Thursday, July 15, 2021

NEI Vision Research Epidemiology Grant (UG1 Clinical Trial Not Allowed)

There are multiple deadlines for this program – September 25, January 25 and May 25 from 2021 through 2024.

 

The Funding Mechanism is a Cooperative Agreement (UG1) so NEI will be actively involved.


Summary:

 

The National Eye Institute (NEI) supports investigator-initiated, complex, multi-center and other high resource risk epidemiologic studies under the cooperative agreement mechanism, UG1 activity code. Specifically, the purpose of this Funding Opportunity Announcement (FOA) is to support new and innovative ocular epidemiology research.

Purpose: 

The purpose of this Funding Opportunity Announcement (FOA) is to support epidemiologic studies that utilize creative and innovative approaches to studying vision diseases and disorders with high public impact and whose findings will inform prevention and treatment strategies as well as basic sciences research.

Background:

Clinical vision research projects, including epidemiologic studies, are part of NEI’s core strategy for improving visual health and decreasing visual impairment in populations through research on the burden of disease, its causes, diagnosis, prevention, treatment and rehabilitation.

Projects should focus on NEI’s mission to protect and improve visual health including, but not limited to:

  • Determining the burden of eye diseases and their visual outcomes in a changing population, particularly disparities in the burden and the influences of sociocultural, environmental, economic, and demographic factors.
  • Improving early diagnosis of ocular diseases and their underlying processes through new screening and detection strategies.
  • Determining risk factors for ocular diseases.
  • Identifying and assessing strategies that will overcome barriers to eye care and convert evidence-based findings into improved patient and population outcomes.
  • Studying the interplay of factors that exacerbate or mitigate risk for eye diseases.

The NEI encourages applications to support ocular epidemiologic research. These projects are supported under the cooperative agreement mechanism.

Applicants are strongly encouraged to contact Scientific/Research staff as plans for an application are being developed (see Section VII, Agency Contacts), preferably no later than 12 weeks prior to the anticipated application submission date.

More information can be found at https://grants.nih.gov/grants/guide/pa-files/PAR-21-204.html

 

 

India Collaborative Vision Research Program (R01 Clinical Trial Not Allowed)

 The deadlines are  November 8, 2021, November 8, 2022, November 8, 2023.

 

Summary:

This Funding Opportunity Announcement (FOA) encourages Multiple Principal Investigator (Multi-PD/PI) applications from United States (U.S.)-based institutions with an Indian institution partner to establish bilateral collaborations that will advance science and technology important to understanding, preventing, and treating blinding eye diseases, visual disorders, and their complications. 

Applications are encouraged from organizations/institutions that propose to conduct research on the basic biology and/or genetics of ophthalmic diseases through collaborations with Indian investigators on the following: diabetic retinopathy, glaucoma, age-related macular degeneration, retinitis pigmentosa, including rare and genetic diseases such as congenital cataracts, as well as other eye conditions such as ocular inflammation/uveitis, refractive error, low vision, and corneal injury. Basic, translational, or epidemiological research may be proposed. Clinical trials will not be supported under this FOA.

 

A. Background

Scientific collaborations between the U.S. and India have been successfully conducted for several years under a variety of bilateral agreements.  Recognizing that continuing collaborative research focused on eye diseases and visual disorders would be of mutual benefit to the U.S. and India, the National Eye Institute (NEI), the Indian Department of Biotechnology (DBT), and a Joint Working Group (JWG) developed a strategic plan for collaborations and to facilitate the expedited review and clearance of proposed bilateral projects.  Both the NEI and the DBT have pledged funds to support joint activities pursued under this bilateral program.

Several eye diseases such as diabetic retinopathy, AMD, and glaucoma are complex and influenced by multiple genetic, epigenetic, and environmental factors including family, nutrition, and exposure to toxins.  During the past decade, progress has been made identifying these factors. In AMD, for example, environmental factors including smoking and sunlight have been shown to increase risk, and a diet rich in fatty acids has been shown to decrease risk. There are likely other unknown factors that are involved in precipitating AMD and other ocular diseases.  Large scale genomic, proteomic, metabolomic, and informatic methods using emergent or current technologies to study unique populations are encouraged to identify new factors that can affect susceptibility to these diseases and/or ocular infections, as well as biomarkers that will provide the basis for accurate diagnostic tests and predict treatment outcome.

There are also many eye conditions and complications such as inflammation that affect some intracommunity populations to a much greater extent, providing a valuable resource for learning more about visual restoration as well as the pathogenesis and physiology of a disorder. For instance, the impact of environmental pollutants, including those generated by cooking stoves, on the development of cataracts, as well as the susceptibility of toxins to cause infections, such as ocular TB and trachoma, are not well understood.  Research on these populations that will further our understanding of neural plasticity including neurogenesis, cognition, and processing after the treatment of visual disorders and injury are also of interest to NEI and the DBT. 

Research Objectives

This FOA is intended to support collaborations between the U.S. and India that focus on the basic biology, epigenetic, and/or genetics of ophthalmic diseases and visual disorders.

Applications may include, but are not limited to collaborations addressing the following areas:

  • Family based genome wide association studies (GWAS) on available cohorts of consanguineous families from India to identify genetic variants that predispose to both Mendelian and complex forms of eye disease;
  • Validation of novel GWAS findings in appropriate animal models;
  • Identification of biomarkers that predict and/or assess risk and response to interventions;
  • Studies of environmental factors that predict risk of eye diseases such as imprinting and other epigenetic effects;
  • Studies to determine the underlying biology of ocular diseases including, AMD, diabetic retinopathy, glaucoma, retinitis pigmentosa, cataracts, myopia and presbyopia;
  • Studies focusing on the basic science of neuroplasticity of vision including perceptual learning and adaptation after eye injury;
  • Studies of the mechanisms through which environmental pollutants/toxins contribute to ocular diseases and their complications including infection and inflammation;
  • Identification of factors that influence the success of corneal transplantation and recovery after surgery. 

 

Collaborations

The FOA requires that the collaboration between the U.S. and Indian research teams be submitted as a Multiple Principal Investigator (Multi-PD/PI) application with both of the lead scientists from each country as the PD/PI.  Applications may be derived from existing collaborations with an established history of interaction, or from new partnerships developed in response to this FOA. The collaboration must be based on interactive relationships that maximize the expertise of the individual U.S. and Indian research teams.

Through this FOA, U.S. and Indian collaborating investigators should work together to develop and submit an application to National Institutes of Health (NIH) and the India Ministry of Science and Technology's Department of Biotechnology (DBT). The Indian application should follow DBT guidance using the 'Proposal Submission form for R&D Projects' format available at the DBT eProMIS portal: http://www.dbtepromis.nic.in/sample_forms.htm. In addition to a detailed research plan, the application must include a leadership plan that describes the roles, responsibilities, and working relationship of the PD/PIs, as well as information about performance sites, the proposed work to be accomplished at each site, and a complete budget for the collaboration. Only those applications that are determined to be meritorious will be considered for joint funding and will be supported by the DBT and NIH under this program.  The DBT

will provide funds for the Indian component and NIH will fund the US component.

The NIH Research Project Grant will directly support salaries of U.S. personnel and research activities within the U.S.  It is anticipated that the Indian award will fund the Indian component and will support research activities within India, salaries of Indian research personnel, and other research cost as per DBT norms.  All research in India will be conducted in accordance with both U.S. and Government of India regulations for the protection of human subjects. 

Note:  Organizations must register and apply with their eRA Commons.  All U.S. and Indian applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration.

Applications Not Responsive to this FOA

The following applications will be considered non-responsive and will not be reviewed for this FOA:

  • Applications that include clinical trials
  • Applications that include research topics that do not fall within the NEI mission and/or the NIH referral guidelines such as the diagnosis and treatment of ocular cancers 

Applicants are encouraged to confer with an appropriate NEI Scientific/Research Contactto discuss the relevance of the research topic to the NEI mission.

More information can be found at: https://grants.nih.gov/grants/guide/pa-files/PAR-21-249.html



 



 

 

NIH Director’s New Innovator Award Program (DP2 Clinical Trial Optional)

 The deadline is August 20, 2021.

Summary

The NIH Director’s New Innovator Award Program supports early stage investigators of exceptional creativity who propose highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. For the program to support the best possible researchers and research, applications are sought which reflect the full diversity of the research workforce. Individuals from diverse backgrounds, including those from underrepresented groups and from the full spectrum of eligible institutions in all geographic locations are strongly encouraged to apply to this Funding Opportunity Announcement. In addition, applications in all topics relevant to the broad mission of NIH are welcome, including, but not limited to, topics in the behavioral, social, biomedical, applied, and formal sciences and topics that may involve basic, translational, or clinical research. The NIH Director's New Innovator Award Program complements other ongoing efforts by NIH and its Institutes and Centers to fund early stage investigators. The NIH Director’s New Innovator Award Program is a component of the High-Risk, High-Reward Research (HRHR) Program of the NIH Common Fund.

 

More info can be found at : https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-016.html

 

Bioengineering Research Grants (BRG) (R01 Clinical Trial Not Allowed)


The next deadline is October 5,2021.

 

Funding Opportunity Summary

“The purpose of this funding opportunity announcement is to encourage collaborations between the life and physical sciences that: 1) apply a multidisciplinary bioengineering approach to the solution of a biomedical problem; and 2) integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. An application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and is appropriate for small teams applying an integrative approach to increase our understanding of and solve problems in biological, clinical or translational science.   

Purpose

The goal for a bioengineering research grant (BRG) is to foster the development of an innovative technology, model, technique, design, or method that has the potential for significant impact on biomedical research by infusing principles and concepts from the quantitative sciences.

The purpose of this FOA is to encourage BRG applications that: 1) apply a multidisciplinary approach to the solution of a biomedical problem; and 2) integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. A BRG application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and is appropriate for small teams applying an integrative approach to increase our understanding of and solve problems in biological, clinical or translational science.

Research Objectives

Many major biomedical research problems are best addressed with a multidisciplinary approach that bridges the life and physical sciences. Principles and techniques in quantitative sciences such as physics, mathematics, chemistry, computer sciences, and engineering are increasingly applied to good effect in biomedical research. Bioengineering approaches integrate principles from diverse technical and biomedical fields, and the resulting multi-disciplinary research provides new understanding, innovative technologies, and new products that improve basic knowledge, human health, and quality of life. This FOA seeks to encourage collaborations of quantitative and physical scientists with biomedical researchers to catalyze the development of innovative bioengineering approaches to the solution of important problems in biomedical research, clinical investigations, and medical practice.

Significant projects may include, but are not limited to: validation and translation of promising tools for prevention, monitoring or intervention; development of quantitative, predictive models of complex biological systems; integration and optimization of technologies that significantly increase sensitivity, specificity, positive predictive value, negative predictive value, efficiency, or throughput of measurements to address unsolved biological or medical questions; or engineering and testing of delivery systems, tissues, therapeutics, implants, and prosthetics that may improve treatment and healthcare. 

Innovation in this biomedical engineering FOA has a broad definition that includes development of new methods, ideas, or tools, integration of existing components into new combinations that deliver greater capabilities, new efficiencies, and/or greater effects. Overall impact of these advances may include reducing disparities in care, promoting wellness and independent living, increasing access to and utility of technologies to improve quality of life, reducing cost and complexity of procedures, and increasing throughput, sensitivity and specificity of diagnostic tests. 

A project must clearly serve the mission of one or more of the NIH Institutes or Centers participating in this FOA. Investigators are encouraged to contact the designated Scientific/Research contacts for individual institute focus areas that will be supported. Applicants who seek to establish proof-of-concept are encouraged to respond to the Exploratory Bioengineering Research Grant (EBRG) FOA [https://grants.nih.gov/grants/guide/pa-files/PA-18-286.html].  Large team projects with a specific goal that can be addressed in 5-10 years are encouraged to respond to the Bioengineering Research Partnership (BRP) FOA [https://grants.nih.gov/grants/guide/pa-files/PAR-18-208.html].

National Eye Institute (NEI) NEI: The National Eye Institute (NEI) supports a broad range of basic and clinical research, clinical trials, epidemiologic studies related to health and disease in the eye and visual system. Research proposed should address a significant aspect of the leading causes of blindness and impaired vision, mechanisms of visual function, preservation of sight, or the special health problems and requirements of the blind.”

 

More information can be found at https://grants.nih.gov/grants/guide/pa-files/par-19-158.html



Small Business Innovation Research (SBIR) and Small Technology Transfer Research (STTR)

 

NIH has issued the omnibus solicitations for SBIR and STTR grants.  Below are the links to find them.  A reminder that SBIR grants need to be submitted by a small business entity and not by the research instittute or university..  

 

SBIR, Clinical Trial Not Allowed

https://grants.nih.gov/grants/guide/pa-files/PA-21-259.html

 

SBIR, Clinical Trial Required

https://grants.nih.gov/grants/guide/pa-files/PA-21-260.html

 

STTR, Clinical Trial Required

https://grants.nih.gov/grants/guide/pa-files/PA-21-261.html

 

STTR, Clinical Trial Not Allowed

https://grants.nih.gov/grants/guide/pa-files/PA-21-262.html

Tuesday, December 5, 2017

Klingenstein-Simons Fellowship Awards in Neuroscience

Agency: The Esther A. & Joseph Klingenstein Fund, Inc.
Program: Klingenstein-Simons Fellowship Awards in Neuroscience
Deadline: February 15, 2018

Summary:
The Klingenstein-Simons Fellowship Awards in the Neurosciences supports, in the early stages of their careers, young investigators engaged in basic or clinical research that may lead to a better understanding of neurological and psychiatric disorders.

The Klingenstein Fund and the Simons Foundation recognize that to accomplish this goal it is necessary to encourage a variety of new approaches. Several areas within the neurosciences are of particular interest:

Cellular and molecular neuroscience—Studies of the mechanisms of neuronal excitability and development, and of the genetic basis of behavior.

Neural systems—Studies of the integrative function of the nervous system.

Translational research—Studies designed to improve the prevention, diagnosis, treatment and our understanding of the causes of neurological and psychiatric disorders.

References:
Klingenstein Fund Website
Philanthropy News Digest RFPS

Tuesday, July 26, 2016

Complex Traumatic Brain Injury Rehabilitation Research Award

Agency: DoD Congressionally Directed Medical Research Programs
Funding Opportunity Title: Complex Traumatic Brain Injury Rehabilitation Research Award
Funding Opportunity Number: W81XWH-16-PHTBIRP-CTRRA
Preproposal Deadline: August 17, 2016
Invited Full Proposal Deadline: November 30, 2016

Summary:
The FY16 PH/TBIRP Complex TBI Rehabilitation Research Award (CTRRA) is intended to support observational studies and clinical trials addressing rehabilitation of patients with complex TBI. TBI is defined as being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain. Not all blows to the head or exposure to external forces result in a TBI. The severity of TBI may range from “mild” — a brief change in mental status or consciousness — to “severe,” an extended period of unconsciousness or confusion after the injury. All applications to the FY16 PH/TBIRP CTRRA must be relevant to complex TBI, defined by a diagnosed TBI in conjunction with symptoms identified in one or more of the following JPC-8/CRMRP Focus Areas:

• The Sensory Systems Traumatic Injury Focus Area involves visual, auditory, and vestibular dysfunction associated with traumatic injury.
• The Pain Management Focus Area is concerned with chronic pain, acute pain in the context of chronic pain, and establishing safety margins for prescriptions, as well as developing strategies to help patients cope with pain.
• The Neuromusculoskeletal Injury Rehabilitation Focus Area deals with amputee care, spinal cord injuries, burns and contractures, and orthopaedic injuries, as well as developing guidelines for standards of care.

In addition, research in the areas described below is very highly encouraged. Patients with complex TBI demonstrate symptoms including, but not limited to, dizziness, visual dysfunction, headaches, and cognitive deficits that are refractory to treatment (i.e., slow/non-response to current treatment regiment, relapsing symptoms following treatment). The FY16 PH/TBIRP CTRRA seeks research on the affected patient populations, mechanisms of comorbidities and potential interventions in the following three Areas of Encouragement:

• Epidemiological studies to define differences between populations of patients with complex TBI whose symptoms are non-responsive as compared to responsive to treatment. (Observational studies only; clinical trials are not supported for this Area of Encouragement. See the definition of a clinical trial and observational studies on
• Etiological studies to identify factors that contribute to differences between patients with complex TBI who respond to treatment and those who do not, with the goal of identifying mechanisms underlying refractory symptoms. (Observational studies only; clinical trials are not supported for this Area of Encouragement. See the definition of a clinical trial and observational studies on page 7 of this Program Announcement/ Funding Opportunity.)
• Interventional studies to evaluate emerging or existing rehabilitation strategies for the treatment of patients with complex TBI compared to existing standards of care. Proposed studies evaluating interventions for patients with TBI and comorbidities that may be refractory to treatment are of particular interest. (Both observational studies and clinical trials are allowed for this Area of Encouragement.)

Additionally, other studies of complex TBI may be considered if they address important issues relevant to the identified JPC-8/CRMRP Focus Areas in the context of TBI if sufficient justification is included in the appropriate sections of the pre-application and application.

Military Relevance: Relevance to the healthcare needs of military Service members, Veterans, and beneficiaries is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate military relevance:
• Explanation of how the project addresses an aspect of the target disease/condition/ technology that has direct relevance to military Service members, Veterans, and/or other military health system beneficiaries
• Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need
• Use of military or Veteran populations or datasets in the proposed research

Award Information

The FY16 PH/TBIRP CTRRA is intended to support both observational studies and clinical trials addressing TBI and co-occurring clinical presentations (neuromusculoskeletal injuries, multisensory dysfunction, and pain) that are often slow/nonresponsive to treatment. The intent of the award is to advance the evidence-based practice for the treatment of TBI with JPC-8/CRMRP-relevant comorbidities by improving understanding of the composition and problems of this population and developing and evaluating treatments.

Applications for this award mechanism may propose epidemiological, etiological, and/or interventional studies (see CTRRA Areas of Encouragement on page 4).
Preclinical studies and studies using animals are not supported by this Program Announcement/Funding Opportunity.

Two different funding levels, based on the type of study proposed, are available under this Program Announcement/Funding Opportunity. It is the responsibility of the PI to select the funding level that is most appropriate for the research proposed based on the following descriptions.

The following, although not all-inclusive, are research projects that would be appropriate to propose under each funding level:

• Funding Level 1: For epidemiological and etiological studies comparing patients with complex TBI responsive versus refractory to treatments. PIs should describe a reproducible methodological approach that will identify or define factors that are associated with slow/non-response to treatment, or relapse of symptoms for patients with complex TBI. Observational studies, but not clinical trials, are permitted at this Funding Level.

• Funding Level 2: For interventional studies to evaluate emerging or existing treatment and rehabilitation strategies. PIs should explain how their work will inform the development, refinement, and/or revision of existing standards of care, clinical recommendations, or guidelines. Both observational studies and clinical trials are permitted at this Funding Level.

Both observational studies and clinical trials, but not preclinical research studies, are allowed in the FY16 PH/TBIRP CTRRA. Observational studies and clinical trials have different submission requirements and it is the responsibility of the PI to correctly identify the type of research proposed and to comply with the relevant submission requirements. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. An observational study is a type of clinical study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given). These types of studies are not considered clinical trials. All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of research.

References:
Program Solicitation