QUALITY OF LIFE FOR INDIVIDUALS AT THE END-OF-LIFE
Release Date: August 2, 2000
PA NUMBER: PA-00-127
National Institute of Nursing Research
National Cancer Institute
National Center for Complementary and Alternative Medicine
National Institute of Allergy and Infectious Diseases
National Institute of Dental and Craniofacial Research
National Institute of Mental Health
National Institute on Aging
This program announcement replaces PA-98-019, which was published in the NIH
Guide, Vol. 26, No. 40, December 19, 1997.
THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.
PURPOSE
The National Institute of Nursing Research (NINR) and 6 other ICs seek
research grant applications that will generate scientific knowledge to
improve the quality of life for individuals who are facing end-of-life issues
and for their families. Research applications may include basic, clinical or
care delivery studies focused on management of physical and psychological
symptoms, patient-provider and patient-family communication, ethics and
clinical decision-making, caregiver support, or the context of care delivery
for those facing life-limiting illnesses. In a broad sense the purpose of this
program announcement is to enhance the quality of life remaining for
individuals who are nearing the end of their lives.
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 Program Announcement (PA), Quality
of Life for Individuals at the End-of-Life, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) Research Project
Grant (R01) award mechanism. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant. The
total project period for an application submitted in response to this PA may
not exceed 5 years.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm
RESEARCH OBJECTIVES
Background
The life expectancy of the American people has reached an all time high, but
along with the increased life expectancy is an increase in the number of
people living with, and dying from, chronic debilitating diseases such as
heart disease, cancer, stroke and chronic obstructive pulmonary disease
(National Center for Health Statistics, 1999). While the elderly with chronic
illnesses comprise a group one might associate with end-of-life issues, there
are other groups for whom these concerns are important. Examples extend
across the life span including neonates in intensive care units, children with
AIDS, teens with cancer, and young adults with degenerative diseases. Coupled
with this spectrum of individuals is the increased availability of
technologies and treatments that can be used to prolong life and, in some
cases, death. Defining when these technologies and treatments shift from life
saving interventions to burdensome and futile procedures that negatively
impact quality of life has proved elusive. When these technologies and
treatments become futile, the individuals families and significant others may
be involved in a difficult period of decision-making about how much aggressive
treatment to try and when to stop. Conversely there is widespread fear that
the only alternative to aggressive treatment is abandonment and suffering.
For many Americans, end-of-life care is fragmented, painful, and emotionally
distressing, with unnecessary transitions between health care institutions,
community-based organizations and home care settings. There are opportunities
for health care providers to learn more about how to deliver optimal end-of-
life care. Results of two separate surveys found on average only 2% of the
content of nursing (Oncology Nursing Forum, 1999) and medical (JAMA, 2000)
text books was relevant to end-of-life care.
There are many national initiatives underway to improve care of the dying.
Significant efforts are being made to better train health professionals and to
encourage public awareness of the issues. Yet important gaps in knowledge
limit our ability to help individuals who are dying achieve the highest
possible quality of life. From the cellular to the social level, much
remains to be learned about how people die and how reliably excellent and
compassionate care can be achieved (IOM, 1997). Research is needed to better
define what is meant by end-of-life, to identify aspects of an optimal death
experience within the cultural and ethnic context of the individual so better
palliative care can be provided, to facilitate communication and ethical
decision-making among those involved in end-of-life decisions, and to support
the development of a well integrated health care system that includes the
family and the multidisciplinary team.
A research workshop convened by the National Institutes of Health in
September, 1997, focused on Symptoms in Terminal Illness . The report from
that workshop is available at http://www.ninr.nih.gov/end-of-life.htm.
Subsequently, a Program Announcement Management of Symptoms at the End-of-
Life and a Request For Applications Research on the Care at End-of-Life
were published. This program announcement builds on those two initiatives.
More needs to be understood about the physical, emotional, social, cultural
and spiritual experiences of people who are dying and about the environmental
context which influences the quality of the life remaining. Issues related to
research methods are important to consider with inquiry into dying. There are
pressing needs to better define key concepts, identify and test appropriate
measures, develop strategies to minimize subject burden, and devise methods
for complex data analysis. Advances in understanding how to help individuals
who are dying to attain the highest quality of life possible can be advanced
with innovative, science-based research.
Objectives:
Topics of interest include, but are not limited to:
Clinical management to promote the quality of life of individuals across the
life span who are at the end-of-life
o pathogenesis of symptoms that result from common end-of-life conditions
such as AIDS, emphysema, heart disease, stroke and cancer
o more effective techniques to prevent and manage symptoms including better
targeted drugs and delivery techniques and alternative and complementary
approaches
o prevention and reduction of secondary side effects of medications used to
treat common end-of-life conditions such as antiretrovirals, steroids, and
chemotherapy
o better understanding of the cultural and ethnic context surrounding the
death event to enhance clinical management and sensitivity to patient and
family choices
o multidisciplinary interventions to enhance the psychological, social or
spiritual well-being of persons facing life-limiting illness such as children
with AIDS or cancer
o the explicit role that mental disorders, symptoms, and related disabilities
play in the quality of life at the end-of-life, specifically, studies on
modifiable risk and protective processes including developing and testing new
interventions
Communication
o interventions relating to patterns and processes of communication between
patients and caregivers which facilitate open discussion, discernment of
patient and family wishes and concerns, and respect for cultural and ethnic
diversity
o strategies to foster high quality care at the end-of-life
Ethics and clinical decision making
o processes that assist providers, patients and families to assess the
situation-specific value of healthcare interventions so they can make informed
decisions about treatments that affect quality of life
o ethical issues for dying persons who are vulnerable such as children and
people who are cognitively impaired
o strategies to better incorporate patients culture, values and preferences
into decisions such as advance care planning
Caregiver support
o strategies used by clinicians to maintain the integrity of the family
through the dying process
o interventions which provide social support for those caring for dying
persons
o efficacy of interventions to support grieving survivors
Care delivery
o identification of the clinical contextual factors that foster an optimal
death experience in persons across the life span
o international studies of the approaches to using life-sustaining devices
such as ventilators and the impact of such devices on quality of life
remaining
o investigations that include evaluation of the economic aspects of providing
culturally-sensitive care at the end-of-life
o organizational and economic determinants of hospice use, including
transitions from acute and nursing home settings and length of stay in
hospices
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided 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 research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994 and is available on the web at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH
Applications received in response to this program announcement are expected to
focus on scientific issues related to aging and to aging-related aspects of
disease. In describing the plan to recruit human subjects, investigators may
cite a focus on aging or on aging-related aspects of disease as the
justification for why children will be excluded. In this regard, applicants
may use Justification 1, the research topic to be studied is irrelevant to
children, from the policy announcement.
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. Reviewers are cautioned that their anonymity may be compromised when
they directly access an Internet site.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only when
there is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $250,000 per year. (Applications that request
more than $250,000 direct costs in any year must follow the traditional PHS
398 application instructions.) The total direct costs must be requested in
accordance with the program guidelines and the modifications made to the
standard PHS 398 application instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year. This is not a Form page.
o Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is included
in the overall requested modular direct cost amount. Include the Letter of
Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations,
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the type
of agreement and the date. All appropriate exclusions must be applied in the
calculation of the F&A costs for the initial budget period and all future
budget years.
o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and five 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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed, assigned a
priority score, and receive a second level review by the National Advisory
Council for Nursing Research.
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 discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. Note that 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.
(1) Significance: Does this study address an important problem? 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?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) 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)?
(5) 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?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
Additional scientific/technical merit criteria specific to the objectives of
the PA and the mechanism used must be included if they are to be used in the
review.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Dr. Ann Knebel
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5966
FAX: (301) 480-8260
Email: aknebel@nih.gov
Dr. Claudette Varricchio
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN 300
Bethesda, MD 20892
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: varriccc@mail.nih.gov
Dr. Mary Ann Richardson
National Center for Complementary and Alternative Medicine
31 Center Drive, Building 31, Room 5B58
Bethesda, MD 20892-2182
Telephone: (301) 402-1272
FAX: (301) 402-4741
Email: marich@od.nih.gov
Dr. Frederick Batzold
Division of AIDS
National Institute of Allergy, Immunology, and Infectious Diseases
Rockledge Drive 6700B, Room 5154
Bethesda MD, 20892
Telephone: (301) 496-8214
FAX: (301) 402-1505
Email: fbatzold@niaid.nih.gov
Dr. Patricia Bryant
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-24E
Bethesda, MD 20892-6500
Telephone: (301) 594-2095
FAX: (301) 480-8318
Email: BryantP@DE45.nidr.nih.gov
Dr. Peter Muehrer
National Institute of Mental Health
6001 Executive Blvd., Room 6189, MSC 9615
Bethesda, MD 20892-9615
Telephone: (301) 443-4708
FAX: (301) 443-4415
Email: pmuehrer@mail.nih.gov
Dr. Sidney M. Stahl
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, #533
7201 Wisconsin Ave.
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
FAX: (301) 402-0051
Email: Sidney_Stahl@nih.gov
AHRQ Statement:
The Agency for Healthcare Research and Quality (AHRQ) supports the development
of knowledge that improves health care services provided for patients at the
end of life. AHRQ is interested in supporting research on the most
appropriate sites of health care for patients at the end of life (e.g., home,
nursing home, hospice, acute care), and on the quality, costs and access to
the services provided in these settings. Methods of improving the process of
decision-making by family, providers and patients themselves, and of relieving
the financial and social burden on family caregivers, are also of interest.
For inquiries regarding AHRQ programmatic issues, contact: Dr. David Lanier,
Center for Primary Care Research, AHRQ, (301) 594-1489. Email:
dlanier@ahrq.gov
Direct inquiries regarding fiscal matters to:
Mr. Robert Tarwater
Office of Grants and Contracts Management
National Institute of Nursing Research
Building 45, Room Number 3AN12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-2807
FAX: (301) 480-8260
Email: Robert_tarwater@nih.gov
Mr. William T. Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd. Room 243
Bethesda, MD 20892
Telephone: (301) 496-7800
FAX:(301) 496-8601
Email: William_Wells@nih.gov
Ms. Suzanne White
Grants Management Branch
National Center for Complementary and Alternative Medicine
6201 Rockledge Drive, MSC 7926
Bethesda, MD 20817-7926
Telephone: (301) 435-0171
FAX: (301) 480-3310
Email: whitesa@nhlbi.nih.gov
Ms. Jane Unsworth
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2128
6700-B Rockledge Drive - MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-6824
FAX: (301) 402-0369
Email: junsworth@niaid.nih.gov
Mr. Martin Rubinstein
Office of Grants Management
National Institute of Dental and Craniofacial Research
Natcher Bldg, Rm 4AN-44A
Bethesda, MD 20892-6402
Phone: (301) 594-4800
FAX: (301) 594-8301
Email: Martin.Rubinstein@nih.gov
Ms. Diana S. Trunnell
Division of Extramural Activities
National Institute of Mental Health
Parklawn Bldg, Room 7C-08
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: diana_trunnell@nih.gov
Mr. David Reiter
Grants Management Office
National Institute on Aging
Gateway Building, #2N212
7201 Wisconsin Ave.
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: David_Reiter@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.361 (NINR), 93.399 (NCI), 93.213 (NCCAM), 93.855 and 93.856 (NIAID), 93.121
(NIDCR), 93.242 (NIMH), 93.866 (NIA), and 93.854 (NINDS). Awards are made
under authorization of sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and administered under NIH grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-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, and 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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