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




Thursday, June 16, 2016

ARVO Publications Grant

Agency: ARVO
Funding Opportunity Title: ARVO Publications Grant
Deadline:  Applications accepted at any time.

Summary:
ARVO’s Publications Grant is available to authors who need funding assistance to publish in one of our three journals: Investigative Ophthalmology & Visual Science (IOVS); Journal of Vision (JOV); and Translational Vision Science & Technology (TVST). This grant is supported by the ARVO Foundation and aligns with ARVO’s goal to capture the full spectrum of vision science in our family of journals.

The grant will provide support to several individuals per year at a maximum of $1,500 per grant.

Application Process:
Corresponding authors must apply for a Publications Grant prior to submitting an article to an ARVO journal. To apply, the corresponding author must submit:

- An application.
- A support letter from an administrator at the author’s institution, describing the need for the grant and lack of funds. ARVO will not consider applications without a support letter. We recommend that the letter be on institution letterhead stationery. Acceptable letter formats include a PDF attachment to the application form or a hard-copy letter mailed to:
    ARVO
    Attn: Journals Department
    1801 Rockville Pike, Suite 400
    Rockville, MD 20852

References:
ARVO Solicitation

Brain Machine Interface Prototype Development for Vision Restoration

Agency: Medical Technology Enterprise Consortium (MTEC)
Funding Opportunity Title: Brain Machine Interface Prototype Development for Vision Restoration
Solicitation Number: MTEC-16-02-Brain Machine Interface
Deadline: August 22, 2016


What is Medical Technology Enterprise Consortium?

The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the U.S. Army Medical Research and Materiel Command (USAMRMC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:

(a) biomedical research and prototyping;
(b) exploration of private sector technology opportunities;
(c) technology transfer; and
(d) deployment of intellectual property and follow-on production.

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International, dba SCRA Applied R&D, represents a Request for Project Proposals (RPP) for MTEC’s support of the Clinical and Rehabilitative Medicine Research Program (CRMRP) technology objectives. Strategic oversight for the award(s) supported by this RPP will be provided by CRMRP.

The Internal Revenue Service recently approved MTC’s application for tax exempt status. MTC is a 501c3 nonprofit.

Summary of Technology Objectives for Brain Machine Interface Project

The overarching goal of this program, is to provide a prototype visual prosthesis for human testing within 5 years that (1) provides the ability to navigate for ambulation, identify faces and objects critical to daily life, and read large print, and (2) is economically feasible. Applications to MTEC should clearly state how the proposed research provides an innovative solution to a critical problem in the development of a brain machine interface prototype for vision restoration.
A critical step towards realization of the overarching goals is the development of an appropriate brain-machine interface. Applications must address the following focus area in vision restoration to be considered:

Specifically, MTEC seeks the prototype development of a device that:
1. Stimulates visual pathways in either the a)the lateral geniculate nucleus (LGN) or b) primary visual cortex.
2. Provides appropriate punctate stimuli with either a) electrical stimulation or b) optical stimulation for photolysis of caged excitatory neurotransmitters, photoswitches, or optogenetics (an optical stimulation delivery device is being sought, NOT the development of caged neurotransmitters, photoswitches or optogenetic tools).
3. Provides density of stimulation for the equivalent of at least 20/40 in the central 2° of visual field.
4. Stimulates neurons normally responsive to the peripheral field providing the equivalent of at least 70° of horizontal visual field for each eye.
5. Proposal must address specific anatomical challenges associated with implantation and communicating with the stimulation device.
6. Proposal must address biocompatibility (i.e.,the prosthesis should ideally function for the lifetime of the patient).
7. Components of the device must be demonstrated as a prototype in animal or appropriate in vitro models.

MTEC seeks applications from investigators comprising multi-disciplinary teams from a wide spectrum of disciplines including, but not limited to, basic science, engineering, translational research, and clinical research.

The current effort aims to promote highly innovative, groundbreaking research; high- impact research with near-term clinical relevance; multidisciplinary, synergistic research; and translational studies to support the fluid transfer of knowledge from basic principles to a working visual prosthesis prototype. Results of studies conducted through this effort should inform the developmental pathway for a visual prosthesis prototype.

Proposed projects must be based on logical reasoning and sound scientific rationale. Please note that awards are not to be exploratory in nature and require a foundation of preliminary data.

Research involving animal or human subjects is allowed, in accordance with the PPG.

Although seven critical specifications of the visual prosthesis prototype are outlined in the above, we encourage you to submit even if you cannot currently meet all seven specifications. However, it is expected that an Offeror’s approach to the visual prosthesis prototype will one day satisfy all seven critical specifications.

Funding Availability and Type of Funding Instrument Issued:
Total funding for awards made from this Funding Opportunity for Fiscal Year 2016 is $2.0M. Awards will be funded based on Milestone completion. The Government intends to award three - Phase 1 awards at $332K each (direct and indirect costs). The Government intends to award one Phase 2 award at $1.0M (direct and indirect costs). The Offeror must include both Phase 1 and Phase 2 study plans and define specific Milestones for the end of Phase 1 and Phase 2. The Government will make a Phase 2 award based on progress towards completion of Phase 1. The Period of Performance (POP) for Phase 1 is not to exceed 12 months. Progress Reports are due to the Government quarterly. The Final Report is due at the end of month 12 for Phase 2 selection. The POP for Phase 2 is not to exceed 24 months. Quarterly Progress Reports and a Final Progress Report are required for Phase 2. As of the release date of this RPP, future year Defense Appropriations Bills have not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this RPP is approximate and subject to realignment. Funding of proposals received in response to this RPP is contingent upon the availability of federal funds for this program. MTEC reserves the right to reduce the second year award, if the Offeror's technology after the first year excels only in a limited number of the requirements/goals/tasks listed in the announcement. MTEC reserves the right to encourage two or three of the first year awardees to collaborate in the second year award to maximize performance across the greatest number of the requirements/goals/tasks listed in the announcement, and may allocate the second year funds in accordance with participation in such a collaboration.

The Government-selected Research Project Awards will be funded under the Other Transaction Agreement Number W81XWH-15-9-0001 (or subsequent OTAs in support of MTEC) with MTEC administered by the CM, SCRA Applied R&D. The CM will negotiate and execute a Base Agreement with MTEC members. This Base Agreement will be governed by the same provisions as the OTA between the Government and MTEC. Subsequently, any proposal that is selected for award will be funded through a Research Project Award issued under the Base Agreement. A sample of the MTEC Base Agreement can be found on the Members Only portion of the MTEC website at www.mtec-sc.org. At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their proposals that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its proposals that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement No. 20XX-XXX.

Offerors are advised to check the MTEC website periodically during the proposal preparation period for any changes to the MTEC Base Agreement terms and conditions.

References:
Full Solicitation
MTEC website

Friday, April 8, 2016

NEI Research Grant for Vision Related Secondary Data Analysis

Agency: NEI
Funding Opportunity Title: NEI Research Grant for Vision Related Secondary Data Analysis
Funding Opportunity Number: PAR-16-168
Due Date: Standard Due Dates, June 16, October 16 and February 16

Summary:
The goal of this funding opportunity announcement (FOA) is to fund meritorious vision related research projects that involve secondary data analyses using existing database resources. The development of statistical methodology necessary for improving methods to analyze vision health data using existing vision data may also be proposed.

Research Objectives:
The NEI supports an extensive portfolio of clinical trials and large-scale epidemiologic research project wherein numerous data collection activities are required to meet each project's specific aims.  The resultant wealth of data generated by these studies often provides unique, cost-effective opportunities to pursue new questions. 

This FOA may be used to develop new statistical methodologies or to test new hypotheses using existing data.  This FOA actively encourages the use of existing database resources to conduct additional analyses secondary to a project's originally-intended primary purpose; it will not support the collection of new data. 

This FOA supports secondary data analysis on existing data sets. A typical project is expected to make substantial progress towards having vision related manuscript(s) submitted in peer reviewed journals within the first year.

Data sets are not limited to those collected under NEI support but these data sets are of the highest programmatic interest.  Applicants should consider the relevance of their proposed analyses to NEI programs and priorities as described in the National Plan for Eye and Vision Research, which is available on the NEI website. http://www.nei.nih.gov.

The full program announcement can be found at the NIH Guide. 

Monday, December 28, 2015

Field Initiated Projects Program

Agency: National Institute on Disability, Independent Living, and Rehabilitation Research
Funding Opportunity Title: Field Initiated Projects Program
Funding Opportunity Number: HHS-2016-ACL-NIDILRR-IF-0124 (Research) and HHS-2016-ACL-NIDILRR-IF-0125 (Development)
Due Date: 02/22/2016

Summary:
The purpose of the Field Initiated (FI) Projects program is to generate new knowledge through research or develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities. Another purpose of the FI Projects program is to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended. In carrying out a research activity under an FI Projects research grant, a grantee must identify one or more hypotheses or research questions and, based on the hypotheses or research questions identified, perform an intensive, systematic study directed toward producing (1) new scientific knowledge, or (2) better understanding of the subject, problem studied, or body of knowledge.

National Robotics Initiative

Program: National Robotics Initiative
Program Solicitation: NSF 16-517
Deadline: March 7, 2016
Note:  Applications to this  multi-agency funding opportunity must be submitted to NSF using NSF guidelines and instructions. NSF is the lead agency overseeing the review process.

Summary:

The NIH is collaborating on a multi-agency funding opportunity, the National Robotics Initiative (NRI), whose goal is to accelerate the development and use of robots in the United States that work beside, or cooperatively with, people (http://www.nsf.gov/pubs/2016/nsf16517/nsf16517.htm), or carry out work for people in dangerous environments.  Innovative robotics research and applications emphasizing the realization of such co-robots working in symbiotic relationships with human partners is supported by multiple agencies of the federal government including the National Science Foundation (NSF), the National Aeronautics and Space Administration (NASA), the National Institutes of Health (NIH), the U.S. Department of Agriculture (USDA), the U.S. Department of Defense (DOD) and the U.S. Department of Energy (DOE). The purpose of this program is the development of this next generation of robotics, to advance the capability and usability of such systems and artifacts, and to encourage existing and new communities to focus on innovative application areas. It will address the entire life cycle from fundamental research and development to manufacturing and deployment. Collaboration between academic, industry, non-profit and other organizations is strongly encouraged to establish better linkages between fundamental science and technology development, deployment and use.

The NIH encourages robotics research and technology development to enhance health, lengthen life and reduce illness and disability. The NIH also supports non-hypothesis driven applications, which includes technology-driven and problem-driven applications. Specifically, the participating NIH Institutes and Centers (ICs) on this solicitation are interested in targeting this solicitation to support the development of assistive robotic technology to achieve functional independence in humans; improve quality of life; assist with behavioral therapy and personalized care; and promote wellness/health. The most significant challenges will be in addressing safety issues, especially for applications to be used in home-based and long-term care settings where integration of complex systems will be required. Additionally, these assistive robots need to quickly adapt to changes of the user and the environment. Human assistive devices should be designed to assist healthcare providers and as well as the individuals needing care. Development of robotic applications is important to NIH because of their potential significant impact on healthcare in the future. Human assistive devices will revolutionize healthcare in the next 20 years as much as personal electronics have changed our daily lives in the past two decades. Affordable and accessible robotic technology can facilitate wellness and personalized healthcare. Continual health assessment and personalized intervention have the potential to offset the shrinking size of the healthcare workforce and the growing elderly and disabled population. In the future, assistive robotics will enable people to engage in all aspects of human life with endurance and dignity.

Examples of assistive robotic technology development include but are not limited to:
- Homecare and long-term personalized care robots
- Robotic wellness/health promotion and maintenance
- Robotic behavioral therapy
- Robotic aids for mobility, manipulation, human communication and cognition, vision for non-sighted persons
- Assistive robotics to eliminate health disparities across populations

Further Information:
NIH Guide Notice
National Robotics Initiative Website
Program Solicitation

Friday, November 20, 2015

NEI Clinical Study Planning Grant (R34)

Agency: National Eye Institute
Program: NEI Clinical Study Planning Grant (R34)
Funding Opportunity Number: PA-16-038
Deadline: February 16, June 16 and October 16 for new applications
Award Budget: Direct Costs of $150,000 per year
Award Project Period: The scope of the proposed project should determine the project period. The maximum period is two years.

Summary:
The NEI Clinical Study Planning Grant provides support for the development of a comprehensive research protocol for a large-scale clinical trial or epidemiologic study. This grant provides early peer review of the proposed clinical study in terms of its rationale, design, organizational structure and implementation plan. The Planning Grant is used to support the development of a detailed MOP.  While the grant may be used to support preliminary studies which refine study procedures or document recruitment potential, the grant must not be used to generate preliminary data in support of the rationale for the trial.

Prospective applicants should note that funding of a Clinical Study Planning Grant does not guarantee nor imply funding for any subsequent competitive application for the support of a full-scale study.

Applicants are encouraged to consider the relevance of their proposed research to NEI programs and priorities as described in the NEI Vision Research, Needs, Gaps, and Opportunities.

Scope:
This FOA is designed to: (1) permit early peer review of the rationale for the proposed clinical trial or epidemiology study; (2) provide support for the development of a detailed MOP; and (3) support the development of other essential elements of the clinical study.

Activities supported by this FOA may include, but are not limited to, the following examples:

- Developing/finalizing the MOP. Basic elements in the MOP should include identification of the patient population; inclusion and exclusion criteria; adequate plans for recruitment and retention of participants; experimental   design and protocols; clear definition of the research hypothesis and outcome measures; quality control/assurance procedures; data management and analytical techniques; sample size estimates with justification; administrative procedures, including regulatory approvals if necessary; collaborative arrangements; duties and responsibilities of the study chairperson, clinical sites, coordinating center, and other central resources such as a reading center; monitoring plans to assure patient protection and data integrity; and plans for addressing Federal gender/minority inclusion and human subjects protection requirements.
- Establishing and documenting collaborative arrangements.
- Instituting means to assure standardization of procedures across sites and among staff.
- Developing tools needed for data collection and data management.
- Developing/finalizing data and safety monitoring plans in the application.  Do not name individuals for the Data and Safety Monitoring Board (DSMB) or Data Monitoring and Oversight Committee (DMOC), but include areas of expertise that will be pertinent in forming these groups.
- Developing plans for any training that is required to carry out the proposed study. This may include, for example, training of data collectors and individuals who will carry out the planned intervention.

See the full announcement for more information.