PATIENT NAVIGATION RESEARCH PROGRAM

RELEASE DATE:  August 6, 2004
 
RFA Number:  RFA-CA-05-019 (also see NOT-CA-04-029) 

EXPIRATION DATE:  November 19, 2004
 
Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.394, 
93.399

LETTER OF INTENT RECEIPT DATE: October 18, 2004
APPLICATION RECEIPT DATE: November 18, 2004 
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Cancer Institute, through its Center to Reduce Cancer 
Health Disparities (CRCHD), invites cooperative agreement grant 
applications (U01) for the Patient Navigation Research Program: 
Eliminating Barriers to Timely Delivery of Cancer Diagnosis and 
Treatment Services (PNRP). This RFA is challenging principal 
investigators to develop operationally effective and cost-effective 
patient navigation interventions. These interventions must address 
patient-access barriers to quality, standard cancer care in a cost-
effective manner. The purpose of the Patient Navigation Research 
Program (PNRP) is to develop interventions to reduce the time to 
delivery of standard cancer care services-non-cancer resolution or 
cancer diagnosis and treatment after identifying an abnormal finding 
from a cancer detection procedure.  

RESEARCH OBJECTIVES

Background

A major disconnect or gap exists between cancer discovery and 
development research and delivery for many Americans. Discovery and 
development research results in beneficial procedures for cancer 
prevention, early detection, diagnosis, and treatment that are intended 
for all Americans. Health disparities arise when the delivery system 
does not provide access to timely, standard cancer care to everyone in 
the nation. NCI has established the goal of eliminating suffering and 
death due to cancer by 2015. To address this goal requires immediate 
action to address the gap between development and delivery, 
particularly among underserved populations. This research concept is 
consistent with DHHS’ Healthy People 2010 goal to eliminate health 
disparities.  

Major reports on health care access mandated by Congress and the 
Administration over the past 3 years provide evidence that this 
nation’s fragmented health care system fails to provide adequate 
information and access to effective cancer prevention, diagnosis, and 
treatment services in an equitable and timely manner. This is 
particularly evident among racial/ethnic minorities, people of lower 
socioeconomic status, residents of rural areas, and members of other 
underserved populations for whom the unequal burden of cancer continues 
to be documented through the nation’s cancer surveillance networks. 
Substantial evidence shows that these population groups do not have 
equal access to health care systems and do not always receive timely, 
standard care when confronted with a cancer diagnosis. Unacceptable 
delays often occur in follow-up of abnormal findings, definitive 
diagnoses, and subsequent treatment due to a range of cancer care 
access barriers. 

While reasons for disparities are complex, a central issue is that 
underserved patients face a variety of barriers (e.g., standard cancer 
prevention, information, screening, diagnosis, treatment, and follow-
up) inhibiting timely access to health services.  Recent government 
reports state that “access to care is essential to receive quality 
care, increase the quality and years of healthy life, and to eliminate 
health disparities,” and that “access-related factors may be the most 
significant barriers to equitable care, and must be addressed as an 
important first step toward eliminating health care disparities.”

The President’s Cancer Panel (2001) reported on barriers contributing 
to the disconnect between development and delivery. These included 
system barriers (e.g., fragmentation of care), financial barriers 
(e.g., lack of insurance or underinsurance), physical barriers (e.g., 
excessive distance from treatment facilities), information and 
education barriers (both provider- and patient-related), and issues of 
culture and bias. Other barriers that must be overcome include 
insufficient culturally sensitive information and educational materials 
for cancer patients and their families; inadequate transportation 
assistance to get to medical appointments; missed appointments due to 
travel or childcare barriers; patients’ fiscal inability to take time 
off from work for screening and wellness care; and failure of providers 
to obtain patients’ medical test or laboratory results in a timely 
fashion. Cultural and language barriers also impede patient 
understanding and acceptance of standard cancer care. These factors are 
not mutually exclusive; multiple barriers usually affect members of 
underserved populations. The cumulative effect of these barriers is 
unequal delivery of cancer prevention services and delays in detection, 
diagnosis, and quality treatment of cancers. Many racial/ethnic 
minorities, people of lower socioeconomic status, residents of rural 
areas, and other underserved populations facing such barriers simply 
give up out of frustration or misunderstanding and drop out of cancer 
care services.

NCI can begin addressing these unequal patterns of standard cancer care 
access by conducting this NCI-sponsored Patient Navigation Research 
Program at multiple sites. This new program, Patient Navigation 
Research Program: Eliminating Barriers to Timely Delivery of Cancer 
Diagnosis and Treatment Services, will begin to address many of the 
cancer access and care barriers described above.

Objective and Scope

The objective of this RFA is to invite research applications for 
cooperative agreements to develop and implement structured patient 
navigation interventions in community areas with an adequate number of 
cancer patients to answer primary and secondary research questions and 
hypotheses proposed in the application. 

For this program,(Program is defined as the overall cooperative 
agreement research effort at the CRCHD-level and consisting of multiple 
individual grant projects), patient navigation for cancer care refers 
to support and guidance offered to persons with abnormal findings in 
accessing the cancer care system and overcoming barriers to quality, 
standard care. Navigation spans the period from abnormal finding from 
cancer detection procedure through necessary cancer diagnostic tests to 
completion of cancer treatment. Individuals working in primary care 
venues, community health centers, or hospitals will offer this support 
and guidance, connecting to a variety of existing programs and service 
delivery systems. Such individuals may be community lay people or 
professional people. Cost-effectiveness of patient navigation is an 
important consideration. The basic goal of patient navigation is to 
facilitate timely access to quality, standard cancer care in a 
culturally sensitive manner for all patients.

The patient navigator will assist patients and their families through 
the cancer care continuum.  Examples of navigation services may 
include: arranging various forms of financial support, arranging for 
transportation to and childcare during scheduled diagnosis and 
treatment appointments, identifying and scheduling appointments with 
culturally sensitive caregivers, coordinating care among providers, 
arranging for translation/interpretation services, ensuring 
coordination of services among medical personnel, ensuring that medical 
records are available at each scheduled appointment, and other services 
to overcome access barriers encountered during the cancer care process. 
The patient navigator will link patients and families with appropriate 
follow-up services.

Presently, many outpatient organizations have to “shop” for providers 
willing to treat underserved populations. Formal arrangements among 
primary care and community health centers with hospitals will assist 
patient navigators in overcoming health care system access barriers 
that should result in decreased time between abnormal finding, 
diagnosis, and resolution for patients in the program. This research 
grant program will develop patient navigator interventions to reduce or 
eliminate disparities in clinical outcomes related to lack of timely 
access to quality, standard cancer care among racial/ethnic minorities, 
people of lower socioeconomic status, and members of other underserved 
populations. Improving timely access to standard cancer care will 
contribute to substantial progress towards the Healthy People 2010 goal 
of eliminating cancer health disparities as well as NCI’s 2015 
Director’s Challenge goal of eliminating suffering and death due to 
cancer.

The proposed research concept focuses on developing a variety of 
effective patient navigator interventions. Each project will encompass 
one or more of the four cancers (breast, cervical, prostate, and 
colorectal) with the greatest disparity in screening and follow-up. 
These Patient Navigation Research Projects (Project is defined as an 
individual patient navigation research grant award) will conduct formal 
qualitative and quantitative evaluations to demonstrate effectiveness, 
in terns of cost and meeting research program objectives.

Examples of the major research questions for this program are:    
1.   What is the impact of the patient navigator assisting patients in 
coordinating services, from point of suspicious cancer finding through 
non-cancer resolution or cancer treatment, e.g., overcoming access 
barriers such as financial, lack of information, and health system 
barriers?
2.   To what extent does type/degree of service result in reduction 
and/or elimination of patient-access barriers, thereby providing more 
timely access to quality standard cancer care for all patients?
3.   To what extent does demographic matching of patient and navigator 
(e.g., race, ethnicity, gender, etc.), or fluency in primary language 
of the patient affect standard-of-care adherence and perceived 
satisfaction with the health care system?
4.   How effective, in terms of cost and meeting research program 
objectives, is a patient navigator in providing patient support and 
assistance to eliminate patient access barriers and improve timely 
delivery of quality, standard cancer care?

Examples of the research hypotheses are that navigated patients will: 
(1) receive timelier, definitive diagnoses following screenings and 
abnormal findings; (2) receive timelier treatments following positive 
diagnoses; and (3) improve their satisfaction with the health care 
system experience. 

Examples of secondary research questions may include: Which patient 
navigation strategies are most effective, i.e., those of an indigenous 
nonprofessional (cancer survivor, community layperson) or those of a 
professional health care provider (nurse, social worker, other allied 
health professional), paid navigator, or volunteer navigator?  Does the 
primary location (e.g., community-based organization, primary care 
screening/diagnosis clinic/center, or hospital/center) of the patient 
navigator have an impact on navigation success?  Does a patient 
navigator assisting patients in coordinating care among multiple 
physicians affect standard-of-care adherence and perceived satisfaction 
with the health care system? Does a patient navigator assisting 
patients through the cancer care continuum increase patients’ and their 
families’ identification and use of a usual source of care, for both 
cancer follow-up and other medical conditions?

Successful implementation of patient navigator interventions to address 
these primary and secondary research questions in diverse underserved 
communities will provide successful implementation of patient navigator 
interventions to address these primary and secondary research questions 
in diverse underserved communities will provide community-based patient 
navigator interventions that can be implemented in other communities 
across the nation. Patient navigator interventions, by identifying 
innovative methods for overcoming access barriers for people in 
underserved communities (thereby improving cancer diagnosis, treatment 
timeliness, and delivery of quality standard care) should have  
substantial impacts on reducing cancer health disparities and the 
burden of cancer within the next decade.

The central data coordination and program evaluation contractor will 
conduct formal qualitative and quantitative evaluations to address a 
variety of process and outcome research questions, along with a 
comprehensive cost-effectiveness evaluation of the patient navigator 
process. Research results from this Patient Navigation Research Program 
will: (1) improve NCI’s knowledge and understanding of how to best 
support racial/ethnic minorities and other underserved populations with 
cancer-related abnormal screening findings in accessing and navigating 
the cancer care system; (2) assess the impact of patient navigators on 
timely provision of quality standard care and patients’ adherence to 
standards-of-care; and (3) encourage research collaborations and 
partnerships across cancer care delivery systems and organizations 
(e.g., primary care facilities, community health centers, hospitals, 
and academic centers).

Applicants must address navigating patients with one or more of the 
following cancer types; breast, cervical, prostate, and colorectal. 
These patients must include a significant number of racial/ethnic 
minorities, people of low socioeconomic status (SES), and members of 
other underserved populations. Applicants must propose approaches to 
develop and implement formal referral and care arrangements between 
community outpatient settings and a hospital that offers quality, 
standard cancer treatment. Applicants will be required to identify, 
where available, other local Federally funded programs that could 
augment successful interventions, such as the Centers for Disease 
Control and Prevention’s (CDC) National Breast and Cervical Cancer 
Early Detection Program - Reducing Mortality Through Screening and 
similar programs funded by CDC, Health Resources and Services 
Administration (HRSA), Centers for Medicare and Medicaid Services 
(CMS), or other agencies, and are encouraged to elicit coordination and 
collaboration with Federal, or similar State, regional, or local 
programs.  The PNRP does not pay for screening, diagnosis or treatment 
costs, existing health care systems are to be used for this purpose.

Applicants must present methodologies and techniques for overcoming 
barriers (e.g., utilizing primary language other than English) to 
timely access to cancer diagnosis and treatment services. Applicants 
must demonstrate that the treatment hospital has a service area with 
adequate cancer screening rates. These rates will need to ensure that a 
sufficient sample (i.e., based on power analysis) of patients with 
abnormal findings are referred to the patient navigator to 
scientifically answer the research questions proposed. Applications 
must address plans for: conducting a needs assessment, selecting and 
training navigators, tracking patients, conducting a rigorous program 
evaluation, and disseminating findings.

The applicant’s research design must include baseline historical data 
and plans for a continuous comparison group throughout the study 
period. This design must address history effects, system biases, 
community activities that may impact changes in cancer disparities 
(e.g., other organizations’ efforts to increase cancer screening 
rates), and other confounding factors. Community cross-sectional 
surveys should be considered to interpret changes over time. All 
research designs will be reviewed for ethical concerns and Human 
Subjects issues within vulnerable populations.

Rigorous evaluations of navigation intervention effectiveness and cost 
effectiveness are critical components of the patient navigator program. 
In collaboration with the Program Scientist of the NCI CRCHD, grantees 
will establish intervention and cost-effectiveness evaluation criteria 
for their research, using qualitative and quantitative indicators 
collected at the start of the project and regularly updated throughout 
the grant period of performance. This Program’s evaluation process, 
cost-effectiveness analysis, and associated outcome metrics will be 
developed to address research hypotheses and other outcome measures. 
Metrics will also provide insights into community changes possibly 
related to the project, such as increases in observed short-term 
reductions in stage at diagnosis; and increases in cancer prevention, 
screening, and treatment knowledge and cancer-preventive behaviors.  
Documentation should be maintained on aspects of the Program that may 
be implemented for other cancers and diseases.

Several anticipated features of this study are described so that 
applicants have a common understanding of the factors necessary for the 
collaborative effort, timetable, general evaluation criteria and data 
collection requirements, and handling of certain central functions. 
Although some of the characteristics of the study populations and 
experimental interventions are specified, the specific design of the 
study testing the effectiveness of patient navigators on timely access 
to standard cancer care services remains in the hands of the 
investigators.

In order to accumulate a sufficient sampling of differing patient 
navigator characteristics, settings, and population groups to test the 
effect of patient navigators on patient access barriers, a 
collaborative effort will be required among participating research 
projects. In this collaborative effort, participant institutions must 
agree to follow a uniform study protocol with respect to CRCHD-required 
standardized data collection and documentation procedures. The 
collaborative protocol will be developed by the Steering Committee 
(SC), composed of the Principal Investigators (PIs) and the NCI CRCHD 
Program Scientist. Awardees are permitted to collect project data to 
address independent research questions.  

Study Design and Timetable 

The PNRP can be implemented in multiple phases as designed by the 
applicant. A first phase might consist of formative research to assist 
the PI in planning, designing, and implementing the unique patient 
navigator research protocol components. A component of the formative 
research might be a needs assessment to determine the most frequent 
patient-access barriers and identify methods and techniques to overcome 
these access barriers in a timely, efficient manner. Based on this 
formative research, different models may be planned and implemented 
within different project settings.

Additional formalized pre-implementation phases might include patient 
navigator training and project start-up. A patient navigator-training 
phase should focus on training the patient navigator individual(s) 
based upon formative research findings. These efforts might include 
selecting, training, and orienting the patient navigator(s) to cancer 
screening, diagnosis, and treatment. In training patient navigators, 
characteristics and qualities identified from the formative research 
process might include:
a.   Ability to provide timely, accurate information to the patient at 
time of abnormal finding in a supportive, culturally sensitive 
manner.
b.   Knowledge of the health care delivery system that cancer patient 
must depend on for care.
c.   Knowledge of various financial resources and financial alternatives 
available to the patient to pay for cancer care services.
d.   Interest in ensuring that culturally and linguistically appropriate 
services are offered to the patient, which are respectful of and 
responsive to cultural and linguistic needs.
e.   Acceptance within the health care system by administrators, 
physicians, and associated health care professionals.
f.   Commitment to high-quality, timely care for all cancer patients.
g.   Consideration and acceptance of patient fears, cultural beliefs, and 
hopes.
h.   Ability to connect and communicate with medical decision-makers in 
the health care system.

The investigators should also gather information on community screening 
rates and numbers of abnormal findings currently in the cancer care 
continuum; establish rapport with primary care and cancer care 
providers and nursing staff; and engage the targeted community(s) in 
the patient navigation process. The patient navigator should establish 
familiarity with screening protocols and procedures within their 
respective health care system. A tracking system should be established 
to cover from the time of referral to treatment resolution. The patient 
navigator and the clinical supervisor may need to jointly develop a 
“scope of practice,” i.e., job responsibility/description in order to 
establish clinical/administrative supervision and mentoring with 
provider senior staff. Also during this early phase of the application 
project, the project should include discussions of the development of 
manual and automated systems for outcome and process measurement 
criteria and data collection procedures. 

During project start-up, the investigator team should develop, 
document, and implement strategies to address and overcome identified 
barriers. From project start-up, the study effort should formally 
implement collection of all core and supplemental process and outcome 
measures. It is expected that intake interviews will be completed at 
the time referrals are sent to the patient navigator.

By the end of the first year after award, the patient navigator project 
should be in full operation, receiving referrals from primary care 
centers for persons with abnormal findings, and navigating patients 
through the cancer care continuum. Through community and hospital 
partnerships and collaborations, the patient navigator project should 
then be capable of sustaining the infrastructure required to overcome 
the unique barriers to cancer care experienced by the targeted 
populations in their community. In addition to working with all 
referred patients, each project should have systems in operation to 
track each patient’s progress through the cancer-care system, to record 
all established outcome and process measures, to provide cancer care 
coordination, to overcome patient barriers to timely care, and to 
establish sustainable cooperation between health care settings and 
cancer care treatment.

The proposed project schedule should include sufficient time to perform 
thorough analyses and evaluations of all project activities. Local data 
should be analyzed with respect to primary and secondary research 
questions. Process data should be analyzed to augment the quantitative 
analyses and to provide information for interpreting outcome results. 
Presentations and publications should be prepared to publicize research 
findings to NCI, the scientific community, and the local targeted 
communities. Documentation of all Patient Navigator Project 
implementation and operation processes should be completed, so those 
successful programs can be transferred to other similar communities.

PNRP Organization and Related Activities

In developing the PNRP organizational structure, issues that might be 
considered include: (1) having a PI and a Co-PI located at the 
diagnosis and treatment facility and the community outpatient setting,  
respectively; (2) having patient navigators to address different 
population segments; (3) having an administrative core group consisting 
of a project coordinator for day-to-day management, a research 
assistant for daily project administration, and a research 
coordinator/data manager to assist in conduct of data collection and 
process documentation activities; and (4) having a research core group 
consisting of qualitative and quantitative researchers to direct and 
conduct the formative research and the required project outcomes 
evaluations.

Each project must establish a Community Advisory Panel (CAP) to advise 
the project PI. This committee would probably be composed of community 
leaders; community-based participatory researchers; clinical personnel 
serving the community; and others needed to carry out objectives of the 
PNRP. At least one-quarter of the panel’s membership should represent 
community-based organizations.  At least one-third of the membership 
should be composed of racial/ethnic minorities, people of low SES and 
members of other underserved populations.  Such a panel must meet at 
least once a year to review project activities and accomplishments as 
well as activities planned for the following year. This committee 
should also advise on methods to sustain the patient navigator 
activities after conclusion of grant funding.

There must be actively participating partnerships with local community-
based organizations, screening and early detection centers, and 
diagnosis and treatment facilities that serve the targeted communities 
experiencing cancer care services disparities.  
Evaluation of the Program

Evaluation of the Program 

The Steering Committee will collaboratively establish a core set of 
standardized processes and outcome evaluation criteria for the 
program’s research using qualitative and quantitative indicators 
collected at the start of the project and regularly updated throughout 
the grant periods-of-performance. This Program’s core evaluation 
process and associated outcome metrics will be developed to address the 
primary research hypotheses stated above. Core metrics will also 
provide insights into community changes possibly related to the 
Program, such as increases in cancer screening rates; observed short-
term reductions in stage at diagnosis; and increases in cancer 
prevention, screening, and treatment knowledge and cancer-preventive 
behaviors. Grantees also will be required to document each step in the 
implementation, training, conduct, and evaluation of navigation 
services to provide a basis for exemplary programs to disseminate 
collaboration and operating information, best practices, and lessons 
learned to other communities throughout the nation. Additional unique 
project qualitative and quantitative indicators to address individual 
project research questions may also be included.

Individual Grant Project Evaluation

A first step in the evaluation of each grantee’s project will be 
baseline research to formally document baseline time from abnormal 
finding to resolution of abnormal findings and time from positive 
cancer diagnosis to commencement of standard cancer treatment. A 
variety of additional pathway measures may be collected as determined 
appropriate by the Steering Committee during start-up meetings.

During conduct of the individual research projects, a core set of 
evaluation metrics will be established collaboratively by the Steering 
Committee and must be collected by all grantees.
These qualitative and quantitative measures may include, but are not 
limited to:

o Number of patients referred;
o Type of cancer and stage at diagnosis;
o Appointments kept/missed and reasons;
o Number of patients accepting navigation;
o Number of current dependents in patient’s family;
o Reasons for accepting or not accepting navigation;
o Baseline knowledge of cancer treatment alternatives;
o Education/information materials provided to patient/family members;
o Patient demographics (i.e., gender, race/ethnicity, age, 
socioeconomic status, primary language);
o Patient-access barriers and time to resolve each barrier, including 
issues addressed in resolving access;
o Distance of patient’s home from diagnosis and treatment centers;
o Recommended diagnostic procedures and adherence to schedule;
o Patient’s primary mode of transportation to diagnosis and treatment 
centers;
o Recommended treatment procedures and adherence-to-treatment protocol; 
and
o Other non-access-specific navigation services requested/provided.

Primary outcome measures for each grantee should include, at a minimum, 
changes in time from abnormal finding to diagnosis or other resolution 
and positive diagnosis to treatment initiation. Other outcome measures 
may include, but are not limited to, improvements in satisfaction with 
the cancer care system experience and measures of how well the patient 
navigator achieves program goals.

Documentation should be maintained on aspects of the Program that are 
reproducible or translatable to other cancers and other diseases. 
Projects should also document to what extent the community and health 
care delivery system can sustain patient navigator services beyond the 
grant funding period. Cost-effectiveness measures will include labor 
cost of the navigator, cost of training the navigator, and time of 
patient navigator spent on various activities (e.g., contacting 
patient, coordinating patient records with providers, overcoming 
various types of access barriers such as arranging transportation, 
community education about navigation processes, and similar patient 
navigator activities). Patient follow-up surveys may be administered to 
measure patient and family changes in knowledge of cancer prevention 
and control-specific to both the patient’s cancer and to cancer in 
general-changes in usual source of care and satisfaction with the 
health system experience. Community outcome measures may include 
community member changes in perceptions regarding accessibility of 
timely, high-quality, standard cancer care; ability of patients with 
abnormal findings to overcome barriers to timely diagnosis and 
treatment; and satisfaction with services and quality of care provided 
by the local cancer care system.

Overall Patient Navigator Program Evaluation

The SC will establish standardized evaluation criteria and associated 
qualitative and quantitative measurement metrics within the first year 
of the Program.  Primary metrics to demonstrate success of this Program 
will be: (1) improved timeliness of resolution following an abnormal 
finding for a majority of participating patients; (2) improved 
timeliness of commencement of standard cancer treatment following a 
positive cancer diagnosis for a majority of participating patients; and 
(3) improved patient satisfaction with the health care system 
experience for a majority of participating patients.

Process evaluation measures will investigate what characteristics are 
important to the patient navigation process, for example: (1) How 
important is matching of patient and navigator demographic 
characteristics? (2) How important is the type of navigator-
professional navigator (nurse, social worker) versus indigenous 
community navigator (cancer survivor, community health worker)? 
(3) What services are critical to provide to the cancer patient-only 
overcoming cancer care access barriers or also emotional, 
psychological, and referral support and access for medical treatment of 
comorbidities? (4) What training and support is critical to the patient 
navigator-cancer prevention and control, hospital procedures and 
administration, medical information, and/or emotional and psychological 
support to minimize burnout? (5) How many patients can a patient 
navigator effectively assist simultaneously? and, (6) Do other program 
linkages and partnerships (e.g., local Federally funded CDC, HRSA, CMS, 
or other agency programs) have an impact on the success of the patient 
navigator intervention strategies?

Centralized data collection, data management, and data quality 
assurance will be coordinated by the NCI CRCHD Program Scientist 
through a central data coordination and evaluation contractor.  All 
awardees will collaborate in the sharing of standardized core process 
and outcome data with the central data coordination and evaluation 
contractor and will collaborate in primary research data analyses and 
publications using the aggregated data sets, as component parts of the 
awarded grant funding.  Collaboratively developed standardized 
evaluation criteria and metrics will be used by all grantees.  
Development of additional, individualized project metrics will also be 
encouraged in order to evaluate unique research hypotheses.  The 
central data coordination and evaluation contractor will assist the 
Steering Committee to monitor Program implementation progress by 
examining patient accruals, conducting periodic analyses of critical 
metrics, and preparing interim reports on trends in outcome measures.  
Continuous monitoring in collaboration with awardees will enable the 
NCI CRCHD Program Scientist to obtain a “snapshot” of the progress and 
to make midcourse Program adjustments, if necessary, among individual 
grantees or in the entire Program’s implementation procedures.    

The NCI CRCHD Program Scientist, in collaboration with grantee 
investigators, will conduct appropriate descriptive and inferential 
statistical analyses of the aggregated data sets to validate that 
patient navigators are an effective method for reducing cancer health 
disparities. Process documentation will be evaluated to describe 
characteristics and qualities of navigators, communication and 
relationships between patients and their patient navigators, and 
communication and relationships between patient navigators and health 
care professionals providing standard cancer care.

Dissemination of PNRP Research Findings 

The PNRP will disseminate its research findings. There are a number of 
ways to achieve this objective, including, but not limited to, having 
findings published in peer reviewed journals or published on the cancer 
control PLANET website (http://cancercontrolplanet.cancer.gov/),  and 
disseminating findings and effective interventions to other communities 
through collaborations between PNRP grantees to develop resource 
documentation. 

MECHANISM OF SUPPORT
 
This RFA will use the NIH cooperative agreement (U01) award mechanism. 
As an applicant you will be primarily responsible for planning, 
directing, and executing the proposed project. Future unsolicited 
applications based on this program will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures. The anticipated award date is July 2005. 
Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated applications using 
the standard receipt dates for NEW applications described in the 
instructions to the PHS 398 application. 

This RFA uses just-in-time concepts.  It uses the non-modular budgeting 
format so follow the instructions for non-modular research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.    

The NIH (U01) is a cooperative agreement award mechanism. In the 
cooperative agreement mechanism, the PI retains the primary 
responsibility and dominant role for planning, directing, and executing 
the proposed project, with NIH staff being substantially involved as a 
partner with the PI, as described under the section "Cooperative 
Agreement Terms and Conditions of Award." 

FUNDS AVAILABLE 
 
NCI intends to commit approximately $4.8 million in FY 2005 to fund six 
grants in response to this RFA. An applicant may request a project 
period of up to 5 years and a budget for total costs of up to $0.8 
million per year.  Please note that facilities and administrative (F&A) 
cost requested by consortium participants are excluded from the direct 
cost limit per NIH Guide Notice NOT-OD-04-040.  Because the nature and 
scope of the proposed research will vary from application to 
application, it is anticipated that the size and cost of each award 
will also vary. Although the financial plans of the NCI provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.  NCI may modify awards to meet geographic, 
racial/ethnic minority and/or underserved population needs, overlaps, 
or program priorities or funds. 

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o For-profit or non-profit cancer services delivery organizations;
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories; 
o Domestic institutions/organizations;
o Faith-based or community-based organizations; and
o Foreign institutions are not eligible to apply.

Applications are invited from groups representing racial/ethnic 
minority populations, such as African American, American Indian and 
Alaska Native, Asian, Hispanic, and Pacific Islanders and underserved 
populations. Applicants should have a documented history of involvement 
with the community and have qualified staff to direct the program. 
Collaborative applications are encouraged. Among collaborators, one 
must be designated as the lead applicant and assume responsibility for 
the project. Organizations that must rely primarily on consultants to 
conduct the project are ineligible. Foreign organizations are not 
eligible and domestic organizations may not include international 
components.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS  

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.  
 
SPECIAL REQUIREMENTS 

Cooperative Agreement Terms and Conditions of Award 

The administrative and funding instrument used for this program is a 
cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial National Cancer Institute 
(NCI) scientific and/or programmatic involvement with the awardee(s) is 
anticipated during performance of the activity. Under the cooperative 
agreement, the NCI purpose is to support and/or stimulate the 
recipient's activity by involvement in and otherwise working jointly 
with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity. 
Consistent with this concept, the dominant role and prime responsibility 
for the activity resides with the awardee(s) for the project as a whole, 
although specific tasks and activities in carrying out the studies will 
be shared among the awardees, the NCI CRCHD Program Scientist, and other 
NCI staff with required expertise.

1. Awardee Rights and Responsibilities

a. Awardees have primary authority and responsibility to define 
objectives and approaches and to plan, conduct, analyze, and publish 
results, interpretations, and conclusions of their projects.  

b.Awardee will participate in PNRP Steering Committee (SC), composed of 
PIs and one NCI CRCHD Program Scientist, agree to follow the SC 
approved standardized data, procedures, protocols, and analyses, and 
agree to share data with the NCI established central data coordination 
and evaluation contractor.  Awardees may collect project data to 
address independent research questions in addition to the collaborative 
projects. Awardees will retain custody of and have primary rights to 
data collected under these awards, subject to Government rights of 
access consistent with current U.S. Department of Health and Human 
Services (DHHS), Public Health Service (PHS), and National Institutes 
of Health (NIH) policies, such as Health Insurance Portability and 
Accountability Act (HIPAA) regulations.

c. Awardees must establish and maintain a Community Advisory Panel 
(CAP). The role and responsibilities of the Panel are described below. 
The NCI CRCHD Program Scientist will serve as a voting member of any 
advisory panel (wirh only one NCI vote on any such panel).  a. Awardees 
will establish and maintain for their projects a CAP whose role is to 
function as an advisory body. The CAP may include the Project PI, all 
Co-PIs, and all Co-Investigators, community leaders and/or 
facilitators, representatives of community-based organizations, 
community-based participatory researchers, clinical personnel serving 
the community, and others with expertise in relevant scientific or 
other cancer-related or disparity-related disciplines necessary to 
carry out objectives of the PNRP. At least one-quarter of the panel’s 
membership should represent community-based organizations.  At least 
one-third of the membership should be composed of racial/ethnic 
minorities, people of low SES and members of other underserved 
populations.  The CAP should provide overall guidance and support for 
project-sponsored activities. This Panel should also advise on methods 
to sustain the patient navigator activities after conclusion of grant 
funding.

d. Awardees must provide annual progress reports and additional 
information, as requested by the NCI CRCHD Program Director. In 
addition to descriptions of past activities and their results, the 
report due at the end of each funding period should provide core 
program evaluation data elements annually, as determined by NCI; 

e.  Awardee must seek technical assistance from NCI staff if it is 
determined that the awardee is not meeting program goals in a timely 
manner. 

f.  Awardee will participate in two meetings per year.

2. NCI Staff Responsibilities - The NCI CRCHD Program Scientist will 
have substantial scientific/programmatic involvement during conduct of 
this activity through technical assistance, advice, and coordination 
above and beyond normal program stewardship for grants, as described 
below. The NCI CRCHD Program Scientist will:

a. participate as a voting member in the PNRP Steering Committee, 
attending semi-annual meetings.

b. Coordinate awardee interaction with the NCI data coordination and 
evaluation contractor.

The NCI Program Director will be responsible for normal stewardship of 
the award.  The Program Director may also serve as the Project 
Scientist.  The Program Director will also designate other NCI staff 
who are subject matter experts to assist the Project Scientist.

For projects with phased implementation, the Program Director must 
approve moving into the next phase based on progress made and proposed 
plans.

NCI reserves the right to terminate or curtail the program (or an 
individual award) in the event of substantial shortfall in the 
performance of requirements for any single Phase or key activity of the 
program.

3. Collaborative Responsibilities 

Awardees and the NCI CRCHD Program Scientist will form a Steering 
Committee, which will be the governing body for the collaborative 
effort of the awardees.  The awardees and the NCI Program Scientist 
will each have one vote.  The chair will be a non-federal person. 

The SC will establish standardized evaluation criteria and associated 
qualitative and quantitative measurement metrics that will be collected 
throughout the period of performance. The SC members will collaborate 
on the design and implementation of program analysis plans; will 
participate in the program process and outcome analyses, and will 
prepare primary outcome publications and presentations. 

a. The SC will plan and implement semi-annual program meetings of all 
PNRP PIs and Co-PIs to share research and operational implementation 
experiences, challenges, and accomplishments; lessons learned; and 
research findings, and identify areas in which improvement is needed 
and additional collaborations are possible. 

4. Arbitration

Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award) between an award recipient and the NCI 
may be brought to arbitration. An arbitration panel will be composed of 
three members: one selected by the SC (or by the individual awardee in 
the event of an individual disagreement); a second member selected by 
the NCI; and a third member selected by the two previously selected 
members. This special arbitration procedure in no way affects the 
awardee’s right to appeal an adverse action if it is otherwise 
appealable in accordance with the PHS regulations at 42 CFR Part 50, 
Subpart D and HHS regulations at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

o Direct your questions about scientific/research issues to:

A. Roland Garcia, Ph.D.
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd, Room 602
Bethesda, MD 20892-8341
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8589
FAX: (301) 435-9225
Email: Garciaar@mail.nih.gov

o Direct your questions about peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email: ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters 
to:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150
Telephone: (301) 496-8796
FAX: (301) 496-8634
Email: crystal.wolfrey@nih.gov

PRE-APPLICATION MEETING

A pre-application workshop will be held on September 15, 2004 from 1-5 
p.m. in the Natcher Auditorium (Building 45) the on NIH campus. This 
meeting is open to the public.  Investigators planning to submit 
applications in response to RFA CA-05-019, "Patient Navigation Research 
Program" are encouraged to attend. This public meeting will provide 
prospective applicants with opportunities to receive answers to their 
questions about the RFA. 

The meeting will include presentations from CRCHD staff on the intent 
and requirements of the RFA, and presentations from other NIH and DHHS 
staff on human subjects protections, grants management, and grant 
writing.  Potential applicants to the RFA are not required to attend 
the pre-application meeting. A written transcript of the meeting will 
be posted at http://crchd.nci.nih.gov/  as a public document as soon as 
possible after the meeting, to provide applicants unable to attend the 
meeting with access to the proceedings. 

The workshop will be webcast at http://www.videocast.nih.gov/.  Please 
click on the Patient Navigator Research Pre-Application Workshop on 
September 15 to access the broadcast. Registration is required for 
participation in the pre-application meeting to facilitate technical 
planning. Participants may register with and direct any questions 
regarding logistics to Christine McCann, NOVA Research Company, at 301-
986-1891, ext. 130, or via e-mail at christine@novaresearch.com.

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NCI 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:

A. Roland Garcia, Ph.D.
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd, Room 602
Bethesda, MD 20892-8341
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7072
FAX: (301) 435-9225
Email: Garciaar@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a Dun and Bradstreet (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.dunandbradstreet.com/. 
The D&B number should be entered on line 11 of the face page of the PHS 
398 form. The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format. For further assistance, contact GrantsInfo; 
Telephone: (301) 435-0714; Email: GrantsInfo@nih.gov.
 
SUPPLEMENTARY INSTRUCTIONS:  See additional guidance in the RESEARCH 
OBJECTIONS section (above) and the following instructions: 
 
RESEARCH PLAN

a. Specific Aims – Specific aims should address the goals and 
objectives as specified in the RFA. 

b. Background and Significance -In this section, the applicant should 
provide a description of cancer care delivery (i.e., diagnosis, 
treatment, and mortality) disparities in the communities to be 
addressed and cancer screening rates and diagnosis rates for the four 
primary screenable cancers, breast, cervical, prostate, and colorectal. 
For each disparity, the description should include, but is not limited 
to, the type of disparity, population to be addressed, cancer site 
affected, and potential reasons for the observed disparity.  

c. Preliminary Studies/Progress Report - description of previous work 
relevant to this RFA. 

d. Research Design and Methods - Describe your Patient Navigation 
Research Project in detail. Provide current hospital screening rates of 
selected cancer sites.  Describe the minority and/or low 
SES/underserved population in your community.  Provide data to 
demonstrate the cancer disparities of these populations within your 
community.  Specifically, describe cancer care delivery activities in 
targeted communities, how patient navigator intervention(s) will be 
implemented within the cancer care delivery infrastructures, how a 
comparison group will be selected and maintained, how cancer care 
delivery organizations will coordinate from abnormal finding through 
completion of treatment, how the targeted communities will participate, 
how intervention activities will be measured and evaluated, how 
research findings will be disseminated back to the targeted 
communities, and how effective programs will be sustained in the cancer 
care delivery system after completion of this research project. 
Applicants must also address methods for conduct of the cost-
effectiveness evaluation and appropriate measurement criteria.  
Describe specifically, how each research aim will be achieved, 
including a discussion of how changes in cancer care disparities in the 
community will be evaluated.

Research Plan Sections e-i, as appropriate.

BUDGET FOR TRAVEL TO PNRP PROGRAM MEETINGS

Budget for travel to Washington, DC (twice per year for up to four 
individuals) to attend these semi-annual 3-day meetings should be 
included in the budget.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form 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.
 
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
five copies of the appendix material must be sent to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428 (for express/courier service)

Appendices should be comprised of unbound materials, with separators 
between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER 
INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to 
courier deliveries (i.e., FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html):  
This change in practice is effective immediately. This policy is 
similar to and consistent with the policy for applications addressed to 
Centers for Scientific Review as published in the NIH Guide Notice at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA. If an 
application is received after that date, it will be returned to the 
applicant without review.  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.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA 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 an RFA, it is to be prepared as a NEW 
application. That is the application for the RFA 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. 

PEER REVIEW PROCESS 
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI. Incomplete and/or non-responsive 
applications will not be reviewed. 

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 Division of Extramural Activities of the 
NCI in accordance with the review criteria stated below. As part of the 
initial merit review, all applications will:

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

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. 
In the written comments, reviewers will be asked to evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. The 
scientific review group will address and consider each of these 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The 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 important cancer disparities? If 
the aims of the application are achieved, will patient access barriers 
be reduced and/or eliminated and will cancer care disparities be 
reduced? What will be the effect of this project’s concepts or methods 
that drive this field? Is the proposed project likely to improve access 
to cancer care service from abnormal findings through cancer treatment 
or non-cancer resolution through cancer care provider collaborations 
and community-based participation? Will the results, such as the 
interventions to be developed, be useful to groups in other parts of 
the country?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
patient navigation to reduce patient access barriers? Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics? Has applicant addressed plans for needs assessments, selecting 
and training navigators, tracking patients throughout the cancer care 
continuum, collecting and sharing information and core data with the 
NCI CRCHD Program Scientist and other grantees, conducting qualitative 
and quantitative program evaluations, and disseminating findings 
through publications and other methods designed to inform communities? 
Has the applicant adequately addressed methods for conduct of the cost-
effectiveness evaluation and appropriate measurement criteria? Has the 
applicant described formation, representativeness, and responsibilities 
of a CAP?

Have cancer care disparities of the community been described 
adequately? Has applicant adequately described institutional, system 
and patient access barriers to timely, quality cancer care and proposed 
methods and techniques for overcoming these barriers?  Are there 
linkages from the cancer care delivery facilities to the cancer 
research base and to the community? Are there indications of the 
potential for applicant’s effectiveness in reaching the most difficult-
to-access segments of the community? Do they have a clear plan for 
establishing and maintaining a suitable comparison group throughout the 
study period?  Are there adequate plans for involving all segments of 
the cancer care services delivery infrastructure to address the problem 
of reducing cancer care access barriers in the targeted community?  Are 
there adequate plans for evaluation of the proposed patient navigation 
interventions?  Does the applicant demonstrate effective approaches to 
developing and implementing formal referral and care arrangements 
between community outpatient settings and a hospital that offers 
quality, standard cancer treatment?

INNOVATION: Does the project employ novel concepts, approaches or 
methods to provide patient navigation access and reduce cancer care 
disparities? Does the project challenge existing paradigms, develop new 
methodologies or technologies, or address critical barriers? 

INVESTIGATOR: Is the investigator appropriately trained and well-suited 
to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers? 
Does the investigator/staff have experience working with the cancer 
care delivery components and communities to be addressed?  Does the 
applicant or its partners have a history of working with the 
communities to be addressed? Does the applicant or partners have 
expertise in cancer care services delivery and research so that they 
can develop interventions to address the Program objective and four 
major research questions specified.

ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed 
interventions take advantage of unique features of the scientific and 
community environments or employ useful collaborative arrangements? 
Does the environment include a significant number of racial/ethnic 
minorities, people of low SES, and members of other underserved 
populations? Is there evidence of institutional support? Is there 
evidence of community support? Is there evidence that applicants have 
identified, where available, other local Federally funded programs and 
other agencies programs that could augment proposed interventions, and 
elicited coordination and collaboration.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will 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 criteria 
included in the section on Federal Citations, below.)

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. Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below.)

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 398 research grant application instructions (rev. 5/2001) 
will be assessed. 

ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA 

Applicants requesting $500,000 or more in direct costs in any year of 
the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing 
plan into the determination of scientific merit or priority score. 

BUDGET: Appropriateness of proposed budget and duration in relation to 
proposed project; reasonableness of proposed budget relative to 
proposed activities-particularly, the allocation ratio of funds 
retained for administrative costs and those for local programming.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: October 18, 2004
Application Receipt Date: November 18, 2004
Peer Review Date: February/March 2005
Council Review: June 2005
Earliest Anticipated Start Date: July 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review);
o Availability of funds; and
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained. (See 
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 
effectiveness and comparative trials (phase III). The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
participants. (See the NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998 at:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.)

Clinical trials supported or performed by NCI require special 
considerations. The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial. Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NCI program staff or a Data and Safety Monitoring Board (DSMB). 
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional Review Board (IRB). For details 
about the Policy for the NCI for Data and Safety Monitoring of Clinical 
trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. 
For Phase I and II clinical trials, investigators must submit a general 
description of the data and safety monitoring plan as part of the 
research application; for additional information, see NIH Guide Notice 
on “Further Guidance on a Data and Safety Monitoring for Phase I and II 
Trials” at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials/.

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 
(http://grants.nih.gov/grants/policy/data_sharing) or state why this is 
not possible. Investigators should seek guidance from their 
institutions, on issues related to institutional policies, local 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.

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 - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects 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 proposals for 
research involving human subjects. You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
A continuing education program in the protection of human participants 
in research is available online at http://cme.nci.nih.gov/.

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 
(see 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. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances. Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA. It is important for 
applicants to understand the basic scope of this amendment. NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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.

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 RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

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

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


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