This grant is for researchers who want to conduct small clinical trials to test new devices that record or stimulate the brain. These trials help gather important information needed to improve these devices, which could treat brain disorders or help us understand the brain better. The trials can be short-term and low-risk or involve more significant risk, needing special approval. The goal is to gather data that can't be obtained through other methods like lab or animal studies.
Who it's for: This grant is suitable for a wide range of applicants, including public and private universities, non-profit organizations, small businesses, state and local governments, tribal organizations, and for-profit entities. It's ideal for those involved in clinical research and development of brain-related devices.
More details
Likely Disqualifiers
- Lack of IRB approval for NSR studies
- No FDA IDE for SR studies
- Insufficient existing safety and utility data
- Proposals not involving clinical trials
- Proposals not focused on brain-related devices
What You May Need
- Institutional Review Board (IRB) approval
- Investigational Device Exemption (IDE) from FDA
- Detailed clinical trial plan
- Partnership with device manufacturers
- Existing safety and utility data
- Memoranda of Understanding (MOU) with manufacturers
- Budget proposal
- Research team qualifications
- Timeline for clinical trial
- Non-clinical testing data
Cautions
- Ensure all necessary approvals are obtained before applying
- Device must have sufficient existing data for safety and utility
- Trial must provide unique data not obtainable through other methods
- Partnerships with manufacturers may be required
Generated from official source details for readability
Eligibility
Eligible Applicant Types
Additional Criteria
This grant is suitable for a wide range of applicants, including public and private universities, non-profit organizations, small businesses, state and local governments, tribal organizations, and for-profit entities. It's ideal for those involved in clinical research and development of brain-related devices.
Overview
This grant is suitable for a wide range of applicants, including public and private universities, non-profit organizations, small businesses, state and local governments, tribal organizations, and for-profit entities. It's ideal for those involved in clinical research and development of brain-related devices.
Likely Disqualifiers
- Lack of IRB approval for NSR studies
- No FDA IDE for SR studies
- Insufficient existing safety and utility data
- Proposals not involving clinical trials
- Proposals not focused on brain-related devices
Use of Funds
Funds can be used to conduct small clinical trials that test the function and design of new brain-related devices. This includes covering costs related to trial setup, data collection, and analysis, as well as obtaining necessary approvals and partnerships.
Cost Sharing
Not Required
Important Dates
- Posted
- Nov 5, 2024
- Deadline
- Sep 28, 2026(107 days)
- Archive Date
- Nov 3, 2026
- Last Updated
- Nov 14, 2024
- Est. Award Date (AI estimate)
- Winter 2026
Application Checklist
- Confirm eligibility as an applicant type
- Secure IRB approval for NSR studies
- Obtain FDA IDE for SR studies
- Develop a detailed clinical trial proposal
- Gather existing safety and utility data
- Establish partnerships with device manufacturers
- Draft a budget and timeline for the trial
- Prepare team qualifications and experience documentation
- Submit Memoranda of Understanding (MOU) if applicable
- Ensure trial addresses unique data collection needs