EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National
Cancer Institute (NCI), (http://www.cancer.gov)
Title: 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
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:
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:
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: 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 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:
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:
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:
squiersl@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
(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:
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:
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.
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: squiersl@mail.nih.gov
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: hesseb@mail.nih.gov
2. Peer Review Contacts:
Referral
Officer
Division
of Extramural Activities
National Cancer Institute
6116
Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX:
(301) 496-0275
Email: ncirefof@dea.nci.nih.gov
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: wolfreyc@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II); 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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