External Funding Announcements

Release Date: July 5, 2022

Full Announcement

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184- NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-194, NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

Early Pregnancy loss (EPL), defined as a pregnancy loss occurring up to 20 weeks gestation, is a very common pregnancy complication, occurring in 12-15% of clinically recognized pregnancies, with increased prevalence associated with increasing maternal age. The use of highly sensitive hCG assays allows the detection of pregnancy earlier in gestation than the time of clinical recognition, and gives an even higher estimated loss of 50-70% of conceptions prior to the second trimester. To achieve a successful pregnancy, a series of strict embryonic and maternal conditions must be met, that include high quality embryos, favorable conditions for embryo implantation, receptive maternal endometrium and optimal uterine environment to sustain the conceptus to term. In addition, maternal immune tolerance and hormonal factors play a critical role. While approximately half of all cases of EPL appear to be due to embryonic aneuploidy, very little is known about the physiologic and pathophysiologic processes that underlie non-aneuploid EPL. As a result, there is also a lack of understanding for the underlying causes of recurrent pregnancy loss (RPL). This NOSI seeks to address these critical knowledge gaps by encouraging basic, translational and clinical studies on biological processes that may uncover potential etiologies of EPL and RPL. This includes research to understand implantation mechanistically and identify a range of key factors, involved in implantation and placentation that are important for early pregnancy establishment, including abnormalities that contribute to sporadic EPL and recurrent pregnancy loss.

The major gaps that this NOSI targets include, but are not limited to the following

Discovering novel contributing factors that disturb embryo implantation, placenta development, endometrial receptivity and decidualization that lead to EPL, as well as the mechanisms that govern these processes
Investigation into maternal- and paternal-derived factors in gametes that may be responsible for EPL
Errors in epigenetic reprogramming in gametes and preimplantation embryo and early pregnancy loss
Studies of immunological disorders (e.g., inflammatory cytokines, NK cell dysfunction) that contribute to EPL
Uncovering male factor contribution and underlying mechanisms that lead to EPL
Development of new model systems that allow mechanistic investigation
Studies of nutrition factor contribution to EPL (e.g., over- or under- nutrition and vitamin/protein factors)
Studies of dynamic communication between endometrium and embryo
Of Special Interest:

Studies that explore immune system interactions between endometrium and placenta or embryo

Model systems that allow mechanistic investigation of multi-component interactions – e.g., organoids and organs on a chip

Studies focused on the following topics will be given low priority unless there is a clear demonstration that they provide special advantages (diagnostics, risk prediction) over current approaches.

Genomic abnormalities, such as aneuploidy, and genetic determinants
Maternal Infections
Uterine structure anomalies, such as adenomyosis, intrauterine adhesions and fibroid

Full Announcement

This Notice of Special Interest (NOSI) seeks to expand the breadth of scientific research on the clinical course, prevention and treatment of diseases within the mission of the National Heart, Lung, and Blood Institute (NHLBI) by leveraging ongoing clinical research studies through ancillary studies. The purpose of this NOSI is to invite research project applications to conduct focused ancillary studies to large ongoing clinical trials (including late-stage T4 implementation clinical trials), observational studies, and registries. This NOSI also serves as a replacement for NOT-HL-20-755 (expired as of November 6, 2021).

An ancillary study may be an appropriate mechanism for conducting the following types of studies (not an exhaustive list):

• Identify additional and/or unique/emerging risk factors for the disease(s) of interest to NHLBI
• Delineate pathogenic mechanisms of disease
• Identify mechanisms or factors that influence and/or predict response to treatment
• Discover or validate biomarkers of disease development and/or progression
• Identify or characterize co-morbid illnesses associated with the disease(s) of interest to NHLBI
• Describe the natural history and risk factors for an additional disease(s) – i.e., different than the focus of the parent grant
• Determine the effects of the parent study intervention(s) on an additional outcome(s) or disease(s)
• Understand local adaptation of evidence-based practices in the context of implementation
• Determine factors that contribute to the sustainability of evidence-based interventions in public health and clinical practice
• Compare cost-effectiveness of dissemination or implementation strategies to reduce health disparities and improve quality of care among rural, minority, low literacy and numeracy, and other underserved populations
• Investigate strategies for reducing or stopping (“de-implementation”) the use of clinical and community practices that are ineffective, unproven, low-value, or harmful
• Identify sex and/or gender differences that effect symptom recognition, diagnostic strategies, adverse events and efficacy of therapy

Specific research examples include, but are not limited to:

• Understand the contributions of factors such as sex, race, ethnicity, and social determinants of health to variations in risk for HLBS disorders
• Investigate risk and mechanisms for cognitive impairment and dementia in individuals with HLBS conditions, including atrial fibrillation, heart failure and sleep apnea
• Characterize the trajectory of the decline and contribution of individual modifiable risk factors to HBLS across lifespan, such as in maternal pre- and post-natal environment, adolescent, and mid-life
• Examine potential correlations between mtDNA haplotypes and various CVD, VCID, end organ damage
• Delineate the contribution of sleep deficiency (i.e., sleep duration, timing, quality) and sleep disorders to heart, lung and blood disease risk and pathobiological mechanisms
• Elucidate risk factors and markers of pathobiology in women associated with increased susceptibility and severity of HLBS

Full announcement

This Catalyst Award is intended to support the development of innovative, often risky, approaches to address significant problems in HIV comorbidities, coinfections, and complications (CCCs) research in areas of interest to one or more of the participating NIH Institutes. This FOA is not intended to expand the PD/PIs’ current research program, but instead projects should be a new direction that is reflected by new insight or understanding. Catalyzing advances may emanate from the application of innovative approaches and/or from testing creative hypotheses.

Catalyst awardees are required to commit a substantial portion of their research effort (at least 4 person-months) to activities supported by the award. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. For example, 33% effort in a 12-month calendar appointment would equal approximately 4.0 person-months (12 x 0.33 = 4.0). For additional details regarding how effort may be calculated in person-months, please refer to information posted on the NIH Office of Extramural Research website (here). Investigators who will not be able to meet this requirement should not submit applications.

Applications appropriate to this FOA should be consistent with the scientific priorities outlined by the NIH Office of AIDS Research (OAR), which were most recently described in NOT-OD-20-018. The award is intended to support innovative, high-impact,research by early stage investigators that will open new areas of HIV/AIDS research related to CCCs within the mission of one or more of the NIH components participating in this FOA. Areas of interest include novel mechanistic research into pathogenic processes, identification of novel preventive or therapeutic targets,interventions, or therapies; novel approaches to delineate unique biological pathways for HIV-associated CCCs in PWH as compared to those CCCs in people without HIV; pathogenesis of multimorbid HIV-associated CCCs; and/or identification of unique potential drug targets in PWH.

The scientific interests of participating Institutes and Centers (ICs) are summarized below. Applicants are encouraged to contact the Scientific/Research contact of the intended IC to ensure that the aims of the proposed project are consistent with IC mission and OAR's scientific priorities.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIDDK encourages innovative projects aimed at elucidating the unique biological mechanisms leading to HIV-associated CCCs within its mission. NIH defines a mechanistic study as a study "designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Submitted proposals are expected to integrate HIV basic science and pathobiology, pathophysiology, and/or metabolism. These include gastrointestinal immune and microbial homeostasis, enteropathy, noncommunicable liver and biliary diseases, viral hepatitis, and obesity; metabolic/endocrine dysfunction and perturbations; kidney disease, benign genitourinary diseases and disorders, and hematologic sequelae. Moreover, NIDDK-relevant pathogenic processes may contribute to HIV pathogenesis in other tissues and organ systems. For example, loss of intestinal epithelial barrier function in HIV-associated enteropathy may result in systemic inflammation that contributes to comorbidities such as obesity or liver disease. Mechanistic interrogation of the processes whereby HIV or its treatment contributes to these CCCs is also encouraged. NIDDK Encourages Research on Sex/Gender Differences, Sexual and Gender Minority-Related Research and Race/Ethnic Diversity as defined in NOT-DK-22-003. Projects addressing how these biologic and social constructs impact physiologic or metabolic pathogenic mechanisms related to NIDDK-relevant HIV CCCs are therefore welcome.   

NIDDK expects projects to undertake a "wet bench" approach and will not support projects with a primarily epidemiological focus. NIDDK will support mechanistic projects that include basic experimental studies involving humans (BESH), which are studies that meet both the definition of basic research and the NIH definition of a clinical trial. Clinical trials seeking to establish safety, assess clinical efficacy or effectiveness, and/or study/manage/implement, preventive, therapeutic, or services interventions will not be supported.

National Cancer Institute (NCI)

NCI encourages research that advances our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying HIV infection. Specifically in areas such as etiologic factors, coinfections, cofactors, immunopathogenesis, diagnosis, and consequences of both non-AIDS defining and AIDS-defining malignancies in populations with an underlying HIV infection.

Cancer focused applications proposing a clinical trial can only propose mechanistic clinical studies that meet NIH's definition of a clinical trial (NIH's Definition of a Clinical Trial). These studies must be designed to understand a biological or behavioral process, the pathophysiology of disease, and/or the mechanism of action of an intervention (examples of mechanistic clinical trials can be found in NOT-OD-18-010). Clinical trials seeking to establish safety, assess clinical efficacy or effectiveness, and/or study/manage/implement, preventive, therapeutic, or services interventions will not be supported.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NICHD supports biomedical research to understand the effects of infection with HIV among populations central to the NICHD mission, including pregnant, postpartum, and lactating women, infants, children, adolescents and young adults, people with intellectual and developmental disabilities, and individuals with physical disabilities or mobility impairments. Studies are expected to align with the HIV/AIDS research priorities outlined by the NIH Office of AIDS Research (OAR) in NOT-OD-20-018 UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.

National Heart, Lung and Blood Institute (NHLBI)

NHLBI intends to support ESIs performing multi-disciplinary and mechanistic research aimed at deciphering the complexity of HIV-associated CCCs related to HLBS priorities, including interactions between HIV infection, aging, the effect of existing risk factors and the impact of multiple medication use. High-priority topics will include (but are not limited to) immune activation and chronic inflammation, effects of the microbiome and virome on HIV-associated CCCs, as well as aging and immune-senescence. Examples of projects that are of interest to the NHLBI and responsive to this FOA include (but are not limited to) those that propose to:

• Identify the common drivers of inflammation/chronic immune activation, initiation, and progression of heart, lung, blood, and sleep (HLBS) disorders in the setting of treated HIV infection;
• Studies aiming to understand molecular mechanisms underlying multilevel effects of biological sex on HIV-associated CCCs related to HLBS diseases;
• Characterize the common inflammatory mechanisms linked to multiple heart, lung, blood, sleep (HLBS)-related end-organ diseases;
• Determine the effects of antiretroviral therapy (ART) on lipid biogenesis/homeostasis and identify the effect on inflammatory profiles
• Explore how ongoing, low-level HIV replication in the setting of ART contributes to immune dysfunction
• Determine how the microbiome and virome interact with the host (and vice versa) to affect metabolism and immune response, potentially contributing to HLBS comorbid disease development;
• Explore how long-term ART use affects HLBS-related organ systems;
• Determine how HIV-induced immunosenescence, in combination with normal inflammaging, contributes to HLBS comorbid disease development;
• Identify potential targets for therapeutics development aimed at reducing immune activation/inflammation in the context of HLBS diseases;
• Explore how therapies that impact inflammation/immune activation can reduce the risk of HLBS comorbidities and/or impact HIV cure;
• HLBS priorities

NHLBI expects projects to undertake a "wet bench" approach and will not support projects with a primarily epidemiological focus. In addition, NHLBI will not support clinical trials with this initiative.

Posting Date: July 14, 2022
Open Date (Earliest Submission Date): September 27, 2022
Letter of Intent Due: 30 days prior to application due date
Due Date: October 27, 2022 and June 27, 2023

Full Announcement

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The over-arching goal of this ORWH R25 program is to support educational activities that complement and/or enhance the training of a diverse workforce to meet the nation’s biomedical, behavioral and clinical research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

Courses for Skills Development: For example, advanced undergraduate courses in a specific discipline or research area, courses on clinical procedures or specialized research techniques, or community-based courses on topics of relevance to sex and/or gender and health. Specifically, this FOA aims to support courses that develop skills in multidimensional and intersectional health-related research and healthcare delivery. The format of the courses may involve a traditional in-person approach, online activities, a hybrid of both approaches, or other methods.

Curriculum or Methods Development: For example, undergraduate STEMM curricula focused on sex and gender in medicine, advanced curricula to improve biomedical, social and behavioral or clinical science education, or development of novel methods or instructional approaches such as graphic medicine. Proposed curricula or methods should have high potential to improve biomedical, social and behavioral, or clinical research education. Specifically, this FOA aims to support innovative curricula or methods at the undergraduate level or higher that integrate knowledge of sex and gender influences into health-related training or enhance understanding of sex and gender influences on health.