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/grants/policy/nihgps_2003/NIHGPS_Part2.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) 710-0267; 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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