Key Dates

Related Announcements

• October 13, 2022 - The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional).  See NOFO RFA-OD-22-028.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This Notice informs potential applicants that the National Institute of Allergy and Infectious Diseases (NIAID) is participating, effective immediately, in the Notice of Funding Opportunity Announcement (NOFO) RFA-OD-22-028, "The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)".

The following sections of RFA-OD-22-028 have been modified (changes shown in bold italics) to reflect NIAID's participation in this NOFO:

Part 1. Overview Information

Components of Participating Organizations

Office of Research on Women's Health (ORWH)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)

Assistance Listing Number(s)

93.313, 93.361, 93.121, 93.213, 93.113, 93.242, 93.866, 93.279, 93.273, 93.172, 93.837, 93.838, 93.839, 93.840, 93.233; 93.855
 

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Areas of Interest of Participating Institutes, Centers and Offices

The participating NIH ICOs below identify priority research approaches and specific topics within the scope of their institute’s scientific mission and consistent with their interests toward a better understanding of the intersection of sex and gender in health and disease.

The National Center for Complementary and Integrative Health (NCCIH)

The mission of the National Center for Complementary and Integrative Health (NCCIH) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their role in improving health and health care. For the purposes of this FOA, NCCIH is interested in research on the contributions of sex, gender, and the intersection of sex and gender on the mechanisms of action of complex interventions including various mind and body approaches and natural products. NCCIH is also interested in research that investigates the influence of sex and gender on utilization of these approaches to improve health outcomes among various populations, including gender diverse populations. Natural products include botanicals, pre/probiotics, and products marketed as dietary supplements. Mind and body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy. NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). NCCIH will accept assignment of applications in the area of complementary and integrative health that do not propose clinical trials, such as observational, basic, and mechanistic (animal) studies. Investigators are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact prior to submitting their application to identify the most appropriate FOA for their research.

National Human Genome Research Institute (NHGRI)

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:

• Division of Genome Sciences:https://www.genome.gov/about-nhgri/Division-of-Genome-Sciences
• Division of Genomic Medicine:https://www.genome.gov/about-nhgri/Division-of-Genomic-Medicine
• Ethical, Legal, and Social Implications Research Program:https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications
• Office of Genomic Data Science: https://www.genome.gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science
• Training, Diversity and Health Equity Office: https://www.genome.gov/about-nhgri/Office-of-the-Director/Training-Diversity-and-Health-Equity-Office

Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI is interested in supporting research to understand the mechanisms of the heart (and vascular), lung, hematologic (blood), and sleep (HLBS) diseases/disorders that present only in women, are more prevalent in women than in men or have a 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 are 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:

• Understanding the intersection of sex and gender in mechanisms 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 postpartum), and in women from different races/ethnicities/origins/heritage groups.
• The influence or interaction of environmental factors (including psychosocial, socioeconomic, and sociocultural determinants of health) in sex differences in mechanisms of HLBS diseases or disorders 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.
• Clinical trials and need for models of effective engagement and retention of women from underrepresented groups as clinical trial participants

National Institute on Aging (NIA)

NIA is interested in supporting research relevant to sex as a biological variable in studies that align with the goals outlined in the National Institute on Aging’s Strategic Directions for Research, 2020-2025. NIA will consider meritorious applications that fall within the Institute’s pay line.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The mission of the NIAAA is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, treatment and recovery of alcohol-related problems, including alcohol use disorder and alcohol-associated organ damage, across the lifespan. NIAAA supports basic and/or translational research in a wide range of alcohol research scientific areas including genetics, neuroscience, epidemiology, prevention, and treatment. For clinical trials, the applicant should have an existing alcohol research clinical trial or a history of experience conducting clinical trials that examine alcohol-related outcomes.

Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. NIAAA encourages the Alcohol Research Centers to recruit a diverse group of scientists to its study teams, including individuals from underrepresented groups (see, e.g., NOT-OD-20-031 (Notice of NIH's Interest in Diversity)). NIAAA is especially interested in recruitment efforts intended to generate interest from racial, ethnic and gender minorities and early-stage investigators.

NIAAA is interested in supporting basic, preclinical, translational and clinical research applications that will examine the influence of sex and gender on treatment, prevention, and management of alcohol use disorder and other alcohol-related health complications (e.g., alcohol-associated organ damage). NIAAA priorities are as follows:

• lmpact of factors including stress and trauma across the lifespan and sleep on sex and gender leading to AUD or cessation of consumption.
• Effects of sex and gender and their interaction on alcohol withdrawal and relapse.

National Institute of Allergy and Infectious Diseases (NIAID)

Areas of programmatic interest to NIAID include, but are not limited to, the following:

• Research that addresses the disproportionate burden of sexually transmitted infections (STIs), HIV, and reproductive tract infections on women, including transgender women, such as projects that develop or enhance prevention and treatment strategies and their implementation.
• Research examining the immune system and its response to vaccination or disease across the lifespan, including at critical timepoints such as puberty, pregnancy, perimenopause, and postmenopause.
• Basic and applied research to better understand, treat, and ultimately prevent other infectious, allergic, and immunologic diseases, including autoimmune diseases more prevalent in women.

The National Institute on Drug Abuse (NIDA)

NIDA invites applications that investigate the intersection of sex and gender factors in vulnerability to substance use and addiction, its consequences, and treatment and prevention outcomes.

National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR is interested in supporting research in its programmatic areas that address mechanisms underlying the manifestations of sex- and gender-based influences in Dental, Oral, and Craniofacial (DOC)-related diseases and conditions. Specifically, NIDCR encourages studies aimed at understanding immune reactivity, genetic variation, environmental triggers, aging, and hormonal changes as they affect sex- and gender-based differences. Further, NIDCR encourages clinical research studies that address the influence of sex and gender on oral disease prevention, diagnosis, and management, and studies that assess the influence of sex and gender on oral health outcomes. Investigators proposing clinical trials must use NIDCR’s UG3/UH3 mechanism. Please see NOT-DE-21-014 for information about NIDCR's clinical trials program. All applicants are strongly encouraged to discuss potential requests with the NIDCR Program Officer listed in the Scientific/Research Contacts.

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 influences in health and disease in response to environmental exposures; research on environmental exposures and sex and gender influences in fundamental biology across the lifespan; research focused on better understanding the role of environmental exposures and sex and gender influences 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)

The National Institute of Mental Health (NIMH) will accept applications that reflect the mission and scientific priorities as identified in the strategic plan NIMH » The National Institute of Mental Health Strategic Plan (nih.gov). For the purposes of this RFA, the NIMH Division of Translational Research has a particular interest in:

• Studies to better understand the interplay between gender affirming hormone therapy, gender identity and sex assigned at birth and how the interaction of those factors impact on mental illness (e.g., mood disorder, schizophrenia, suicidal thoughts and behavior, bipolar disorder).
• Studies to increase knowledge about the intersection of sex and gender as risk/protective factors for trauma and violence and to identify target of actions for intervention development.
• Studies that examine how sex and gender identity interact to influence the neurocircuitry of the brain and the resulting brain behavior.
• Studies that elucidate the intersection of sex and gender and their effects on the trajectory of mental illness across the lifecourse (e.g., prepuberty, puberty, menopause, later life)
• Studies that incorporate and examine the intersection of 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 the intersection of sex and gender influences 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 NIH defined health disparity populations (e.g., racial and ethnic groups), less privileged socioeconomic status (SES), underserved rural and sexual and gender minorities (SGM) and any populations that can be characterized by two or more of these descriptions.

The NIMH Division of AIDS Research high priority areas of research within this announcement include, but are not limited to, the following:

1.Studies to better understand the interplay between gender affirming hormone therapy, gender identity, and sex at birth, and how interactions between those factors impact HIV prevention and treatment outcomes.

2.Intervention research to improve HIV prevention and treatment outcomes for transgender individuals that focuses on the influences of sex and gender.

3.Studies to better understand the differential effects of sex and gender on neurocognitive outcomes among people living with HIV.

4.Studies to understand how the interactive effects of sex and gender influence intersectional stigma, trauma/violence, mental health and, ultimately, HIV prevention or treatment outcomes

Clinical Trials Information

Applications proposing a clinical trial must contact the NIMH program staff listed on this announcement before an application will be accepted for review.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.

NINR is especially interested in applications that propose research on sex/gender influences in HIV/AIDS research.

Section VII. Agency Contacts

Scientific/Research Contact(s)

Chyren Hunter, Ph.D.
Office of Research on Women's Health (ORWH)
Phone: 301-496-7849
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Kate Nagy
National Institute on Aging (NIA)
Phone: none
E-mail: [email protected]

Marrah Elizabeth Lachowiczscroggins
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0222
E-mail: [email protected]

Dena Fischer, DDS, MSD, MS
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4876
E-mail: [email protected]

Preethi Chander
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-443-7230
E-mail: [email protected]

Thaddeus Schug, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-3319
E-mail: [email protected]

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Ebony Madden, PhD
National Human Genome Research Institute (NHGRI)
Phone: 301-503-5620
Email: [email protected]

Ivana Grakalic, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-7600
E-mail: [email protected]

Jessi Drew
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-3915
Email:  [email protected]

Keisher’s Highsmith
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1984
E-mail: [email protected]

Inna Belfer, MD, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-1573
Email: [email protected]

Teri Senn, Ph.D. (HIV POC)
National Institute of Mental Health (NIMH)
Telephone: 301-761-7852
Email: [email protected]

Tamara Lewis Johnson, MPH, MBA (non-HIV POC)
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963
Email: [email protected]

Financial/Grants Management Contact(s)

E. C. Melvin
National Institute on Aging (NIA)
Phone: (301) 594-3912
E-mail: [email protected]

Taryn Cobb
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-8025
E-mail: [email protected]

Diana Rutberg, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: [email protected]

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: [email protected]

Dhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

All other aspects of the NOFO remain the same.

Inquiries

Please direct all inquiries to:

Jessi Drew
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-3915
Email: [email protected]