Expired RFA-CA-06-015: Exploratory Grants for Increasing the Utilization and Impact of the National Cancer Institute’s Cancer Information Service (R21)

Department of Health
and Human Services (HHS)

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EXPIRED

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: Exploratory Grants for Increasing the Utilization and Impact of the National Cancer Institute’s Cancer Information Service (R21)

Announcement Type
New

Request For Applications (RFA) Number: RFA-CA-06-015

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates
Release Date: February 1, 2006
Letters of Intent Receipt Date(s): March 20, 2006
Application Receipt Dates(s): April 19, 2006
Peer Review Date(s): June-July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 27, 2006
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: April 20, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The major goal of this funding opportunity is to promote innovative research in cancer communications that explores the development and testing of national, regional, or community-based interventions that increase the utilization of scientifically accurate and up-to-date cancer information by the underserved and the impact of receiving such information. Specifically, the purpose of this funding opportunity is to stimulate research that explores effective messages, channels, outreach, promotional strategies, and/or other interventions that increase the utilization and impact of the existing cancer information resources such as NCI’s Cancer Information Service (CIS) by underserved populations.
The NIH exploratory/developmental R21 grant mechanism is being used for this funding opportunity, and it is anticipated that five or six grants will be awarded.
Eligible institutions and organizations include: for-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of local governments; units of State governments; eligible agencies of the Federal government; Domestic institutions; and faith-based or community-based organizations.
Eligible principal investigators include 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 programs.
Applicants may submit more than one application, provided they are scientifically distinct.
See Section IV for application and submission information.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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 purpose of this RFA is to promote innovative research and to develop and test national, regional, or community-based interventions that increase the utilization and assess the impact of scientifically accurate and up-to-date cancer information delivered through existing cancer information resources. Specifically, this RFA was developed to stimulate research that explores effective messages, channels, outreach, promotional strategies, or other interventions that increase the utilization and impact of the National Cancer Institute’s Cancer Information Service (CIS) by underserved populations. For the purposes of this RFA, underserved populations are defined as those who experience social inequities. Examples of domains related to social inequality include insurance status, socioeconomic position, race/ethnicity, immigrant status, gender, age, sexuality, language spoken, literacy, disability, geography (urban/rural), and housing status. Of special interest is formative research that explores how to engage health care providers, especially those serving the underserved populations, in using and referring patients to the CIS for relevant prevention, screening, treatment, and survivorship information and education. In addition, studies that test the delivery of strategies that connect underserved populations to the CIS through established organizations, networks, and/or advocacy groups are desired. The research should be conducted in collaboration with at least one CIS contractor/regional office.

Background

According to analysis of the NCI’s Health Information National Trends Survey (HINTS), about half of adults in the United States (U.S.) have ever looked for information. Access to cancer information is greater than ever before, but the American public is facing challenges in finding credible cancer information that meets their needs. About half of HINTS cancer information seekers (NCI, HINTS, 2004; http://cancercontrol.cancer.gov:0/hints/questions.jsp) indicated that:

they wanted more information, but did not know where to find it;
it took a lot of energy to find the information that they needed;
they didn t have enough time to get all the information that they needed;
they felt frustrated during their search for cancer information; and
they were concerned about the quality of the information that they found.

NCI plays an instrumental role in translating and disseminating evidence-based research to the public so they can make informed decisions related to cancer prevention, screening, diagnosis, treatment, survivorship, and end-of-life. Through the National Cancer Act (1971) and its amendments (National Cancer Act Amendments; 1974, 1977), the U.S. Congress mandated that the National Cancer Institute provide accurate and up-to-date information about cancer to all segments of the U.S. population. NCI is fulfilling this mandate by offering the public two main access points for obtaining cancer information, which are the NCI’s web site (http://www.cancer.gov) and the Cancer Information Service (CIS).

In response to the increasing proportion of Americans who have access to the Internet, NCI has developed an award-winning website that provides cancer information and educational materials. Currently, 63% of Americans have access to the Internet. However, gaps in access by demographic subgroups remain; demographic subgroups that less likely to have Internet access are also more likely to be suffering from cancer-related health disparities. While these groups may not have ready access to the Internet for seeking scientifically accurate cancer information, they do have access to cancer information through other channels such as the telephone. Recent data indicate that only about 2% of adults in the U.S. are without landline or wireless telephone access. Even among the poorest adults, 93% had either landline or wireless telephone coverage in 2004. Therefore, even Americans who are poor and with low educational attainment could theoretically use the telephone to access cancer information.

NCI has invested heavily in providing the public with access to cancer information through the CIS (http://cis.nci.nih.gov/) which operates a toll-free telephone number (1-800-4-CANCER). Callers are connected to a highly trained information specialist who provides them with individually tailored information related to their specific inquiry and needs. Services are available in both English and Spanish. Information specialists help answer questions about cancer, identify and send appropriate educational materials, explain medical information, and often translate cancer information individuals receive from other sources such as health care providers and the Internet. The CIS has been providing the public with up-to-date, evidence-based information related to cancer prevention, detection, diagnosis, treatment, and survivorship across the U.S. and around the world for nearly 30 years. Between 1976 and 2004, the CIS answered more than 10 million calls. In 2004, there were 252,750 inquiries to the CIS, of which 92% were via the telephone.

While the CIS has expanded the channels by which the American public can access cancer information from the NCI, call volume has been steadily declining over the last decade. This decline has not been offset by increases in utilization of LiveHelp and email inquiries. No study has been conducted to determine if the decline in utilization of the CIS is an indication that the public’s cancer information needs are being met by other available resources or if levels of awareness of the service have also declined over time. To date, no research has been conducted that identifies the specific environmental or psycho-social factors related to this decline. As a national resource for cancer information, it is critical for the NCI to understand how to connect the public, especially underserved populations, to the right information, through the right channel, at the right time. Understanding the public s perceived barriers to using existing resources such as cancer.gov and the CIS, and exploring new ways NCI could disseminate cancer information to the public is vital to meeting the Director’s challenge goal of eliminating suffering and death due to cancer.

Before the public can use available cancer information resources and services, they must first be aware that such resources and services are available. In its 30-year history, the CIS has never embarked upon any large-scale national promotion. Some small-scale regional campaigns have promoted 1-800-4-CANCER in their efforts to collaborate on other cancer awareness campaigns. These regional promotions have had a modest impact on call volume. NCI’s HINTS has enabled CIS for the first time to determine a baseline rate of the public’s level of awareness of the National Cancer Institute, the CIS, and other national resources. Compared to other national organizations, overall awareness of the CIS (including awareness of the 1-800-4-CANCER phone number) is low (33%). The demographic profile of those who are aware of the CIS based on analysis of HINTS data is quite different than the demographic profile of actual CIS clients (74% White, 12% African American, 10% Hispanic.) Comparisons indicate that there is a gap between levels of awareness and levels of utilization of the CIS among groups who traditionally suffer from cancer health disparities. Currently unknown is whether the information needs of those suffering from cancer health disparities are being met through other resources.

HINTS data indicate that the public’s preferred and most trusted source for cancer information is their health care provider. Given existing time constraints that confront health care providers when seeing patients, physicians are often unable to spend time providing basic information about cancer, educating patients about the variety of treatment options and clinical trials, or offering referrals to support services. The CIS can supplement time-constrained patient-provider interactions in a variety of ways, including: 1) by providing patients with both basic and complex cancer information that providers are not able to share during medical encounters due to time constraints; 2) by helping patients identify questions that they can ask a health care provider; and 3) by helping patients better understand and interpret information provided to them by providers or found from other sources, such as the Internet. If providers were more aware of the CIS and the services and resources offered, perhaps they would more readily refer patients or even use the service to meet their own information needs.

Currently, only 10% of CIS clients are health care professionals and few CIS clients (6%) are referred to the CIS by health care providers. Little research has been conducted on health care providers awareness, use, and perceptions of the CIS. Research is needed to obtain a baseline estimate of providers awareness of the CIS and to assess reasons they do and do not refer patients to the CIS, and reasons they do and do not use CIS themselves. In addition, research is needed to test specific ways the CIS can provide ongoing informational support to patients within health care systems or health care practices.

The CIS is positioned to help translate research findings to inform and educate the public. The CIS is staffed and able to support additional volume. The Partnership Program is able to work with community-based organizations to develop and implement sustainable strategies to increase awareness and utilization of the CIS as well as deliver cancer education to underserved populations. Finally, in this new 5-year contract, the Research Program (http://cis.nci.nih.gov/research/research.html) has four doctorally prepared Senior Research Coordinators who can both develop and guide research that contributes to the field of cancer communication and inform the delivery of the cancer information services that NCI is charged with providing to the public. Understanding how to increase the utilization and impact of the CIS will benefit both the American public and the NCI, and will contribute to the evolution of the CIS. The CIS is a living laboratory for health communication and can test new strategies to increase the utilization and optimize the delivery of scientifically accurate and up-to-date cancer information.

Investigators should review the CIS Research Program website (http://cis.nci.nih.gov/research/research.html) to obtain the following information that would be helpful in their research proposal:

1. A description of the CIS Research Program;
2. A copy of the CIS Research Agenda, supporting Literature Overview, and brochure;
3. The following Fact Sheets:

a. Contact information for Senior Research Coordinators (SRCs) for the CIS Research Program (researchers should contact the SRC that covers their state to discuss their research proposal);
b. Telephone and Instant-Messaging Service;
c. Data Collection Tool: The CIS Electronic Contact Record Form; and
d. The Partnership Program

4. The location and key contact information for each of the 15 regional CIS Program offices ( descriptions of each of the program components [e.g., Partnership Program, Contact Center/Information Service, and Research Coordination] held by each office are also listed); and
5. Additional information posted specifically for this RFA.

For additional information about the CIS Program and resources, contact the Scientific/Research Contacts listed in Section VII.

Researchers may also want to visit the Cancer Control PLANET web site (http://cancercontrolplanet.cancer.gov/) for information or data that could be included in their applications.

Research Goals and Scope

The major goal of this initiative is to promote innovative research in cancer communications that explores the development and testing of national, regional, or community-based interventions that increase the utilization of scientifically accurate and up-to-date cancer information by the underserved and the impact of receiving such information.

Examples of specific research questions of interest to the NCI include, but are not limited to, the following:

Are there unmet information needs among the underserved? How do underserved populations currently obtain needed cancer information? How satisfied with and useful do they find existing channels and sources?

Among the underserved, what are the preferred channels or sources for seeking information? Does channel selection and preferred source vary by type of information sought, phase on the cancer continuum, or socio-demographic characteristics?

What sources of cancer information (including sources such as the CIS and cancer.gov) are perceived as credible? What are the barriers to accessing and using existing cancer information resources such as the CIS among the underserved? How do these barriers differ by population subgroups? How could programs such as the CIS better support the information and education needs of underserved populations?

What do health care providers need to support the information and education needs of their underserved patients? To what extent are health care providers aware of existing sources for up-to-date and scientifically accurate cancer information such as the CIS and cancer.gov? To what extent do providers use and refer patients to existing sources? What are their perceptions of such sources? What are providers perceived barriers to using currently available sources? How could programs such as the CIS better support the information and education needs of health care providers and their underserved patients?

To what extent do community-based interventions, social marketing approaches, or interventions within health care systems or provider groups increase access to and use of the scientifically accurate and up-to-date cancer information from existing resources such as the CIS among underserved populations?

Once underserved populations access programs or sources that provide scientifically accurate and up-to date cancer information (such as the CIS or cancer.gov), what is the impact of that information on cancer-related cognitions or behaviors?

When feasible, investigators should use current surveillance and service data to plan and assess study outcomes. Investigators may choose any of the full range of scientific approaches to conduct their work. This R21 exploratory/developmental award mechanism is appropriate for testing interventions in pilot studies for feasibility or using rigorous qualitative research methods to assess the potential efficacy of an intervention. Applications should include justifications of study designs, methods, and sample sizes. In addition, applicants should identify the theoretical framework used and clearly indicate the significance of the research and where it will lead.

This RFA is designed to encourage investigators from a variety of academic, scientific, and public health disciplines to apply their skills to specific behavioral research investigations involving cancer information and education. It is expected that these R21 grants will serve as a basis for planning future behavioral research project (R01) grant applications. Because the NIH developmental/exploratory R21 grant mechanism is designed to support the collection of pilot data and to allow an avenue for the exploration of new concepts and new methodologies, preliminary data as evidence of feasibility are not required. The applicant does have the responsibility for developing a sound research plan with a strong theoretical or empirical basis. Feasibility of the proposed research and potential significance for ongoing research are major considerations in the evaluation.

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 exploratory/development R21 award mechanism (see http://grants.nih.gov/grants/funding/r21.htm ). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The applicant may request a project period of up to 2 years with a combined budget for direct costs of up to $275,000 for the 2-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. These grants are non-renewable and continuation of projects developed under this RFA will be through the traditional unsolicited investigator initiated grant program.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

The National Cancer Institute intends to commit approximately 1.3 million dollars in FY 2006 to fund five or six new and/or competing continuation grants in response to this funding opportunity. An applicant may request a project period of up to 2 years and a budget for direct costs up to $275,000 for the 2-year period with no more than $200,000 dollars in any single 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. The expected amount for individual awards will range from $200,000 to $275,000. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Anticipated start dates will occur in September 2006. Periods of performance are 2-year terms running from approximately from September 2006 through September 2008.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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:

For-profit organizations;
Non-profit organizations;
Public or private institutions, such as universities, colleges, hospitals, and laboratories;
Units of local governments;
Units of State governments;
Eligible agencies of the Federal government;
Domestic institutions; and
Faith-based or community-based organizations.

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 programs.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current 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

None

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most 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 on line 2 of the face page of the application form and the YES box must be checked.

All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R21 applications (see also http://grants.nih.gov/grants/funding/r21.htm):

1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, with direct costs requested in $25,000 modules, up to the total direct costs limit of $275,000 over the 2 years of the R21. No more than $200,000 in direct costs will be allowed in any single year.

2. Although preliminary data are not required for an R21 application, they may be included.

3. Sections a-d of the Research Plan of the R21 application may not exceed 15 pages, including tables and figures.

4. R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix materials will only be provided to the primary reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix:

Up to five publications, including manuscripts (submitted or accepted for publication), abstracts, patents, or other printed materials directly relevant to the project; these documents may be stapled as sets.
Surveys, questionnaires, data collection instruments, and clinical protocols; these documents may be stapled as sets.
Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 15 page limit of items a-d of the research plan.

3. Submission Dates and Times

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

3.A. Receipt, Review, and Anticipated Start Dates

Letters of Intent Receipt Date(s): March 20, 2006
Application Receipt Dates(s): April 19, 2006
Peer Review Date(s): June-July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 27, 2006

3.A.1. Letter of Intent

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

Descriptive title of proposed research;
Name, address, and telephone number of the Principal Investigator (PI);
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.

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 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:

Linda Squiers, Ph.D.
Office of Communication, Cancer Information Service Program
National Cancer Institute
6116 Executive Boulevard, Room 3029, MSC 8322
Bethesda, MD 20892-8322 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 594-9075
FAX: 301-402-0555
Email: [email protected]

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 (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 express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428

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 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

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.

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

Principal Investigators (PIs) will be required to attend an annual meeting of all funded investigators. Please include travel to and accommodations in Bethesda, Maryland, for an annual 2-day meeting for all PIs. In addition, PIs are expected to participate in monthly teleconferences with NCI program staff.

Specific Instructions for Modular Grant applications
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

NIH policy requires that grant awardee 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 NCI 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:

Scientific merit of the proposed project as determined by peer review;
Availability of funds;
Relevance of program priorities;
Responsiveness to research goals and scope specified in Section I; and
Demonstration of collaboration with the CIS.

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 the National Cancer Institute in accordance with the review criteria stated below.

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

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.

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.

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

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?

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

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 PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

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?

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

Not applicable

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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 at http://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
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the 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 NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

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:

Linda Squiers, Ph.D.
Office of Communication, Cancer Information Service Program
National Cancer Institute
6116 Executive Blvd, Room 3029, MSC 8322
Bethesda, MD 20892-8322 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 594-9075
Email: [email protected]

Bradford Hesse, Ph.D.
Division of Cancer Control and Population Sciences
Health Communication and Informatics Research Branch
National Cancer Institute
6130 Executive Blvd., Room 4068, MSC 7365
Bethesda, MD 20892-7365 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 594-9904
Email: [email protected]

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 496-0275
Email: [email protected]

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institution
6120 Executive Blvd., EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); 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 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 at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm.

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 funding opportunity 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 percent 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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NIH Funding Opportunities and Notices