparative effectiveness of the screening processes for different tests (see details below).
The two open Individual Research Projects may include, but are not limited to, the following directions:
Mandatory Research Project must be dedicated to comprehensive studies on:
(1) The assessment of the benefits and harms associated with screening processes and the comparative effectiveness of the screening processes for the cancer of focus.
Examples of responsive research for the mandatory project might include but are not limited to:
Non-responsive: Projects with the following attributes are non-responsive to this FOA and will not be considered:
B. REQUIRED MAIN COMPONENTS OF THE PROSPR RESEARCH CENTERS
1. Research Team: For the multidisciplinary research necessary to meet the goals of this FOA, the proposed PRCs must have the expertise relevant to evaluation and improvement of screening in an appropriate variety of diverse disciplines relevant to the PRC’s focus. The team must provide full expertise necessary to complete the proposed research program and specific research projects.
Disciplines represented may include primary care medicine, molecular biology, genetics, oncology, psychology, anthropology, health services economics, communications, informatics, behavioral and social sciences, oncology, and radiology. For example, teams could include clinical scientists, epidemiologists, and experts in sociology, health behavior, and psychology, as appropriate. It is not necessary for all team investigators to have a specific record in cancer research.
Because of the need to secure access to cancer screening and other clinical data, it is essential to establish collaboration with investigator(s) (including clinicians) and data management personnel within a participating Clinical Providers Network. These individuals must be able to provide access to the CPNs data for the PRC and must be willing to collaborate in pursuing the scientific aims of the PRC. PRC applicants must provide a letter of support from the participating Clinical Providers Networks leadership/administrative officials that documents the CPN commitment in terms of the appropriate personnel involved as well as the ability and willingness to provide the relevant data.
All the team members must be willing and able to work jointly in and across the required/represented disciplines to ensure the successful conduct and completion of the proposed studies.
2. Leadership and Organization of the Proposed Research Center: Given the need for scientific leadership in diverse disciplines, applicants are encouraged to consider the advantages of the multiple Program Director/Principal Investigators (PDs/PIs) option. However, if this option is used, a carefully considered leadership structure should be defined, in which one PD/PI is identified as lead PD/PI for the overall Center. Each PROSPR center could be a virtual center, i.e., its facilities may be physically located at various institutions and geographical sites. Participating institutions/organizations may be a mix of academic, other non-profit, and/or for-profit entities, as needed.
Each individual PRC must organize an Administrative Core as an infrastructure resource to facilitate the administrative activities within the PRC as well as coordinate various trans-Network activities (e.g., team meetings, PROSPR-wide meetings and conferences as described below).
3. The Screening Process Documentation Unit. Each PRC must form a dedicated unit to provide centralized documentation and management of screening process data for the appropriate cancer type. The Screening Process Documentation Unit must handle all data transfers from the participating CPN (and other data sources, if applicable), appropriate routine data processing as needed, as well as regular (at least once per year) transmission of source and processed data to the PROSPR Coordination Center.
4. Research Program: A well-developed research program design must have a distinct theme and include 3 specific Individual Research Projects (two open projects and one mandatory project) consistent with the requirements outlined above.
To serve the PRC research program, applicants may propose one optional Shared Research Resources Core. Such a Core, if proposed, is expected to serve at least 2 of the 3 research projects.
5. Developmental Trans-Network Capabilities: The screening process for each cancer type is expected to be documented and studied by multiple (3-5) PROSPR Research Centers. Therefore, applicants must anticipate (and plan for) collaborations with other PRCs studying the same cancer type. These collaborations are expected to involve the comparative effectiveness studies within their cancer type of focus, and standardizing the terminology to measure benefits and harms across known risk factors. In addition, PRCs will be expected to collaborate across the network on the consistent terminology for all the three cancer types. PRCs would also collaborate across cancer types to establish standard terminology for measuring the comparative effectiveness of screening technologies, including the descriptions of test benefits and harms (trans-network activities), and engage into trans-Network projects (see details below).
Collaborations may also be helpful for such aspects as:
The collective goal for the PROSPR network of PROSPR Research Centers is to establish a common conceptual and methodological framework for comparative effectiveness studies in screening, and for studies of the benefits and harms of screening. Given that the screening processes are different for breast, colon, and cervical cancer, the initial evaluations of the screening processes will focus on an individual cancer type. As common data definitions are developed, however, cross-evaluation and comparison of the screening processes for various cancer types will be possible through trans-network studies.
In addition to regular research projects, each PROSPR Research Center will be expected to participate in Trans-Network developmental projects. No such projects are to be proposed in the application as their directions and specific topics will be selected and decided later by the PROSPR Steering Committee. However, applicants are expected to outline their vision of a feasible and important scientific question that would benefit from trans-Network data and collaboration. For example applicants might outline their ideas regarding how the analysis of data from their respective cancer-specific measurements of benefits and harms might be the foundation of a similar comparison across cancer types. In addition to outlining the scientific question, applicants are asked to identify their capabilities that might be particularly suitable to addressing it.
It is envisioned that trans-Network projects will involve collaborations not only with other PROSPR awardees but may also involve outside organizations and investigators. Trans-Network activities are expected to capitalize on unique strengths and expertise available to PROSPR, including networks examining the same cancer screening process(es) and networks examining the screening process for other cancers. Trans-Network projects could include, but not be limited to, the directions identified above. The Trans-network and data definitions work will be led by the PROSPR Statistical Coordination Center created through the parallel FOA.
6. Dissemination, Data Sharing and Program Evaluation
a. Dissemination Plan: The PROSPR Research Centers will connect to, and become a resource for, the larger community. Applicants should propose ways to actively share data, develop collaborations, synthesize and disseminate results to the larger clinical, public health, policy, and cancer research communities. PROSPR investigators are encouraged to link with other relevant research initiatives or clinical trial groups through the PROSPR Scientific Consulting Committee described below, but also outside of PROSPR as applicable. These linkages can be supported in the form of co-authorship on papers, specific consultations regarding national data standards, sharing of the data with external investigators for their use in related analyses, workshops, conferences, and transdisciplinary research collaborations.
b. Data Sharing and Security: Each PROSPR Center must include information documenting their knowledge of data security issues, plans for linking individual data over time while maintaining it in a de-identified form, provisions for sending a data set to the PROSPR Coordinating Center annually, and addressing other issues presented, but not limited to, those described in Section IV 6 below.
c. Evaluation. All PROSPR Research Center awardees will be expected to participate in the evaluation of the PROSPR initiative. The evaluation will be a cooperative effort with the PROSPR Steering Committee, individual Research Centers, and NCI Program Staff.
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.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity will use the U54 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 NCI has committed $13M in total costs for FY2011 and $65M in total costs over a 5 year period for this U54. Approximately 9-12 awards for PROSPR Research Center are expected as a result of this FOA.
Future year amounts will depend on annual appropriations.
It is expected that budget requests for most applications will be between $0.75 million and $1.5 million per year (total costs). Higher budgets may be requested if justified, e.g., by an exceptional breadth of the research programs proposed. However, no requests may exceed $2 million per year (total costs).
Applicants may request project period of 5 years.
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
The following organizations/institutions are eligible to apply:
Foreign institutions may not submit applications for this FOA, but are allowed to participate under consortium/subcontractual arrangements on applications submitted by an eligible Domestic (U.S.) Institution. Experienced investigators from countries with organized screening programs may bring relevant scientific expertise to this effort and may be included as consultants or investigators with appropriate justification. However, foreign institutions and health care providers may not be used as a source of screening data as this effort is focused on community screening practice in the United States.
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. Applicant institutions may submit more than one application in response to this FOA provided each focuses on a different cancer type. The separate applications may be led by the same PDs/PIs but the investigators involved must be able to commit appropriate effort to each of them. If an institution submits multiple applications, there should be some attention to describing how the proposed administrative core would be adapted to integrate the independent applications, including identification of a single overall leader for the institution.
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) 710-0267, Email: [email protected].
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.
The
exceptions from the standard PHS398 Instructions and detailed information on
the application structure and components are provided in Section IV.6. Other
Submission Requirements: All applicants must follow the specific instructions
in that section.
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: January 9, 2011
Application Receipt Date: February 9, 2011
Peer Review Date: May 2011
Council Review Date: August 2011
Earliest Anticipated Start Date: September,
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: [email protected]
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: [email protected]
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 a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
The PROSPR Research Center (U54) applicants must demonstrate in the application their ability to meet:
PHS398 Research Plan Sections
All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:
A) 6 pages for Overview of the PROSPR Research Center;
B) 6 pages for Research Team, Research Capabilities, and Administrative Core;
C) 6 pages for Screening Process Documentation Unit;
D) 12 pages per each of 3 Research Projects in the Research Program;
E) 6 pages for Optional Shared Research Resources Core (if proposed); and
F) 6 pages for Trans-Network and Dissemination Capabilities.
For the PROSPR Research Center 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 of the Proposed PROSPR Research Center and Its Thematic Focus
B. Research Team, Research Capabilities, and Administrative Core
C. Screening Process Documentation Unit
D. Research Program (3 Individual Research Projects)
E. Optional Shared Resources Core
F. Trans-Network and Dissemination Capabilities
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).
Budget (PHS 398 Form Pages 4 and 5): 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). Include appropriate budget pages for any sub-contractual arrangements proposed.
Core resources should be budgeted to include centralized data collection and archive to the PROSPR Coordination Center.
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:
Note: Budget for the Administrative Core must include:
1) appropriate travel fund for the participation of three representatives of the PRC in twice/year PROSPR Investigators Meetings;
2) as a separate line item (under Other Costs and starting with year 2), enter an amount of $40,000/year earmarked for the future developmental trans-Network projects (note that the activation of these funds will be possible only for projects selected and approved by the PROSPR Steering Committee).
RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:
A. Overview of the Proposed PROSPR Research Center and its Thematic Focus (up to 6 pages)
Present the overall vision for the proposed PROSPR including the following segments:
The proposed overarching theme and organizing framework for the Center.
B. Research Team and Research Capabilities, Center Organization, and Administrative Core (up to 6 pages).
In this section, describe the following aspects.
C. The Screening Process Documentation Unit (6 pages):
This mandatory Documentation Unit must ensure efficient and comprehensive documentation of the screening processes investigated and rigorous handling of the clinical data. Therefore, it is expected that this Unit will include Key Personnel with relevant academic appointments, and/or appointments in the collaborating Clinical Provider Network. In particular, on the side of the collaborating Clinical Provider Network(s), this Documentation Unit should include at least one leader/clinician and one person devoted to data management for transfer to the PROSPR Research Center (both with appropriate effort and commitment to participate in the planning and functioning of the Unit).
This section must include:
Note: As an additional documentation relevant to this section, applicants must provide letter(s) from the leadership/administrative official(s) of the participating Clinical Provider Network(s) (to be attached in the standard section Letters of Support (Section 14 of the PHS 398 Research Plan). These letters must clearly state the commitment of a given Clinical Provider Network to provide screening data for the proposed PRC and the entire PROSPR Network (including data uploading/processing by the PROSPR Statistical Coordinating Center).
D. Research Program (3 Individual Research Projects, up to 12 pages per each project).
Each application must include 3 connected Individual Research Projects consistent with the PROSPR research objectives and overall scientific scope (as defined in Section I of the FOA). All these projects must be focused on the same cancer type. (Note: More than 3 Individual Research Projects are NOT allowed).
Applicants are to fully define the scope of 2 of these 3 Individual Research Projects ( open Projects). The third Project must address in a comprehensive way: (i) the assessment of benefits and harms associated with the screening processes evaluated, and (ii) the comparative effectiveness of screening processes..
For this mandatory project, applicants must:
a) describe their assessment of the salient harms and benefits of the screening process for the cancer of interest and how their measurement will be undertaken.
b) document the effectiveness of an existing screening test for the cancer of interest. The applicants should justify the tests chosen, and the proposed measure of effectiveness. The applicants should also propose how they will document the effectiveness of at least one secondary test that is also expected in community practice for the cancer of interest. Finally, applicants should propose how they would consider modifying their data collection to document the effectiveness of a newly emerging test
For all projects, applicants must clearly describe how the proposed projects will address significant existing questions with respect to the screening process for a particular cancer, and complement, but not duplicate, existing work. Emphasis should be placed on demonstrating why the proposed concepts and approaches are important within the context of related research and how the expected product/results will overcome currently existing limitations in our knowledge of the screening process.
For each of the 3 Individual Research Projects, the description must contain the following elements:
Describe the literature base and activities of each research project in sufficient detail to enable reviewers to judge its importance, scientific merit, and how it will contribute to improving the screening process.
E. Optional Shared Resources Core (up to 6 pages, if proposed)
Applicants may propose, as needed, one appropriate shared technical resource. This shared resource must not duplicate analogous NIH-funded resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested).
The description of Shared Resources Core must include:
F. Trans-Network and Dissemination Capabilities (up to 6 pages)
In this section, outline your vision of how the proposed Research Center might contribute to trans-Network activities and developmental projects and how such projects may be formulated and prioritized. Suggest a scientific question/problem that may arise from your cancer type-specific work but warrants investigation across cancer types. Also describe the capabilities of the proposed Research Center that might be particularly suitable to addressing such a project.
Examples of directions that might be appropriate for trans-Network studies include (but are not limited to):
Note that specific trans-Network developmental projects to be pursued will be decided later by the PROSPR Steering Committee. Some of these activities will be supported through the funds allocated to the PROSPR Statistical Coordinating Center. In addition, each Research Center applicant must reserve $40,000 per year (starting in year 2 of the funding period) for the developmental projects. Note that these funds will be activated only for pilot projects approved by the PROSPR Steering Committee.
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 send individual demographic information and screening process data from
their clinical networks to the PROSPR Statistical Coordination Center (PSCC) at
least once/year. The PSCC should describe the documentation it will need and
its approach to ensuring the protection of individual identities of providers
and patients. The PSCC experience with data management and analytic tools for
large data sets will also be needed. The PSCC 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 will likely create opportunities for collaborations with investigators not funded by PROSPR and to share data with investigators outside of PROSPR. PRC 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 proposed Research Center (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?
In addition, specific for this FOA: What is the likelihood that the proposed research program will lead to significant improvements in the screening process for the cancer type of focus? Will the proposed research aid efforts to create a high quality screening process in US clinical practice?
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?
In addition, specific for this FOA: Is the range of expertise of the team investigators sufficient for the expected multidisciplinary efforts and relevant to the overall theme? Are representatives of the key disciplines (e.g., clinicians) properly represented in the team? Is there a clear relationship between the PRC investigators and the collaborating Clinical Providers Network(s) that will facilitate the interaction over time? What is the experience of the participating investigators in large-scale collaborative efforts?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, specific for this FOA: Are new technologies or applications of old technologies suggested that might provide new perspectives on measurement of benefits and harms of screening?
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?
In addition, specific for this FOA: Is there a comprehensive vision that integrates the comparative effectiveness research, measurement of harms and benefits, and the research projects? Will the PRC and the Clinical Practice Network(s) be capable of documenting the entire screening process for the cancer type of focus as required by the FOA?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, specific for this FOA: How appropriate is/are the affiliation(s) with participating CNP(s) in terms of CNP(s) commitment to the proposed PRC and availability of data? What is the experience of the applicants and the participating CNP(s) in recording, submitting, processing the relevant data in accordance with required data standards?
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. Overall Integration of the proposed Research Center (including Administrative Core)
B. Review Criteria for Individual Research Projects:
C. Review Criteria for Screening Process Documentation Unit:
D. Review Criteria for Optional Shared Resource Core (IF APPLICABLE):
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.
Biohazards. Not applicable to this FOA.
Resubmission Applications. Not applicable to this FOA.
Renewal Applications. Not applicable to this FOA.
Revision Applications. Not applicable to this FOA.
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.
Applications from Foreign Organizations. Not applicable to this FOA.
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 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:
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 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.
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.
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/Applied Research Program
National Cancer
Institute
6130 Executive Blvd,
MSC 7344
EPN 4005, Room Number
4102
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: [email protected]
2. Peer Review Contacts:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard,
Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville,
MD 20852 (for non-USPS delivery)
Telephone:
(301) 496-3428
FAX:
(301) 402-0275
Email: [email protected]
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:
[email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health
Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); 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 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-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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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