Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)

Components of Participating Organizations
National Cancer Institute (NCI) http://www.cancer.gov/

Title: Coordination Center for Transdisciplinary Research in Energetics and Cancer (Limited Competition U01)

Announcement Type
This is a reissuance of RFA-CA-05-011.

Request For Applications (RFA) Number: RFA-CA-10-501

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

Key Dates
Release Date: December 3, 2009
Letters of Intent Receipt Date: January 26, 2010
Application Receipt Date: February 26, 2010
Peer Review Date(s): May/June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: February 27, 2010

Due Dates for E.O. 12372

Not Applicable

PRE-APPLICATION CONFERENCE CALL

The NCI anticipates holding a pre-application conference call on Monday, January 8, 2010 at 2 PM EST to which all interested prospective applicants are invited. NCI Program and review staff members will explain the goals and objectives for TREC, discuss the application peer review process, and to answer questions. Information about this Pre-Application Conference Call will be available at URL: http://cancercontrol.cancer.gov/trec/index.html

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
 A. Additional Review Criteria
 B. Additional Review Considerations
 C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
 A. Cooperative Agreement Terms and Conditions of Award
 1. Principal Investigator Rights and Responsibilities
 2. NIH Responsibilities
 3. Collaborative Responsibilities
 4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

This funding opportunity announcement (FOA) issued by the National Cancer Institute is a component of the Transdisciplinary Research on Energetics and Cancer (TREC) program. The reissued TREC program focuses upon the research areas of nutrition, energetics, energy balance, physical activity, obesity, and cancer conducted primarily in TREC Research Centers (to be funded through a companion FOA (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-10-006.html).

This FOA is a limited competition solicitation to continue the operation of the TREC Coordinating Center. Only the current TREC Coordinating Center awardee  is eligible to apply in response to this FOA. Note that the companion FOA for TREC Research Center awards (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-10-006.html) solicits applications from all qualified applicants).

Overall Goals of the TREC Program. The field of energetics and cancer research has been expanding rapidly during the past 5 years, with great progress. The TREC initiative, started in 2005, has established a transdisciplinary infrastructure to promote research collaborations. To continue this progress, the reissuance of the TREC initiative expands into other research areas including: cancer survivorship, childhood obesity, genomics, and environmental aspects of obesity that include use of tools such as geospatial analysis. Competitive renewal of the initiative will enable NCI to expand this research model in energetics and cancer with renewed emphasis on testing and integrating health theories, challenges in survivor populations, systems analysis (to address challenges across multiple levels), accelerating capacity using animal and human studies in diverse research designs (biological and physiological), and expansion of the application of biological markers to inform behavioral based-research.

Role of TREC Coordinating Center. The main role for the TREC Coordinating Center will be the integration of efforts across the network of individual TREC Research Centers and facilitation of transdisciplinary research. TREC Center will be expected to achieve this goal by communication, coordination, and collaboration across multiple participating research institutions forming TREC Research Centers as well as close interactions with the NCI program staff members.

Definitions:

Transdisciplinary research is defined as research efforts conducted by investigators from different disciplines working jointly to create new conceptual, theoretical, methodological, and translational innovations that integrate and moves beyond discipline-specific approaches to address a common problem.

Energetics in the context of this FOA is defined as the study of the flow and transformation of energy through living systems (i.e., bioenergetics).

Background

When the TREC initiative was first conceptualized in 2004, obesity and overweight occurred in over two-thirds of the adult United States (U.S.) population, and physical inactivity and poor diets were common. In the interim, weight gain, overweight and obesity rates have stabilized for some adults but continue to rise for children in the U.S.. At the same time, levels of physical activity have decreased. Racial and ethnic differences in obesity rates remain, with the highest rates in non-Hispanic black men and women. An estimated 17% of children and adolescents 2-19 years of age are overweight according to the 2003-2004 NHANES. Among children 6 to 11 years of age, the percentage of those considered overweight increased from 4.2% to 18.8% (a 34.8% increase) between 1963-1965 and 2003–2004. Populations at high risk for developing obesity continue to be children and specific racial and ethnic groups. The costs of obesity are high in the U.S. According to the U.S. Centers for Disease Control and Prevention, medical costs of obesity in the U.S. were estimated at more than $92 billion in 2002, and the total treatment cost for obesity and ancillary chronic diseases is anticipated to top $586 billion in 2009.

Obesity due to unhealthy lifestyle (e.g., poor diet, sedentary behavior) has an adverse public health impact, is associated with shortened life expectancy similar in scope to that associated with tobacco use, and is perhaps the most important morbidity and mortality risk factor among non-smokers. Recent reviews and meta-analyses provide strong evidence from a number of research designs that overweight/obesity and fat distribution are associated with risk for many cancers. Similar evidence exists that increased physical activity is associated with a reduced risk of a number of cancers. The evidence is extensive for major cancers and expanding for more rare cancers that healthy weight, physical activity and some characteristics of diet are associated with beneficial changes in a number of outcomes for cancer survivors, including quality of life, comorbid conditions, lymphedema, and now emerging, survival. Basic science and small randomized controlled trials among both high-risk populations and cancer survivors in the areas of diet, physical activity, and intentional weight loss indicate that these health behaviors result in beneficial changes in a number of mechanisms and pathways that are thought to influence risk and prognosis. Further, for a number of cancers, evidence suggests that a combination of physical activity, beneficial diet, and healthy weight is associated with greater benefits than one of these behaviors or outcomes alone. The synergistic relationship between genes, behavior, and the environment continue to come to light, which necessitates our further understanding of these complex relationships.

The relationship between overweight/obesity, physical activity, and sedentary lifestyle and cancer risk are complex. Obesity may increase cancer risk by several mechanisms including increased estrogens and testosterone leading to increased risk of breast and endometrial cancers; hyperinsulinimia and insulin resistance leading to increased risks of colon, breast, and pancreatic cancers; and increased inflammation and depressed immune function leading to select cancer risk.

Evaluation of biomarkers has enabled investigators to assess the biological factors thought to be involved in the causal pathway between exposure and carcinogenesis. The proposed biomarkers for the observed associations among physical activity, overweight/obesity, and cancer have focused upon sex steroid hormones (estrogens/androgens). Additional biomarkers under investigation include hyperinsulinemia and insulin resistance, other metabolic hormones (i.e., leptin, adipokines), increased inflammation (i.e., prostaglandin, C-reactive protein), depressed immune function (i.e., natural killer cells, leukocytes, T helper cells) and oxidative stress. Physical activity, diet, and energy balance potentially affect all of these biomarkers.

Continued evidence suggests that increased physical activity can exert cancer-preventive effects at many stages during the process of carcinogenesis, including both tumor initiation and progression. Exercise may alter tumor initiation events by modifying carcinogen activation, specifically by enhancing the cytochrome P450 system and enhancing selective enzymes in the carcinogenic detoxification pathway, including but not limited to, glutathione-S-transferases. Exercise may reduce oxidative damage by increasing a variety of anti-oxidative enzymes, enhancing DNA repair systems, and improving intracellular protein repair systems. It may exert a cancer protective effect by dampening the processes involved in the promotion and progression stages of carcinogenesis.

Considering the difficulty in reversing obesity and that obesity has been related to the development and course of many cancers, research on obesity prevention and healthy weight maintenance is sorely needed. As noted, children may be particularly at risk, as the obesity rate among children has steadily risen and evidence suggests that a majority of overweight children will continue to be obese in adulthood. Similarly, weight gain among survivors of many cancers is common and is associated with poor prognosis. Among high-risk populations for obesity (e.g., non-Hispanic blacks), these populations also experience greater morbidity rates from cancers of the breast and other cancers for which obesity, lack of physical activity, and poor diet are risk factors. Investigators have focused on the etiologic factors in the development of obesity and youth with special emphasis on ethnic differences during critical periods of adolescent growth. Available evidence suggests that factors at the biological, individual, and social-contextual and environmental levels may all play a role in obesity development, and as such, research is needed that furthers our understanding of mechanisms operating at each level as well as research paradigms that consider a multi-level approach, or a systems approach, to obesity prevention.

Obesity links with diet and physical activity are established, but current research is exploring more complex relationships that have come to light. In the early 2000s, research expanded rapidly on the adverse effect of inadequate sleep and sleep habits on obesity, hyperinsulinemia, hypertension, and a number of other chronic diseases. Limited evidence at that time suggested that inadequate sleep might have adverse effects on cancer outcomes. For example, sleep and the disruption of associated circadian patterns of hormones, such as cortisol and melatonin, has pervasive effects on the body, ranging from fatigue and depression, to increases in the rate of cancer progression and risk of cancer incidence. There is evidence that abnormal circadian clock gene expression is associated with cancer (i.e., breast, ovarian). Loss of normal circadian variation in cortisol predicts earlier mortality among metastatic breast cancer patients, independent of other known risk factors including estrogen/progesterone receptor status, age at diagnosis, and disease-free survival. Therefore, research on the influence of sleep, or lack thereof, on obesity, health habits, and cancer was a novel aspect of the first TREC initiative.

Finally, various research efforts begin to integrate diverse aspects, including those related to health services, economics, urban planning, geography, informatics, and communications. This integration is expected to facilitate progress in identifying effective population-level interventions to prevent obesity among high-risk populations at local, state, and federal levels. The results of such studies may inform obesity-related policymaking and promote critical policy changes counteracting obesity-promoting factors.

References to the issues discussed above are available at http://cancercontrol.cancer.gov/trec/.

In summary, the research that has resulted from the initial TREC initiative contributes to the understanding of energy balance at the molecular, cellular, organismal, and population levels as it relates to cancer prevention. The continuation of the TREC program is expected to accelerate research in promising directions and have a greater impact. As in the first TREC initiative, the reissued program continues to emphasize the collaboration across diverse disciplines: behavior science, physiology and metabolism, sociology, communications, geography, psychology, kinesiology, nutrition, biostatistics, biochemistry, molecular biology along with other diverse disciplines.

Specific Research Objectives and Requirements for TREC Coordination Center

General Requirements for TREC Coordinating Center:

TREC Coordinating Center (to be funded as a result of this FOA) will have important role in integrating the efforts of individual TREC Research Center to be funded under a companion FOA (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-10-006.html). To fulfill this role, the Coordinating Center applicant team must have prior experience in coordinating large multi-site programs, providing logistic infrastructure for such programs, and organizing related career development/training programs and result dissemination programs.

TREC Coordinating Center will be expected to provide intellectual, scientific leadership as well as logistic support infrastructure for TREC Research Centers. The Coordinating Center will work with all the TREC Research Centers and NCI to bring together expertise and data relevant to the funded research. Coordinating Center should be able to connect available resources and serve as research data management center.

TREC Coordinating Center will be expected to integrate activities of all of the awarded TREC Research Centers to minimize resources/effort duplication and utilize existing resources available. The Coordination Center will have substantial responsibility for the continued self-evaluation of TREC awardees and the evaluation of the entire TREC Program.

The applicants must have appropriate professional expertise and experience in the areas defined above. The applicant institution must have the necessary facilities to meet the special requirements mentioned in the FOA.

Strategic Goals for the TREC Coordination Center:

TREC Coordinating Center applicant team must address the following strategic objectives:

  1. Facilitate transdisciplinary research through scientific leadership and organizational support with emphasis on efficient communication, coordination of efforts, and scientific collaboration across multiple research institutions
  2. Facilitate and mediate contacts between TREC awardees and NCI professional staff to allow for efficient interactions, consultations, and oversight functions.
  3. Create significant new opportunities for transdisciplinary training of scientists at every stage in their careers in the area of energy balance and cancer.
  4. Create and manage relevant logistic infrastructure (including research data management and bioinformatics) to support the TREC Research Centers.
  5. Create opportunities to disseminate results across multiple venues.

Required Structure and Main Components of the TREC Coordination Center:

All TREC applicants must address the following main aspects for the proposed TREC (for details see Section IV. Content and Form of Application Submission):

1. Leadership and Administrative Core. Coordinating Center must be able to provide close coordination of transdisciplinary research efforts of TREC Research Centers. This role will require strong leadership, scientific insight, and capacity to bring diverse teams together.

Because of the central requirement for interactions across TREC Research Centers, the TREC Coordination Center will be responsible for the following activities:

a)   Providing scientific leadership and serving as an intellectual/scientific hub for TREC Research Centers and the entire TREC Program.

b)   Providing leadership for the TREC Steering Committee and helping to bring together appropriate experts to advise Steering Committee.

c)   Compiling state-of-the-art instruments for multiple methodologies, biomarkers, and other relevant measures in use across the TREC Research Centers, and leveraging their use.

d)   Bringing together expertise from across the network of TREC of Research Centers and help establish topical “Working Groups” (such as a behavioral research and intervention group, or a specimen collection and biomarkers group) relevant to the funded TREC research and scientific needs across the initiative..

e)   Providing logistical infrastructure serving TREC Research Centers and facilitating trans-TREC functions and activities.

f)    Facilitating and mediating contacts between TREC awardees and NCI professional staff to allow for efficient interactions, consultations, and oversight functions.

g)   Providing logistical and administrative support for all the activities of the Steering Committee and its subcommittees, including External Advisory Panel.

h)   Organizing the semiannual meetings of TREC investigators (in cooperation with the NCI representatives) and meetings of topical work groups to be formed by the TREC Research Centers investigators.

i)     Coordinating TREC self-evaluation and integration (see more detail below under Integration and Self-Evaluation Core).

j)     Providing state-of-the-art cross-site communication tools for TREC awardees.

2. Data and Bioinformatics Core. TREC Coordinating Center will be primarily responsible for a Central Data Core (i.e., Bioinformatics Core).

The main goal of this Core must be to facilitate data sharing and results dissemination across TREC awardees and between TREC and NCI.

The Bioinformatics Core must providing infrastructure for data collection and archiving to meet standards for common data systems and future data repositories. Specifically, informatics and data sharing approaches proposed for the TREC Coordinating Center must aim at achieving compatibility with the NCI's cancer Biomedical Informatics Grid (caBIG).

It is expected that this Core will strongly involve resource and personnel at individual TREC Research Centers. Note that the data management functions of the Coordinating Center may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site.

3. Education/Training and Outreach Core. The Coordinating Center must include a training program that is integrated across all TREC Research Centers and dedicated to the development of a new cadre of transdisciplinary scientists and a program to disseminate research findings and data sharing is mandatory. Plans for this Core must include the following elements:

a)     Developing (in a partnership with the TREC Research Centers) training modules in diverse disciplines, such as genetics and proteomics, or health behavior theory, or advanced self reporting tools, and/or technologies for assessment of diet and physical activity to support transfer of knowledge across disciplines.

b)    Facilitating TREC integration and promote TREC research, the outreach efforts of the Coordinating Center must include the setup and maintenance of a website for TREC investigator as well as a public, generally accessible web site.

c)     Organizing sessions to present TREC outcomes at relevant national meetings (e.g., meetings of American Association for Cancer Research, North American Association for the Study of Obesity, Society for Behavioral Medicine, and/or American Association for the Advancement of Science).

d)    Expanding and promoting the TREC Program, by actively synthesizing and disseminating relevant TREC results, and disseminating cancer energetic information regarding measurement, biomarkers and interventions to the larger medical, public health, policy, and cancer research community.

4. Developmental Cross-TREC Core. Developmental Core will be responsible for coordinating collaborative research to be developed and conducted by TREC awardees post-award. Specifically, plans for this Core must include the following:

a)     Identifying commonalities in research directions and specific questions being explored across the TREC Research Centers to promote cross-TREC collaborative efforts.

b)    Identifying scientific problems across TREC Research Centers that could be jointly explored.

c)     Coordinating and/or facilitating development of specific collaborative projects and their presentation for Steering Committee approval.

To enable developmental cross-TREC projects, Coordination Center applicants must budget appropriate funds as TREC Core Funds”. A minimum of $100,000 in direct cost per year must be allocated. These Core Funds are reserved and their use for specific projects must be approved by the TREC Steering Committee (with the consent of the NCI).

For example, Core Funds can be used to support projects to evaluate common measures, or develop new methodologies that can be validated at multiple centers and in larger populations. Core Funds can also be used to fund projects that involve investigator other than TREC awardee teams who may have desirable expertise that is not part of the awarded TREC Research Centers. However, Core Funds should not be used for activities that have been supported under the awards for individual TREC Research Centers.

5. Integration and Self-Evaluation Core.. The proposed TREC Coordinating Center must have a well developed capacity to enable timely self-evaluation mechanisms promoting effective self-correcting actions. In this area, the Coordinating Center will have to closely collaborate with the TREC Steering Committee (see below), individual Research Centers, and NCI Program Staff. An appropriate evaluation system is expected to be integrated into the Coordination Center’s design and operations.

This self-evaluation system should track the relevant performance benchmarks of each TREC Research Center and compare its performance to that of other TREC Research Centers. The outcomes will help Steering Committee and individual awardees to take corrective steps and optimize their performance.

In addition, to the self-evaluation, the entire TREC program will be subject to external evaluation to be coordinated by the NCI Program Staff (see below). The self-evaluation of the TREC awardee (and the activities of this Core) will be essential for facilitating and enhancing the external program evaluation. TREC Coordinating Center (and specifically this Integration and Self-Evaluation Core) will be expected to cooperate with NCI in the evaluation process.

For example, this component includes evaluating the quality and innovativeness of the science conducted by the TREC Research Centers as well as assessing critical intermediate indicators of success such as infrastructure development and capacity building, career development, linkages and resource sharing arrangements within and among the TREC Research Centers, and the interdisciplinary and multilevel nature of the research. Evaluation variables may include items such as peer-reviewed publications, developed web sites, theoretical-based models within new initiatives, evidence-based diffusion or dissemination strategies, or new collaborations and partnerships.

Areas for the self-evaluation and desirable outcomes will include such aspects as:

  1. The overall capacity to study the mechanisms underlying the association between energy balance and carcinogenesis across the cancer continuum, from causation and prevention through survival, in the TREC Research Centers;
  2. The capacity to study the relationship between nutrition, physical activity, and energetics, as they relate to the goal of reducing cancer incidence, morbidity, and mortality associated with obesity;
  3. The contribution to these capacities of resource sharing and collaboration within and among TREC Research Centers;
  4. The effectiveness of collaborative relationships within and among TREC Research Centers;
  5. Training and career development opportunities created for new and established investigators;
  6. A “transdisciplinary research culture” engendered which takes into account the perspectives of multiple disciplines and multiple levels of analysis; and
  7. TREC Center investigators’ abilities to compete for future R01 grants and participate in other research mechanisms have been enhanced.

Governance of the NCI Transdisciplinary Research on Energetics and Cancer (TREC)

The TREC initiative will be governed by the TREC Steering Committee and the Sub-committee of Experts to be established. The TREC Steering Committee will oversee and coordinate the activities of all TREC Research Centers, including developmental pilot projects, cross-TREC activities and career development opportunities. The TREC Steering Committee will have the ability to establish sub-committees to advise the Steering Committee. Working collaboratively with TREC Primary Investigators, the TREC Steering Committee, Sub-committee of Experts, and NCI staff will identify and develop transdisciplinary research opportunities (e.g., developmental pilot projects and cross-TREC pilot projects) that capitalize on unique strengths and expertise. This includes connecting with other existing research initiatives and data resources outside of TREC (e.g., NIH Clinical Center, the Women’s Health Initiative, others).

Details on the composition and functions of TREC Research Centers are provided in Section VI.2.A.3, Terms and Conditions of Cooperative Agreement “Collaborative Responsibilities.”

External Evaluation of the Program

As the efficiency of the funded research is an increasing priority for NCI, TREC awardees will be expected to participate in an external evaluation process coordinated by involved NCI program staff members. Outcomes to be assessed will include peer-reviewed publications, educational and outreach programs, and effectiveness of a collaborative research development model. The purpose of the evaluation process is to monitor and assess the performance of the TREC awardees in achieving the goals of the TREC Program. This component includes evaluating the quality and innovation of the research conducted at the TREC Research Centers and Coordinating Center, as well as assessing critical intermediate determinants of the overall success, such as infrastructure development and capacity building, career development, linkages and resource and data sharing arrangements within and among TREC Research Centers, and the transdisciplinary nature of the research.

In terms of the overall impact of the TREC Program, particular focus will be on the relationship between energy balance and obesity based on the integration of social, behavioral, and biological sciences into more comprehensive study design. Examples of highly desirable outcomes include the development of:

  1. New theories or conceptual models ranging from genetics, psychology, molecular biology, and anthropology, to urban planning, informatics, social sciences, health behavior, and communication;
  2. New measures of dietary, physical activity, and anthropometric assessment or psychometric and statistical methodology for coding self-reported data;
  3. New biological markers of genetics, molecular biology, and physiology of obesity; and
  4. New treatments or interventions that address the individual-level determinants of behavior to the effective population-level interventions in prevention of obesity, and the social-environmental or policy level interventions across diverse at risk populations.

The relevant outcomes to use as measures of program success will be identified from the conceptual framework presented earlier and from other theoretical models and empirical evidence in the literature.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

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

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The estimated amount of funds available for support for one center awarded as a result of this announcement is $ 2 million for fiscal year 2010, and $10 million over 5 years.

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

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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 http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. 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.

Although the multiple PDs/PIs option is available, the applicants are encouraged to consider a single PD/PI, if this solution is preferred.

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

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

Renewal. Renewal applications are permitted in response to this FOA.

Number of Applications. Current TREC Coordinating Center awardee may submit only one application in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

The exceptions from the 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, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

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 26, 2010
Application Receipt Date: February 26, 2010
Peer Review Date(s): May/June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010

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:

Yvonne F. Grant
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, MSC 7335
Executive Plaza North, Room 4056
Bethesda, Maryland 20892‑7335 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-2838
FAX: (301) 435-7547
Email: granty@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

Research Plan Page Limitations

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

For the TREC Coordinating Center application 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- E:

A. Overview and Progress Report

B. Leadership and Administrative Core

C. Data and Bioinformatics Core

D. Education/Training and Outreach Core

E. Integration and Self-evaluation Core

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).

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 following individual application components:

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

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

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

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

A. Overview and Progress Report (up to 12 pages)

In this section, describe the following aspects:

Include a Progress Report for the previous funding period. Referring to the goals and objectives of the original TREC Coordinating Center award, describe the following elements:

B. Leadership and Administrative Core (up to 12 pages)

In this section, describe the following aspects:

C. Data and Bioinformatics Core (up to 6 pages)

In this section, describe the following aspects:

D. Education/Training and Outreach Core (up to 6 pages)

In this section, describe the following:

Note: a minimum of $100 K in direct costs must be allocated to these activities in the budgetary request.

E. Integration and Self-evaluation Core (up to 6 pages)

In this section, describe the following:

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI2.A “Award Administration Information.”

OTHER REQUIREMENTS

Awardees must agree to the award administration information detailed in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award.”

Site Visits and Annual TREC Scientific Meetings. Because of the complexity of the TREC, NIH/NCI program staff members will conduct at least one administrative site visit. TREC applicants must agree to participate in this process and should plan for one visit (with appropriate budget, including travel for collaborators and other necessary costs).

Applicants must plan appropriate travel funds for the PDs/PIs and team leaders to participate in the semiannual TREC Scientific meetings. They should also plan such funds for travel of key administrative staff, consultants, and new/junior investigators to these meetings.

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 must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: 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/.

Data/resource sharing with institutions/organizations comprising the TREC initiative. In addition to the NIH wide requirements, all institutions/organizations participating in a given TREC Center will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the TREC award. An appropriate binding agreement, signed and executed by all entities participating in a given TREC award (applicant institution and all institutional/organizations participating on a subcontractual basis), will be required prior to the initiation of the award.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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

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

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

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

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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?

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?

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?

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 to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

A. Criteria for Progress:

Has the applicant shown adequate progress in developing the research infrastructure, programs, collaborations and evaluation plan? How significant is the contribution of the applicants’ currently funded TREC to the overall TREC’s scientific contributions in energy balance and cancer? How well have the applicants accomplished the specific objectives proposed in the original TREC application?

B. Criteria for Research Team, Leadership and Administrative Core:

Is there adequate evidence for the managerial and collaborative capabilities of the proposed TREC leadership? How appropriate is the leadership structure of the proposed TREC in terms of (a) the overall goals of TREC initiative; (b); the coordination of efforts of multiple institutions participating in a given TREC; and (c) the participation in and coordination of cross-TREC activities? Are the backgrounds, expertise, and commitments of the PI and other key personnel sufficient for the proposed scope of activities and in line with the overall goals for TREC initiative?

C. Criteria for Education/Training and Outreach Core:

How appropriate and balanced are the proposed training and education activities in the context of the specific goals proposed? Is the Education/Training Program well justified, and does it describe a program that will successfully support new investigators capable of establishing independent multi- /transdisciplinary research on energetics and cancer?

D. Criteria for Bioinformatics Core:

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

E. Criteria for Integration and Evaluation Core:

How well does the evaluation plan demonstrate the capacity of the TREC Coordination Center to collaborate with the TREC Research Centers and NCI program staff on critical evaluation of scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships?

Additional Review Criteria

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.

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.

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.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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.

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.

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).

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

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.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 TREC research in accordance with terms and conditions of the award.

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

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

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

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

All TREC awardees (Coordinating Center and TREC Research Centers) will be responsible for ensuring that Informatics and data sharing approaches used are appropriate to seek compatibility with caBIG.

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 normal stewardship role in awards, as 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 TREC’s scientific activities.

All NCI staff members who may be involved in the scientific activities of TREC, including the Project Scientist, will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict interest.

Additionally, one 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.

Main NCI responsibilities to TREC awardees (both Research Centers and Coordinating Center) include:

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those TREC 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 TREC Program.

2.A.3. Collaborative Responsibilities

The TREC Steering Committee will serve as the main governing board for the TREC initiative.

The committee will consist of the following voting members:

Additional NIH staff members may participate in Steering Committee meeting as non-voting members.

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

In addition, the designated NCI Program Official will participate in the activities of the TREC Steering Committee as a non-voting member. Additional non-voting members to serve in an advisory capacity may be added to the TREC Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies (e.g., Centers for Disease Control and Prevention).

The TREC Steering Committee will have primary responsibility for:

The TREC Steering Committee will establish a scientific advisory panel (subcommittee) to serve the TREC Steering Committee and the TREC awardees.

The Advisory Panel Subcommittee will comprise scientific experts from outside the TREC initiative and will be charged with the following activities:

TREC Steering Committee is also expected to form topic-specific working groups, which will be a resource of cross-TREC expertise. Representatives from the NCI organizational units (DCCPS, DCP, DCB), as well as other NIH institutes (e.g., NHLBI, NIDDK), or other Federal agencies (e.g., CDC) will participate in working groups as appropriate (but will not serve as chairs of these working groups).

Members of the TREC network (i.e., TREC Research Center awardees and TREC Coordinating Center awardee) will be required to accept and implement policies approved by the TREC Steering Committee.

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. 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.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Linda Nebeling
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, MSC 7335
Executive Plaza North, Room 4056
Bethesda, MD 20892-7335 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-2841
FAX: (301) 435-7547
Email: nebelinl@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and 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/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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NIH Funding Opportunities and Notices


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