REDUCING BARRIERS TO SYMPTOM MANAGEMENT AND PALLIATIVE CARE 

RELEASE DATE:  May 26, 2004
 
RFA Number:  RFA-CA-05-013 

EXPIRATION DATE:  September 27, 2004
 
Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI)  
 (http://www.nci.nih.gov/)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
Office of Research on Women’s Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.399 (NCI); 93.361 (NINR)

LETTER OF INTENT RECEIPT DATE:  August 24, 2004
APPLICATION RECEIPT DATE:  September 24, 2004
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this RFA is to solicit grant applications for research 
directed at developing and testing interventions to reduce or overcome 
barriers to the delivery of appropriate symptom management and 
palliative care to patients suffering from disease and/or treatment-
related sequelae.  Historically, the cancer symptom management research 
community has focused largely on describing symptom prevalence and 
testing new interventions to ameliorate one or more symptoms.  Many of 
these studies have shown efficacy, yet, because of a number of patient, 
clinician, and health system-related barriers, the larger cancer 
community is not adopting these findings. Research is needed to 
discover new or innovative way to implement evidenced based practices 
into routine clinical care. We must expand and accelerate our potential 
to address the problems of inadequate symptom management and palliative 
care among diverse populations in the United States. Given NCI’s 
challenge goal of eliminating the suffering and death due to cancer by 
2015, efforts must be directed to improving the delivery of treatments 
to prevent or ameliorate the adverse physical and psychosocial 
consequences associated with the diagnosis and treatment of cancer.

RESEARCH OBJECTIVES

Background

As a result of advances in the early detection, prevention, and 
treatment of cancer, the population of individuals living with, 
through, and beyond a cancer diagnosis in this country is growing. 
Currently, an estimated 9.6 million Americans are living with a history 
of malignancy. At one time almost uniformly fatal for most, cancer has 
now become a chronic condition for many. Success in achieving this 
goal, however, has not been without cost. None of our current cancer 
therapies is symptom-free. Side effects may range from mild and 
transient (e.g., alopecia, nausea, neutropenia), to chronic (e.g 
fatigue, sexual dysfunction, lymphedema), to late and potentially life-
threatening (e.g., second cancers, cardiomyopathy). While prevalence 
estimates vary widely, a substantial number of patients and survivors 
experience cancer- and treatment-related physical and psychosocial 
impairments.  Pain, depression, and fatigue, alone or in combination, 
are the most frequently cited symptoms that occur along the trajectory 
of the cancer experience. Cancer patients may also suffer from 
anorexia, cachexia, gastrointestinal problems, cognitive impairments, 
dyspnea, and anxiety at various stages of their illness. Although the 
chronicity of cancer-associated conditions mandates symptom management 
and palliative care throughout the course of the disease, many cancer 
patients fail to receive such care and continue to suffer needlessly. 

The prevalence of a number of cancer-related symptoms, most notably 
pain, depression, and fatigue, has been unacceptably high for more than 
two decades and there is little indication that it is decreasing.  Of 
the 29 epidemiological studies reporting on the prevalence and/or 
incidence of cancer-related pain between 1982 and 2001, no single 
survey identified a pain prevalence rate below 14 percent of the 
patients surveyed. One recent study reported a pain prevalence rate of 
52 percent among 240 Veterans diagnosed with both solid tumors and 
hematological cancers. For both the clinician and the cancer patient, 
depression is often viewed as a “natural” symptom or outcome of the 
disease.  To the contrary, cancer patients are three times more likely 
than the general population and almost two times more likely than other 
medically hospitalized patients to develop depression.  A number of 
studies have shown that depressed cancer patients are more likely to 
request euthanasia or physician-assisted suicide and are more likely to 
commit suicide.   The prevalence of depression is higher in cancer 
patients with the greatest disability and distressing physical 
symptoms, such as pain. Similar to cancer-related pain and depression, 
the prevalence of cancer-related fatigue is high and often variable.  
Three studies, conducted on a total of 1,796 cancer patients diagnosed 
with a variety of cancer types and stages, reported prevalence rates 
ranging from 26 percent to as high as 58 percent.
 
The variability in the prevalence of specific cancer related symptoms 
could be attributed to a variety of factors, which include: disease 
characteristics, patient demographics, clinician and health system 
characteristics, and methodological issues, such as lack of consensus 
on the “best” measures of symptoms.  For example, stage of disease is 
frequently cited as an important predictor of symptom incidence and 
severity.   Cleeland and colleagues, surveying 54 treatment locations 
affiliated with the Eastern Cooperative Oncology Group (ECOG), 
estimated that 67 percent of metastatic cancer patients (871 of 1308) 
had pain.  Vuorinen, on the other hand, found a much lower prevalence 
of pain, 28 percent, in 240 newly diagnosed cancer patients.   

We believe that a number of advances have been made in the 
understanding and treatment of cancer-related symptoms, but these 
advances have not translated into standard-of-care practices in the 
cancer setting.  Many cancer patients report that they are not 
routinely asked about their symptoms, are reluctant or afraid to report 
symptoms, are unaware of available symptom management treatments, do 
not adhere to symptom treatments when provided, and at times are not 
offered any treatment even when they do report problematic symptoms.  
In the same study conducted by Cleeland and colleagues, 42 percent of 
those with pain were inadequately managed.  Clearly, the prevalence of 
one or more symptoms would be much lower and overall quality of life 
improved if patients were asked about their symptoms, were offered 
treatments, and were assisted in adhering to the treatment plan.  
Special populations, such as children, the elderly, minority, and 
individuals of lower socio-economic status are at higher risk for 
receiving inadequate or no treatment for their cancer-related symptoms.  
Barriers unique to vulnerable and medically underserved populations 
include pharmacies that do not stock opiods or have inadequate supplies 
of these drugs and individuals lacking knowledge of federal, state, and 
local benefits that may assist them in accessing hospice and end of 
life care.
 
Pain management has been well-studied, resulting in the publication and 
wide dissemination of clinical practice guidelines through multiple 
channels and organizations, including requirements through the Joint 
Commission on Accreditation of Healthcare Organizations (JCAHO).   
Despite the long publication history of these guidelines, cancer 
patients continue to suffer from inadequate relief of their pain.   The 
identification and treatment of psychiatric disorders and psychosocial 
distress have also greatly improved, but in patients with cancer, they 
continue to be under diagnosed and under treated, especially in those 
with advanced cancer.  The American Society of Clinical Oncology 
conducted a survey in 1998 of more than 3,200 oncologists and found 
that one of their top educational needs was to improve their ability to 
diagnose and treat depression and psychosocial distress in cancer 
patients, especially those nearing the end-of-life (Ezekial Emmanuel, 
personal communication, 2003).  Interventions must be developed that 
reduce the barriers to patients receiving optimal relief of their 
symptoms, not only to eliminate suffering, but also to ensure adherence 
to cancer treatment when cancer can be cured or controlled.
 
Physician-related barriers to delivering symptom management are most 
often related to inadequate skills and knowledge in the areas of 
communication, assessment, and treatment.   The physician, for example, 
may not remember or think to ask a patient about symptoms, while the 
patient may not feel comfortable raising issues beyond immediate cancer 
care. There are often difficulties in communication, notably in 
children, the elderly, and across cultures. The physician may hesitate 
to prescribe narcotics for pain control for fear of potential addiction 
or side effects. In treating patients who are on multiple medications 
for co-morbidities, which are common to many older cancer patients, the 
physician may be unsure how best to manage additional medications.  
Lack of adequate time and staff may also compromise a physician’s 
ability to treat symptoms appropriately.  Further exacerbating the 
problem is the fragmentation of follow-up care of cancer survivors.  
Oncologists, which can include medical, surgical, and radiation 
oncologists, as well as primary care providers, mental health 
specialists, and other subspecialties may all be involved in the care 
of cancer patients and survivors, yet there may not be a point person 
coordinating the logistics of these many specialties.  Communication 
between and among all the health care providers caring for a cancer 
patient can be difficult, particularly if they are in different 
locations, without a common database for medical records.

A number of health system factors can potentially hinder the delivery 
of symptom management. They can range from environmental, legal and 
regulatory restrictions to the “macro” (hospital policies and 
pharmacies, information systems) and “micro” (shared practice cultures 
and processes) within health care systems.  The legal and regulatory 
restrictions compound the problem because they often vary from state to 
state and reimbursement policies can vary among private health 
insurance and public programs. All such factors can affect safety, 
effectiveness, patient-centeredness, timeliness, efficiency, and 
equity.  For example, problems related to the larger healthcare system 
include inadequate reimbursement, restrictive regulation of controlled 
substances, and problems of availability of opioids in the patient’s 
pharmacy.

Effective delivery of palliative care within a health care environment 
depends on the timely coordinated response to patient needs.  Examples 
of problems include inadequate information systems to learn about 
patient symptoms and to provide resources both to clinicians and 
patients to address them.  Examples of challenges at the level of the 
office or clinic include organizing care processes to anticipate need, 
to respond to individual patient preferences and to problems when they 
are most needed, to address capacity and patient flow, to gather 
information about patterns of care for use in designing processes and 
improving care, and to develop effective multidisciplinary teams that 
use the skills and knowledge of all members.  Addressing these 
challenges might go beyond a focus on the patient visit to include 
other forms of communicating with patients and providing care using a 
variety of telecommunication platforms.   Any proposal, however, needs 
to be evaluated in relation to its effect on patient care and outcomes.

In addition to system and provider barriers, patients and their family 
members or caregivers may also contribute to problems in the delivery 
of optimal symptom management. Among the most common recipient barriers 
is lack of awareness of need. For example, many patients, like their 
providers, may simply assume that symptoms of depression or anxiety are 
expected when the diagnosis is cancer. The adverse impact on patients’ 
functioning of insomnia and fatigue, among the more common symptoms 
experienced in those in active treatment, is often underappreciated. 
The frequently parallel belief that there is nothing to be done when a 
symptom occurs is a further barrier to receipt of appropriate help. 
Reluctance to appear weak or foolish or unable to cope additionally can 
contribute to failure to report symptoms when they do occur, even when 
these are troublesome to patients. For example, a woman undergoing 
chemotherapy may be very upset by her hair loss but fail to mention 
this to her treating team because she feels her preoccupation is a 
‘vain’ concern in the context of the seriousness of her illness. 

The perceived stigma associated with needing or having to ask for help 
itself can be a potent barrier to accessing care.  This may be 
particularly true among different ethnocultural groups where a premium 
is placed on stoicism.  In other cases, concern about taking up limited 
clinic time or physician visits to discuss what may seem to be 
unrelated or seemingly non-medical issues (e.g., anxiety, social 
isolation) may cause patients to avoid these important topics in 
discussions with their doctors or clinic staff.  Patients may also wait 
for a physician to introduce a topic before expressing their concerns.   
At times, embarrassment can keep a patient from discussing a bothersome 
symptom. This is especially true when the symptom affects bowel, 
bladder, or sexual functioning domains.   Finally, even when effective 
help is offered, patients may be resistant to use the interventions 
that are recommended. This may be due to fear of an intervention’s 
consequences. A classic example is the often expressed concern that 
narcotic use for pain will lead to subsequent addiction. Alternatively, 
they may be overwhelmed with the challenge of self-medicating and 
adjusting dosage to maximize benefits.  Reluctance to seek help (e.g., 
counseling or rehabilitation services) may also be driven by lack of 
insurance or financial resources to pay for these services.

Cancer and treatment-related symptoms among survivors may pose an 
additional set of problems. These post-treatment symptoms may be 
interpreted as potential disease recurrence and result in fear and a 
reluctance to acknowledge them. Alternatively survivors may believe 
that chronic symptoms (e.g., pain, fatigue, lymphedema) are simply 
something with which they must learn to live.  Because research 
documenting the types and frequency of long-term and late effects of 
cancer is only now beginning to appear, it is difficult to know how 
common some symptoms are in the growing population of both young and 
older Americans living with a history of cancer.

For their part, both family and non-family caregivers often share 
concerns and reservations similar to those experienced by patients 
themselves. They may fail to recognize that the patient’s symptom 
warrants further workup or care, may want to believe the individual for 
whom they are caring is coping well, may think there is little to be 
done for a given problem, may worry about addicting a patient or 
inducing undesirable side effects by providing medication, or may 
believe they or others in the home or external care setting can provide 
all the support or intervention required to meet a patient’s symptom 
needs.  

In summary, there is compelling evidence that cancer patients do not 
receive adequate symptom management or palliative care throughout the 
course of their disease. We need to be able to identify who is at risk 
for cancer-related symptoms and test methods that will ensure the 
routine delivery of interventions across the continuum of cancer care.  
Results of research related to this RFA should (1) generate knowledge 
about how to reduce barriers to the delivery of symptom management and 
palliative care, (2) address barriers for vulnerable, medically 
underserved, and special populations to access and receive palliative 
care, and (3) encourage research collaborations across disciplines and 
cancer care delivery systems (i.e., academic centers, community 
hospitals, HMOs, doctor practices, hospices) and public-private 
partnerships.

Objectives and Scope

The goals of this research initiative are to develop and test 
interventions to overcome barriers to the delivery of symptom 
management and palliative care, thereby decreasing the suffering and 
improving the health and quality of life of persons living with cancer.  
Program staff at the NCI and other NIH Institutes and Centers that are 
participating in this RFA conceptualize symptom management as one 
component of the care delivered to cancer patients at risk for or 
experiencing disease-and treatment-related symptoms. Other components, 
as defined by the World Health Organization, include communication, 
decision-making, management of complications of treatment, psychosocial 
care of patient and family, and care of the dying. To address the 
complex and interdependent physical, social, psychological, and 
existential needs of patients and their families requires a 
multidisciplinary team approach.  Ideally, palliative care begins at 
the diagnosis of cancer or other illness and is given in conjunction 
with disease directed therapies, such as chemotherapy or radiation 
therapy. Accordingly, the focus of this initiative is broad and 
includes cancer patients across the disease trajectory.  Settings where 
interventions could be tested include, but are not limited to, acute 
care facilities, the home, skilled nursing facilities, outpatient 
clinics, and hospices. Given the significant number of cancer patients 
being treated in community settings, we are particularly interested in 
applications that would access this type of setting or would develop 
interventions that are generalizable to the broader community setting.  
For example, the unique research infrastructures of the Community 
Clinical Oncology Program 
(http://www3.cancer.gov/prevention/ccop/aboutccop.html) and the HMO 
Cancer Research Network (http://hmoresearchnetwork.org/) make them 
particularly suitable for implementing these types of interventional 
research projects. 

Common strategies to disseminate evidenced based practice guidelines, 
e.g., scientific publications, direct mailings, electronic 
dissemination, etc., have been found to be insufficient to change or 
improve clinical practice.  New methods are needed to implement 
(sometimes referred to as translate) what is known to be effective or 
appropriate symptom management into routine cancer care.  The focus of 
this RFA is to solicit applications in this emerging field of 
translational research.

The proposed interventions should build on current knowledge and 
research findings in the area of patient, family/informal caregiver, 
clinician, and/or health care system barriers.  We anticipate that most 
projects will meet the following NIH operational definition of a 
clinical trial, “a prospective biomedical or behavioral research study 
of human subjects that is designed to answer specific questions about 
biomedical or behavioral interventions.”  Please note, clinical trials 
that are testing agents or drug delivery systems to improve one or more 
symptoms will not be considered responsive to this RFA.  In addition, 
projects that are primarily descriptive or observational will not be 
considered responsive to this RFA.  

Appropriate Topics

The following list of research topics are for illustrative purposes.  
Applications on topics not explicitly listed below, but which fall 
within the objective described above, are also welcome.

A)  Research Related to Patient, Family, or Informal Caregiver 
Barriers:

o Examine the effects of patient concerns, patient choices, decision-
making strategies, and caregiver values on adhering to symptom 
management or palliative care strategies.
o Test interventions that will promote patients’ and caregivers’ 
understanding and use of medications for symptom relief.
o Test whether interventions to improve patient’s and caregiver’s 
ability to report onset, severity, and duration of symptoms at any 
point along the cancer continuum will improve patient reported 
symptoms.
o Test interventions targeted to specific age groups that experience 
challenges to optimal symptom management due to developmental stage, 
such as young children, adolescents and young adults, or the elderly. 
Include both patients and caregivers wherever appropriate. 

B)  Research Related to Health Care Providers:

o Determine if systematic use of clinical practice guidelines improves 
patient outcomes.
o Examine the effect of knowledge of ethical and legal codes on the 
quality of symptom management.
o Test whether interventions that incorporate the routine use of a 
brief, validated symptom assessment tool would improve symptoms.
o Test whether interventions to increase clinician referral to and/or 
recommendation for the use of support groups would improve patient 
outcomes. 
o Test interventions to improve clinician’s communication, assessment 
and management of symptoms or problems that are under reported or 
difficult to discuss, i.e., end of life issues, sexual dysfunction.
o Test interventions to reduce communication barriers between provider 
and patients and/or caregivers that impede symptom relief and HRQOL 
throughout the cancer trajectory.  

C)  Health Care System
 
o Assess the efficacy of and cost effectiveness of new ways for 
patients and families to report distressing symptoms to their health 
care providers.
o Examine the impact of novel technologies to enhance patients’ and 
their families’ abilities to report distressing symptoms. 
o Examine the impact of a feedback mechanism that would routinely 
describe practice patterns for assessing and managing symptoms.
o Test novel strategies that improve delivery of symptom management to 
medically underserved and vulnerable cancer populations.
o Test innovative models of care coordination within health care 
systems that will improve communication and quality of care for 
patients transitioning between care delivery systems, i.e., acute care 
to hospice.
o Examine the effect of standardizing elements of palliative care 
within clinical information systems.
o Examine the impact of shared formularies when patients move to 
another site of care.   

The cultural, ethnic, and developmental aspects of the population 
targeted for study must be considered in designing interventions.  
Validation of established assessment guides in low literacy and non-
English speaking populations should be considered as part of a broader 
intervention where appropriate.  Biological and behavioral variables 
should be included as appropriate to the research question.  
Collaboration across disciplines and the inclusion of community and 
primary care givers on the research team are considered essential 
elements to the success of the project. 

MECHANISMS OF SUPPORT
 
This RFA will use NIH R01 (research project grant) and R21 
(exploratory/developmental grant) award mechanisms.  As an applicant 
you will be solely responsible for planning, directing, and executing 
the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project 
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.

For R21 submissions, an applicant may request a project period of up to 
2 years and submit budgets up to $100,000 direct cost (four budget 
modules) per year unless the application includes consortium costs, in 
which case the limit is $125,000 direct costs (five budget modules) per 
year. These grants are non-renewable and continuation of projects 
developed under this RFA will be through the traditional unsolicited 
investigator initiated grant program.

For R01 submissions, an applicant may request a project period of up to 
5 years and is strongly encouraged to submit budgets that do not exceed 
$500,000 in direct costs in any year of the project.

(Please note that facilities and administrative [F&A] costs requested 
by any consortium participants are excluded from the direct cost limit 
per NIH Guide Notice NOT-OD-04-040.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html )

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
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.  

FUNDS AVAILABLE 
 
The participating ICs intend to commit $5,200,000 in FY 2005 to fund 
ten to fifteen new and/or competitive continuation grants in response 
to this RFA.  Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the 
size and duration of each award will also vary. Although the financial 
plans of the ICs 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. At this time, it is 
not known if this RFA will be reissued. 
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations; 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories; 
o Units of state and local governments;
o Eligible agencies of the Federal government;  
o Domestic or foreign institutions/organizations; and
o Faith-based or community-based organizations.
 
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 
 
Data Safety and Monitoring:  applicants should describe the 
organizational structures and procedures they will employ to ensure the 
safety of participants and the validity and integrity of the data.  
Please see
http://grants.nih.gov/grants/guide/notice-files/not98-084.html for 
additional guidance.

Annual Meetings:  Applicants funded under this RFA will be required to 
attend meetings in which study plans, findings, and issues of common 
interest and concern will be shared and discussed.  All R01 applicants 
should include in their budgets funds for attending an initial “kick-
off” meeting at or near the time of the award, and annual meetings 
thereafter through the end of the requested term of award.  All R21 
applicants should include in their budgets funds for 1 meeting in the 
second year of the grant.  For budgeting purposes, applicants should 
assume that the meetings will be held in Bethesda, Maryland at the 
National Institutes of Health and require the attendance of at least 
the Principal Investigator (PI).  Travel and lodging costs should be 
addressed.

Reporting Requirments:

Final Report: at the completion of the project, the Principal 
Investigator (PI) must provide a detailed report to the Program 
Director that addresses: 

o overall aims / goals of the proposal,
o the extent to which the aims were accomplished, 
o the challenges encountered,
o the detailed results of the study and of interim analyses,
o detailed list of presentations, abstracts, and papers (accepted, in 
press, published),
o hard copies of publications (accepted, in press, published), and
o copies of any products developed as part of the research (e.g. 
measurement tools, educational materials, intervention manuals, etc).

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:

Ann O’Mara, Ph.D., M.P.H., R.N.
Program Director
Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd., EPN Room 2012
Bethesda, MD 20892-8329
Rockville, MD 20854 (for express/courier service)
Telephone: (301) 496-8541
Email: omaraa@mail.nih.gov

Martha L. Hare, Ph.D., R.N
NIH/National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD  20892-4870 (Courier: 20817)
Telephone: 301-451-3874
Fax: 301-480-8260
Email: Martha.hare@nih.gov

Lisa Begg, Ph.D.
Director of Research Programs
NIH/OD/ORWH, ORWH
1 Center Drive
Bethesda, MD 20892
Telephone: 301-496-7853
FAX: (301)-402-1798
E-Mail: beggl@od.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, MSC 8329
Bethesda, MD 20892-8329
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:

Brian Martin
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD  20892-7150
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 846-1014
FAX:  (301) 846-5720
Email: martinbr@nih.gov
 
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:

Ann O’Mara, Ph.D., M.P.H., R.N.
Program Director
Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd., EPN 2012
Bethesda, MD  20892-7150
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8541
Email: omaraa@mail.nih.gov

Prospective applicants are strongly encouraged to contact the program 
director listed above at their earliest convenience.

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 DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS 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.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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 
all five copies of the appendices must be sent to:
 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329

Appendices should be comprised of single-sided, 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 policy is similar to and consistent with the policy for 
applications addressed to Centers for Scientific Review as published in 
the NIH Guide Notice 
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 an appropriate national advisory 
council or 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 an important problem in barriers 
to delivering symptom management and palliative care? If the aims of 
the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Is there a well-designed evaluation plan of the effect of 
the intervention on patient outcomes? Does the applicant acknowledge 
potential problem areas and consider alternative tactics? Does this 
intervention carry the potential to be incorporated in routine cancer 
care? Is it likely to be sustainable after research funding has ended? 

INNOVATION: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?

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 
(if any)?

ENVIRONMENT: Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?  

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).

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data 

Applicants requesting more than $500,000 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:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  August 24, 2004
Application Receipt Date:  September 24, 2004
Peer Review Date:  February 200
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
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 dose-finding studies (phase I); efficacy studies (phase 
II); efficacy, 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 the participants. (See 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).  

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.

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/.

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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