July 26, 2023
- May 12, 2020 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required). See NOFO PA-20-201.
- May 12, 2020 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required). See NOFO PA-20-202.
- May 12, 2020 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed). See NOFO PA-20-203.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
The purpose of this Notice of Special Interest (NOSI) is to promote the availability of Mentored Clinician Scientist Research Career Development Awards (K08) applications in research areas covered by the NIH BRAIN Initiative . This program will provide support and protected time (3-5 years) for clinicians to develop new and/or expand their expertise in intracranial human neuroscience research. The goal of the program is to build an interdisciplinary and diverse research workforce dedicated to capitalizing on intracranial neural recording and/or stimulating technologies to answer high-impact questions in human neuroscience.
Background
Since 2014, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.
As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN Initiative were initially guided by the "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Notices of Funding Opportunity (NOFOs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.
The NIH BRAIN Initiative recognizes that teams comprised of individuals with a diversity of experiences and perspectives that work together often outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031.
The BRAIN Initiative: Research Opportunities in Intracranial Human Neuroscience
Investigations within the human brain offer revolutionary, but challenging, opportunities for experimental investigation of how the human brain senses, perceives, remembers, plans, makes decisions, registers emotions, and activates movements. Invasive surgical procedures offer the opportunity for unique intracranial interventions, such as the ability to record and stimulate neurons within precisely localized brain structures in humans. The BRAIN Initiative is committed to research that adheres to the highest ethical standards. Human studies using intracranial technology are often constrained by a limited number of patients and available resources, and frequently the resulting datasets need to be aggregated across sites to achieve sufficient statistical power. To overcome these fundamental barriers and to investigate high-impact questions in human neuroscience, diverse, integrated, multi-disciplinary teams need to be assembled.
Objectives
Clinician scientists are a critical component of the multidisciplinary team-science approach. The purpose of the BRAIN Initiative Mentored Clinician Scientist Research Career Development Awards (K08) program is to provide salary and research support for a sustained period of "protected time" (3-5 years) for individuals with clinical doctoral degrees (e.g., MD, DDS, DMD, DO, DC, OD, ND, DVM, PharmD, or PhD in clinical disciplines) to newly develop and/or expand their expertise in intracranial human neuroscience research, and to build an interdisciplinary and diverse research workforce dedicated to capitalizing on intracranial neural recording and/or stimulating technologies.
This NIH BRAIN K08 program may be used by clinician scientists with different levels of prior human neuroscience research training and at different stages in their mentored career development. For example, a candidate with limited experience in human neuroscience research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience in human neuroscience, specifically focusing on intracranial human neuroscience research. A candidate with previous human neuroscience research experience and training may not require extensive additional didactic preparation and may use an award to support a career development experience that focuses on an intensive, supervised intracranial human neuroscience research experience. This program should strengthen the candidate’s potential to contribute vital clinical or methodological/technological perspectives to investigate high-impact questions in human neuroscience by providing protected time to develop or update research skills, conduct rigorous research that adheres to high ethical standards, advance research career plans, generate preliminary data, engage interdisciplinary research teams, and seek independent funding.
Responsive Areas of Research
The list below includes representative, but not exhaustive, examples of activities in human subjects that could be considered responsive to this NOSI.
- Utilize direct intracranial recording, interventions (e.g., tract transections) and/or stimulation to answer high-impact questions in human neuroscience.
- Integrate non-invasive technologies to image and/or perturb the nervous system for use in conjunction with invasive implants to cross spatial and temporal scales.
- Propose a combination of quantitative psychophysics and behavioral assays in combination with brain recording or stimulating that test mechanistic hypotheses. Behavioral assays with time resolution comparable to neural recording assays are strongly encouraged.
- Utilize approved, chronic implants, (e.g., DBS implants; FDA-approved indwelling electrodes) to address mechanistic hypotheses about brain function, plasticity, etc.
Topics Supported
The list below includes representative, but not exhaustive, examples of topics that could be considered responsive to this NOSI.
Independent Clinical Trial Not Allowed Studies:
These studies should use parent NOFO PA-20-203, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed). This NOFO is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this NOFO are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFO, PA-20-202.
- Human research studies as mechanistic investigations. A mechanistic investigation is designed to understand a biological or behavioral process.
- Investigative studies for understanding the neurobiology of cognitive functions specifically advanced in humans.
- Approaches to understanding network coding of sensory information.
- Paradigms to assess motor coding during complex behaviors.
- Approaches to understand neural circuitry associated with social behaviors.
- Circuit functions underlying the brain's ability to store information and to learn new behaviors (plasticity).
- New approaches designed to capture and assess information processing across brain regions during memory consolidation, memory retrieval, learning, spatial/relational processing, attention, or planning.
- Assessment of distributed representations and information processing associated with advanced mental processes such as language, decision-making, numerical cognition, reasoning, consciousness, and metacognition.
- Investigation of distributed circuits that contribute to the coordination of motivational states and reward behavior.
- Empirical and analytical approaches to understand how behavioral states are emergent properties of the interaction of neurons, circuits, and networks.
Independent Basic Experimental Studies Involving Humans (BESH) Required Studies:
BESH are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. These studies should use parent NOFO PA-20-201, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required). These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should be submitted under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Applicants not planning an independent clinical trial or basic experimental study with humans, or proposing to gain research experience in a clinical trial or basic experimental study with humans led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion NOFO, PA-20-203.
- Human research studies as mechanistic investigations. A mechanistic investigation is designed to understand a biological or behavioral process.
- Investigative studies for understanding the neurobiology of cognitive functions specifically advanced in humans.
- Approaches to understanding network coding of sensory information.
- Paradigms to assess motor coding during complex behaviors.
- Approaches to understand neural circuitry associated with social behaviors.
- Circuit functions underlying the brain's ability to store information and to learn new behaviors (plasticity).
- New approaches designed to capture and assess information processing across brain regions during memory consolidation, memory retrieval, learning, spatial/relational processing, attention, or planning.
- Assessment of distributed representations and information processing associated with advanced mental processes such as language, decision-making, numerical cognition, reasoning, consciousness, and metacognition.
- Investigation of distributed circuits that contribute to the coordination of motivational states and reward behavior.
Independent Clinical Trial (non-BESH) Required Studies:
These studies should use parent NOFO PA-20-202, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required).
- First in human clinical trials designed to answer specific questions about safety, tolerability, efficacy, and/or effectiveness of device (invasive or non-invasive) interventions.
Applications Not Responsive to this NOSI
Studies that are not responsive to this NOSI and will not be reviewed include the following:
- Studies for which the primary goal is to achieve regulatory approval of neurotechnology (see http://braininitiative.nih.gov/ for other BRAIN NOFOs supporting this activity, and the NIH bioengineering grant program https://www.nibib.nih.gov/research-funding/bioengineering-research-partnerships) or the peripheral nervous system (see NIH SPARC http://commonfund.nih.gov/sparc/index).
- Imaging approaches not coupled with intra-cranial interventions, recording, or stimulating.
- Implementing rehabilitation therapies.
- Projects focused on augmentation of neural function in healthy individuals.
- Applications that do not include information on neuroethical considerations.
Applicants are strongly encouraged to consult Program Staff regarding the appropriateness of the planned application to the BRAIN Initiative’s mission, scientific areas of interests and programmatic priorities. When applying applicants should apply to the parent K08 NOFO, citing this NOSI, that best fits their scientific project. Non-BESH clinical trials should use the ‘clinical trial required’ K08 NOFO, PA-20-202.
Application and Submission Information
This NOSI applies to the due date on February 12th, 2024 only.
Submit applications for this initiative using one of the following notices of funding opportunity (NOFOs) or any reissues of these announcements through the expiration date of this notice.
Because of the differences in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts for PA-20-201, Table of IC-Specific Information, Requirements and Staff Contacts for PA-20-202, and Table of IC-Specific Information, Requirements and Staff Contacts for PA-20-203, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.
PA-20-201 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required).
PA-20-202 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required).
PA-20-203 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed).
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
- For funding consideration, applicants must include “NOT-AA-23-011” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
- All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to the NDA.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.
General Contact(s)
Ivana Grakalic, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the BRAIN Initiative
Telephone: 301-443-7600
Email: igrakalic@mail.nih.gov
Scientific/Research Contact(s)
Merav Sabri, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD) and the BRAIN Initiative
Telephone: 301-827-0908
Email: merav.sabri@nih.gov
Peer Review Contact(s)
RV Srinivas, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@drg.nih.gov
Financial/Grants Management Contact(s)
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov
and Human Services (HHS)
