NEW DIRECTIONS IN PAIN RESEARCH:  I

Release Date:  September 4, 1998

PA NUMBER:  PA-98-102

P.T.

National Institute of Neurological Disorders and Stroke
National Institute of Dental Research
National Cancer Institute
National Institute on Aging
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute on Deafness and Other Communication Disorders
National Institute on Drug Abuse
National Institute of General Medical Sciences
National Institute of Nursing Research
Office of Research on Women's Health

PURPOSE

The National Institute of Neurological Disorders and Stroke (NINDS) and the
National Institute of Dental Research (NIDR), serving as the lead Institutes
for the National Institutes of Health (NIH) Pain Research Consortium, together
with the National Cancer Institute (NCI), National Institute on Aging (NIA),
National Institute of Allergy and Infectious Diseases (NIAID), National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National
Institute on Deafness and Other Communication Disorders (NIDCD), National
Institute on Drug Abuse (NIDA), National Institute of General Medical Sciences
(NIGMS), National Institute of Nursing Research (NINR), and the Office of
Research on Women's Health (ORWH), encourage investigator-initiated research
project grant applications to study mechanisms underlying analgesic response
and pain to advance the development of novel pain interventions, treatments
and management strategies.  The purpose of this New Directions in Pain
Research:  I program announcement (PA) is to inform the scientific community
of broad, shared interests in pain research encompassing the various
components of the NIH, and to stimulate and foster a wide range of basic,
translational and patient-oriented clinical studies on pain.  Applications are
particularly encouraged to study pain throughout the lifespan from the
perspectives of molecular genetics, transcriptional controls, signal
transduction, including cellular/molecular mechanisms, innovative imaging
technologies, plasticity and from hormonal or gender influences.  The pain
experience needs to be examined at all levels of analysis from the gene,
molecule, cell, tissue, and organ, to the individual, family and community,
with the ultimate goal of developing new insights into pain intervention,
treatment and management.

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 PA, New Directions in Pain
Research:  I, is related to the priority areas of chronic disabling
conditions, cancer, and clinical prevention services.  Potential applicants
may obtain a copy of "Healthy People 2000" (Full Report:  Stock No. 017-
001-00474-0 or Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, 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

The mechanism of support will be the research project grant (R01).  Applicants
are strongly encouraged to contact the program official listed under INQUIRIES
for information.  Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant.  Awards will be
administered under PHS grants policy as stated in the Public Health Service
Grants Policy Statement (April 1, 1994).

RESEARCH OBJECTIVES

Background

Pain is a significant national health problem.  It is the most common reason
individuals seek medical care, with millions of medical visits annually;
costing the American public more than $100 billion each year in health care,
compensation and litigation.  Some studies suggest that more than a third of
the American population suffers from a chronic pain condition at some point in
their life.  Pain-related disability presents a significant and costly
liability to workers, employers and society.  In the workplace, a significant
proportion of employees, about 14%, take time off from their jobs due to pain
conditions.  In hospitalized patients, pain has been associated with increased
length of stay, longer recovery time, and poorer patient outcomes, all of
which have health care quality and cost implications.  Pain, therefore, has a
profound impact on the quality of life and health-associated costs for all
Americans.

Significant progress is being made in understanding the neurobiology of pain. 
New approaches to more effective diagnostic tools as well as treatment and
management strategies, offer unique scientific challenges.  Individuals during
development and aging, may react in very different ways to pain, perhaps due
to the influence of genetic differences, gender, hormones, and/or past
experiences.  Thus, pain needs to be studied at all levels of basic and
clinical research, including the gene, molecule, cell, tissue, and organ, and
individual, with the ultimate goal of developing innovative approaches to
intervention and management of pain.

In order to develop a Trans-NIH research agenda, NIH sponsored a major
Symposium: "New Directions in Pain Research," in November 1997.  This meeting,
under the aegis of the NIH Pain Research Consortium, resulted in the
identification of research needs reflecting recommendations from a broad
spectrum of the scientific community expert in pain and non-pain research.

Scope of Research Sought

Basic, translational, and patient-oriented clinical research on pain is
solicited through this program announcement.  The areas in which pain research
is encouraged cuts across the interests and missions of many NIH Institutes,
Offices, Centers and programs.  Applications should not be limited to theses
topics or viewed as restricted to only one specific Institute, Office or
Center.  Current NIH referral guidelines will be used to assign grant
applications to the most appropriate NIH Institute based on the scientific
focus of the application.

The following examples are provided as topics falling within the scope of this
program announcement.  These examples are presented illustratively, are not
exclusive, and are not presented in any particular priority order.

o  Investigation of the genetic contribution of differences in pain response,
perception and modulation, using tools such as quantitative trait locus
analysis for identifying genes that contribute to complex traits and diseases,
such as pain.

o  Development of new model systems of the molecular genetics of pain
transmission, modulation and perception, that would include individual and
multiple gene mapping, transgenic animal models, and studies of individual and
multiple gene expression.

o  Exploration of the neuromolecular basis of pain, by investigating targets
in signal transduction pathways, e.g., calcium, potassium or sodium ion
channels, that may be the most effective points for drug development and
intervention.

o  Exploration of the role of second messenger systems, including G protein-
coupled receptors and protein kinases, in pain transmission and modulation.

o  Expansion of research on neuroimaging of pain, including analytical
techniques for the study of structural and functional correlates of pain
perception, particularly for diagnostic purposes.

o Research on neuroplastic processes as these relate to the development and
persistence of chronic pain conditions.

o Mechanisms underlying differences in pain and analgesic response due to
hormonal or gender-related factors.

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 is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
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 of March
18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the program staff
or contact person listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the 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 specific 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://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) 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,
telephone (301) 710-0267; Email:  [email protected].  The title and number of
the PA must be typed in Section 2 on the face page of the application.

The completed original application and five legible copies must be sent or
delivered 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 that are complete will be evaluated for scientific
and technical merit by an appropriate peer 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
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 review, comments on the following aspects of the application will
be made 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 the assignment of the overall score.

(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?

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

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to that institute/center (IC).  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 concerning this program announcement are encouraged.  The
opportunity to clarify any issues or questions from potential applicants is
welcome.

Direct inquiries regarding programmatic issues to:

Dr. Cheryl A. Kitt
Division of Convulsive, Infectious and Immune Disorders
National Institute of Neurological Disorders and Stroke
Federal Building, Room 504
Bethesda, MD  20892
Telephone:  (301) 496-1431
FAX:  (301) 402-2060
Email:  [email protected]

Dr. Patricia Bryant
Temporomandibular Joint Disorders and Neuropathies and Neurodegenerative
Diseases
National Institute of Dental Research
45 Center Drive, Room 4AN-24E
Bethesda, MD  20892-6402
Telephone:  (301) 594-2095
FAX:  (301) 480-8318
Email:  [email protected]

Claudette Varricchio, DSN, FAAN
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 300
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
FAX:  (301) 496-8667
Email:  [email protected]

Judith A. Finkelstein, Ph.D.
Neuroscience and Neuropsychology of Aging Programs
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307 - MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email:  [email protected]

John Y. Killen, M.D.
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2A18
Rockville, MD  20892-7620
Telephone:  (301) 496-0545
FAX:  (301) 402-1505
Email:  [email protected]

James S. Panagis, M.D., M.P.H.
Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-37K, MSC 4500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  [email protected]

Rochelle Small, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400C MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3464
FAX:  (301) 402-6251
Email:  [email protected]

David A. Thomas, Ph.D.
Division of Basic Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-19
Rockville, MD  20857
Telephone:  (301) 443-6975
Email:  [email protected]

Alison E. Cole, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.49K, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-1826
FAX:  (301) 480-2802
Email:  [email protected]

Mary D. Leveck, Ph.D., RN
Program Director
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD 20892-6300
Telephone: (301) 594-5963
FAX: (301) 480-8260
Email: [email protected]

Joyce Rudick
Office of Research on Women's Health
National Institutes of Health
Building One, Room 201
Bethesda, MD  20892
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

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:  [email protected]

Mr. Martin R. Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44A
45 Center Drive, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
email:  [email protected]

William G Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 250
FAX:  (301) 496-8601
Email:  [email protected]

Joseph Ellis
Grants Management Officer
National Institute on Aging
Gateway Building, Suite 2N12
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
Email:  [email protected]

Vicki Maurer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-49A, MSC 4500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  [email protected]

Ms. Sharon Hunt
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC 7180
Bethesda, MD  20892-7170
Telephone:  (301) 402-0909
FAX:  (301) 402-1757
Email:  [email protected]

Gary Fleming, JD, M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  [email protected]

Ms. Toni Holland
Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, Room 2AN-50B, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5132
FAX:  (301) 480-2554
Email:  [email protected]

Jeff Carow
Grants Management Officer
National Institute of Nursing Research
6300 Center Drive, Room 3AN-12, MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.131, 93.279, 93.846, 93.853, and 93.854.  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 administered
under PHS grants policies and Federal Regulations 42 CFR 52 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 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, 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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