Full Text PA-95-056 BIOBEHAVIORAL PAIN RESEARCH NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-056 P.T. 34 Keywords: Behavioral/Experimental Psychology Pain Psychology Genetics Neuroscience Endocrinology National Institute of Nursing Research National Institute of Dental Research National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Drug Abuse National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Office of Alternative Medicine PURPOSE The purpose of this biobehavioral pain research program announcement is to inform the scientific community of the interests of the various institutes at the National Institutes of Health (NIH) and to stimulate and foster a wide range of basic and clinical studies on pain as they relate to the missions of these Institutes. Applications are encouraged to study individual differences in pain responses which may be due to factors such as genetic differences, endocrine activity, neural activity, immune function, psychological state, disability state, age, gender, and cultural background. Research is also needed in areas such as understanding the neuroanatomical pathways and the neurophysiological mechanisms in pain. The pain experience needs to be examined at all levels of research including the gene, molecule, cell, organ, and individual with the goal of developing biobehavioral interventions to manage or prevent pain. 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, "Biobehavioral Pain Research," 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT The mechanisms of support will be the research project grant (R01) and the FIRST award (R29). Additionally, some institutes will use the small research grant (R03) mechanism; applicants are advised 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 Pain is a critical national health problem. It is the most common reason for medical appointments, nearly 40 million visits annually, and costs this country over $100 billion each year in health care and lost productivity. Pain has a profound effect on the quality of human life. In addition to possible deleterious effects on immune function, pain can cause disruptions in sleep, eating, mobility, and overall functional status. In the hospitalized patient, pain may be associated with increased length of stay, longer recovery time, and poorer patient outcomes, all of which have health care quality and cost implications. Progress is being made in understanding the neuroanatomical pathways and the neurophysiological and neurochemical mechanisms involved in pain. However, understanding the subjective pain experience in individuals presents unique scientific challenges. Even though the basic physiology may be similar, people react in very different ways, perhaps due to genetic differences, endocrine activity, neural activity, immune function, stress, psychological state, age, gender, and cultural background. Thus, the pain experience needs to be examined at all levels of basic and clinical research, including the gene, molecule, cell, organ, and individual, with the goal of developing biobehavioral interventions to manage or prevent pain. In order to develop a research agenda, ten NIH institutes sponsored a workshop, "Biobehavioral Pain Research: A Multi-Institute Assessment of Cross-Cutting Issues and Research Needs," in January 1994. This meeting, under the aegis of the NIH Health and Behavior Coordinating Committee, resulted in the identification of research needs from a broad spectrum of the scientific community expert in pain research. The following pain research areas cut across Institutes and programs and should not be viewed as restricted to only one specific Institute. 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 topics and study areas are not intended to be comprehensive or exclusive: Understanding Critical Interfaces Between Biology and Behavior o Explore the neural basis of pain perception and discover targets in the signal transduction pathways that may be the most effective points for interventions in the control of pain across the lifespan. o Examine the neuroendocrine and immunological correlates of pain. o Investigate both pharmacological and behavioral interventions to prevent pain. o Refine neuroimaging algorithms for the study of structural and functional correlates of pain perception. o Conduct animal and human studies on the temporal patterning of pain. o Explore the basic developmental aspects of pain processing, including an integration of psychological, neurochemical, and molecular approaches which could impact the treatment of pain across the life span. o Identify genes relevant to pain and pain inhibitory mechanisms. o Examine the role of placebo effect in pain treatment. Pain, Suffering, and Emotion o Explore basic mechanisms of the conscious perception of pain and the affective responses to pain. o Examine the relative importance of biological, socioenvironmental, and psychological variables in explaining variations in pain- expressive behaviors. o Clarify the relationship between depression and chronic pain by elucidating the biological factors, characteristics of the pain (e.g., location, quality, timing), environmental circumstances, and personal characteristics that are predictive of this relationship. o Elucidate emotions and emotional disturbances, in addition to depression, (e.g., anger, fear, anxiety) which are associated with acute and chronic pain conditions, and determine how these emotions modify the experience of pain. Pain and Behavior o Explore the sensory, cognitive, and affective aspects of acute and chronic pain across the lifespan. o Elucidate the interaction of biological markers, central nervous system mechanisms, and drug and behavioral interventions. o Determine the relative contributions of biological, psychological, behavioral, and environmental predictors of the course of pain, pain dysfunction, and response to treatment for pain. o Examine addiction risk in patients taking controlled drugs for pain; the role of tolerance, addiction and dependence in the consumption of these drugs; and implications of long-term use in noncancer disease states. o Develop and refine biobehavioral techniques for optimizing adherence to pain management. Behavior-Related Interventions o Evaluate research strategies to integrate medical, nursing, dental, neurological, pharmacological, and behavioral treatments for pain problems. Compare the relative effectiveness of each mode of treatment, and combined treatments, and their potentiating effects on multiple outcomes, such as pain, physical functioning, psychological functioning, health care utilization, and costs. o Conduct research on the mechanisms and process variables that are responsible for the efficacy of behavioral interventions. This research includes studies to understand better the effect of patients' expectations and beliefs, psychophysiological states (e.g., anxiety, relaxation, stress), adherence, and specific cognitive (e.g., imagery) and social (e.g., support) components in behavioral interventions. o Determine which behavioral treatments are most effective for specific subgroups of patients differentiated by factors such as age, gender, race, ethnic group, level of dysfunction, or psychosocial characteristics. o Conduct clinical trials of cognitive/behavioral pain control methods and combinations of medical, pharmacological, and cognitive/behavioral pain control methods. o Compare the costs of various types of interventions for pain, including economic analyses of pain, pain dysfunction, and pain treatments with different and combined biomedical and biopsychosocial models of treatment. o Investigate the effectiveness and appropriate targeting of alternative treatments (e.g., hypnosis, massage, spinal manipulations, acupuncture) using randomized, controlled trials of these treatments in association with conventional medical approaches. o Assess methods for primary, secondary, and tertiary prevention of pain. o Establish dose-response curves for biobehavioral interventions. o Test interventions to improve health care practice in such areas as pain assessment, analgesic management, pain prevention, and rehabilitation. Commonalities and Differences in Pain Expression, Experience, and Treatment o Study cognitive factors in the experience of pain, disability, and pain behaviors across disorders, including such factors as self- efficacy, perceived control, and pain beliefs. o Establish the factors that prevent a person with acute pain from developing a chronic pain problem and a chronic pain- related disability. Areas to assess include patient biological/organic, psychosocial, and socioeconomic characteristics, interactions of the patient with health care providers, family and social supports, and workplace factors. o Refine existing techniques for measuring pain and develop new techniques that are disease- and outcome-specific for different populations. o Determine the supraspinal mechanisms of pain modulation, determine the effects of specific pain treatments on these central nervous system processes, and apply new findings on CNS plasticity to the understanding of pain. o Examine the interrelationships between pain and other symptoms and comorbidities (e.g., fatigue, sleep alterations, nausea, vomiting, anxiety, mood disorders, physical deconditioning, stress). Pain in Special Populations o Test culturally sensitive approaches to pain assessment and management, including translation of the instruments into foreign languages and validation as needed. o Investigate biobehavioral pain treatments for special populations including infants, children, elderly, cognitively impaired, ethnic minority groups, substance abusers with pain disorders, and individuals with disabilities. o Determine effective biobehavioral interventions for HIV- and AIDS- related pain, as well as the pain prevalence, scope, and severity of patients who are HIV-infected. Explore alterations in nociceptive mechanisms and pain perception in patients with HIV. o Investigate the roles of sleep and circadian variation in the precipitation and modulation of pain in populations who have special rest - activity needs such as infants, children, elderly, pregnant women, night-shift workers. This research could include studies of the effect of pain and its pharmacological treatment on sleep and daytime alertness, as well as the effects of disturbed sleep on pain and pain perception. Studies of seasonal and other variations are also appropriate. o Test and evaluate pharmacotherapies and behavioral treatments in patients with current and past histories of addiction, including infants born to drug-, alcohol-, and tobacco-dependent mothers, and HIV-infected persons. o Investigate the effectiveness of biobehavioral pain management in terminally ill and dying patients. o Study the interrelationship of Axis II, as well as Axis I, psychiatric disorders (e.g., borderline personality, histrionic, antisocial) and chronic pain, and relate these findings to pharmacological and behavioral therapies. o Determine gender-related differences in the pain experience, such as whether the experience of clinical chronic pain varies during the menstrual cycle and, if so, the hormonal, immunological, neuronal, and psychological correlates of this variability. o Investigate biobehavioral approaches to managing pain associated with acute and chronic illness such as arthritis, cancer, diabetes, sickle cell disease, low back pain, headaches, temporomandibular disorders, and other orofacial pain conditions. 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 the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. 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 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) 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 Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. After May 8, 1995, the telephone number will be (301) 435-0715 and the address will be as below. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants 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 reviewed for scientific and technical merit, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Applications that are complete and responsive to the program announcement 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 he appropriate national advisory council or board. Review Criteria o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 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 are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Mary Lucas Leveck National Institute of Nursing Research Natcher Building, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov Dr. Patricia Bryant Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24K Bethesda, MD 20892-6402 Telephone: (301) 594-2095 Email: BryantP@DE45.nidr.nih.gov Dr. Andrew Monjan Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 Email: monjana@gw.nia.nih.gov Dr. Julia B. Freeman Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-19F Bethesda, MD 20892-6500 Telephone: (301) 594-5052 Email: freemanj@ep.niams.nih.gov Dr. Claudette Varricchio Community Oncology and Rehabilitation Branch National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 Email: varriccc@dcpcepn.nci.nih.gov Dr. Louis Quatrano National Center for Medical Rehabilitation Research National Institute on Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: quatranl@hd01.nichd.nih.gov Dr. Joseph Frascella Behavioral Neurobiology Research Branch National Institute on Drug Abuse Parklawn Building, Room Number 10A-19 Rockville, MD 20857 Telephone: (301) 443-4877 Email: jf80t@nih.gov Dr. Peter G. Kaufmann Behavioral Medicine Research Group National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0404 Email: pvk@cu.nih.gov Dr. Fred Altman Basic Prevention and Behavioral Medicine Research Branch National Institute of Mental Health Parklawn Building, Room Number 10-104 Bethesda, MD 20892 Telephone: (301) 443-4337 Fax: (301) 443-4045 Email: hfb@cu.nih.gov Dr. Cheryl A. Kitt Division of Demyelinating, Atrophic and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 802 Bethesda, MD 20892 Telephone: (301) 496-1431 Email: kittc%nindsfed%nih@fedtcp.ninds.nih.gov Dr. John Spencer Office of Alternative Medicine Executive Plaza South, Suite 450 Bethesda, MD 20892-9904 Telephone: (301) 402-4333 Email: spencerj@odeps.nih.gov Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Nursing Research Natcher Building, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Email: snichols@ep.ninr.nih.gov Theresa Ringler Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: Rubenstein@DE45.nidr.nih.gov Joanne Colbert Grants Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Email: colbertj@gw.nia.nih.gov Mary Graham Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19A Bethesda, MD 20892-6500 Telephone: (301) 594-3504 Email: grahamm@ep.niams.nih.gov Bob Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Email: Hawkinsr@gab.nci.nih.gov Mary Ellen Colvin Grants Management Specialist National Institute of Child Health and Human Development Building 61, Room 8A17G Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Email: colvinm@hd01.nichd.nih.gov Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov Jane Davis Grants Management Officer National Heart, Lung, and Blood Institute Rockledge Two, Room 7174 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 Email: janedavis:nhlbi-wb-1:nih Diana Trunnell Grants Management Officer National Institute of Mental Health Parklawn Building, Room 7C08 Bethesda, MD 20892 Telephone: (301) 443-3065 Email: dt21a@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: Karen_Shields%NINDSFED%NIH@fedtcp.ninds.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361. 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 routing 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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