and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
Office of Research on Women’s Health (ORWH) |
|
Funding Opportunity Title |
Specialized Centers of Research (SCOR) on Sex Differences (P50) |
Activity Code |
P50 Specialized Center |
Announcement Type |
Reissue of RFA-OD-06-003 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-OD-11-003 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.103, 93.847, 93.846, 93.279, 93.242, 93.865, 93.866, 93.865 |
FOA Purpose |
The ORWH and participating organizations and institutes seek to expand the Specialized Centers of Interdisciplinary Research (SCOR) on Sex Differences. These centers will provide opportunities for interdisciplinary approaches to advancing studies in sex differences research. Each SCOR should develop a research agenda bridging basic and clinical research underlying a health issue that affects women. |
Posted Date |
June 28, 2011 |
Letter of Intent Due Date |
September 4, 2011 |
Application Due Date(s) |
October 4, 2011 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
February - March, 2012 |
Advisory Council Review |
|
Earliest Start Date(s) |
July 2012 |
Expiration Date |
October 5, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
1.
Research Objectives
PURPOSE
The Office of Research on Women's Health (ORWH) serves as a focal point for
women's health research at the NIH. The ORWH promotes, stimulates, and
supports efforts to improve the health of women through biomedical and
behavioral research. ORWH works in partnership with the NIH Institutes as well as
the Food and Drug Administration (FDA) to ensure that women's health research
is part of the scientific framework at NIH and throughout the scientific
community.
ORWH and other participating organizations invite research grant applications to develop new knowledge about sex differences that affect women’s health. Awareness of potential sex/gender differences in health research permeates the entire synergistic process of the research endeavor (Woods, Women's Health Issues, 2011). The ORWH announces the Specialized Centers of Interdisciplinary Research on Sex Differences (SCOR) program. ORWH intends to stimulate and encourage the exploration of biological sex differences at multiple levels, from genes to hormones to complex biological systems. The contributions of biological sex and social parameters of gender can assist in understanding the diversity of health outcomes and this knowledge can be applied in the development of the next generation of interventions and medical treatments leading to improvements in women’s health. Each SCOR should develop an interdisciplinary research agenda bridging basic and clinical research on sex/gender factors underlying a priority women’s health issue.
In 1999, after an extensive national collaborative effort that convened major stakeholders, the ORWH released its landmark report Agenda for Research on Women’s Health for the 21st Century: A Report of the Task Force on the NIH Women’s Health Research Agenda for the 21st Century (DHHS, 1999). Ten years later, in September 2010, after a one and a half year long process that represented recommendations from five regional meetings and involved major stakeholders from the extramural scientific community, researchers, advocates, patients and providers, ORWH introduced a new strategic plan for women’s health research. The first of the six goals of the new strategic plan is to expand sex differences research to encompass basic science as well as clinical research. The NIH is especially interested in fostering research in women’s health in the high priority areas of prevention, diagnosis and treatment, and the biological, behavioral, cellular and molecular basis of sex and gender differences. The SCOR is a trans-NIH, collaborative effort but the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will be the service center for the administration of this program.
This FOA is expected to result in interdisciplinary,coordinated sex differences research centers supported through the P50 center grant mechanism. ORWH envisions these centers as a model for stimulating research in women's health and sex differences from the cellular and molecular level to translational and clinical research for women with significant applications to gender-specific human health. We would encourage topics that address the cellular, molecular and behavioral basis of sex differences in the natural history of development and treatment for disease; a clearer definition of the impact of the hormonal milieu on risk and progression of diseases in women; and an integrated approach to understanding how neurological, psychological and physiological factors impact development of disease in women.
BACKGROUND
The Office of Research on Women's Health (ORWH) and cosponsors seek to promote interdisciplinary research in sex differences through the Specialized Centers of Interdisciplinary Research (SCOR). Each SCOR will promote interdisciplinary collaborations and develop a research agenda bridging basic and clinical research underlying a priority women s health issue. The SCOR program will complement other Federally supported programs addressing women's health issues. Such programs include the Building Interdisciplinary Research Careers in Women's Health (BIRCWH),
http://orwh.od.nih.gov/interdisciplinary/bircwhmenu.html, the Advancing Novel Science in Women's Health Research Program (ANSWHR) and numerous NIH FOAs.
Description of a SCOR
The objective of the SCOR program is to expedite interdisciplinary development and application of new knowledge to human diseases that affect women, to learn more about the etiology of these diseases, and to foster improved approaches to treatment and/or prevention.
Each SCOR should have a central theme related to the area of health or disease or biological system to which individual projects relate and which serves as an integrating force. The SCOR must provide an interdisciplinary approach utilizing both laboratory and clinical research to focus on a particular health problem and provide for a mutually supportive interaction between basic scientists and clinical investigators. Emphasis in proposed projects should be on interdisciplinary development of innovative approaches, elaboration of new and significant hypotheses, and generation of improved strategies for approaching current issues relating to the disease area addressed. Collaboration among institutions is encouraged within a given SCOR to share scarce resources.
A SCOR consists of at least three individual, but interrelated, research projects, each with high scientific merit and clear research objectives and, in the aggregate, devoted to a specific major health area. Both basic and clinical research must be present. An administrative core must be proposed to coordinate the research program, providing intellectual leadership as well as basic management functions. Funding may also be requested for one or more core resources. A core is defined as a resource shared by multiple investigators that enhances research productivity and increases the functional capacity of the SCOR.
NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies, (2) Epidemiologic and behavioral studies, (3) Outcomes research and health services research.
Although the focus of the SCOR is on sex/gender differences, it is not required to have both a male and female cohort. However, if female-only research is proposed, the background section must include the current state of knowledge and review of the literature of studies related to men that can justify studies that will include cohorts of women only, consistent with NIH inclusion policies.
Support for large clinical trials or for applications that contain exclusively clinical or exclusively basic studies will not be provided within this SCOR program.
Applicants from institutions which have a Clinical and Translation Science Center (CTSA) funded by the NIH National Center for Research Resources may wish to identify the CTSA as a resource for conducting the proposed research.
In summary, a SCOR must include:
1. a broad interdisciplinary theme capturing an important issue in women's health and sex differences research in a priority women’s health issue (See sections on Research Scope and Required Overarching Themes, below);
2. two overarching themes that are an integral part of the research plan: Sex/Gender Determinants and Interdisciplinary Research;
3. an Administrative Core with a Center Director, Associate Director and executive committee with outstanding interdisciplinary credentials for advancing the research theme;
4. a minimum of three interdisciplinary research projects, representing both basic and clinical research; and
5. an established research program in areas related to the SCOR theme.
Additional core(s) supportive of two or more of the proposed projects may also be requested.
RESEARCH SCOPE
The research scope for the SCOR program derives from three major sources:
1. The Institute of Medicine report, "Exploring the Biological Contributions to Human Health, Does Sex Matter?" defined the use of "sex" and "gender" (p. 8 and 176) as follows. In the study of human subjects, the term "sex" should be used as a classification, generally as male or female, according to the reproductive organs and functions that derive from the chromosomal complement. In the study of human subjects, the term "gender" should be used to refer to a person's self-representation as male or female, or how that person is responded to by social institutions based on the individual's gender presentation. Gender is rooted in biology and shaped by environment and experience. In most studies of nonhuman animals, the term "sex" should be used. The term sex genotype refers to the XX andXY chromosomes. The term sex phenotype refers to the phenotypic expression of the genotype (See http://www.nap.edu and http://www.iom.edu/CMS/3740/5437.aspx.
2. The intellectual background for establishing SCORs in sex/gender factors originated in the 1999 landmark ORWH report mentioned earlier, "An Agenda for Research on Women's Health for the 21st Century." This outline represents the recommendations from three national topic meetings examining research needs for women's health: (1) Scientific areas; (2) Sex and Gender perspectives throughout the Life Cycle; and (3) Differences among populations of women throughout the Life cycle.
3. Each year, the ORWH works with the NIH Coordinating Committee on Research on Women’s Health (CCRWH), composed of representatives from the NIH institutes and centers, to consider continuing gaps in knowledge, and emerging scientific opportunities for current research priorities in women’s health. The recommendations are reviewed and approved by the CCRWH and the Advisory Committee on Research on Women's Health (ACRWH). Based on the NIH strategic plan released in September 2010, entitled, Moving Into the Future With New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research[i], the FY 2011 NIH research priorities will focus on the key components highlighted within the strategic plan.
Research opportunities are described in terms of overarching themes, special emphasis areas, and areas of research interest. The priorities signify approaches and areas for which there is a need to stimulate and encourage research on women’s health or sex differences research, and the advancement of women in biomedical research careers. These research priorities are not an exclusive list of research areas important to women’s health; therefore other innovative or significant research areas should also be considered.
I. OVERARCHING THEMES
The following four overarching themes are important for addressing research on women’s health: Lifespan, Sex/Gender Determinants, Health Disparities/Differences and Diversity, and Interdisciplinary Research.
Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age. Women’s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and frail elderly. Many women’s lives and health status are also influenced by factors such as work inside and outside the home, care-giving such as childcare and elder care responsibilities, reproductive status, marital status, and chronic illness. Each of these may influence health, disease, lifestyle and treatment choices, and response to therapy. Researchers should consider these variables in designing studies related to women’s health.
Sex/Gender Determinants: Women and men are characterized by both sex and gender, as highlighted in the new strategic plan, Moving Into the Future With New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research, and the Institute of Medicine report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter? In this context, the term sex refers to being male or female according to reproductive organs and functions assigned by chromosomal complement. Sex factors that contribute to the biological differences include chromosomes, reproduction, and hormones. Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by the environment and experience. Gender and sex are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. Consideration of these variables may be critical to the accurate interpretation and validation of research affecting the various aspects of women’s health. These variables determine how health or disease processes may differ among women, or between men and women.
Health Disparities/Differences and Diversity: Women are disproportionately affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment. Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, genes, culture, education, effects of poverty, access to care, quality of care, and access to opportunities for inclusion as research subjects in clinical trials and studies. Thus, clinical research should include, but not be limited to, population-specific characteristics such as cultural diversity, environmental exposures, race/ethnicity, immigrant status, rural or inner city (urban) residency status, effects of poverty or low socioeconomic status, sexual orientation, and physical or mental disabilities.
Interdisciplinary Research: With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary, collaborative approach. Advances in women’s health can be better achieved by promoting partnerships across disciplines. Interdisciplinary approaches can integrate knowledge from multiple specialties and disciplines, thus enhancing the likelihood of defining underlying pathologic processes. Collaborations among researchers in academia, private industry, and federal settings can provide access to the latest scientific tools and technologies and expertise for women’s health research.
II. SPECIAL EMPHASIS AREAS
The NIH is especially interested in fostering women’s health and sex differences research in the high priority areas outlined in the strategic plan, including:
Advancing the understanding of sex differences research in health and disease, especially from the molecular level to clinical applications
Emerging scientific fields and technologies that can provide unique opportunities to maximize women’s health and sex differences research
Fostering strategic partnerships and alliances to improve the translation and dissemination of health information, and public health outreach, in order to improve women’s health and that of their families and communities.
LIST OF POSSIBLE TOPICS
Examples of sex differences are evident in a wide variety of biomedical areas. Women have lower thermal pain thresholds than men, which appear to be mediated by estrogen levels, suggesting that this sex difference is phenotypic (Fillingim, Pain Forum, 1995). Sex differences exist in cardiovascular disease (CVD) prevalence and risk factors. Attention to sex-specific issues related to CVD has contributed to recent declines in disease-specific mortality, as reported from the CDC’s National Center for Health Statistics noting 10, 000 fewer annual deaths in women since 2000 (a 10% reduction) (Merz. et.al. Journal of Women’s Health, 2010).
The IOM report http://www.iom.edu/Reports/2010/Sex-Differences-and-Implications-for-Translational-Neuroscience-Research.aspx identified the following areas of research interest in Women's health. As part of the NIH new Strategic Plan for Women's Health Research, ORWH has adopted these research areas as priority areas for future directions and the topics listed below are examples of the type of reseach that could be within the scope for this FOA.
This list is not intended to be comprehensive and applicants should not be confined by the examples listed below. Appropriate topics include but are not limited to those listed below. Applicants are encouraged to contact the listed program officials regarding specific questions about scientific scope:
Conditions such as chronic fatigue syndrome, chronic pain, or autoimmune diseases which may be chronic and/or multi-systemic.
Studies that explore sex differences in the structure and function of male and female cells (including stem cells), tissues, organs and physiological systems.
Studies of sex differences using a systems biology-based approach including research based on new technology platforms such as microbiomics, genomics, phenomics, proteomics, and metabolomics.
Studies of basic and translational research on sex/gender differences in the pathobiology and prevention and treatment of diseases including HIV/AIDS, urinary tract and sexually transmitted infections.
Sex and gender differences in vulnerability to and clinical course of neurologic, psychiatric and substance abuse disorders.
Investigations of the actions of steroid hormones and hormone-mimicking environmental agents on gene expression, cells, tissues, and organs and the application of this knowledge in the prevalence, symptoms, management and outcomes, in conditions such as lupus and cardiovascular diseases.
Studies that exploit high-resolution bioimaging technologies to provide structural and functional imaging of sex differences in a variety of areas such as pain, brain activity, metabolism, infectious diseases, inflammation, and drug delivery.
Develop and validate sex-specific animal models of critical brain processes implicated in the pathophysiology of sex differences in psychiatric disorders.
Studies that examine the relationships among host, microbiome and environment.
Different mechanisms of CVD progression between sexes and whether they are related to differences in stem cell function or effects of estrogen and progesterone.
Studies that examine prenatal exposures ( addictive drugs, environmental toxins, stressors, nutrient intake) and their effects during critical windows of development and how they affect future health outcomes.
Studies examining the mechanisms of chronic disease risk across the life course e.g., biological, environmental, behavioral and physical factors that contribute to or protect against chronic diseases such as depression.
Studies that explore the pathophysiology, genetics, systemic treatments, and evidence-based treatments for chronic diseases with oral health sequelae, such as Sjogren's syndrome, diabetes, HIV, and temporomandibular disorders (TMJ).
Progression diabetes, treatment differences between the sexes and cardiovascular complications
Studies on incidence and effects of musculoskeletal diseases such as osteoarthritis and osteoporosis and sports injuries such as anterior cruciate ligament for which women have a higher risk than men.
Gastrointestinal and digestive health and diseases, including the effect of hormones and the menstrual cycle on the digestive system;irritable bowel syndrome;functional bowel disorders and other gastrointestingal motor disorders.
Opththalmic diseases including dry eye with and without rheumatic disease, macular degeneration, and glaucoma.
Source:
NIH Strategic Plan for Women's Health Research: Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women’s Health Research Vol II
SPECIAL REQUIREMENTS
The director and co-director should budget for an annual two day meeting in Bethesda, MD with ORWH staff. The director should be prepared to devote at least 3 person-months (25 percent total effort) as both the director and as the PD/PI on a Center project. Each project and core PD/PI should be prepared to devote at least 1.8 person-months (15 percent effort).
Funding Instrument |
Grant |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The ORWH and its funding partners intend to commit at least $9 million in FY 2012 to fund 9 new and/or renewal sites in response to this FOA. Relevant NIH Institutes and Centers will commit to and administer funds for applications that are relevant to their mission. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. Applicants may submit a budget for direct costs of up to $750,000 per year for five years, excluding indirect costs of subcontracts. |
Award Project Period |
The total project period for an application submitted in response to this FOA may not exceed 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 support.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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 IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent to:
Joan Davis Nagel, M.D. M.P.H.
Program Director, Interdisciplinary Research Programs
Office of Research on Women’s Health (ORWH)
National Institutes of Health (NIH)
Department of Health and Human Services (DHHS)
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892
Telephone: 301-496-9186
Fax: 301- 402-1798
Email: joandav@mail.nih.gov
Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.
For each Research Project component and Core unit, provide the name of the PD/PI and include biographical sketches for any personnel not identified previously.
Overview of the Center (12 pages)
A. History and Purpose of the Program
Discuss the overall P50 Center’s objectives and general plans for the proposed grant period, including research grant history with yearly funding level.
B. Administration, Organization, and Operation
Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of advisory committees, and space assignment. Describe organizational framework and provide an organizational chart.
C. Research Program
Discuss the proposed research program, highlighting its central theme. List by title and investigator's name the component Research Projects and Core units. Describe the relationship between the projects and the Core units and their relationship to the central theme.
D. Description of Assurances and Collaborative Agreements
Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Letters of Assurance/Agreement for these arrangements are included below.
Research Project Descriptions (12 pages for each Research Strategy component)
Identify each project by a Roman numeral (I, II, III...) and a title.
A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Begin the presentation of each Research Project component on a separate page, and include the following:
A. Research Project Cover Page (1 page)
Title of Project
Research Project Director (Principal Investigator), title, affiliation
Other investigators, titles, affiliations
B. Research Project Summary (1 page; use PHS-398 Form Page 2)
Discuss the purpose and nature of the project and its relevance to the program's overall theme.
C. Content of Research Plan (Begin each section with a section header)
Specific Aims (1 page)
Research Strategy (12 pages; Significance, Innovation, and Approach): Start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.
For new applications, include information on relevant Preliminary Studies within the page limits of the Research Strategy.
Indicate the Research Project's use of Core unit services, including why needed and the advantages and cost effectiveness of Core unit usage for the project.
Inclusion Enrollment Report (renewal applications only)
Bibliography and References Cited, Progress Report Publication List
Protection of Human Subjects
Inclusion of Women and Minorities
Targeted/planned Enrollment Table
Inclusion of Children
Vertebrate Animals
Select Agent Research
Investigators
Consortium/contractual arrangements
Letters of Support: Include pertinent letters of assurance and collaboration for the Research Project. For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.
Core Unit Descriptions
Identify each proposed Core unit by a letter (A, B, C...) and a title (e.g., Administrative Core, Service Core, Other Cores). Provide a full description of each Core unit. Begin the presentation of each Core unit on a separate page. Include the following:
A. Core Unit Cover Page (1 page)
Title of Core Unit
Core Director (PD/PI, title, affiliation)
Other investigators, titles, affiliations
B. Core Project Summary (1 page; use PHS-398 Form Page 2)
Include an Abstract that identifies and describes the purpose of the proposed Core unit. Summarize the Core unit's overall objectives; highlight the decision-making process for use of Core services and plans for cost-effectiveness and quality control.
C. Core unit Structure, Administration, and Services (6 pages for each core)
Administrative Core
Objective
Organization
Staffing (Professional and Support)
Resources: include description of space and physical resources
Services provided to other Core units and Research Projects
Management plan for the overall center, within-center data sharing, and proposed publication plan to be implemented across the center
Protocols for extra-center data sharing
Service Core
Objective
Organization
Staffing (Professional and Support)
Plans for translating and disseminating research based findings to the broader scientific and practitioner communities; include detailed information about the dissemination aims and implementation plans to achieve these aims.
Mentorship and inclusion plan for graduate students, post-doctoral fellows, and/or early stage investigators in the scientific plans proposed in the project; the plan should at minimum include information about project staff who would be involved in mentorship, the nature of this involvement, mentorship activities planned that are appropriate for the mentee’s career level, and how the mentees progress would be evaluated.
Additional Core Unit(s)
Objective
Staffing (Professional and Support)
Resources: provide description of space and physical resources
Administration
Justification: describe services provided with their bearing on productivity and quality
Usage: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for Core usage
Progress Report Publication List (for competing renewal applications only)
List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.
Letters of Assurance/Agreement
Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
For this particular announcement, note the following:
Since the ORWH is interested in funding only the best research, individual research projects of lesser quality may not be funded, even if approved under the umbrella of the SCOR mechanism. For this reason, each project will be assigned a separate impact score. A SCOR must include at least three highly meritorious interdisciplinary research projects representing both basic and clinical research.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the SCOR to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a SCOR that by its nature is not innovative may be essential to advance a field.
Significance
Does the SCOR address an important problem or a critical barrier to progress in the field? If the aims of the SCOR are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the SCOR? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project advance the theme of the SCOR and contribute to the interaction of basic research and clinical investigation?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the SCOR? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the SCOR involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Review Criteria for the overall application:
After the review of the individual components of the application, an overall impact score will be assigned to the application. This score will reflect not only the individual quality of the projects, cores, and administration, but also how the proposed SCOR will bring together all these elements in a workable unit. The overall score may be higher or lower than the average of the descriptors based on the assessment of whether the whole is greater than the sum of its parts.
Does the SCOR address sex differences affecting health?
Does the application adequately explain the relationship of the two required overarching themes of sex differences and interdisciplinary research to the overall theme of the SCOR?
Does the SCOR contain both human and animal projects and are they conceptually linked?
Does the institution have an established research program in areas related to the SCOR theme? Does the application describe how the proposed Center will enhance the established research base of the host institution?
Does the proposed SCOR combine basic and clinical research into the scientific goals and research theme?
Is the value of proposing a Center versus independent R01s justified by the applicant?
Review criteria for SCOR leadership:
Do the Director and Associate Director have the leadership and research qualifications to lead the SCOR? Do the projects and cores included in the application reflect this leadership?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable.
Renewals
For Renewals, the committee will consider the progress made in the last funding period, and address the following questions:
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Not Applicable.
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
REVIEW CRITERIA FOR INDIVIDUAL RESEARCH PROJECT COMPONENTS
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for each research project to exert a sustained, powerful influence on the research field(s) involved.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project advance the theme of the SCOR and contribute to the interaction of basic research and clinical investigation?
Approach
Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Are potential problems, alternative strategies,
and benchmarks for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly risky
aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
REVIEW CRITERIA FOR CORE UNITS
Reviewers will assign an impact/priority score for each core unit component, based on the assessment of each Core unit independently in terms of the specified review criteria for Cores. Separate criterion scores will not be assigned for Cores.
Review Criteria for the Administrative Core:
Are the qualifications, experience, and commitment of the core director and other core personnel appropriate?
Will the quality of services provided enable center investigators to achieve their research goals?
Are there scientific and administrative leadership, commitment and ability, and adequate time commitment of the SCOR Director for the effective management of the SCOR program? Does the SCOR director have a minimum time commitment of at least 1.2 person-months (10 percent effort) to the overall administration of the program plus 1.8 person-months (15 percent effort) as a PD/PI of a SCOR project?
Is there a clinical investigator named in the Administrative Core who will be responsible for the translation of basic research to clinical research? Is there a plan to promote patient based research?
Has the role of an Advisory Committee been described?
Is there cost effectiveness in the core; will there be quality control measures taken for core procedures?
Is there a plan for the establishment and maintenance of internal communication and cooperation among the SCOR investigators?
Is there a decision-making process within the proposed center for the evaluation of research productivity, for allocation of funds and for management of the resources? What is the overall strength of the plan for center evaluation, including the use of any internal and external advisory groups?
What is the overall strength of the internal data sharing and publication plan?
For the Service Core: Is there a well articulated plan for mentoring pre-doctoral, post-doctoral, and/or early career investigators? How effectively have the PD/PIs integrated mentees into the individual projects and larger activities of the center? Is there a formal plan to monitor the progress of mentees toward formalized career goals? Does the applicant describe an effective plan for outreach/education activities? Do the activities proposed appear scientifically appropriate given the proposed audience(s) for the scientific outcomes from the center?
Review Criteria for additional proposed cores:
Does the core have utility to at least two of the SCOR projects? Is the relationship of the core to each project addressed?
Are the procedures to provide quality control for the core services clearly described and appropriate?
Do the services offered best fit within a core structure?
Are the personnel functions addressed and are the personnel appropriate to the intent of the core?
Are the facilities and equipment adequate? Is there institutional commitment to the core?
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), NIH, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Joan Davis Nagel, M.D. M.P.H.
Program Director, Interdisciplinary Research Programs
Office of Research on Women’s Health (ORWH)
National Institutes of Health (NIH)
Department of Health and Human Services (DHHS)
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892
Phone: 301-496-9186
Fax: 301- 402-1798
Email: joandav@mail.nih.gov
Kathleen M. O'Leary, M.S.W.
Acting Chief, Women's Program
Office of Research on Disparities and Global Mental Health
National Institute of Mental Health
Phone: 302-443-2847
Fax: 301-443-8552
Email: olearyk@mail.nih.gov
Frank A. Hamilton, M.D., MPH
Director , Gastrointestinal Motility Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney
Diseases
National Institutes of Health
Democracy 2, Room 669
6707 Democracy Blvd.
Bethesda, Maryland 20892-5450
Phone 301 594-8877
FAX 301 480-8300
E mail fh14e@nih.gov
Chris Mullins, Ph.D.
Director of Basic Cell Biology Programs
Division of Kidney, Urologic and Hematologic Diseases
NIDDK, National Institutes of Health
Two Democracy Plaza, Room 637
6707 Democracy Blvd.
Bethesda, MD 20892-5458
Phone: (301) 451-4902
Fax: (301) 480-3510
E-Mail: mullinsC@extra.niddk.nih.gov
Bernadette Tyree, Ph.D.
Director
Cartilage and Connective Tissue Program
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
TEL: (301) 594-5055
FAX: (301) 480-1284
E mail: tyreeb@mail.nih.gov
Cora Lee Wetherington, Ph.D.
Women & Gender Research Coordinator
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Phone: (301) 435-1319
Fax: (301) 594-6043
Email: cwetheri@mail.nih.gov
Marsha Henderson, MCRP
Assistant Commissioner for Women's Health (Acting)
Director, Office of Women's Health
Food and Drug Administration
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD 20993-0002
Phone: 301-796-9440
Email: marsha.henderson@fda.hhs.gov
Svetlana Radaeva, Ph.D.
Program Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 2033
Bethesda, MD 20892-9304
Phone: (301) 443-1189
Email: sradaeva@mail.nih.gov
Sooja Kim, Ph.D.
Center for Scientific Review, NIH
CSR/DPPS/EMNR
Two Rockledge Center, 6182
6701 Rockledge Dr,
MSC 7892
Bethesda, MD 20892 (20817 for overnight mail)
Phone: (301) 435 -1780
Email: sooja.kim@nih.gov
Melinda Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
6701 Democracy Blvd.Suite 800
Bethesda, Maryland 20892
Phone: (301) 301-435-5278
Fax: (301) 480-5450
E-mail: Melinda.nelson@nih.gov
Christine Kidd
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Blvd, MSC 9560
Bethesda, MD 20892-9555
Phone: (301) 435-1372
E-mail: ckidd@nida.nih.gov
Patricia Bradford
Management Analyst
FDA/OWH
WO Bldg 32, Rm 2318
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-9440
Email: patricia.bradford@fda.hhs.gov
Terri Kendrix
Administrative Officer
NIH/ORWH
Executive Plaza South, Rm 150A
6120 Executive Blvd, MSC 7116
Bethesda, MD 20892-7116
Phone: 301-435-6724
Email: kendrixt@od1tm1.od.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
1- [i] NIH Strategic Plan for Women's Health Research: Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women s Health Research
2- NIH Strategic Plan for Women's Health Research: Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women’s Health Research Vol II
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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