NHLBI Announces Participation in RFA-OD-19-013 "Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional)"

Notice Number: NOT-HL-18-669

Key Dates
Release Date: December 11, 2018

Related Announcements
RFA-OD-19-013

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform potential applicants that the National Heart, Lung, and Blood Institute (NHLBI) is participating, effective immediately, in RFA-OD-19-013 "Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional)".

The following sections of RFA-OD-19-013 have been updated (shown in italics) to reflect the participation of NHLBI in this Funding Opportunity Announcement.

Part 1. Overview Information

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers listed below. ORWH may co-fund applications assigned to those Institutes/Centers.

National Heart, Lung, and Blood Institute (NHLBI)

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 on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)


Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.313, 93.866, 93.846, 93.279, 93.847, 93.242, 93.273, 93.113, 93.233; 93.837; 93.838; 93.839; 93.840

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:

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.

National Heart, Lung, and Blood Institute (NHLBI)
The NHLBI is interested in supporting research to understand mechanisms of heart (and vascular), lung, hematologic (blood), and sleep (HLBS) disorders/diseases that present only in women, are more prevalent in women than in men, or have different presentation, manifestation, outcomes or treatment effects in women as compared with men as well as their interaction with the broader environment. NHLBI is interested in applications that include, but not limited to, multidisciplinary approaches that are relevant across more than one HLBS areas. In addition, the NHLBI is especially interested in applications that address topics relevant to its Strategic Vision.

Specific areas of interest to NHLBI include, but are not limited to, the following:

  • Mechanisms of disease of HLBS diseases and disorders or resilience of the entire spectrum of health/disease topics within NHLBI's mission/research priorities, and throughout women’s life course (including pregnancy and post-partum as well as older age), and in women from different races, ethnicities, origins, heritage groups.
  • Sex and gender differences in mechanisms of disease for HLBS diseases and disorders that need to be better understood.
  • The influence or interaction of environmental factors (including psychosocial, socioeconomic, and sociocultural determinants of health) in sex differences in mechanisms of HLBS diseases ordisorders and/or resilience.
  • Mechanisms of disease of non-HLBS diseases and disorders with increased or exclusive HLBS manifestation in women.
  • Sex differences in HLBS diseases and disorders symptomatology, presentation, and long-term outcomes.
  • Sex differences in response to therapies for HLBS diseases and disorders, including adverse events.
  • Sex differences in response to therapies for non-HLBS diseases and disorders but affecting HLBS organs and tissues.
  • Clinical trials and models of effective engagement and retention of women from underrepresented backgrounds.
  • Studies on models of both efficient and effective HLBS healthcare delivery to women across the life course, especially those from underserved populations or communities, and/or that promoteHLBS healthcare equity for women from all race, ethnic, national, cultural, socioeconomic, geographic backgrounds.
  • Studies on models of effective community engagement and health communication that can contribute to increased awareness and dissemination of scientific findings, especially in low income or underserved communities.
  • Consideration of sex- and gender-specific challenges in the development of health policy and evidence-based guidelines resulting from translation and implementation research.
  • Training needs (at any career stage) to promote mechanistic and clinical studies that investigate sex/gender differences in HLBS diseases, disorders or resilience.
  • Training needs (at any career stage) to promote studies on effective models of healthcare delivery, health policy, and implementation science.

Section VII. Agency Contacts

Scientific/Research Contact(s)

Xenia Tigno, PhD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: Xenia.Tigno@nih.gov 


Financial/Grants Management Contact(s)

Debbie Chen
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8023
Email: debbie.chen@nih.gov 

All other aspects of this FOA remain unchanged.

 

Inquiries

Please direct all inquiries to:

Megan Mitchell, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7950
Email: Megan.Mitchell@nih.gov