RESEARCH ON CARE AT THE END OF LIFE

Release Date: January 20, 1999

RFA:  NR-99-004

P.T.

National Institute of Nursing Research
Agency for Health Care Policy and 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
National Institute of Neurological Disorders and Stroke

Letter of Intent Receipt Date:  April 30, 1999
Application Receipt Date:  May 21, 1999

PURPOSE

The National Institute of Nursing Research (NINR), the Agency for Health Care
Policy and Research (AHCPR), the National Cancer Institute (NCI), the National
Center for Complementary and Alternative Medicine (NCCAM) the National Institute
of Allergy and Infectious Diseases (NIAID), the National Institute of Dental and
Craniofacial Research (NIDCR), the National Institute of Mental Health (NIMH),
and the National Institute on Aging (NIA) seek research grant applications that
will generate scientific knowledge to lead to improved care for those at the end
of life.  Research applications may include basic, clinical or health care
studies focused on the clinical 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.  The purpose of this initiative is to generate
research that will improve the quality of dying for Americans and decrease the
distress for their caregivers.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Applications (RFA),
þResearch on Care at the End of Lifeþ, is related to the areas of heart disease
and stroke, cancer, diabetes and chronic disabling conditions, and HIV infection. 
Potential applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

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. AHCPR cannot, by law, make grants to for-profit
organizations.  However, for profit organizations may participate as
subcontractors or members of consortia.  Organizations described in section 501þ4
of the Internal Revenue Code that engage in lobbying are not eligible. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism and the exploratory/developmental grant (R21) mechanism. 
Responsibility for the planning, direction, and execution of the proposed project
will be solely that of the applicant. This RFA is a one-time solicitation. The
anticipated award date is September 30, 1999.

R01 Applications.  R01 awards will vary in size and duration reflecting the
nature and scope of the research proposed. Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to customary peer review.

R21 Applications. The objective of the exploratory/developmental mechanism (R21)
is to encourage applications from individuals who are interested in testing
innovative or conceptually creative ideas that are scientifically sound and may
advance our understanding of dying.  Another objective is to encourage necessary
initial development to provide a basis for future research project applications.

Exploratory/developmental studies are not intended for large-scale undertakings,
nor to support or supplement ongoing research. Instead, investigators are
encouraged to explore the feasibility of an innovative research question or
approach which may not yet be sufficiently justified through existing research
to compete as a standard research project grant (e.g., R01), and to develop a
research basis for a subsequent application through other mechanisms.

Exploratory/developmental (R21) grants, may not exceed $75,000 per year in direct
costs, not including indirect costs for collaborating institutions, if any.  The
total project period for an R21 application submitted in response to this RFA may
not exceed three years.  These grants are non-renewable and continuation of
projects developed under the R21 program will be through the traditional
unsolicited (R01 or P01) grant programs.

FUNDS AVAILABLE

The NINR, AHCPR, NCI, NCCAM, NIAID, NIDCR, NIMH, NIA, and NINDS collectively
intend to commit at least $2.7 million in FY 1999 to fund 10-12 new grants in
response to this RFA. Additional projects will be considered on a case by case
basis. Because the nature and scope of the research proposed may vary, it is
anticipated that the size of awards will also vary. Although the financial plans
of the participating institutes 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 applications of outstanding scientific and technical merit. 
At this time, it is not known if competing renewal applications will be accepted
and/or if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

During the past several decades biomedical advances have changed the way
Americans die. The dying process now tends to be more extended, in part because
medical treatments can manage pneumonia, infections, kidney failure, and other
immediate causes of death.  Many deaths involve a difficult period of decision-
making between the patientþs family and the clinical team about how much
aggressive treatment to try and when to stop.  Because it is often difficult to
recognize futility, many patients experience burdensome diagnostic procedures and
therapies that are exhausting, expensive, demoralizing, and of no ultimate
benefit.  Conversely there is widespread fear that the only alternative to
aggressive treatment is abandonment and suffering.

The healthcare system is primarily oriented to the cure of patients with acute
medical conditions and injuries.  It does not recognize that the medical needs
of the dying patient are fundamentally different and require the integration of
both medical and social service interventions.  There is little infrastructure
coordination between care service organizations.  For most dying Americans end
of life care is fragmented, painful, and emotionally distressing, with
unnecessary transitions between medical care institutions.

In response to these fears and concerns, 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 the evidence base for care of the
dying.  þFrom the cellular to the social level, much remains to be learned about
how people die and how reliably excellent and compassionate care can be
achievedþ. (IOM, 1997).  Research is needed to better understand the
circumstances under which treatment is likely not to succeed, to facilitate
communication and decision-making among those involved in end-of-life decisions,
to support the development of a well integrated health care system and to provide
better palliative care when comfort becomes the primary objective.

A research workshop, convened by the National Institutes of Health in September,
1997, focused on þSymptoms in Terminal Illnessþ.  The report from that workshop
is available at http://www.ninr.nih.gov/end-of-life.htm.  A subsequent Program
Announcement was published in December, 1997, PA-98-019 þManagement of Symptoms
at the End of Lifeþ http://www.nih.gov/grants/guide/pa-files/PA-98-019.html.  The
research objectives from that program announcement are subsumed within the
expanded focus of this request for applications.

In addition to basic biomedical research into the epidemiology and
pathophysiology of symptoms and the mechanisms of symptom relief, the foundation
for improved care at the end of life requires social, behavioral and health
services research.  More needs to be understood about the emotional, social,
cultural and spiritual experiences of people who are dying and about the
attitudinal, organizational, legal, cultural and other factors which influence
the care of those persons.

Currently, issues related to research methods play an important role in
constraining 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 the
scientific knowledge base for end-of-life care can only occur if resources are
committed to these fundamental requirements.

Deficiencies in basic scientific knowledge about dying affect at some point the
care of every individual.  Biomedical, behavioral, social and health services
research is needed to provide the scientific foundation to support public and
professional efforts to improve care at the end of life.

Objectives:

Specific areas of interest include, but are not limited to, the following topics:

Symptom management
o epidemiology, pathogenesis, and clinical management of symptoms common at the
end of life
o improved prevention and reduction of secondary side effects of drugs (including
dysguesia and oral stomatitis)
o better targeted drugs
o improved techniques for drug delivery
o more precise assessment strategies for complex clinical problems
o identification of prognostic factors that help guide strategies to prevent or
ease symptoms
o studies of the outcomes and quality of end of life care, including development
of outcomes and quality measures
o additional descriptive data of symptom patterns and physiological changes
surrounding the death event to enhance clinical management and information-
sharing with family members
o research on the management/treatment of pain at the end of life

Communication
o patterns of communication between patients and caregiveers and processes which
facilitate open discussion, discernment of patient and family wishes and
concerns, and respect for diverse decision-making styles
o strategies to activate patients and families to expect and negotiate high
quality care at the end of life

Ethics and clinical decision making
o sources of information that assist providers, patients and families to assess
the situation-specific value of healthcare interventions
o autonomy issues for dying persons who are cognitively impaired
o strategies to better incorporate patientsþ values and preferences into advance
care planning
o cultural variations influencing patient and family preferences
o interventions to enhance the psychological, social or spiritual well-being of
persons facing life-limiting illness

Caregiver support
o strategies to assist professional caregivers to maintain the integrity of the
patient-family dyad
o interventions which enhance existential meaningfulness, social support and
perception of professional availability for those caring for dying persons
o efficacy and appropriateness of therapies for grieving survivors

Context of care delivery
o collaborative investigations that combine community and social service
organizations with medical care institutions in the care of chronically ill
patients at the end of life
o innovative structures and processes to help patients and families to make
transitions among care settings
o clinical information systems that capture data important to care at the end of
life
o medical demographic studies in this and other countries of trends in the use
of life-sustaining devices such as respirators
o investigations of the economic aspects of care at the end of life, including
studies of the costs and avoidable costs of end of life care
o models of palliative care that are appropriate for dying persons with no
primary caregiver
o identification of contextual factors that foster or deter a þgoodþ death
o models of palliative care appropriate for nontraditional settings or special
populations

Research applications may be descriptive or correlational, but where possible
should be hypothesis-driven. New knowledge should be anticipated that can be
generalized beyond the program being studied. Applicants may propose secondary
analyses of existing data, provided that new questions will be answered.
Applications addressing the methodological issues that constrain research into
the care of the dying would also be appropriate.

Applicants are encouraged to make use of ongoing research efforts where feasible.
Applications from institutions that have a General Clinical Research Center
(GCRC) may wish to identify these programs as a resource for conducting the
proposed research.  If so, a letter of agreement from the program director or the
Principal Investigator should be included with the application.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH and AHCPR 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 is 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 was 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, available on the web at:
http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html. 
AHCPR follows these guidelines as applicable.

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. 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://www.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.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel and
participating institutions, and the number and title of the RFA in response to
which the application may be submitted.  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 staff to estimate the
potential review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to:

Robin L. Gruber, MPS
National Institute of Nursing Research
Building 45, Room 3AN-12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-2736
Fax:  (301) 480-8260
Email: robin_gruber@nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research and from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email: GrantsInfo@nih.gov.

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  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.

Submit a signed, typewritten original of the application, including the
Checklist, and four 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, also send one additional copy of the application to:

Robin L. Gruber, MPS
National Institute of Nursing Research
Building 45, Room Number 3AN-12, MSC 6300
Bethesda, MD  20892-6300

Applications must be received by 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.

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.  The CSR
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and for
responsiveness by the participating institutes.  Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration. 
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 CSR in accordance with the review criteria stated below.  As part of the
initial merit review, a process will be used by the initial review group in which
applications 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 the applications under review, will be discussed, assigned a priority score,
and may receive a second level review by the institutes' National Advisory
Councils or Boards.

Review Criteria

The goals of the supported research are to advance our understanding of
biological systems, improve the control of disease, improve health care services,
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.

The initial review group will also examine the provisions for the protection of
human subjects and the safety of the research environment.

Schedule 

Letter of Intent Receipt Date:    April 30,1999
Application Receipt Date:         May 21, 1999
Peer Review Date:                 July 1999
Council Review:                   September 1999
Earliest Anticipated Start Date:  September 30, 1999

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.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding general programmatic issues to:

Dr. June Lunney
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room Number 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  June_Lunney@nih.gov

Dr. David Lanier
Center for Primary Care Research
Agency for Health Care Policy and Research
2101 East Jefferson Street
Rockville, MD  20892
Telephone: (301) 594-1489
FAX: (301) 594-3721
Email: dlanier@ahcpr.gov

Dr. Claudette G. Varricchio
Division of Cancer Prevention
National Cancer Institute
Executive Plaza North, Room 300
Bethesda, MD  20892- 7340
Telephone:  (301) 496-8541
FAX: (301) 496 8667
Email:  CV9H@nih.gov

Dr. Richard L. Nahin
Division for Research, Training and Review
National Center for Complementary and Alternative Medicine
Building 31, Room 5B-36
Bethesda, MD  20892-2182
Telephone:  (301) 496-4792
FAX:  (301) 594-6757
Email:  NahinR@od.nih.gov

Dr. Frederick Batzold
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2B27
Bethesda, MD  20892-7640
Telephone:  (301) 402-0143
FAX:  (301) 480-4582
Email:  fb10c@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. David M. Stoff
Office on AIDS Research
National Institute of Mental Health
Parklawn Building, Room 18-101
Rockville, MD 20847
Telephone:  (301) 443-4625
FAX: (301) 443-9719
Email:  dstoff@nih.gov

Dr. Sidney M. Stahl
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Room 533
Bethesda, MD  20895-9205
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email:  Sidney_Stahl@nih.gov

Dr. Cheryl A. Kitt
Division of Convulsive, Infectious and Immune Disorders
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 504
Bethesda, MD  20892
Telephone: (301) 496-1431
FAX:  (301) 402-2060
Email:  kittc@ninds.nih.gov

An application in response to this RFA may be of interest to the National Heart,
Lung, and Blood Institute (NHLBI).  Possible assignment to that institute will
be considered on a case-by-case basis depending on the objectives of the study. 
For inquiries regarding NHLBI programmatic issues, contact:

Dr. Gail G. Weinmann
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10018
Bethesda, MD  20892
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email:  weinmang@gwgate.NHLBI.NIH.gov

Direct inquiries regarding fiscal matters to:

Jeff Carow
Grants and Contracts Management Office
National Institute of Nursing Research
Building 45, 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone: (301) 594-6869
FAX:  (301) 480-8260
Email:  jeff_carow@nih.gov

Mable L. Lam
Grants Management Office
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone: (301) 594-1844
FAX: (301) 594-3210
Email: mlam@ahcpr.gov

William T. Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone: (301) 496-7800, ext. 250
FAX: (301) 496-8601
Email: William_Wells@nih.gov

Suzanne White
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7156, MSC 7926
Bethesda, MD  20892-7926
Telephone: (301) 435-0171
FAX: (301) 480-3310
Email: sw52h@nih.gov

Mary Kirker
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4B21
Bethesda, MD  20892-7610
Telephone:  (301) 402-6400
FAX:  (301) 480-3780
Email:  mk35h@nih.gov

Martin Rubenstein
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX: (301) 480-8301
Email:  Rubenstein@DE45.nidr.nih.gov

Diana S. Trunnell
Grant Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD  20847
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Crystal Ferguson
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD  20892
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  Crystal_Ferguson@nih.gov

Karen D. Shields
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
Email: s26n@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.361 (Nursing Research), No. 93.226 (AHCPR), No. 93.399 (Cancer Control),
93.213 (Alternative Medicine), No. 93.855 (Immunology, Allergy, and
Transplantation Research), No. 93.856 (Microbiology and Infectious Disease
Research), No. 93.121 (Dental) No. 93.242 (Mental Health), No. 93.866 (Aging) and
No. 93.854 (Neurology). Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-
158, 42 USC 241 and 285) and Title IX (42 USC 299-299c-6).  Awards are
administered under PHS grants policies and Federal Regulations 42 CFR 52 and 67,
subpart A, and 45 CFR Part 74.  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 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, 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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