and Human Services (HHS)
EXPIRED
VULVODYNIA - SYSTEMATIC EPIDEMIOLOGIC, ETIOLOGIC OR THERAPEUTIC STUDIES RELEASE DATE: March 27, 2002 PA NUMBER: PA-02-090 (This PA has been reissued, see PA-06-302) EXPIRATION DATE: March 1, 2005, unless reissued. National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE This PA replaces PA-98-112. The Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) invites new and experienced basic scientists, epidemiologists, and clinical investigators to submit research grant applications to further our understanding of the epidemiology, etiology, prevalence, criteria for accurate diagnosis, underlying pathophysiology and pain mechanisms, and treatment strategies for vulvodynia. Research grant applications are encouraged that address preclinical or clinical, biomedical and/or behavioral research that concentrates on studies of relevance to vulvodynia. This solicitation is intended to stimulate and strengthen a multidisciplinary approach to this complex, underresearched area of women's health and form a framework for assessing future research needs. The goal is to build a substantive scientific knowledge base related to this debilitating condition. RESEARCH OBJECTIVES Background Vulvodynia is one of the poorly understood complex focal pain syndromes, representing a complex, multifactorial clinical syndrome of unexplained vulvar pain, sexual dysfunction, and psychological disturbance. On April 2- 3, 1997, the NICHD, in collaboration with the Office of Research on Women's Health, Office of Rare Diseases, and the National Institute of Arthritis, Musculoskeletal and Skin Diseases, convened the "Vulvodynia Workshop: Current Knowledge and Future Directions" to explore the state-of-the-science by reviewing current definitions, etiology, epidemiology, and treatment modalities. In response to recommendations made at the conclusion of this workshop, emphasis was placed on stimulating clinically relevant research on promising biomedical, clinical or behavioral studies that would expand our knowledge of vulvodynia. The Program Announcement (PA-98-112), "Vulvodynia Systematic Epidemiologic, Etiologic or Therapeutic Studies," was published on September 29, 1998. This announcement was followed by another initiative, Pathophysiology, Epidemiology and Treatment of Vulvodynia (RFA-HD-00-008) in February 2000. It was anticipated that studies in this under-researched area would form a foundation for assessing future research needs and complement our overall commitment to support research important to women's health. As a result of the workshop, subsequent PA, and RFA, the research community was made aware of our interest in this area. Notwithstanding this programmatic emphasis, additional efforts are now needed to strengthen the science base. This PA represents a continuation of ongoing research efforts to reduce the burden of this disease and ultimately improve the quality of life for women affected with this disorder. Moreover, this initiative reflects the NICHD research agenda for identifying and characterizing the pathophysiologic factors and potential avenues for treatment related to benign gynecologic disorders. Vulvodynia is a clinical condition with several different and poorly defined antecedents. There is a need to increase knowledge and understanding about vulvodynia and the biological processes that lead to its development and long-term sequelae. The factors influencing a patient's decision to seek care and the criteria by which the clinician selects therapy are not uniform. Patients frequently experience dyspareunia, persistent vulvar irritation, burning, and pain. Symptoms also may be associated with the urinary and gastrointestinal tracts. In addition, diagnostic criteria that define the categories and subtypes of vulvodynia are neither well defined nor utilized consistently by many clinicians. While the true prevalence of vulvodynia remains unknown, there are several common diagnostic subtypes that are recognized, including: (1) vulvar vestibulitis, (2) dysesthetic vulvodynia, and (3) vulvar dermatosis and dermatitis. Vulvar vestibulitis, thought to be the most common subtype, has been found in 15 percent of patients in a general clinical practice in some studies. While histologic studies suggest a chronic inflammatory reaction, the causes of the inflammation, as well as its significance, remain unclear. The role of pelvic floor dysfunction as a catalyst for the development of vulvar pain syndromes, particularly dysesthethic vulvodynia, has been proposed in several published studies, but its true impact is uncertain. Published studies also comment on the influence of neurophysiological parameters as a potential association that should be taken into account. Surgery has been reported to be a successful intervention for selected cases of vulvar vestibulitis, and is reserved for women with severe and long- standing symptoms. However, optimum surgical management is still undetermined and very few well-designed, long-term studies document the outcome of surgical procedures. In addition, pharmacological and behavioral therapies would benefit from treatment standardization and prospective clinical studies. Despite the use of surgery, pharmaceutical regimens, psychological support, physical therapy, and pain management techniques such as biofeedback and behavior modification, there is no consensus on which procedure(s) offers the most improvement and patient satisfaction. A combination of therapies is frequently utilized and, while there are several options available for the treatment of vulvodynia, most of the literature supports the conclusion that cures for vulvodynia are uncommon and a specific inciting cause can be diagnosed in a relatively small percentage of patients. Consideration of these factors must be an integral part of the management of patients with vulvodynia and this underscores the need to examine this condition in a multidisciplinary context. This elusive pain syndrome has many unexplored questions. Therefore, an overall strategy of augmenting and strengthening a multidisciplinary approach to this distressing condition, leading to improved diagnosis and therapy, is warranted. Improvements in pain management, as well as approaches to the treatment and prevention of vulvodynia, will require insight and increased knowledge of the underlying etiology and pathophysiological mechanisms. Research Scope Several research strategies are deemed important for the potential development of new leads or approaches. Examples of the scope of research areas considered responsive to this announcement include, but are not limited to, the following: o Elucidation of pathogenic antecedents involved in stimulating the biological processes that lead to the development and long-term sequelae of vulvodynia. Evaluation of the role of pathologic vaginal microbial and viral agents or altered vagina flora in this process. o Development of chronicity and inclusion/exclusion criteria for refining the definition for and diagnosis of vulvodynia and its subtypes. Rigorous definitions will permit uniform study designs leading to comparability at the national and international levels. o Development of novel experimental preclinical or clinical studies in animal models and/or humans to evaluate normal and dysfunctional neurophysiological parameters and mechanisms. Determination of the role of neurogenic irritability and/or regional autonomic dysfunction and its influence on symptoms, muscle instability, tissue injury, and repair in vulvodynia. o Documentation of the use and evaluation of the effects of adjunctive therapy in clinical trials, including behavioral, surgical, and medical treatment, in women with vulvodynia. Investigation and translation of promising, innovative, preclinical findings into clinical research applications, including designing clinical trials of novel therapeutic interventions. o Assessment of the natural history of vulvodynia. Creation and validation of population-based epidemiological studies that assist in defining the prevalence and resolution of vulvodynia and its subtypes. Feasibility and effectiveness of risk factor modification for prevention of vulvodynia. o Initiation and implementation of controlled clinical epidemiological studies to determine if at-risk groups can be identified for prospective or interventional studies. o Assessment of normal tissue structure, muscle integrity, cellular mechanisms, structural defects, and the factors involved in the transition between latent injury, symptoms, and tissue rehabilitation in vulvodynia. Detection of the role of nerve damage, muscular damage, and/or direct tissue disruption. o Initiation and implementation of well-controlled multidisciplinary clinical trials of therapeutic protocols for treating vulvodynia in a well- defined population. o Determination of the influence of risk factors such as race, ethnicity, and co-morbid medical conditions or previous surgery associated with the occurrence of vulvodynia, treatment outcomes, and complications. Prospective applicants are encouraged to consider relevant topics other than those listed here and to discuss their ideas with the program staff listed under WHERE TO SEND INQUIRIES, below. MECHANISM OF SUPPORT This PA will use the NIH Research Project Grant (RO1) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise, follow the instructions for non- modular research grant applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Estella Parrott, M.D., M.P.H. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: ep61h@nih.gov o Direct your questions about financial or grants management matters to: Ms. Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: kathy.hancock@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: 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) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o 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 comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, as appropriate, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data, if appropriate. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.864, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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