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
Thursday, June 16, 2016
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
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.
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.
Wednesday, October 21, 2015
Upcoming Changes to NIH Grant Instructions and Forms
NIH is making quite a few changes to the NIH grant instructions and forms. The changes will be implemented in two phases with the first phase effecting grants due on or after January 25, 2016 and the second phase effecting grants due on or after May 25, 2016. Here are the areas that will be impacted and guide notices explaining the changes so you can familiarize yourself with them.
Phase I Changes – Effective on or after January 25, 2016
Rigor and Transparency in Research – NIH is changing application requirements and review language to enhance reproducibility of research findings through increased scientific rigor and transparency. These changes will take effect for most research grant applications (including small business and complex research grant applications), but will not impact institutional training and individual fellowship applications until Phase II. Changes include:
Updates to application guide instructions for preparing your research strategy attachment
Use of a new "Authentication of Key Biological and/or Chemical Resources" attachment (uploaded in Other Attachments section of R&R Other Project Information form)
Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications
NIH Guide Notice
Vertebrate Animals – NIH is removing redundancy with Institutional Animal Care and Use Committee review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Changes include:
Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia)
A description of veterinary care is no longer required
Justification for the number of animals has been eliminated
A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals
NIH Guide Notice
Definition of Child – NIH is redefining the age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old.
NIH Guide Notice
Research Training – NIH is updating requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form to reflect recent policy guidance and reduce applicant burden. Changes include:
"Recruitment and Retention Plan to Enhance Diversity" - applicants will be asked to focus on recruitment
"Human Subjects" - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information
"Vertebrate Animals" - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
"Progress Report" - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process
Phase II changes – effective on or after May 25, 2016
New grant forms will be released. In addition the following changes will also take effect:
Rigor and Transparency – NIH is extending Phase 1 changes to include institutional training and individual fellowship applications. They are adding a new "Authentication of Key Biological and/or Chemical Resources" attachment to the following forms in FORMS-D application packages:
PHS 398 Research Plan
PHS 398 Career Development Supplemental Form
PHS Fellowship Supplemental Form
New “Plan for the Instruction in Methods for Enhancing Reproducibility” attachment will be added to the PHS 398 Research Training Program Plan form in FORMS-D application packages.
NIH Guide Notice
Vertebrate Animals – NIH is extending Phase 1 changes to include institutional training and individual fellowship applications. They are adding new questions regarding euthanasia to the following forms in FORMS-D application packages to replace the euthanasia criteria in the vertebrate animals section:
PHS 398 Research Plan
PHS Fellowship Supplemental Form
Inclusion Reporting – NIH is adding an optional PHS Inclusion Enrollment Report form to FORMS-D application packages. The new form, with additional study descriptors, will replace the optional Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms found in FORMS-C application packages. They will provide more details about these changes prior to release of the updated forms.
Data Safety Monitoring – NIH is adding a new “Data Safety Monitoring Plan” to the following forms in FORMS-D application packages:
PHS 398 Research Plan
PHS 398 Career Development Supplemental Form
PHS Fellowship Supplemental Form
PHS 398 Research Training Program Plan
This new attachment must be included with all applications involving clinical trials.
Although the requirement of a data and safety monitoring plan for clinical trials is not new, the use of a separate attachment to collect this information will emphasize its importance and facilitate systematic enforcement of its presence.
Research Training – NIH is changing the research training data table format. Changes include:
Reducing the number of tables from 12 to 8
Minimizing the reporting of individual-level information
Extending the tracking of trainee outcomes from 10 to 15 years
NIH’s xTRACT system to help applicants prepare the new tables will be available October 16, 2015.
NIH Guide Notice
Appendices – NIH is reevaluating the current appendix policy. A notice describing specific appendix policy changes will be issued by spring 2016.
New PHS Assignment Request Form (Formerly a Cover Letter) - NIH is adding an optional PHS Assignment Request Form to FORMS-D application packages to provide a consistent way to collect application referral information, including:
Awarding component (NIH institute) assignment preference
Study Section preference
List of potential reviewers in conflict, and why
List of scientific expertise needed to review the application
NIH Guide Notice
Font Requirements - NIH is providing additional flexibility regarding the fonts allowed in PDF attachments included in grant applications. Although they will continue to recommend specific fonts, they will also allow other fonts (both serif and non-serif) as long as they comply with specific type density and line spacing guidelines.
NIH Guide Notice
Biosketch Clarifications – NIH is clarifying biosketch instructions. Clarifications include:
Indicating that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography
Allowing publications (peer-reviewed and non-peer-reviewed) and research products to be cited in both the personal statement and the contributions to science sections
Explicitly stating that graphics, figures and tables are not allowed
Phase I Changes – Effective on or after January 25, 2016
Rigor and Transparency in Research – NIH is changing application requirements and review language to enhance reproducibility of research findings through increased scientific rigor and transparency. These changes will take effect for most research grant applications (including small business and complex research grant applications), but will not impact institutional training and individual fellowship applications until Phase II. Changes include:
Updates to application guide instructions for preparing your research strategy attachment
Use of a new "Authentication of Key Biological and/or Chemical Resources" attachment (uploaded in Other Attachments section of R&R Other Project Information form)
Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications
NIH Guide Notice
Vertebrate Animals – NIH is removing redundancy with Institutional Animal Care and Use Committee review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Changes include:
Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia)
A description of veterinary care is no longer required
Justification for the number of animals has been eliminated
A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals
NIH Guide Notice
Definition of Child – NIH is redefining the age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old.
NIH Guide Notice
Research Training – NIH is updating requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form to reflect recent policy guidance and reduce applicant burden. Changes include:
"Recruitment and Retention Plan to Enhance Diversity" - applicants will be asked to focus on recruitment
"Human Subjects" - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information
"Vertebrate Animals" - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
"Progress Report" - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process
Phase II changes – effective on or after May 25, 2016
New grant forms will be released. In addition the following changes will also take effect:
Rigor and Transparency – NIH is extending Phase 1 changes to include institutional training and individual fellowship applications. They are adding a new "Authentication of Key Biological and/or Chemical Resources" attachment to the following forms in FORMS-D application packages:
PHS 398 Research Plan
PHS 398 Career Development Supplemental Form
PHS Fellowship Supplemental Form
New “Plan for the Instruction in Methods for Enhancing Reproducibility” attachment will be added to the PHS 398 Research Training Program Plan form in FORMS-D application packages.
NIH Guide Notice
Vertebrate Animals – NIH is extending Phase 1 changes to include institutional training and individual fellowship applications. They are adding new questions regarding euthanasia to the following forms in FORMS-D application packages to replace the euthanasia criteria in the vertebrate animals section:
PHS 398 Research Plan
PHS Fellowship Supplemental Form
Inclusion Reporting – NIH is adding an optional PHS Inclusion Enrollment Report form to FORMS-D application packages. The new form, with additional study descriptors, will replace the optional Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms found in FORMS-C application packages. They will provide more details about these changes prior to release of the updated forms.
Data Safety Monitoring – NIH is adding a new “Data Safety Monitoring Plan” to the following forms in FORMS-D application packages:
PHS 398 Research Plan
PHS 398 Career Development Supplemental Form
PHS Fellowship Supplemental Form
PHS 398 Research Training Program Plan
This new attachment must be included with all applications involving clinical trials.
Although the requirement of a data and safety monitoring plan for clinical trials is not new, the use of a separate attachment to collect this information will emphasize its importance and facilitate systematic enforcement of its presence.
Research Training – NIH is changing the research training data table format. Changes include:
Reducing the number of tables from 12 to 8
Minimizing the reporting of individual-level information
Extending the tracking of trainee outcomes from 10 to 15 years
NIH’s xTRACT system to help applicants prepare the new tables will be available October 16, 2015.
NIH Guide Notice
Appendices – NIH is reevaluating the current appendix policy. A notice describing specific appendix policy changes will be issued by spring 2016.
New PHS Assignment Request Form (Formerly a Cover Letter) - NIH is adding an optional PHS Assignment Request Form to FORMS-D application packages to provide a consistent way to collect application referral information, including:
Awarding component (NIH institute) assignment preference
Study Section preference
List of potential reviewers in conflict, and why
List of scientific expertise needed to review the application
NIH Guide Notice
Font Requirements - NIH is providing additional flexibility regarding the fonts allowed in PDF attachments included in grant applications. Although they will continue to recommend specific fonts, they will also allow other fonts (both serif and non-serif) as long as they comply with specific type density and line spacing guidelines.
NIH Guide Notice
Biosketch Clarifications – NIH is clarifying biosketch instructions. Clarifications include:
Indicating that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography
Allowing publications (peer-reviewed and non-peer-reviewed) and research products to be cited in both the personal statement and the contributions to science sections
Explicitly stating that graphics, figures and tables are not allowed
Monday, September 28, 2015
Research on the Mechanisms and/or Behavioral Outcome Measures of Multisensory Processing (R01)
Agency: NIH
Program: Research on the Mechanisms and/or Behavioral Outcomes of Multisensory Processing (R01)
Funding Opportunity Number: PA-15-347
Deadline: Standard NIH due dates for new grants – February 5th, June 5th and October 5th
Summary:
This Funding Opportunity Announcement (FOA) invites applications focusing on the mechanisms and/or behavioral outcomes of multisensory processing, the integration or processing of at least two distinct types of sensory input as defined by distinct receptor-type transduction, neural pathways and cognate perceptual quality. Specifically, multiple sensory inputs may include the major traditional modalities of hearing, vision, taste, smell, balance, and touch. Additional submodalities of body senses include but are not restricted to thermosensation, body position and proprioception, pain, itch, and general visceral sensation. This FOA encourages research grant applications investigating multisensory processing in perception or other behavioral and social outcomes and/or the mechanisms underlying multisensory processing in the context of the described specific areas of research interests from the participating ICOs. The FOA is intended to encourage basic, behavioral, and/or clinical research projects focused on two or more sensory modalities or research projects examining the interactions between other neural systems, such as cognitive, affective, or motor processes, and multiple sensory modalities. Multisensory research applications that do not align with the specific areas of research interests described below by the participating NIH Institutes and Centers (ICs) should be submitted in response to the parent R01 FOA, PA-13-302.
Background:
We perceive the world through a variety of senses, including vision, audition, olfaction, gustation, somatosensation (cutaneous and subcutaneous tactile sense, thermosensation, proprioception, nociception, and visceral sensation), and vestibular sensation. In general, the senses are studied separately. However, our experience of the world is mostly unitary; we do not perceive a barking dog as a visual stimulus, a sound, and perhaps a smell, but as a single multisensory object. Accordingly, mounting evidence indicates that the senses cannot be treated as independent channels. That is, perceptions in one modality can be enhanced, attenuated, or completely changed by sensory input from another modality. For example, touch can improve judgments of visual colors, even though touch itself cannot convey color, and vision can alter taste. Furthermore, multisensory processing can influence subsequent unimodal sensory processing (e.g., exposure to simultaneous auditory and visual stimuli can recalibrate the way that each of these stimuli is processed in the future, even in isolation), and can have synergistic effects on neural processing in cognitive, affective, motivational, or motor systems. In addition, there are enormous individual and lifespan differences in sensory processes across different senses, as well as other factors that could contribute to systematically differing perceptions of cross-modal stimuli. For example, research has uncovered a remarkable span of individual differences in gustation (e.g., supertasters), which may make the multisensory perception of flavor vastly different across individuals.
Sensory processes are relevant to a wide variety of health impacts, including neurological, mental and emotional health; consumption (e.g., food and alcohol intake, smoking); basic daily functions (e.g., walking, reaching/grasping); lifestyle activities (e.g., exercise, navigation, dancing, art activities, driving); communication and interpersonal transactions; medical diagnosis, and healthcare utilization. Understanding the scope and the limits of multisensory perception also informs the therapeutic space for sensory substitution in primary sense deficits (e.g. Braille reading for the blind) and temporary sensory alterations caused by disease or treatments for disease. Thus, the interplay among multiple sensory modalities also has important implications for neural, cognitive, behavioral and social science research and for subsequent health outcomes.
Despite growing interest in how individuals integrate these ubiquitous signals, the mechanisms by which different sensory systems are integrated, interact with each other, or influence the processing of the connected neural systems in the brain remain largely unknown. The roles of biochemical and physiological changes, genetics and epigenetics, psychological experiences, or physical environments in regulating multisensory processing are mostly unexplored. Furthermore, the impact of multisensory processing on behavior continues to be understudied.
In 2012, the NIH Basic Behavioral & Social Sciences Research Opportunity Network (OppNet, http://oppnet.nih.gov) sponsored an FOA on Basic Behavioral Research on Multisensory Processing (R21; RFA-EY-13-001), which supported 10 exploratory grants. The current FOA intends to expand on this previous initiative by encouraging studies of the neural circuitry and mechanisms of multisensory processing, in the context of relevant diseases and disorders of the nervous system, or in relevance to social behaviors, clinical diagnostics, or therapies.
Applications to this FOA will be assigned to an appropriate NIH IC according to research priorities of the participating ICs. Relevant assignment factors include primary sense(s) under study, and research impacts within IC funding priorities (see participating IC "Specific Areas of Research Interest" below).
Scope:
This FOA supports innovative studies using animal or human subjects to examine two or more senses (visual, auditory, olfactory, gustatory, somatosensory including pain or other submodalities of body senses, and vestibular) for the elucidation of mechanisms and behavioral outcomes of multisensory processing. Therefore, applications submitted to this FOA should focus on mechanisms, or the behavioral impact, or both. The initiative encourages the use of diverse methodologies, including basic biochemical, molecular, cellular, genetic approaches, neuroimaging and neurophysiological analyses, experimental psychophysics, “real world” settings, immersive virtual technology, and animal models.
For this FOA, applicants should address multisensory integration across at least two of the broadly different senses (smell, sight, taste, touch, hearing, balance) or the submodalities of body senses including but not restricted to thermosensation, body position and proprioception, pain, itch, and general visceral sensation. Audio-visual, visual-vestibular and chemo-tactile integration already have been noted as examples. However, the perception of form by integrating color contrast with shape-from-shading would be considered visual, and integration of linear with angular acceleration would be considered vestibular, and not appropriate here. This FOA also supports research on the interaction of pain (as part of the somatosensation) with other sensory systems.
Applicants are strongly encouraged to contact the Scientific/Research Contacts from various NIH ICs listed in Section VII prior to submission to discuss IC program relevance.
See the full announcement for specific IC interests.
Program: Research on the Mechanisms and/or Behavioral Outcomes of Multisensory Processing (R01)
Funding Opportunity Number: PA-15-347
Deadline: Standard NIH due dates for new grants – February 5th, June 5th and October 5th
Summary:
This Funding Opportunity Announcement (FOA) invites applications focusing on the mechanisms and/or behavioral outcomes of multisensory processing, the integration or processing of at least two distinct types of sensory input as defined by distinct receptor-type transduction, neural pathways and cognate perceptual quality. Specifically, multiple sensory inputs may include the major traditional modalities of hearing, vision, taste, smell, balance, and touch. Additional submodalities of body senses include but are not restricted to thermosensation, body position and proprioception, pain, itch, and general visceral sensation. This FOA encourages research grant applications investigating multisensory processing in perception or other behavioral and social outcomes and/or the mechanisms underlying multisensory processing in the context of the described specific areas of research interests from the participating ICOs. The FOA is intended to encourage basic, behavioral, and/or clinical research projects focused on two or more sensory modalities or research projects examining the interactions between other neural systems, such as cognitive, affective, or motor processes, and multiple sensory modalities. Multisensory research applications that do not align with the specific areas of research interests described below by the participating NIH Institutes and Centers (ICs) should be submitted in response to the parent R01 FOA, PA-13-302.
Background:
We perceive the world through a variety of senses, including vision, audition, olfaction, gustation, somatosensation (cutaneous and subcutaneous tactile sense, thermosensation, proprioception, nociception, and visceral sensation), and vestibular sensation. In general, the senses are studied separately. However, our experience of the world is mostly unitary; we do not perceive a barking dog as a visual stimulus, a sound, and perhaps a smell, but as a single multisensory object. Accordingly, mounting evidence indicates that the senses cannot be treated as independent channels. That is, perceptions in one modality can be enhanced, attenuated, or completely changed by sensory input from another modality. For example, touch can improve judgments of visual colors, even though touch itself cannot convey color, and vision can alter taste. Furthermore, multisensory processing can influence subsequent unimodal sensory processing (e.g., exposure to simultaneous auditory and visual stimuli can recalibrate the way that each of these stimuli is processed in the future, even in isolation), and can have synergistic effects on neural processing in cognitive, affective, motivational, or motor systems. In addition, there are enormous individual and lifespan differences in sensory processes across different senses, as well as other factors that could contribute to systematically differing perceptions of cross-modal stimuli. For example, research has uncovered a remarkable span of individual differences in gustation (e.g., supertasters), which may make the multisensory perception of flavor vastly different across individuals.
Sensory processes are relevant to a wide variety of health impacts, including neurological, mental and emotional health; consumption (e.g., food and alcohol intake, smoking); basic daily functions (e.g., walking, reaching/grasping); lifestyle activities (e.g., exercise, navigation, dancing, art activities, driving); communication and interpersonal transactions; medical diagnosis, and healthcare utilization. Understanding the scope and the limits of multisensory perception also informs the therapeutic space for sensory substitution in primary sense deficits (e.g. Braille reading for the blind) and temporary sensory alterations caused by disease or treatments for disease. Thus, the interplay among multiple sensory modalities also has important implications for neural, cognitive, behavioral and social science research and for subsequent health outcomes.
Despite growing interest in how individuals integrate these ubiquitous signals, the mechanisms by which different sensory systems are integrated, interact with each other, or influence the processing of the connected neural systems in the brain remain largely unknown. The roles of biochemical and physiological changes, genetics and epigenetics, psychological experiences, or physical environments in regulating multisensory processing are mostly unexplored. Furthermore, the impact of multisensory processing on behavior continues to be understudied.
In 2012, the NIH Basic Behavioral & Social Sciences Research Opportunity Network (OppNet, http://oppnet.nih.gov) sponsored an FOA on Basic Behavioral Research on Multisensory Processing (R21; RFA-EY-13-001), which supported 10 exploratory grants. The current FOA intends to expand on this previous initiative by encouraging studies of the neural circuitry and mechanisms of multisensory processing, in the context of relevant diseases and disorders of the nervous system, or in relevance to social behaviors, clinical diagnostics, or therapies.
Applications to this FOA will be assigned to an appropriate NIH IC according to research priorities of the participating ICs. Relevant assignment factors include primary sense(s) under study, and research impacts within IC funding priorities (see participating IC "Specific Areas of Research Interest" below).
Scope:
This FOA supports innovative studies using animal or human subjects to examine two or more senses (visual, auditory, olfactory, gustatory, somatosensory including pain or other submodalities of body senses, and vestibular) for the elucidation of mechanisms and behavioral outcomes of multisensory processing. Therefore, applications submitted to this FOA should focus on mechanisms, or the behavioral impact, or both. The initiative encourages the use of diverse methodologies, including basic biochemical, molecular, cellular, genetic approaches, neuroimaging and neurophysiological analyses, experimental psychophysics, “real world” settings, immersive virtual technology, and animal models.
For this FOA, applicants should address multisensory integration across at least two of the broadly different senses (smell, sight, taste, touch, hearing, balance) or the submodalities of body senses including but not restricted to thermosensation, body position and proprioception, pain, itch, and general visceral sensation. Audio-visual, visual-vestibular and chemo-tactile integration already have been noted as examples. However, the perception of form by integrating color contrast with shape-from-shading would be considered visual, and integration of linear with angular acceleration would be considered vestibular, and not appropriate here. This FOA also supports research on the interaction of pain (as part of the somatosensation) with other sensory systems.
Applicants are strongly encouraged to contact the Scientific/Research Contacts from various NIH ICs listed in Section VII prior to submission to discuss IC program relevance.
See the full announcement for specific IC interests.
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