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: Centers of Excellence in Cancer Communication Research II (CECCR II) (P50)

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-03-007, which was issued on March 21, 2002.

Update: The following update relating to this announacement has been issued:

Request For Applications (RFA) Number: RFA-CA-08-004

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates
Release Date: November 9, 2007
Letters of Intent Receipt Date: January 22, 2008
Application Receipt Date: February 22, 2008
Peer Review Date(s): May/June 2008
Council Review Date: October, 2008
Earliest Anticipated Start Date: September 2008
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: February 23, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Cancer Institute (NCI) invites P50 grant applications for Centers of Excellence in Cancer Communication Research (CECCRs). Communication science plays a critical role both at the individual level (e.g., provider-patient dyad) as well as at the community, societal, and population levels (through traditional mass media and emerging diverse electronic channels). This Funding Opportunity Announcement (FOA) reflects recognition of cancer-related communications as a vital component of the efforts to improve population health.

The NIH specialized center (P50) grant mechanism is being used to promote interdisciplinary cancer communication research. For this FOA, the term interdisciplinary refers to the strategy of drawing from, and integrating from, two or more academic disciplines, fields, technologies, or departments, in order to develop a greater understanding of a problem that is too complex to be understood by one discipline alone. Applicant teams responding to this FOA should include specialists from a number of different disciplines, which might include communication, behavioral science, informatics, public health, health systems engineering, or medicine. These interdisciplinary teams should propose an integrated research program for the proposed Center to create the new evidence base for communication approaches that would be applicable to practical, and life saving, cancer communication efforts. The center grant mechanism will allow grantees to bring resources to bear from across their respective institutions to evaluate research questions from a broader, more generalizable perspective. The training component of the center grant will encourage grantees to prepare a new generation of transdisciplinary cancer communication scientists.

This CECCR II FOA stems from the original CECCR initiative (covered by RFA-CA-03-007) and current CECCR awardees may submit competing continuation applications. However, this FOA is an open solicitation available to new applicants as well. All the applicants must recognize an important shift in the emphasis of the CECCR II program. A specific, distinguishing characteristic of CECCR II is the requirement for at least one research project designed and conducted with the goal of relevance to clinical settings. For purposes of this FOA, clinical settings are considered to be those environments in which licensed, medical practice is authorized to take place. Much of the existing portfolio sponsored by the Health Communication and Informatics Research program at the NCI includes projects dealing with primary and secondary prevention efforts in the general population. That aspect of evidence-based communication research is vital (see for example NIH publication # 02-5145, Making Health Communication Programs Work). However, gaps exist in knowledge of how patient-centered communications (Institute of Medicine, 2001) can be improved to remove various barriers to the achievable quality of cancer care, thereby positively contributing to clinical outcomes across the cancer care spectrum. This identified need for clinically relevant communication research must be addressed by each proposed CECCR. To facilitate such research projects, the NCI encourages prospective applicants to establish appropriate collaborative relationships, for instance with one or more of the NCI-designated Comprehensive Cancer Centers (http://www.cancer.gov/cancertopics/factsheet/NCI/cancer-centers) or, one or more of Community Cancer Centers that have been funded more recently (http://ncccp.cancer.gov/).

Using Communication to Extend Knowledge Benefits Equitably throughout the Population

Another hallmark of the CECCR initiative is to use best practices in communication science to extend the reach of biomedical benefits equitably throughout the population. Issues of health disparities, the digital divide, knowledge gaps, and health literacy will all be considered important topic areas for research and application.

The crucial role that communication plays in accelerating national progress against cancer was recognized by the National Cancer Act of 1971 (and subsequent amendments). As the communication environment surrounding cancer control and prevention changes, the need to accelerate promotion of healthy behaviors in such a dynamic [or non-static] environment increases. However, the gap between those with regular, effective access to digital and information technology, and those without this access (referred to as digital divide ) poses a challenge to health communication researchers concerned about how to reduce, not widen, health disparities (Kreps, 2005). More recently, the NCI-designated Cancer Centers encouraged the NCI to invest in expanded health communication research, particularly via the Health Communications and Informatics Research Branch, to improve understanding of evidence-based communications approaches as a way of extending benefits of current knowledge more rapidly throughout the population (Cancer Center Directors Working Group, 2006).

Origins of the Centers of Excellence in Cancer Communication Research (CECCRs) Program

In 2003, the NCI announced funding for the first round of its Centers of Excellence in Cancer Communication Research (CECCRs) grants. The program was modeled on the highly successful Transdisciplinary Tobacco Use Research Centers (TTURC) initiative supported by the NCI Division of Cancer Control and Population Sciences. The TTURC emphasized the importance of transdisciplinary science (Abrams, 2006) to tackle the problem of cancer control at multiple levels of intervention. Due to the multifaceted nature of cancer communication, the CECCR Program was also initiated as a way of optimizing inputs from multiple disciplines. Communication scientists are needed to understand the changing environment of mass and interpersonal communication; behavioral scientists are needed to refine theories of message framing and behavioral support in this new environment (Croyle, 1995); and computer and information scientists are needed to track the implications of the information revolution (Hesse, 2005). By the third year in the initiative, the four CECCRs had collectively produced some 156 scientific publications, made 279 presentations at professional conferences, leveraged resources to obtain 106 new grants, and put 52 small pilot projects into the field. The cadre of scientists working together at the Centers to solve the cancer communication problem expanded to include interdisciplinary representatives from the areas of communication, public health, psychology, journalism, oncology, health services research, genetics, statistics, epidemiology, engineering, environmental health, sociology, anthropology, marketing/management, nursing, computer science, and education.

Extended Scope of CECCR Program to Include Clinically-relevant Research

The first round of CECCRs research has been heavily focused on issues of prevention and public health. Communication, however, lies not just at the core of effective prevention campaigns, but it is also an integral part of the life-saving advances that contribute to survivorship along the entirety of the cancer care spectrum. For example, the point at which cancer is first diagnosed is a crucial period, in which the patient needs to be properly informed to make time-sensitive decisions. This process must be optimally supported by the health care system. Ineffective communication during this crucial stage and patient confusion may result in suboptimal decisions and/or inaction. Consequently, this situation may lead to delays in diagnosis and suboptimal care and in the extreme situations even premature patient death.

Similarly, continuity of care during the treatment phase of cancer care is essential for monitoring the quality and responsiveness of prescribed therapies. During the treatment phase, which can be short (e.g., through surgery) or protracted (e.g., through chemotherapy or radiation treatment), effective communications are needed to: (a) foster healing relationships, (term introduced by the Institute of Medicine in its Crossing the Quality Chasm report to emphasize continuity of care over time) (b) exchange information between the healthcare delivery team, the patient, and the patient’s family, (c) respond to emotions, (d) manage uncertainty, (e) support decision making, and (f) enable patient self-management (Epstein & Street, 2007). In an improved quality care model, the cancer patient (irrespective of his/her level of health literacy) and the patient s caretakers should be both considered indispensable parts of the treatment team. Communications must be as clear to patients and their families as they are between physicians, specialists, and other health care providers to promote quality of care. For example, a poorly worded set of instructions on a medication container or on discharge instructions can disrupt those essential communications and may lead to disastrous consequences (Institute of Medicine, 2004). Likewise, a medical team that does not take full advantage of a patient s perspective as the reporter of first resort in monitoring for symptoms will likely miss an opportunity to correct side effects early.

Research Goals

The CECCR initiative is designed to create centers of critical mass, in which scientists trained in different disciplines will form teams to solve the complex problems associated with cancer communication in a changing communication environment. The NIH P50 centers mechanism also allows for internal coordination through the administrative and shared resources (cores), flexible funding of new directions (through the use of developmental projects), and training of cancer communication researchers. The overall research goals of the CECCR initiative are as follows:

(1) Accelerate the integration of effective and evidence-based communication approaches into outreach efforts both at the individual and community levels.

(2) Strengthen the understanding of the roles that communication plays across the spectrum of cancer care, with special emphasis on the areas of diagnosis, treatment, and survivorship.

(3) Provide models of how clinical/health care environments can be re-engineered to better serve patient-communication needs, including the needs of patients of low literacy levels and varied ethnic backgrounds, which are factors affecting the quality of cancer care.

(4) Extend the reach of communication beyond traditional barriers (e.g., socioeconomic status) and newly emerging barriers (e.g., digital divide ), as one factor in efforts to diminish health disparities.

(5) Produce evidence-based communication interventions that can be used to modify cancer risk-related behaviors and improve informed decision making in real-world settings.

(6) Train interdisciplinary investigators capable of conducting cutting-edge communications research directly relevant to the context of cancer prevention, detection, treatment, control, and survivorship.

(7) Advance the science of cancer communication and informatics as evidenced by an increase in peer-reviewed publications in the area, professional presentations, and the development of leveraged opportunities in related areas.

Summary of Main Requirements

CECCR applications in response to this FOA must conform to the following requirements:

(1) Investigator team should include specialists from multiple disciplines, such as departments of communication, behavioral science, informatics, public health, health systems engineering, and medicine;

(2) A minimum of three full research projects must be proposed (and present in any funded CECCR);

(3) At least one of these three required research projects must be designed so its results will be directly applicable to clinical settings. Applications without such projects will be considered non-responsive and will be returned to the applicants without being reviewed;

(4) Appropriate career development opportunities must be proposed for new investigators or established investigators who wish to pursue careers in cancer communication research;

(5) Plans must be described for funding and conducting innovative pilot projects (Developmental Projects); and

(6) Interactions (on a regular basis) must be planned with other CECCRs to share information, participate in NCI-directed evaluation activities, promote and coordinate collaborative efforts, identify opportunities for common measures in the field, and review areas of growth and opportunity in the emerging fields of cancer communication and informatics research.

Applicants should anticipate the use of shared protocols and methodologies across the CECCRs. This sharing is intended to benefit collaborative efforts in evaluating the efficacy and effectiveness of communication approaches at the individual and community levels. The CECCRs will be expected to work with the NCI in extending the benefits of the cancer Biomedical Informatics Grid (caBIG) into the population and behavioral sciences, and to work together in identifying shared vocabularies and ontologies in the areas influenced by cancer communication research. The CECCRs will also be encouraged to be cognizant of systemic changes occurring in health care within the United States changes such as the diffusion of electronic medical records, development of personalized medicine, human factors efforts to improve quality and prevent communication errors, direct to consumer advertising, commoditized medicine, and support for persons with low health literacy. The centers are encouraged to form partnerships with industry, universities, hospitals, and/or other entities needed to facilitate high quality, and potentially even life-saving, communications within the context of change in cancer care.

Specific types/areas of research that may be appropriate as the required clinically relevant project include but are not limited to the following examples:

References Cited

Abrams DB. (2006). Applying transdisciplinary research strategies to understanding and eliminating health disparities. Health Educ Behav, 33(4), 515-531.

Cancer Center Directors Working Group. (2006). Accelerating Successes against Cancer. Washington, DC: U.S. Department of Health and Human Services.

Croyle RT, (Ed.). (1995). Psychosocial effects of screening for disease prevention and detection. New York: Oxford.

Croyle, RT, Lerman, C. (1999). Risk communication in genetic testing for cancer susceptibility. Journal of the National Cancer Institute Monographs;25:59-66.

Culliton, B. J. (2006). Extracting Knowledge From Science: A Conversation With Elias Zerhouni. Health Aff (Millwood).

Cvengros, J. A., Christensen, A. J., & Lawton, W. J. (2004). The role of perceived control and preference for control in adherence to a chronic medical regimen. Ann Behav Med, 27(3), 155-161.

Epstein RM, & Street RL. (in press). Patient-Centered Communication in Cancer Care: Promoting Healing and Reducing Suffering. Bethesda, MD: National Cancer Institute.

Hesse BW. (2005). Harnessing the power of an intelligent health environment in cancer control. Stud Health Technol Inform, 118, 159-176.

Hesse, BW & Shneiderman, B (2007). eHealth research from the user’s perspective. Am J Prev Med, 32(5 Suppl), S97-103.

Hewitt, M. E., Ganz, P. A., Institute of Medicine (U.S.)., & American Society of Clinical Oncology (U.S.). (2006). From cancer patient to cancer survivor : lost in transition : an American Society of Clinical Oncology and Institute of Medicine Symposium. Washington, D.C.: National Academies Press.

Institute of Medicine (US). Committee on Quality of Health Care in America (2001). Crossing the quality chasm: a new health system for the 21st century. Washington, D.C.: National Academy Press.

Institute of Medicine (US). Committee on Health Literacy (2004). Health literacy: a prescription to end confusion. Report, Washington, D.C.: National Academy Press.

James, B. C. (2001). Making it easy to do it right. N Engl J Med, 345(13), 991-993.

Klein, W. M., & Stefanek, M. E. (2007). Cancer risk elicitation and communication: lessons from the psychology of risk perception. CA Cancer J Clin, 57(3), 147-167.

Kreps GL. (2005). Disseminating relevant health information to underserved audiences: implications of the Digital Divide Pilot Projects. J Med Libr Assoc, 93(4 Suppl), S68-73.

Leyden, W. A., Manos, M. M., Geiger, A. M., Weinmann, S., Mouchawar, J., Bischoff, K., et al. (2005). Cervical cancer in women with comprehensive health care access: attributable factors in the screening process. J Natl Cancer Inst, 97(9), 675-683.

Viswanath, K. (2006). Public communications and its role in reducing and eliminating health disparities. In G. E. Thomson, F. Mitchell, M. Williams & National Research Council (U.S.). Committee on the Review and Assessment of the NIH's Strategic Research Plan And Budget to Reduce and Ultimately Eliminate Health Disparities. (Eds.), Examining the health disparities research plan of the National Institutes of Health : unfinished business. Washington, DC: National Academy Press.

Wagner, E. H. (2004). Chronic disease care. Bmj, 328(7433), 177-178.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH specialized center grant (P50) mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

Each applicant institution may submit only one application. Both new applications and competitive continuation applications (from previous CECCR awardees) may be submitted. Revised applications will not be accepted.

2. Funds Available

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

2. Cost Sharing or Matching

Cost sharing is not required.

The current NIH Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Not Applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo -- Telephone: (301) 710-0267; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions(http://grants.nih.gov/grants/funding/phs398/phs398.html) and the standard PHS398 Forms unless specific exceptions and/or additional requirements are noted below.

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS

Table of Content (PHS 398 Form Page 3): Modify the standard PHS 398 Table of Contents to account for the modified sections of the Research Plan (see below).

Budget (PHS 398 Form Pages 4 and 5): Following the current PHS 398 instructions, use Form pages 4 and 5, respectively, to provide a detailed composite budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period as well as budget justification (Form page 5).

Use additional Form Pages 4 and 5 to provide separate budget information for the following individual application components:

RESEARCH PLAN: The standard PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html) are modified as follows:

Standard Sections A-D of the PHS 398 Research Plan are replaced by the following new Sections 1-6 (specified below). The PHS 398 standard page limit for Sections A-D is replaced by a new limit of 40 pages for these new sections plus additional allocation of 22 pages for each full Research Project proposed (numbers of pages suggested below for individual sections are provided solely as a nonbinding guidance for applicants). Other sections of the standard PHS 398 Research Plan (Sections E-L) remain unchanged and must be completed following the PHS 398 instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Section 1. Overall CECCR Description (up to 10 pages suggested)

This section should be used to present the overall vision for the proposed CECCR. This summary should contain the long and short-term scientific objectives, specifically addressing how the cancer communication activities supported through the Center will impact clinical and preventive cancer care. The CECCR description should serve as an overview, with a more detailed description of each component to be presented in a later section. Of importance is the discussion of the interdisciplinary expertise of CECCR Teams. As with the first round of CECCRs, the rationale for funding P50 grants is to create a critical mass of interdisciplinary researchers all focused on the common problem of advancing the science of health communication in order to reduce the national burden of cancer. Each center will be expected to have its own set of unifying themes, through which participating center investigators will contribute in an organized fashion toward solutions on a common piece of the cancer puzzle. The center’s plans should be problem focused, and should show a clear logic for how the activities within the center will achieve national goals.

Within this section, all applicants should include a separate segment Background/Progress Report . New applicants should describe in this segment relevant background information on their main accomplishments pertinent to the goals of CECCR II and the specific research theme proposed by the applicant team. Both new applicants and current CECCR awardees submitting renewal applications should describe highlights of their published contributions to communication science within the past 3 years and other strengths of their team pertinent to the goals of CECCR II (e.g, new investigators, new relevant peer-reviewed funding, initiated pilot projects, etc.)

For current CECCR awardees, this segment should largely amount to a succinct Progress Report summarizing their accomplishments towards the original goals of their CECR I project in the current funding period, including summary of publications, career development, and new peer reviewed research funding resulting from the original CECCR. (The description should list the objectives of the originally funded CECCR to help reviewers assess how well these goals were accomplished.)

Section 2. Administrative Core (up to 6 pages suggested).

It is expected that each center will organize an administrative core. Summarize in this section the proposed administrative structure for the CECCR, concisely defining the leadership structure and the integration of the required research projects, the shared resources component, the training and developmental project components, and their relationships to each other. In addition, relationships between the proposed CECCR and other research, academic, and administrative units of the applicant institutions (such as institutes, medical or public health departments) and the central administration should be described in this section.

Attendance at CECCR grantee meetings and cross-center activities. Plans should be made (and appropriate funds budgeted) for the participation for at least four investigators from each proposed CECCR to attend semi-annual grantee meetings throughout the duration of the award. Locations will vary, depending on sites funded through the initiative. The meetings will provide a venue for presenting scientific findings from each of the funded centers and are intended to facilitate synergistic interactions between Centers within the evolving community of cancer communication scientists. PIs will be expected to participate in conference calls for planning purposes on a monthly basis. Other investigators should set time aside as needed to participate in cross-cutting research interest groups and other collaborative activities as a way of advancing cancer communication as a science.

Participation in evaluation activities. Each CECCR award and the entire CECCR program will be periodically evaluated by the NCI. Applicants should acknowledge their readiness to participate in such evaluation. Objective criteria to guide the evaluation of CECCR program by the NCI may include: (a) evidence of success in advancing the knowledge base of communication science (e.g., publication in peer-reviewed journals) through the use of transdisciplinary team science; (b) evidence of contribution to individual (e.g., patient measures) or public (e.g., population measures) outcomes in health and quality of life; (c) demonstration of improvement in reach, efficiency, and/or effectiveness for communication programs and/or activities; (d) innovation in content and/or methodology; and (e) potential dissemination of results to real-world settings.

Section 3. Individual Full Research Projects (up to 22 pages suggested for each project).

No fewer than three (and not more than five) full research projects providing a sufficient level of multidisciplinary interactions must be described in the application. Each applicant must propose research on evidence-based approaches to cancer communication that would be immediately relevant to the clinical enterprise.

At least one of the three required projects must be designed to obtain results that will be directly relevant and useful in a clinical environment with an emphasis on patient-centered care.

Describe each research project in sufficient detail to enable reviewers to judge the scientific merit from the written application. Do not present separate "subprojects." Each project should have a single theme and budget consistent with the priorities outlined in Section II.

Each Research Project must contain the following elements:

Section 4. Developmental Projects (up to 6 pages total suggested)

This section should include a description of the process by which Developmental Project(s) will be initiated during the first year of CECCR funding, including a summary of resources that will support the projects, and the level of support that will occur. It is important that proposed CECCRs use funds to stimulate projects that take advantage of new research opportunities, especially in an environment of rapidly changing communication technology and science. Such projects may be collaborative among scientists within one or more CECCRs, or with scientists outside the CECCR environment. The CECCR application should propose and describe an institutional review process that selects pilot projects for center funding based on innovation, interdisciplinarity, and contribution to cancer control goals. Applicants should supply a short description (2 pages maximum per project) of up to two eligible projects as examples.

Applicants should describe decision-making process and oversight responsibilities, including the process for selecting, monitoring, and terminating the Developmental Projects. Developmental Projects should not be viewed as a supplemental source of funding for established investigators who are already well-funded and/or will be leading a CECCR full project. Since the Developmental Projects will be flexible, only projects proposed for implementation in the first year of award should be included in the application. The Developmental Projects must be interdisciplinary. The number of Developmental Projects to be initiated will be determined by the CECCR applicants.

Section 5. Shared Resources (i.e., Cores) (up to 10 pages total suggested)

In addition to the Administrative Core (described in New Section 2), each CECCR is expected to establish appropriate (one or more, as needed) shared technical resources, or cores. The structure and administration of these cores will be left to the discretion of the applicant. Activities for consideration may include: (a) a statistical or methods component to ensure that all projects adhere to an equally stringent level of scientific research and which will lead to activities to harmonize measurement and data collection strategies across the various components; (b) an evaluation and dissemination component which will lead participation in evaluation activities and connect with other partners.

Requirements to be supported by the overall center, and that may be supported by activities in the cores, are as follows:

(1) Harmonizing measurement and data. In order to increase research efficiency and rapidly move science forward, partners in the cancer research paradigm must work together to solve complex health problems using standard vocabularies, data standards, and ontologies (see https://cabig.nci.nih.gov/ for an example). Eligible applicants must be willing to participate in exercises to harmonize data collection strategies across the various components that comprise cancer communication. Viable approaches may include, but are not limited to: (a) selecting existing measurement definitions from an NCI-approved common data standards repository compliant with caBIG requirements; (b) participating in the harmonization of data elements across centers; (c) identifying minimum data set standards to enable prospective meta analyses in common areas of behavioral communication science; (d) demonstrating psychometric equivalency for alternative measurements of the same construct; or (e) complying with DHHS standards for utilizing existing medical vocabularies (e.g., SNOMED).

(2) Dissemination. One of the goals of the Division of Cancer Control and Population Sciences is to close the gap between research discovery and program delivery by getting evidence-based information and interventions into use (see http://cancercontrol.cancer.gov/d4d/about.html). Partnerships within practice settings (e.g., comprehensive cancer centers, community cancer centers, health maintenance organizations, public health departments, community resource centers) are encouraged to provide a real world conduit for testing the effectiveness of interventions. Applicants should describe how their interactions within these practice environments will be optimized to improve chances for success in dissemination. In thinking through issues of dissemination, applicants are encouraged to familiarize themselves with the resources being developed by the NCI’s own Research Dissemination and Diffusion Team at http://cancercontrol.cancer.gov/d4d/.

Section 6. Training and Career Development Program (up to 6 pages suggested).

Training and Career Development opportunities sponsored by CECCRs will provide a limited number of trainees with access to a highly trans-disciplinary experience. The extent of the training activities is to be defined by the applicant, based on the needs and capabilities of the CECCR participants. The CECCR must demonstrate a consistent and significant commitment to a career development program in cancer communication research. This activity may focus on graduate students, post-doctoral candidates, junior faculty, and/or established investigators who wish to develop or refocus their careers on cancer communication research and learn to function in a transdisciplinary manner. The application should include the policies, criteria, and processes for selecting candidates, including special efforts to recruit qualified women and minorities. The plan should include the number and types of positions that will be made available, the criteria for eligibility and selection of candidates, and a description of the selection process. The plan should not include stipends and trainee costs though salary support for career development candidates may be requested.

Consortium/Contractual Arrangements: If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.

Foreign Organizations

Several special provisions apply to applications submitted by Foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

For details on what items are generally allowed as Appendix materials, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

Do not attach Appendix materials to the application. These materials must be submitted directly to the NCI, see Section IV. 3.B. Sending an Application to the NIH).

After application submission, no supplementary materials will be accepted.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: January 22, 2007
Application Receipt Date: February 22, 2008
Peer Review Date(s): May/June 2008
Council Review Date: October 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Bradford W. Hesse, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4068, MSC 7365
Bethesda, MD 20892-7365 (for U.S. Postal Service Express or regular mail)
Telephone: (301) 594-9904
FAX: (301) 480-2198
Email: hesseb@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

For paper submission using the PHS 398, Appendix materials may be submitted in paper format; five collated sets are needed. Applicants are encouraged to send Appendix materials submitted with paper PHS 398 applications on a CD in PDF format in lieu of the five collated sets. See application instructions for details on preparing CDs. Only a single CD need be sent.

At the time of submission, two additional paper copies of the application and one copy of the appendix material in paper or pdf format must be sent to the address below:

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

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the National Cancer Institute. Incomplete and 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 http://grants.nih.gov/grants/policy/policy.htm.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by Division of Extramural Activities of the NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Criteria for overall evaluation of CECCR applications:

SIGNIFICANCE: Does this application address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, and/or preventative interventions that drive this field?

Specific for this RFA: Does the proposed CECCR address an important cancer-related communication research problem? Will the research have an impact (either direct or indirect) on cancer care and prevention? Are the scientific objective(s) appropriate and adequate to achieve the long-term goals of the CECCR? Will the proposed CECCR be able to aid efforts against cancer by integrating evidence-based communication approaches into the cancer enterprise both at the individual and community levels?

APPROACH: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Specific for this RFA: Are the conceptual framework and the experimental design, methods, and analyses proposed for each of the proposed CECCR components sound and feasible? Are the individual Research Components appropriately integrated with the other Research and Shared Resources Components and the Administrative Core? Does the applicant ensure that there will be sufficient coordination and communication among the PIs and with other CECCRs? Are the administrative plans for the management of the research appropriate, including plans for resolving conflicts? Can the approach taken by the applicant strengthen the knowledge base for the role that communication plays across the cancer care continuum, with special emphasis on the understudied areas of diagnosis, treatment, and survivorship?

INNOVATION: Is the project original and innovative? For example: Does the project challenge existing paradigms and/or clinical practice; address an innovative hypothesis and/or critical barrier to progress in the field? Does the project develop and/or employ novel concepts, approaches, methodologies, tools, and/or technologies for this area?

Specific for this RFA: Are the experimental designs of the proposed research focused on innovative cancer communication methodologies and are they original and novel? Does the innovative nature of the research methods shorten the time from investigation to impact, and focus resources more efficiently on the center’s critical path in accelerating communication solutions to cancer care problems?

INVESTIGATORS: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Specific for this RFA: Are the PI, Project Leaders, and other key personnel appropriately trained and well suited to the organizational and scientific responsibilities of the proposed CECCR? Do recent publications by the investigators in the team demonstrate background and knowledge pertinent to the themes of the proposed CECCR? Is there evidence that the investigators are committed to productive, interdisciplinary interactions? Do research projects have the appropriate mix of co-investigators from different disciplines? Do the applicants document active and/or evolving collaborations with other scientists in the field, and with other community and medical partners?

ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Specific for this RFA: Is there evidence of significant commitment of the participating institution(s) to fulfilling the objectives of the CECCR, including an emphasis on overcoming issues related to health disparities? Do the proposed research projects take advantage of unique features in the clinical environment (for the required clinically-relevant projects)?

In addition to the overall evaluation, each component of CECCR application will be reviewed using the following criteria:

1) Criteria for Progress Accomplished by Current CECCR I Awardees (renewal applications only). How significant is the contribution of the applicants currently funded CECCR to scientific knowledge in cancer communications? Have the applicants fully accomplished the specific objectives proposed in the original CECCR application? Has the currently funded CECCR succeeded in attracting new investigators and securing new research funding in the field?

2) Criteria for Administration/Administrative Core. Is the organizational, scientific, and operational framework reasonable, well-integrated, and appropriate to the aims of the CECCR? Will the proposed CECCR employ novel approaches or methods for facilitating scientific interaction? Are the PI and leadership of the proposed CECCR appropriately trained and well-suited to the organizational and scientific responsibilities associated with the Center? Is there sufficient oversight of Research Projects, Developmental Projects, and Training Programs to ensure their integration for the overarching goals of CECCR? Is there evidence of significant commitment of the institution(s) to fulfilling the objectives of the CECCR? If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the CECCR? Can this CECCR increase the number of peer-reviewed publications in the area of cancer communication, informatics, and behavioral support?

3) Criteria for Individual Full Research Projects.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, and/or preventative interventions that drive this field? How will the communication intervention translate into tangible benefits for the public and patients in terms of preventing or reducing the burden of cancer?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the approach sustainable in real-world settings such as the clinic, the hospital, the community, and the environment beyond the communication laboratory?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms and/or clinical practice; address an innovative hypothesis and/or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, and/or technologies for this area? Do the projects reflect awareness of national trends in policy and technology?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Do the investigators have track records of participation in multidisciplinary research? Are co-investigators representing complementary disciplines enlisted for the projects, when appropriate?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is the project interactive with other components of the CECCR, conceptually, experimentally, and translationally?

4) Criteria for Developmental Projects. Do the proposed developmental projects take advantage of new research opportunities, especially in an environment of rapidly changing communication technology and science? Are the projects collaborative among scientists within one or more CECCRs, or with scientists outside the CECCR environment? Does the CECCR propose and describe an institutional review process that selects developmental pilot projects for center funding based on innovation, interdisciplinarity, and contribution to cancer control goals?

5) Criteria for Shared Resources (all Cores will be assessed jointly). Do the proposed cores fit well in the overall goals of the individual center without overlaps or unaddressed needs? Will the cores allow the proposed CECCR, as a whole, to be responsive to the technical and scientific challenges that each of the individual projects may face? Are the functions of the cores appropriately articulated? How will the shared resources help the center meet requirements for dissemination and data harmonization as outlined in Section IV of this FOA?

6) Criteria for Training and Career Development Program. Is the Training Program well justified, and does it describe a program that will successfully train investigators capable of establishing independent multidisciplinary cancer communication research programs? Are the proposed mentors in the Training Program experienced in the types of training proposed? Is the process for selecting candidates for training adequate, and does it seek out and include qualified minorities and women? Will it train interdisciplinary investigators capable of conducting cutting-edge communications research directly relevant to the context of cancer prevention, detection, treatment, control, and survivorship?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and athttp://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

See Section IV.3.A.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in Item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Bradford W. Hesse, Ph.D.
Chief, Health Communication and Informatics Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4068, MSC 7365
Bethesda, MD 20892-7365 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 594-9904
FAX: (301) 480-2198
Email: hesseb@mail.nih.gov

Sabra F. Woolley, Ph.D.
Health Communication and Informatics Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4084, MSC 7365
Bethesda, MD 20892-7365 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-4589
FAX: (301) 480-2087
Email: woolleys@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Ms. Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7340 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8634
E-mail: crystal.wolfrey@nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public 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.

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov.

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