Showing posts with label R01. Show all posts
Showing posts with label R01. Show all posts

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

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.

Wednesday, August 12, 2015

U.S. - India Collaborative Vision Research Program (R01)


Agency: NEI
Program: U.S. - India Collaborative Vision Research Program (R01)
Deadline: November 9, 2015; November 9, 2016; November 9, 2017

Summary:

This funding Opportunity Announcement (FOA) encourages 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.  The U.S.-India Collaborative Vision Research Program is designed to develop collaborations between scientists and institutions in the United States and India to conduct high quality vision research of mutual interest and benefit to both countries while developing the basis for future institutional and individual scientific collaborations.

This FOA is intended to support collaborations between the U.S. and India that focus on the basic biology and/or genetics of ophthalmic diseases including diabetic retinopathy and ocular inflammation, using the unique resources that exist in India, such as large families with extensive pedigrees.  Research examples include, but are not limited to:

- Family based genome wide association studies (GWAS) on cohorts of consanguineous families from India to identify genetic factors that predispose to both Mendelian and complex forms of eye diseases.
- Deep sequencing to examine existing genetic variants identified in other populations;
- Validation of novel GWAS findings in appropriate animal models;
- Identification of biomarkers that predict and/or assess risk and response to interventions;
- Define the contributions of specific genetic risk factors and environmental exposures that underlie eye diseases;
- Studies on birth cohorts in India to determine the effects of the environment on the development of factors that predict risk influencing eye diseases such as imprinting and other epigenetic effects.

Full Announcement