This Funding Opportunity Announcement (FOA) from the Office of Research on Women’s Health (ORWH) invites applications for Specialized Centers of Research Excellence (SCORE) on Sex Differences. Each SCORE will serve as a National resource focused on translational research at multiple levels of analysis to identify the role of biological sex differences on the health of women. Centers of Excellence will also serve as vital hubs for education and dissemination of innovative sex-based and informed translational research methods and best practices. In addition, they will provide leadership in the development and promotion of standards and policies for the consideration of sex differences in biomedical research. The contributions of biological sex can assist in understanding the diversity of health outcomes, and this knowledge can be applied to the development of the next generation of interventions and medical treatments leading to improvements in women’s health.
It is expected that SCORE Centers will:
- Develop or strengthen awardee institutions’ programs that focus and sustain progress on a key area in women’s health research.
- Provide intellectual leadership and innovation to advance research that elucidates the role of sex differences on the health of men and women;
- Facilitate and develop novel interdisciplinary research strategies;
- Stimulate incorporation of emerging technologies, methods and scientific advances into research designs as appropriate;
- Provide research career enhancement opportunities in sex differences research;
- Stimulate translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on findings from basic research;
- Collaborate with other SCOREs on projects such as integrating data systems, supporting multi-center observational studies;
- Interface where possible with other NIH-funded programs and centers; and
- Leverage institutional resources.
Background
The ORWH serves as a focal point for women’s health research at the National Institutes of Health (NIH). The ORWH works in partnership with the NIH Institutes, Centers and Offices, as well as with federal agencies, including the Food and Drug Administration, to ensure that women’s health research is an integral part of the scientific framework throughout the scientific community.
The Specialized Centers of Research (SCOR) program, a predecessor to the Specialized Centers of Research Excellence (SCORE) program represented by this FOA, was first announced by ORWH (in partnership with the FDA) in 2002 to support research to understand and explore the continuous interaction between sex and gender, human health that is determined by both biology and expression of gender. Sex and gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. The consideration of these variables and comparisons of males and females are critical to the accurate interpretation, validation, and generalization of research findings in biomedical research. Sex and gender may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of preventive and therapeutic interventions in both sexes. Sex-based comparisons in research may also ensure that findings are applicable to both women and men. The SCOR specialized centers were thus established to 1) expedite interdisciplinary development and application of new knowledge to human diseases that affect women, 2) learn more about etiology of these diseases, and 3) foster improved approaches to treatment and prevention.
The SCOR program represents an innovative interdisciplinary research program focusing on sex differences and major medical conditions affecting women in the U.S., and supports established scientists at centers across the country who conduct ground breaking research that integrates basic, clinical, and behavioral research approaches to incorporate sex differences. ORWH committed $10 million initially to fund 9-10 Specialized Centers (P50 grants). Eleven centers were co-funded with the help of a number of NIH IC partners and the U.S. Food and Drug Administration. To date, a total of 32 SCORs have been funded with an investment of over $132 million providing support at 21 US institutions.
An outcome evaluation of the SCOR program, completed in 2017 found the SCOR program to be fully successful in accomplishing its stated goals. Moreover, the SCOR program goals were on the leading edge of the need for renewed focus on research on sex differences. In a 2014 Nature commentary, NIH leadership called attention to a lack of knowledge about the influence of biological sex in preclinical research. In particular, an overreliance on male animals and cells in basic and preclinical research may obscure key sex differences that could guide clinical studies. Inadequate specification of the sex of cells, inadequate inclusion of female animals in experiments, and inadequate analysis and reporting of data by sex, may also contribute to irreproducibility of preclinical biomedical research. Additional information can be found in the article “Studying both sexes: a guiding principle for biomedicine” published by Dr. Janine Clayton in FASEB J, 2016.
To advance the consideration of sex and other biological variables, NIH adopted a new policy in January 25, 2016, “Enhancing Reproducibility through Rigor and Transparency” (NOT-OD-15-103), which mandated that investigators provide scientific justification of Sex as a Biological Variable (SABV). NOT-OD-15-102 provides specific guidance regarding SABV.
The ORWH SCOR program then, has been at the forefront of sex differences research and SCOR investigators have made seminal contributions to the study of sex differences that affect women’s health. With this FOA, ORWH is leveraging 15 years of investment in the study of sex differences and building upon advances in the field by expanding the SCOR program to add the expectation of excellence with the establishment of the Specialized Centers of Research Excellence (SCORE).
Guided by current research, as well as the input we received from the evaluation and from stakeholders, the next generation SCORE program will have an enhanced focus on 1) translational science with the goal of translating biomedical discoveries into clinical applications that improve the health of women and 2) education, to disseminate innovative translational research methods and best practices; and provide leadership in the development and promotion of standards and policy for the consideration of sex differences in biomedical research.
Overview of Centers of Excellence
The objective of the SCORE program is to expedite the 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.
Applicants to this FOA should develop a translational research program in an area of research that considers sex differences underlying women’s health issues. The translational science spectrum represents each stage of research along the path from the biological basis of health and disease to interventions that improve the health of individuals and the public. The spectrum is not linear or unidirectional; each stage builds upon and informs the others. The path from the biological basis of health and disease to interventions that improve health, encompassing: Basic Research, Pre-Clinical Research, Clinical Research, Clinical Implementation, and Public Health. For more information, please see Translational Science Spectrum on the National Center for Advancing Translational Science (NCATS) website. SCORE applications can support: patient-oriented research, including epidemiological and behavioral studies or outcomes research or 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. Applicants proposing clinical trials should consult ORWH program staff prior to submission of their applications.
With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary and collaborative approach. Interdisciplinary approaches can integrate knowledge from multiple specialties and disciplines, thus enhancing the likelihood of defining underlying pathologic processes. SCORE applicants are expected to employ interdisciplinary research approaches, recognizing the complex interplay of factors that impact the health of women. Collaborations among researchers in academia, private industry, and federal settings should be leveraged, as appropriate to advance the SCORE research program. Although the focus of the SCORE program is on sex differences, research programs are not required to have both male and female cohorts. However, if female only research is proposed, the background section must include the current state of knowledge and review of the literature justifying that studies will include cohorts of women only, consistent with the NIH inclusion policy. This FOA allows applications for women’s health research relevant to the mission of the participating NIH ICs (see below: Research Areas of Interest).
Prospective applicants are urged to consult with the Scientific/Research Contacts of the NIH early in the preparation of the application (see Section VII. Agency Contacts).
Research Projects: required
A SCORE program consists of at least three-individual, but interrelated, research projects, each with high scientific merit. The overall program should have clear translational research objectives and, in the aggregate, be devoted to a specific major health area relevant to women’s health and to incorporate sex as a biological variable (SABV) when planning, analyzing, and reporting data.
For the purposes of this FOA only Phase 0 or Phase I, Phase II may be supported. SCORE Centers are strongly encouraged to establish collaborative clinical trial activities early in the development of projects that have clinical trials/studies as their goals.
In addition, a SCORE program must have a Leadership Administrative core (LAC), and a Career Enhancement Core (CEC).
Leadership Administrative Core (LAC): required
A Leadership Administrative Core (LAC) must be included for the SCORE program. The LAC will (1) monitor, stimulate, evaluate, and report on the research projects and educational programs particularly with respect to the overall goals of the SCORE; and (2) provide Intellectual leadership in support of the activities of the SCORE consortium.
The SCORE PD/PI or his/her designee will have overall responsibility for the LAC.
Annual meetings of the SCORE Directors will be held. Planning and execution of annual meetings will be shared between the ORWH, NIH ICs Program Staff, and the Steering Committee. By providing a focused and interactive agenda, the annual meeting fosters the initiation and maintenance of collaborative efforts and resource sharing among the Centers. SCORE PD/PIs should budget funds for the PD/PI and one to -two designees to attend an annual two-day meeting.
Awarded SCOREs are expected to actively participate in the organization and programmatic objectives of a research consortium. The goal of the consortium is to share expertise, research results and identify emergent issues, new research opportunities and establish research priorities and collaborations on conditions underlying women’s health issues. The SCORE research consortium will also serve as a vehicle for collaborating on education and career enhancement initiatives and the promotion of diversity in the translational science workforce.
Career Enhancement Core (CEC): required
A Career Enhancement Core (CEC) must be proposed as part of this FOA. The goal of the CEC is to meet the career enhancement needs of translational science in the study of sex differences. As a required element of the SCORE, the CEC must be maintained throughout the entire term of the funding period. Funds from this program may be used to support junior faculty or established investigators who wish to enhance or refocus their careers on translational research. Investigators supported by NIH career development award (K series) may also be eligible for support through this program. PDs/PIs are highly encouraged to support Early Stage Investigators and Early-Established Investigators through this Core. Pilot studies and complementary education programs should provide opportunities in rigorous research methodologies and transparency in experimental design and reporting. The CEC should provide unique opportunities to understand women’s health and to incorporate sex as a biological variable (SABV) when planning, analyzing, and reporting data. This funding opportunity also seeks to facilitate educational opportunities of participants. Participants from diverse backgrounds, underrepresented in the biomedical science are especially encouraged. Current estimates regarding the state of health of US women are variable, with many health, disease, mortality and morbidity outcomes differing significantly by race, ethnicity, and socioeconomic status. Training a diverse biomedical workforce will enhance the scope of intellectual capacity brought to bear on intransigent issues of health and disease to positively affect the health of all women.
Resource Support Core(s) (RSC): optional
SCORE applicants may propose one or more Resource Support Core(s) (RSC) to support two or more research projects, e.g., animal, pathology, and or informatics. SCOREs may also find that their research goals would be facilitated by interactions with industry or the private sector, Pharma, or other federal agencies (e.g., CDC, FDA).
Additional Considerations
Institutional Support:
It is expected that the sponsoring institution will provide resources in support of the SCORE application. Applicants should identify scientific, administrative, and financial support provided by the sponsoring department(s) and/or institutional official(s). Examples of appropriate institutional commitment to the program include the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed career enhancement program, or other commitments essential to successful educational opportunities.
SCORE Consortium Steering Committee (CSC):
The SCORE CSC is led by a Chair and an Executive Committee, who work with the ORWH and NIH IC Project Scientist(s) to achieve program goals. The Chair’s term is one year, to start and end at the annual Director’s meeting. The Steering Committee Executive Committee will consist of past, current and rising Chairs. Each SCORE Director will be expected to participate on the Steering Committee for the duration of award. Additional outside members from the research community may be added on an ad hoc basis to address emergent issues within the program. The ORWH and NIH IC Project Scientist(s) should be included as ex officio participants for all meetings and correspondence.
SCORE Advisory Committees:
Advisory Committees are a required component of a SCORE program. Both External and Internal Advisory Committees provide critical evaluation of the progress of a Center and make recommendations to the Center in advance of NIH requests for information for programmatic review and evaluation or NIH site visits. The reports from Advisory Committees should be included in the Center’s annual progress report. NIH officials reserve the right to perform a site visit(s) during the funding period.
The PD/PI should provide a plan for the appointment of Advisory Committees to monitor progress of the program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members need not be named in the application if it is new or resubmission; but for renewal applications, the members must be named.
ORWH Areas of Interest
The new 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research “Advancing Science for the Health of Women” highlights research priorities to improve the health of women. The overarching themes of the Strategic Plan important in this FOA include but are not limited to: sex determinants, evidence-based interventions, advancing women in biomedical research, innovative approaches, mentoring, networking, collaborations, and evaluations of NIH investments.
Research areas may encompass the etiology, pathogenesis and/or new treatments, diseases and conditions that affect women including studies on the various manifestations of disease. The overall themes of proposed research projects, and associated cores must inform the etiology, pathogenesis and/or treatment of a condition underlying women’s health.
The centers funded under this initiative will be expected to participate in this consortium and to collaborate effectively with each other to maximize the chances of overall success of the program. Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium. Each project is expected to comply with applicable consortium policies and procedures. In addition, the PD/PI(s) and designated individuals will be active members of the consortium, which meets on interim basis.
Areas of Interest of Participating Institutes, Centers and Offices
While applications submitted in response to this FOA may propose research in any disease or health area that falls within the broad areas of women’s health research, there are also specific areas of interest to the NIH institutes, centers and offices that are participating in FOA. Specifically:
National Institute on Aging (NIA) supports genetic, biological, clinical, behavioral, social, and economic research on aging.
Specific areas of interest for this FOA include:
- Sex and gender differences in health and disease at older ages;
- Sex differences in the basic biology of responses to interventions at older ages;
- Studies of sex differences and sex-specific aging of cognitive, emotional, sensory, and motor function, including Alzheimer’s disease and related dementias;
- Sex-specific responses to therapeutic interventions in elderly women, including those with comorbid conditions;
- Research on aging women with emphasis on prevention of frailty, promotion of healthy lifestyles, maintenance of independent living, self-management of symptoms, preservation of cognitive functions, and health-related quality of life;
- Demographic and economic studies of gender-specific health outcomes and well-being at older ages;
- Experimental models that can address sex differences across the lifespan and in aging;
- New paradigms and approaches to study the impact of experience, hormones, developmental stage, and aging on sex differences in steroid hormone signaling.
National Institute on Digestive Diseases and Kidney (NIDDK): Research areas must focus on priority interests within the mission of NIDDK. Contact with program staff in NIDDK is highly recommended to ensure that your application would be considered. Examples include benign conditions of the genitourinary tract; acute and chronic kidney disorders; chronic conditions of the digestive system with significant sex disparities; research focused on better understanding the natural history of dysglycemia in pregnancy and the postnatal long-term metabolic effects of dysglycemia in pregnancy in both mother and offspring; and sex differences in diabetes treatment outcomes.
National Institute of Environmental Health Sciences (NIEHS): Research areas must focus on interests within the mission of NIEHS. Examples include research on sex and gender differences in health and disease in response to environmental exposures; research on environmental exposures and sex and gender differences in fundamental biology across the lifespan; research focused on better understanding the role of environmental exposures and sex and gender differences in relation to pregnancy, reproductive disorders and disease, metabolic diseases, cancers, metabolic disease, cardiovascular disease, and other disease conditions.
National Institute of Mental Health (NIMH) (https://www.nimh.nih.gov/about/strategic-planning-reports/strategic-research-priorities/index.shtml) has interest in:
- Studies of basic and translational research investigating sensitive periods (e.g., pre-puberty, puberty, reproductive years, menopause, later life) across the lifespan that may contribute to risk and resilience for developing mental illness.
- Basic and translational research that explores sex differences in mechanisms responsible for vulnerability and resilience to social stressors.
- Studies that elucidate biological and environmental factors as well as mechanisms to prevent and/or cure mental illness.
- Studies of sex and gender differences in vulnerability to clinical course of psychiatric disorders.
- Integrative neuroscience studies that examine sex differences in neural circuits that govern social, cognitive and emotional functions.
- Studies that examine mechanisms underlying mood disorders that impact women (e.g., perinatal depression) and determine whether these represent a subtype of mood disorders with distinct pathophysiological underpinnings.
- Studies that foster collaboration (e.g., data sharing, technology transfer and dissemination) among investigators to advance sex differences research in mental illness.
- Studies that incorporate, sex, age, race, social economic status (SES), culture and gender factors as a means to reduce health disparities and to ensure that effectiveness of diagnostic and therapeutic breakthroughs are equitable across all populations with mental illness.
- Studies on sex differences that further our understanding of how community engagement and health care system factors can contribute to improved treatment adherence, retention, and outcomes in mental health care specifically designed for, or modified for women across the life course, including socio-demographically and culturally diverse populations.
NIMH supports hypothesis-driven mechanistic clinical trial studies in basic and/or translational discovery research in healthy human subjects and in the pathobiology, pathophysiology, and psychopathology of mental disorders and in HIV infection of the CNS. The goal is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding mental health and mental disorders. Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention for mental disorders. NIMH supports biomarker studies that may provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses. The submitted studies are defined as clinical trials but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions. These latter studies will not be accepted, but instead should seek the appropriate NIMH Clinical Trial FOA under which to submit. The NIMH Clinical Trial FOAs are listed on NIMH’s Clinical Trials Funding Opportunity Announcements Web page.
Deadline: January 10, 2019 (full proposals; letters of intent due 30 days prior to the deadline)
URL: https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-19-013.html
Filed Under: Funding Opportunities