Can you explain the R61/R33 mechanism, especially from an engineering perspective?
From an engineering perspective, in terms of tool development, the grant will have milestones to be met after the first R61 phase, where the research team will identify what the criteria of the success is for the development stage. The experiments in the R61 should focus on demonstrating those milestones, e.g. what would be needed to really make the tool ready for human testing and demonstrate that it is ready for use in humans. The second phase (R33) of this grant you would validate and test the tool in humans. Note that this RFA is not just for the development of the wearable or the sensor but an integration on the back-end and the R33 phase integration with other data, including invasive data, noninvasive data, physiologic data, etc., that’s not inherent in that sensor.
For the purposes of this RFA, what do you consider as behavior?
Think about behavior very expansively and in terms of multiple dimensions, such as basic peripheral physiology, environment (social and/or physical), any kind of movement, vocalization, and other aspects of behavior. We encourage a broad perspective when considering ways to think about and characterize behavior and the integration of multiple data (neural, environmental, behavioral) to gain the most complete understanding of the brain-behavior relationship.
What do we kind of mean by simultaneous recording in this RFA?
The answer to this question depends on what modalities you choose and what the temporal resolution of those modalities are. When considering real-time recording, the intent is to accelerate/improve the behavioral temporal scale in what is captured in terms of sensors, including interactions of an individual(s) with the environment. We are interested in research that is focused on optimizing designs in terms of addressing both the spatial resolution component and the temporal resolution component of behavioral and neural data, as well as the environmental and/or physiological data—In order to achieve this, the use of and/or combination of various types of modalities may be employed.
Does this RFA focus mostly on cognition in more naturalistic environments?
For this RFA we are interested in behavioral aspects of cognition, as well as other behaviors in naturalistic environments and in a wide range of environments. The focus is on innovation. For example, if the tool for synchronizing brain and behavior already exists, moving that out of the lab into a naturalistic environment would be a way of innovating. Technologies that allow for the capture of natural behaviors that might not occur in the lab e.g., a low-frequency behavior or one that requires a complex environment that only exists in the home, would be innovative. The more naturalistic and more portable the technology is can also add innovation.
What counts as brain data?
This FOA encourages the use of both invasive and noninvasive approaches in order to quantify brain-behavior relationships at a high level of temporal and spatial resolution. This FOA encourages the use of multiple neural, behavioral, and environmental sensing modalities and the ability to integrate all of them in order to gain a more holistic understanding of how the brain gives rise to behavior. Is MRI data considered brain data? MRI could be considered one type of modality; one consideration is that MRI and other similar imaging modalities are limited in terms of the temporal resolution. So, in order to be responsive, consider ways to incorporate other modalities to achieve a time resolution that would allow for answering questions about behavior in real-time using novel tools.
Are studies required to use multimodal approaches for understanding the brain-behavior relationship(s)?
Multimodal techniques are strongly encouraged. Which and how many modalities used in a project will depend on the question(s) being asked and what modalities are most appropriate to answer that question and what modalities are complementary in that space. One of the focuses of this RFA is the incorporation of multimodal approaches and the integration of these multiple data streams (neural data, behavioral data, environmental data, etc.) in order to answer specific questions related to behavior and how brain gives rise to behavior.
How much the emphasis is on the recording/technology aspects verses the computational aspects of projects submitted to the RFA?
This RFA is a phased award (R61/R33) such that the first phase is really focused on innovating the tools, developing the tools, and that can be a computational tool or a software-based tool. This RFA encourages machine learning approaches and artificial intelligence–based approaches to quantifying behavior(s) and the relationships of brain data. The second phase of this award, the R33 phase, is focused on the validation of these approaches/methodology/tools in humans.
Would the study of neurodegenerative disease (or other specific disease states) be okay for this RFA?
Yes, this RFA encourages research being undertaken in health and disease states across a range of patient populations. So, as long as you’re not asking a question related to efficacy in a specific patient group for a specific indication (which would constitute more of a therapeutic clinical trial), and as long as the questions being asked are mechanistic in nature, such that the particular patient population(s) data is aimed at answering mechanistic questions about the brain-behavior relationship, utilizing these populations is within scope of this RFA.
How much preliminary data is recommended?
The answer depends on the state of the technology that is being developed, as well as the goals/objectives of the tool—all of which will inform how much data is required to support a strong application in terms of the rationale for the tool. For example, if the tool is something entirely new, such as creating the tool and getting the preclinical data that would be needed for future trials in humans, the type of data needed to support this application would be different from an application for a tool that is being to repurposed for another use, where there is already a body of data.
What is the definition of a Neuroethicist, as it relates to this FOA?
For the purposes of this FOA, a neuroethicist is someone who explores ethical considerations as they specifically relate to research with the brain. For more information please see the BRAIN Neuroethics page:
The RFA says $10 million for 2024 to fund about 8–10 awards for each year. Is that $10 million budget the total for all 5 years or is it per year?
BRAIN has allocated $10 million to fund the first year of 8–10 projects and $10 million in each of the following fiscal years.
Are multidisciplinary teams required for this RFA?
Multidisciplinary teams are strongly encouraged when applying to this and other BBQS RFAs. It is very important to reach out to colleagues outside of your area(s) of expertise. For instance, if you are sensor expert, reach outside your own silo to integrate different disciplines (behavioral science, data/computational science, neuroscience, etc.) in order address the ambitious goals of this RFA.
Is the Plan for Enhancing Diverse Perspectives (PEDP) a requirement for this FOA?
Yes, this is a requirement for this FOA. If the application does not include a Plan for Enhancing Diverse Perspectives attachment as part of the application, it will be withdrawn and not reviewed. The BRAIN Initiative website provide guidance regarding the PEDP or email your questions to: BRAINInitiative_PEDP@nih.gov