Notice of NIAMS' Participation in RFA-OD-18-004 "Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 - Clinical Trail Optional)"

Notice Number: NOT-AR-18-013

Key Dates
Release Date: April 18, 2018

Related Announcements
RFA-OD-18-004

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

This Notice informs potential applicants that the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) will participate, effective immediately, in RFA-OD-18-004, "Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54)"
 
The following changes and updates have been made to reflect NIAMS' participation in this FOA:
 

Part 1. Overview Information

Components of Participating Organizations
 

National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Drug Abuse (NIDA)
 
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. 
 
The following NIH Offices may co-fund applications assigned to those Institutes/Centers:
Office of Research on Women's Health (ORWH)
 
Catalog of Federal Domestic Assistance (CFDA) Number(s)
 
93.313, 93.866, 93.846; 93.242, 93.273, 93.847, 93.113
 

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description
 
 
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:
 
The National Institute on Aging 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 of Arthritis and Musculoskeletal and Skin Diseases: Research areas must focus on interests within the mission of NIAMS. Examples include novel studies on how health and disease processes differ among women, or between women and men, and how such differences inform the development and testing of preventive and therapeutic interventions in both sexes for arthritis, rheumatic, skin, bone, muscle, and musculoskeletal diseases and disorders. Sex-based comparisons in research related to arthritis and rheumatic diseases, skin biology and diseases, bone biology and diseases, muscle biology and diseases, and musculoskeletal biology and diseases may also ensure that findings are applicable to both women and men. See the NIAMS Long-Range Plan for further details and specific disorders with regard to the mission of NIAMS (https://www.niams.nih.gov/about/long-range-plan). 
 
National Institute on Digestive Diseases and Kidney:  Research areas must focus on interests within the mission of NIDDK. Examples include benign, noninfectious conditions of the bladder and lower urinary 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, the treatment of gestational diabetes, and the postnatal long-term metabolic effects, and diabetes risk to the mother and offspring; and sex differences in diabetes risk, prevention, treatment, and complications.
 
National Institute of Environmental Health Sciences:  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 (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 sociodemographically 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.
 
The following contacts have been added to the FOA.

Part 2. Section VII. Agency Contacts

Scientific/Research Contact(s)

Gayle Lester, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3511
Email: lester1@mail.nih.gov
 
Financial/Grants Management Contact(s)

Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-0610
Email: jonesan@mail.nih.gov
 
All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Gayle Lester, Ph. D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3511
Email: lester1@mail.nih.gov