DARPA, the Brain Initiative, and Involuntary Human Test Subjects (aka Targeted Individuals, TIs)

DARPA and the Brain Initiative

https://www.darpa.mil/program/our-research/darpa-and-the-brain-initiative

Webmaster’s Comment: Speaking for the many thousands to many millions of other non-consenting (and uncompensated) human test subjects (aka lab rats/”targeted individuals”) who have lost their civil liberties and their lives for this and related research, we are much relieved to learn from the “Nonsurgical Neural Interfaces Could Significantly Expand Use of Neurotechnology” (2018) report below that:

“DARPA is being similarly proactive in considering the ethical, legal, and social dimensions of more ubiquitous neurotechnology and how it might affect not only military operations, but also society at large. Independent legal and ethical experts advised the agency as the N3 program was being formed, and will continue to help DARPA think through new scenarios that arise as N3 technologies take shape. These individuals will also help to foster broader dialogue about how to maximize societal benefit from those new technologies. Separately, proposers to N3 must also describe mechanisms for identifying and addressing potential ethical and legal implications of their work. As the research advances, published N3 results will further facilitate broad consideration of emerging technologies.”

Personally, I believe any panel of “targeted individuals” should be convened to determine their ethical responsibilities. Most probably, such a panel would conclude that their ethical response would include finding the means to target, torture, torment, and/or otherwise neutralize the DARPA bosses and scientists who conduct this destructive and unethical research.

As prelude to that essential step, we hereby request that DARPA and cooperating research institutions be required to disclose the names of their human test subjects.

The White House announced the BRAIN initiative in April 2013. Today, the initiative is supported by several federal agencies as well as dozens of technology firms, academic institutions, scientists and other key contributors to the field of neuroscience. DARPA is supporting the BRAIN initiative through a number of programs, continuing a legacy of DARPA investment in neurotechnology that extends back to the 1970s. An article in our 60th anniversary magazine provides an overview of the agency’s recent research aimed at expanding the frontiers of the field and enabling powerful, new capabilities.

Electrical Prescriptions (ElectRx)

The ElectRx program aims to help the human body heal itself through neuromodulation of organ functions using ultra-miniaturized devices, approximately the size of individual nerve fibers, which could be delivered through minimally invasive injection.

Work Begins to Support Self-Healing of Body and Mind
ElectRx Has the Nerve to Envision Revolutionary Therapies for Self-Healing
President Obama Highlights New DARPA Program Aimed at Developing Novel Therapies Customized to Individual Patients
Hand Proprioception and Touch Interfaces (HAPTIX)
The HAPTIX program aims to create fully implantable, modular and reconfigurable neural-interface microsystems that communicate wirelessly with external modules, such as a prosthesis interface link, to deliver naturalistic sensations to amputees.

Neuroscience of Touch Supports Improved Robotic and Prosthetic Interfaces
HAPTIX Starts Work to Provide Prosthetic Hands with Sense of Touch
By Restoring Sense of Touch to Amputees, HAPTIX Seeks to Overcome Physical and Psychological Effects of Upper Limb Loss
Neural Engineering System Design (NESD)
The NESD program aims to develop an implantable neural interface able to provide unprecedented signal resolution and data-transfer bandwidth between the brain and the digital world.

Towards a High-Resolution, Implantable Neural Interface

Bridging the Bio-Electronic Divide

Neuro Function, Activity, Structure and Technology (Neuro-FAST)

The Neuro-FAST program seeks to enable unprecedented visualization and decoding of brain activity to better characterize and mitigate threats to the human brain, as well as facilitate development of brain-in-the loop systems to accelerate and improve functional behaviors. The program has developed CLARITY, a revolutionary tissue-preservation method, and builds off recent discoveries in genetics, optical recordings and brain-computer interfaces.

Researchers Identify Conductor of Brain’s Neural Orchestra & Begin to Decode the Score
Advanced CLARITY Method Offers Faster, Better Views of Entire Brain
Next-Generation Nonsurgical Neurotechnology (N3)
The N3 program aims to develop a safe, portable neural interface system capable of reading from and writing to multiple points in the brain at once. Whereas the most advanced existing neurotechnology requires surgical implantation of electrodes, N3 is pursuing high-resolution technology that works without the requirement for surgery so that it can be used by able-bodied people.

Six Paths to the Nonsurgical Future of Brain-Machine Interfaces

Nonsurgical Neural Interfaces Could Significantly Expand Use of Neurotechnology

Reliable Neural-Interface Technology (RE-NET) (Archived)
The RE-NET program seeks to develop the technologies needed to reliably extract information from the nervous system, and to do so at a scale and rate necessary to control complex machines, such as high-performance prosthetic limbs.

Minimally Invasive “Stentrode” Shows Potential as Neural Interface for Brain
Atom-width Graphene Sensors Could Provide Unprecedented Insights into Brain Structure and Function
New Nerve and Muscle Interfaces Aid Wounded Warrior Amputees
Restoring Active Memory (RAM)
The RAM program aims to develop and test a wireless, fully implantable neural-interface medical device for human clinical use. The device would facilitate the formation of new memories and retrieval of existing ones in individuals who have lost these capacities as a result of traumatic brain injury or neurological disease.

Progress in Quest to Develop a Human Memory Prosthesis
Targeted Electrical Stimulation of the Brain Shows Promise as a Memory Aid
Restoring Active Memory Program Poised to Launch
Restoring Active Memory – Replay (RAM Replay)

The RAM Replay program will investigate the role of neural “replay” in the formation and recall of memory, with the goal of helping individuals better remember specific episodic events and learned skills. The program aims to develop novel and rigorous computational methods to help investigators determine not only which brain components matter in memory formation and recall, but also how much they matter.

DARPA Aims to Accelerate Memory Function for Skill Learning
Revolutionizing Prosthetics
The Revolutionizing Prosthetics program aims to continue increasing functionality of DARPA-developed arm systems to benefit Service members and others who have lost upper limbs. The dexterous hand capabilities developed under the program have already been applied to small robotic systems used to manipulate unexploded ordnance, reducing the risk of limb loss among Soldiers.

DARPA Helps Paralyzed Man Feel Again Using a Brain-Controlled Robotic Arm
Neurotechnology Provides Near-Natural Sense of Touch
From Idea to Market in Eight Years, DARPA-Funded DEKA Arm System Earns FDA Approval
Systems-Based Neurotechnology for Emerging Therapies (SUBNETS)
The SUBNETS program seeks to create implanted, closed-loop diagnostic and therapeutic systems for treating neuropsychological illnesses.

Breakthroughs Inspire Hope for Treating Intractable Mood Disorders
Journey of Discovery Starts toward Understanding and Treating Networks of the Brain
SUBNETS Aims for Systems-Based Neurotechnology and Understanding for the Treatment of Neuropsychological Illnesses

Targeted Neuroplasticity Training (TNT)

The TNT program seeks to advance the pace and effectiveness of cognitive skills training through the precise activation of peripheral nerves that can in turn promote and strengthen neuronal connections in the brain. TNT will pursue development of a platform technology to enhance learning of a wide range of cognitive skills, with a goal of reducing the cost and duration of the Defense Department’s extensive training regimen, while improving outcomes.

TNT Researchers Set Out to Advance Pace and Effectiveness of Cognitive Skills Training

Boosting Synaptic Plasticity to Accelerate Learning

2) Bridging the Bio-Electronic Divide

New effort aims for fully implantable devices able to connect with up to one million neurons

OUTREACH@DARPA.MIL
1/19/2016

Bridging the Bio-Electronic Divide

A new DARPA program aims to develop an implantable neural interface able to provide unprecedented signal resolution and data-transfer bandwidth between the human brain and the digital world. The interface would serve as a translator, converting between the electrochemical language used by neurons in the brain and the ones and zeros that constitute the language of information technology. The goal is to achieve this communications link in a biocompatible device no larger than one cubic centimeter in size, roughly the volume of two nickels stacked back to back.

The program, Neural Engineering System Design (NESD), stands to dramatically enhance research capabilities in neurotechnology and provide a foundation for new therapies.

“Today’s best brain-computer interface systems are like two supercomputers trying to talk to each other using an old 300-baud modem,” said Phillip Alvelda, the NESD program manager. “Imagine what will become possible when we upgrade our tools to really open the channel between the human brain and modern electronics.”

Among the program’s potential applications are devices that could compensate for deficits in sight or hearing by feeding digital auditory or visual information into the brain at a resolution and experiential quality far higher than is possible with current technology.

Neural interfaces currently approved for human use squeeze a tremendous amount of information through just 100 channels, with each channel aggregating signals from tens of thousands of neurons at a time. The result is noisy and imprecise. In contrast, the NESD program aims to develop systems that can communicate clearly and individually with any of up to one million neurons in a given region of the brain.

Achieving the program’s ambitious goals and ensuring that the envisioned devices will have the potential to be practical outside of a research setting will require integrated breakthroughs across numerous disciplines including neuroscience, synthetic biology, low-power electronics, photonics, medical device packaging and manufacturing, systems engineering, and clinical testing. In addition to the program’s hardware challenges, NESD researchers will be required to develop advanced mathematical and neuro-computation techniques to first transcode high-definition sensory information between electronic and cortical neuron representations and then compress and represent those data with minimal loss of fidelity and functionality.

To accelerate that integrative process, the NESD program aims to recruit a diverse roster of leading industry stakeholders willing to offer state-of-the-art prototyping and manufacturing services and intellectual property to NESD researchers on a pre-competitive basis. In later phases of the program, these partners could help transition the resulting technologies into research and commercial application spaces.

To familiarize potential participants with the technical objectives of NESD, DARPA will host a Proposers Day meeting that runs Tuesday and Wednesday, February 2-3, 2016, in Arlington, Va. The Special Notice announcing the Proposers Day meeting is available at https://www.fbo.gov/spg/ODA/DARPA/CMO/DARPA-SN-16-16/listing.html. More details about the Industry Group that will support NESD is available at https://www.fbo.gov/spg/ODA/DARPA/CMO/DARPA-SN-16-17/listing.html. A Broad Agency Announcement describing the specific capabilities sought is available at: http://go.usa.gov/cP474.

DARPA anticipates investing up to $65 million in the NESD program over four years.

NESD is part of a broader portfolio of programs within DARPA that support President Obama’s brain initiative. For more information about DARPA’s work in that domain, please visit: http://www.darpa.mil/program/our-research/darpa-and-the-brain-initiative.

Image Caption: The Neural Engineering System Design program aims to develop an implantable neural interface able to provide unprecedented signal resolution and data-transfer bandwidth between the human brain and the digital world. (Source: Shutterstock)

3) Nonsurgical Neural Interfaces Could Significantly Expand Use of Neurotechnology

New program seeks high-resolution neural interfaces for use by able-bodied Service members

OUTREACH@DARPA.MIL

3/16/2018

Image caption: DARPA’s Next-Generation Nonsurgical Neurotechnology program aims to develop a high-resolution, portable neural interface system capable of reading from and writing to multiple points in the brain at once. Such a noninvasive system would extend the power of advanced neurotechnology to able-bodied individuals and could support future Department of Defense efforts to improve human-machine teaming.
Over the past two decades, the international biomedical research community has demonstrated increasingly sophisticated ways to allow a person’s brain to communicate with a device, allowing breakthroughs aimed at improving quality of life, such as access to computers and the internet, and more recently control of a prosthetic limb. DARPA has been at the forefront of this research.

The state of the art in brain-system communications has employed invasive techniques that allow precise, high-quality connections to specific neurons or groups of neurons. These techniques have helped patients with brain injury and other illnesses. However, these techniques are not appropriate for able-bodied people. DARPA now seeks to achieve high levels of brain-system communications without surgery, in its new program, Next-Generation Nonsurgical Neurotechnology (N3).

“DARPA created N3 to pursue a path to a safe, portable neural interface system capable of reading from and writing to multiple points in the brain at once,” said Dr. Al Emondi, program manager in DARPA’s Biological Technologies Office (BTO). “High-resolution, nonsurgical neurotechnology has been elusive, but thanks to recent advances in biomedical engineering, neuroscience, synthetic biology, and nanotechnology, we now believe the goal is attainable.”

Noninvasive neurotechnologies such as the electroencephalogram and transcranial direct current stimulation already exist, but offer nowhere near the precision, signal resolution, and portability required for advanced applications by people working in real-world settings. Potential N3 researchers will face numerous scientific and engineering challenges to bypass those limitations, but by far the biggest obstacle will be overcoming the complex physics of scattering and weakening of signals as they pass through skin, skull, and brain tissue.

“We’re asking multidisciplinary teams of researchers to construct approaches that enable precise interaction with very small areas of the brain, without sacrificing signal resolution or introducing unacceptable latency into the N3 system,” Emondi said. The only technologies that will be considered in N3 must have a viable path toward eventual use in healthy human subjects.

If early program deliverables overcome the physics challenges, along with the barriers of crosstalk and low signal-to-noise ratio, subsequent program goals would include developing algorithms for decoding and encoding neural signals, integrating sensing and stimulation subcomponents into a single device, evaluating the safety and efficacy of the system in animal models, and ultimately testing the technology with human volunteers.

DARPA intends the four-year N3 effort to conclude with a demonstration of a bidirectional system being used in a defense-relevant task that could include human-machine interactions with unmanned aerial vehicles, active cyber defense systems, or other properly instrumented Department of Defense systems. If successful, N3 technology could ultimately find application in these and other areas that would benefit from improved human-machine interaction, such as partnering humans with computer systems to keep pace with the anticipated speed and complexity of future military missions.

“Smart systems will significantly impact how our troops operate in the future, and now is the time to be thinking about what human-machine teaming will actually look like and how it might be accomplished,” Emondi said. “If we put the best scientists on this problem, we will disrupt current neural interface approaches and open the door to practical, high-performance interfaces.”

DARPA has invited federal regulators to participate from the beginning of the N3 program, serving as aids for researchers to help them better understand regulatory perspectives as they begin to develop technologies. Later in the program, these regulators will again serve as a resource to guide strategies for submitting applications, as needed, for Investigational Device Exemptions and Investigational New Drugs.

DARPA is being similarly proactive in considering the ethical, legal, and social dimensions of more ubiquitous neurotechnology and how it might affect not only military operations, but also society at large. Independent legal and ethical experts advised the agency as the N3 program was being formed, and will continue to help DARPA think through new scenarios that arise as N3 technologies take shape. These individuals will also help to foster broader dialogue about how to maximize societal benefit from those new technologies. Separately, proposers to N3 must also describe mechanisms for identifying and addressing potential ethical and legal implications of their work. As the research advances, published N3 results will further facilitate broad consideration of emerging technologies.

DARPA is hosting a Proposers Day on April 3, 2018, in Arlington, Virginia, to provide more information about N3. For additional information, including registration, visit: https://www.fbo.gov/spg/ODA/DARPA/CMO/DARPA-SN-18-38/listing.html.

Full program details will be included in a forthcoming Broad Agency Announcement to be published to the Federal Business Opportunities website.

Image caption: DARPA’s Next-Generation Nonsurgical Neurotechnology program aims to develop a high-resolution, portable neural interface system capable of reading from and writing to multiple points in the brain at once. Such a noninvasive system would extend the power of advanced neurotechnology to able-bodied individuals and could support future Department of Defense efforts to improve human-machine teaming.

4) Six Paths to the Nonsurgical Future of Brain-Machine Interfaces

Teams selected for DARPA’s Next-Generation Nonsurgical Neurotechnology program will pursue a mix of approaches to developing wearable interfaces for communicating with the brain

OUTREACH@DARPA.MIL

5/20/2019

Next-Generation Nonsurgical Neurotechnology (N3)

DARPA has awarded funding to six organizations to support the Next-Generation Nonsurgical Neurotechnology (N3) program, first announced in March 2018. Battelle Memorial Institute, Carnegie Mellon University, Johns Hopkins University Applied Physics Laboratory, Palo Alto Research Center (PARC), Rice University, and Teledyne Scientific are leading multidisciplinary teams to develop high-resolution, bidirectional brain-machine interfaces for use by able-bodied service members. These wearable interfaces could ultimately enable diverse national security applications such as control of active cyber defense systems and swarms of unmanned aerial vehicles, or teaming with computer systems to multitask during complex missions.

“DARPA is preparing for a future in which a combination of unmanned systems, artificial intelligence, and cyber operations may cause conflicts to play out on timelines that are too short for humans to effectively manage with current technology alone,” said Al Emondi, the N3 program manager. “By creating a more accessible brain-machine interface that doesn’t require surgery to use, DARPA could deliver tools that allow mission commanders to remain meaningfully involved in dynamic operations that unfold at rapid speed.”

Over the past 18 years, DARPA has demonstrated increasingly sophisticated neurotechnologies that rely on surgically implanted electrodes to interface with the central or peripheral nervous systems. The agency has demonstrated achievements such as neural control of prosthetic limbs and restoration of the sense of touch to the users of those limbs, relief of otherwise intractable neuropsychiatric illnesses such as depression, and improvement of memory formation and recall. Due to the inherent risks of surgery, these technologies have so far been limited to use by volunteers with clinical need.

For the military’s primarily able-bodied population to benefit from neurotechnology, nonsurgical interfaces are required. Yet, in fact, similar technology could greatly benefit clinical populations as well. By removing the need for surgery, N3 systems seek to expand the pool of patients who can access treatments such as deep brain stimulation to manage neurological illnesses.

The N3 teams are pursuing a range of approaches that use optics, acoustics, and electromagnetics to record neural activity and/or send signals back to the brain at high speed and resolution. The research is split between two tracks. Teams are pursuing either completely noninvasive interfaces that are entirely external to the body or minutely invasive interface systems that include nanotransducers that can be temporarily and nonsurgically delivered to the brain to improve signal resolution.

The Battelle team, under principal investigator Dr. Gaurav Sharma, aims to develop a minutely invasive interface system that pairs an external transceiver with electromagnetic nanotransducers that are nonsurgically delivered to neurons of interest. The nanotransducers would convert electrical signals from the neurons into magnetic signals that can be recorded and processed by the external transceiver, and vice versa, to enable bidirectional communication.

The Carnegie Mellon University team, under principal investigator Dr. Pulkit Grover, aims to develop a completely noninvasive device that uses an acousto-optical approach to record from the brain and interfering electrical fields to write to specific neurons. The team will use ultrasound waves to guide light into and out of the brain to detect neural activity. The team’s write approach exploits the non-linear response of neurons to electric fields to enable localized stimulation of specific cell types.

The Johns Hopkins University Applied Physics Laboratory team, under principal investigator Dr. David Blodgett, aims to develop a completely noninvasive, coherent optical system for recording from the brain. The system will directly measure optical path-length changes in neural tissue that correlate with neural activity.

The PARC team, under principal investigator Dr. Krishnan Thyagarajan, aims to develop a completely noninvasive acousto-magnetic device for writing to the brain. Their approach pairs ultrasound waves with magnetic fields to generate localized electric currents for neuromodulation. The hybrid approach offers the potential for localized neuromodulation deeper in the brain.

The Rice University team, under principal investigator Dr. Jacob Robinson, aims to develop a minutely invasive, bidirectional system for recording from and writing to the brain. For the recording function, the interface will use diffuse optical tomography to infer neural activity by measuring light scattering in neural tissue. To enable the write function, the team will use a magneto-genetic approach to make neurons sensitive to magnetic fields.

The Teledyne team, under principal investigator Dr. Patrick Connolly, aims to develop a completely noninvasive, integrated device that uses micro optically pumped magnetometers to detect small, localized magnetic fields that correlate with neural activity. The team will use focused ultrasound for writing to neurons.

Throughout the program, the research will benefit from insights provided by independent legal and ethical experts who have agreed to provide insights on N3 progress and consider potential future military and civilian applications and implications of the technology. Additionally, federal regulators are cooperating with DARPA to help the teams better understand human-use clearance as research gets underway. As the work progresses, these regulators will help guide strategies for submitting applications for Investigational Device Exemptions and Investigational New Drugs to enable human trials of N3 systems during the last phase of the four-year program.

“If N3 is successful, we’ll end up with wearable neural interface systems that can communicate with the brain from a range of just a few millimeters, moving neurotechnology beyond the clinic and into practical use for national security,” Emondi said. “Just as service members put on protective and tactical gear in preparation for a mission, in the future they might put on a headset containing a neural interface, use the technology however it’s needed, then put the tool aside when the mission is complete.”

Additional details of the program schedule and metrics are available in the 2018 broad agency announcement: https://go.usa.gov/xmK4s.

# #
Media with inquiries should contact DARPA Public Affairs at outreach@darpa.mil

Targeted Electrical Stimulation of the Brain Shows Promise as a Memory Aid

Research could lead to therapies for wounded warriors and others with memory deficits caused by traumatic brain injury or disease
OUTREACH@DARPA.MIL

9/11/2015

DARPA’s Restoring Active Memory (RAM)

Electrical arrays implanted in the memory centers of the brain are showing promise for their ability to help patients improve their scores on memory tests, raising hope that such approaches may someday help individuals suffering from memory deficits as a result of traumatic brain injury or other pathologies. The preliminary findings, from DARPA’s Restoring Active Memory (RAM) program, were presented in St. Louis on Thursday at Wait, What? A Future Technology Forum, hosted by the Agency.

Just over one year into the effort, the novel approach to facilitating memory formation and recall has already been tested in a few dozen human volunteers, said program manager Justin Sanchez. The subjects in the study have neurological problems unrelated to memory loss, but volunteered to test the new neurotechnological interventions while they were undergoing brain surgery. In the study, small electrode arrays are placed in brain regions known to be involved in the formation of declarative memory—the relatively simple sort of memory used, for example, to recall lists of objects—as well as in regions involved in spatial memory and navigation.

The study aims to give researchers the ability to “read” the neural processes involved in memory formation and retrieval, and even predict when a volunteer is about to make an error in recall. The implanted electrodes also provide a means of sending signals to specific groups of neurons, with the goal of influencing the accuracy of recall.

Initial results indicate that it is indeed possible to capture and interpret key signals or “neural codes” coming from the human brain during memory encoding and retrieval, and improve recall by providing targeted electrical stimulation of the brain.

“Everyone has had the experience of struggling to remember long lists of items or complicated directions to get somewhere,” Sanchez said. “Today we are discovering how implantable neurotechnologies can facilitate the brain’s performance of these functions.”

Among other details, Sanchez said, the work is addressing the important issue of the ideal timing of electrical stimuli involved in the neural codes. “Should we provide electrical inputs when the lists are first being taught and memorized, or should we stimulate when the person is working to recall those items? We still have a lot to learn about how the human brain encodes declarative memory, but these early experiments are clarifying issues such as these and suggest there is great potential to help people with certain kinds of memory deficits,” Sanchez said.

Details about the early RAM results are being withheld for now, Sanchez said, pending peer review and publication in one or more scientific journal articles.

In related work, DARPA is about to launch a new effort to develop neurotechologies that may help individuals not just better remember individual items but learn physical skills. Complex skills can take people years to master, and it’s not just repetition of the physical movements that matters. The process also often involves the repeated mental and physiological “replaying” of the skill during wakefulness and sleep to solidify the skill. DARPA’s RAM Replay program, poised to begin in October, will aim to shed light on this replay process through a combined approach of studying direct neural and physiological interfaces, environmental cues, and the sleep-wake cycle. The selected performers will study the role of replay in the consolidation of episodic memories and newly learned skills, as well as how these memories are recalled and used by people during subsequent task performance.

Meanwhile, promising preliminary results also are coming out from DARPA’s Systems-Based Neurotechnology for Emerging Therapies (SUBNETS) program, Sanchez noted, which aims to provide relief for patients with post-traumatic stress disorder and other neuropsychiatric conditions.

Just one year into the SUBNETS effort, engineers at the Lawrence Livermore National Laboratory and Draper Laboratory have produced customized electrode arrays and miniaturized neural interface hardware, prototypes of which are on display at this week’s Wait, What? event in St. Louis. The prototypes include microfabricated electrode arrays that are flexible and can interface with large numbers of neurons; fully implantable hardware to amplify and interpret brain signals; and new circuitry to deliver precise, function-restoring feedback to the brain.

In the first clinical tests of some of these technologies, researchers at the University of California, San Francisco, placed arrays on the brains of seven patients and, by providing electrical impulses to a specific neuronal region, markedly reduced the patients’ anxiety levels.

“As the technology of these fully implantable devices improves, and as we learn more about how to stimulate the brain ever more precisely to achieve the most therapeutic effects, I believe we are going to gain a critical capacity to help our wounded warriors and others who today suffer from intractable neurological problems,” Sanchez said. “It is a very complex and challenging frontier, but one I am convinced we will learn to navigate and leverage to good effect in people who today have no effective therapeutic options.”

For more information about DARPA’s Wait, What? event, please visit: https://archive.darpa.mil/WaitWhat/.

5) BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional)

https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-19-400.html

https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-19-400.html

BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional)
Activity CodeR01 Research Project Grant
Announcement TypeReissue of RFA-MH-18-500
Related Notices
March 10, 2020 – Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
August 23, 2019 – Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
July 26, 2019 – Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
January 22, 2019 – Notice of Data Sharing Policy for the BRAIN Initiative. See Notice NOT-MH-19-010.
Funding Opportunity Announcement (FOA) NumberRFA-MH-19-400
Companion Funding OpportunityNone
Number of ApplicationsSee Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.242, 93.213; 93.286; 93.853; 93.866; 93.866; 93.279; 93.865; 93.173; 93.273

Funding Opportunity Purpose

This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, is one of several FOAs aimed at supporting transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” this FOA specifically seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative.

Efforts supported under this FOA are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

Key Dates
Posted DateOctober 17, 2018
Open Date (Earliest Submission Date)January 04, 2019
Letter of Intent Due Date(s)30 days prior to the application due dates
Application Due Date(s)February 4, 2019, October 9, 2019 and October 9, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)Not Applicable
Scientific Merit ReviewJune 2019, ?February 2020, February 2021
Advisory Council ReviewAugust 2019, May 2020, May 2021
Earliest Start DateSeptember 2019, July 2020, July 2021
Expiration DateOctober 10, 2020
Due Dates for E.O. 12372Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents

Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This FOA is based on careful consideration by the NIH of the recommendations in the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

NIH encourages BRAIN Initiative applications from investigators that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.

NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs (http://braininitiative.nih.gov/funding/index.htm).

In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research.

The BRAIN Initiative will require a high level of coordination and sharing between investigators. While this FOA does not use a cooperative agreement mechanism, it is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.

This FOA is related to the Recommendations in the BRAIN 2025 report (http://www.nih.gov/science/brain/2025/index.htm). Specifically, this FOA solicits applications that will address recommendations from “Section III- Implementation: Goals, Deliverables, Timelines and Costs” of the Final Report regarding the “Ethical conduct of research” and “Ethical and societal implications of new technologies and scientific discoveries”.

Research Objectives

One of the defined themes in the BRAIN 2025 report is: “Considers ethical implications of neuroscience research.” Although ethical issues that are common to other areas of biomedical science also impact brain research, there are special ethical considerations unique to brain research. Considering that the brain gives rise to consciousness, our innermost thoughts, and our most basic human needs, it comes as no surprise that mechanistic studies of the brain have revealed novel social and ethical questions. With respect to research supported by the BRAIN Initiative, it is clear there are additional ethical issues in areas such as brain imaging and modulation, data privacy, informed consent, and several additional opportunities that warrant focused attention. It is clear that these critical issues should be considered both through thoughtful discussion and empirical research. Specifically, BRAIN 2025 describes the importance of “Support for data-driven research to inform ethical issues arising from BRAIN Initiative research, ideally with integrated activities between ethicists and neuroscientists.” In addition, feedback solicited through a recent BRAIN Neuroethics Request for Information underscores that the broader public and scientists alike endorse that scientific advances and technology development are well-served by thoughtful consideration of potential ethical issues.

This FOA seeks to provide opportunities to directly consider the integration of ethical issues with BRAIN-supported scientific advances. Specifically, this FOA seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements in research and development supported by the BRAIN Initiative. The hope is that efforts supported under this initiative might be both complimentary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

While there are many ethical topics that might be suitable for leveraging an integrated research approach, input from the Neuroethics Working Group (https://braininitiative.nih.gov/about/neuroethics.htm) of the BRAIN Multi-Council Working Group and feedback from a Request For Information (RFI) on BRAIN Neuroethics has helped inform priority areas of ethics best suited for this FOA. Indeed, the BRAIN Initiative currently supports several research project grants focused on neuroethics. For this FOA, applications that focus on the following areas relevant to the BRAIN Initiative would be considered of particular interest:

Research on risk/benefit analyses and informed consent practices in human neuroscience research with neural devices, and long-term obligations to patient populations

Studies that probe the ethical implications/considerations of both collecting large volumes of brain data and the sharing of such for broader scientific purposes
Studies that explore the evolving richness of collected human neural data and considerations such as data ownership, access, de-identification and re-use practices, privacy, and unintended uses
Studies that consider the ethical implications of evolving neuromodulation and neuroimaging technologies, specifically as they pertain to the infrastructure of these technologies (activation and monitoring of devices, long-term maintenance, data security, intended and unintended use of these new technologies)
Studies that empirically consider different perspectives on the distinction between invasive versus non-invasive brain imaging and/or neuromodulation; particularly as those views are similar or different between groups such as participants, researchers, physicians, families, and the broader public view

The ethical implications of access to and use of emerging neurotechnologies and their relationship to informed consent (participant perspective on the consent process, consent with special populations, changes in consent capacity associated with disease progression)
Ethical issues unique to research that leverages opportunities with human brain tissue
Ethical issues associated with predictive/diagnostic research related to brain disorders
Public, researcher, and/or research participant attitudes and decision-making about monitoring or modulating brain function for purposes of improving our understanding of human brain function and/or reducing illness and disability due to brain diseases and disorders
Cybersecurity/privacy considerations, such as effective security and safeguards for human brain data and wireless transmissions to/from neural devices; gaps/provisions needed in existing regulatory models
Studies focused on the advances in neural recording and/or neuromodulation specifically for use in children
Research efforts to link neural data with behavioral data to better understand and/or diagnose brain diseases and disorders
All potential applicants are strongly encouraged to consult the Scientific/Research Contacts listed below to discuss the alignment of their proposed work with the FOA goals.

Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types AllowedNew
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?Optional: Accepting applications that either propose or do not propose clinical trial(s)
Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards
Issuing IC and partner components intend to commit an estimated total of $3 million in FY2019 to fund up to 8 awards.

Award Budget
Application budgets are limited to $300,000 in direct costs in any project year and need to reflect the actual needs of the proposed project.

Award Project PeriodThe scope of the proposed project should determine the project period. The maximum project period is 4 years?.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants
Eligible Organizations
Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government – including the NIH Intramural Program
U.S. Territory or Possession
Other
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Required Registrations
Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) – All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons – Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)
Section IV. Application and Submission Information
1. Requesting an Application Package
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity
The letter of intent should be sent to:

nimhpeerreview@mail.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
Applications must provide clear evidence that the proposed research team is comprised of highly skilled investigators in all areas of interdisciplinary science needed to advance the proposed research. Where appropriate, applicants are encouraged to propose embedding ethicists into BRAIN Initiative-supported research projects.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Research supported through this FOA should focus on novel, transformative approaches that thoughtfully consider the integration of ethical considerations with evolving advancements in BRAIN Initiative research. Applicants should make a compelling case as to why a specific ethical topic is particularly fertile for exploration at this point in time and how it relates to advancements in the type of research that the BRAIN Initiative supports. Applicants should describe how the proposed research will revolutionize how we think about ethics and/or integration of ethical considerations as research is planned and conducted. Sufficient details should be provided regarding the methodological approach and discussion of how this line of research will be beneficial to brain research as well as the broader public. Finally, consideration regarding additional research that might stem from the proposed project should be described.

Current State-of-the-Art Statement: Investigators should clearly state the specific goals of their application, to include defining the current state of the science/technology as a benchmark against which the proposed research will be measured. Critically, applicants should provide an assessment of how their application will advance beyond the state-of-the-art, with an emphasis on the current specific ethical issues they expect to understand/improve, and how the proposed studies will enable and guide transformative advances in brain science.

High-risk projects with limited preliminary results are welcome if they have suitable high impact. A sound rationale should be provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful.

Project Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes operationally-defined indicators of progress at critical junctures. These junctions include the translation from pilot research, if needed, to the translational efforts to systematically integrate advancements in ethical research into brain research. These milestones should be tailored to the unique scope of each project and written concretely enough to evaluate exactly what will be achieved during the course of the project. This should include the specific proof-of-concept test(s), if applicable, that will indicate how the proposed approaches will be tested and validated along with alternative strategies should an effort fail to perform as expected. The application should describe the potential implications of how the proposed research might extend beyond the purview of BRAIN Initiative supported research. Investigators should describe how results will be used to inform future phases of research and development, and how our current ethics standards will be transformed by the findings from the proposed research.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.

6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Has the state of the art been accurately described? Are sufficient details discussed of how this line of research will be beneficial to brain research as well as the broader public? Has a compelling case as to why a specific ethical topic is particularly fertile for exploration at this point in time and how it relates to advancements in the type of research that the BRAIN Initiative supports been established? Will the proposed research lead to transformative advancements in our understanding of ethical issues that should be considered in light of evolving brain science and technological advancements? If the proposed research is successful, will the implications of this research extend beyond the purview of BRAIN Initiative supported research? Will the results from this project inform future phases of research and development and how our current ethics standards might be transformed?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application have highly skilled investigators in all areas of interdisciplinary science needed to advance the research? If appropriate, does the proposed research leverage an embedded ethicist approach?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Do the specific goals of the application include defining the current state of the science/technology as a benchmark against which the proposed research will be measured? Is there an assessment of how the proposed research will advance beyond the state-of-the-art, with an emphasis on the current specific ethical issues they expect to understand/improve? If the project is high-risk with limited preliminary results, has a sound rationale been provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful? Are the proposed milestones operationally-defined and appropriate indicators of progress at critical junctions? Are these milestones tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project? Is there discussion of the translational efforts to systematically integrate advancements in ethical research into brain research? Are there specific proof-of-concept test(s) that indicate how the proposed approaches will be tested and validated, along with alternative strategies should an effort fail to perform as expected? Does the application consider where additional research might arise from the proposed project?Are sufficient details provided regarding the methodological approach?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trialss

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Study Timeline

For FOAs that allow but do not require clinical trials (“CT-optional FOAs”), include the heading below. These questions should be placed below any FOA-specific questions that apply to both CT and non-CT applications

Specific to applications involving clinical trials

For all CT FOAs, add the following questions, before the Human Subjects Protections criterio

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Mental Health, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices
If the application is under consideration for funding, NIH will request “just-in-time” information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the “responsible party” must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption

Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award
Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)
James Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3621
Email: James.Churchill@nih.gov

Khara Ramos, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-594-92614
Email: ramoskm@ninds.nih.gov

Peer Review Contact(s)
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Financial/Grants Management Contact(s)
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

One Reply to “DARPA, the Brain Initiative, and Involuntary Human Test Subjects (aka Targeted Individuals, TIs)”

  1. Knowing that Neighbor Nazi stalkers would “overhear” me, I started reading this information in a loud tone of voice, inserting my own commentary. Naturally, the on-duty Nazi made my phone ring (one of the ways they express their displeasure at me). 🙂

    You know, I do think we ought to get up our own study and apply for funding. It would be really great to get $300,000 to try to figure out what’s going on in the (admittedly microscopic) brains of these mad scientists and their psychopathic minions. We’d need a really, really strong microscope, though! Dr. Karlstrom, you can be the P.I.

Leave a Reply

Your email address will not be published. Required fields are marked *