Single IRB Plan for NIH Grant Applications
This file details the requirements for the Single IRB Plan related to NIH grant applications. It includes information on compliance, supporting documentation, and the application process. Essential for researchers involved in multi-site studies seeking NIH funding.
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How do I fill this out?
To fill out this form, begin by gathering all required information before starting the application process. Ensure you are familiar with the sIRB policy and how it applies to your study. Finally, follow the instructions provided in the application guide for a seamless submission.
How to fill out the Single IRB Plan for NIH Grant Applications?
1
Gather all necessary information and documentation.
2
Familiarize yourself with the sIRB policies and requirements.
3
Complete the new FORMS-E application including the sIRB plan.
4
Obtain Letters of Support from required institutions.
5
Submit your application by the NIH deadline.
Who needs the Single IRB Plan for NIH Grant Applications?
1
Researchers applying for NIH multi-site grants.
2
Institutional Review Boards (IRBs) overseeing studies.
3
Grant administrators needing to verify compliance.
4
Principal Investigators (PIs) coordinating approvals.
5
Participating sites' representatives confirming arrangements.
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What are the instructions for submitting this form?
To submit this form, complete all required sections and attach necessary documentation. Send your completed application package to the NIH via the designated online submission portal. Ensure that all Letters of Support are included and that your application meets the specified deadlines for proper consideration.
What are the important dates for this form in 2024 and 2025?
Important dates for the sIRB Plan include submission deadlines aligned with NIH grant application cycles. Researchers should be aware of upcoming application deadlines typically set in January and July of each year. Keeping these dates in mind ensures compliance and timely submissions.
What is the purpose of this form?
The purpose of the Single IRB Plan is to streamline the process of institutional review for multi-site research studies. It ensures compliance with NIH policies by providing a centralized review of research protocols, enhancing efficiency in the approval process. This plan promotes collaboration amongst sites while maintaining the integrity of the research conducted.
Tell me about this form and its components and fields line-by-line.
- 1. Name of sIRB: The name of the Institutional Review Board designated as the sIRB.
- 2. Compliance Description: A description of how the study complies with the sIRB requirements.
- 3. Communication Plan: Details on how communication will be structured between sites and the sIRB.
- 4. Reliance Agreement: Confirmation of the reliance agreement signed by all participating sites.
- 5. Supporting Documentation: Letters of Support from relevant parties, confirming agreement with the sIRB plan.
What happens if I fail to submit this form?
Failing to submit the sIRB Plan can result in application rejection and delayed study initiation. This can adversely affect project timelines and funding availability. Therefore, it's critical to ensure all forms are submitted accurately and on time.
- Delayed Project Start: Without submission, the project cannot commence, impacting research timelines.
- Funding Issues: Failure to meet submission requirements may jeopardize grant funding opportunities.
- Compliance Risks: Not submitting the plan can lead to non-compliance with NIH regulations.
How do I know when to use this form?
- 1. Multi-site NIH Grants: Required for any multi-site studies when applying for NIH funding.
- 2. IRB Compliance: Ensures that all participating sites agree to the sIRB process.
- 3. Study Coordination: Facilitates communication and compliance across various research locations.
Frequently Asked Question
What is a Single IRB Plan?
A Single IRB Plan outlines how a single Institutional Review Board will review research studies that involve multiple sites.
Who needs to submit this plan?
Researchers and their institutions involved in NIH multi-site studies must submit this plan as part of their grant application.
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What information is required in the sIRB plan?
The sIRB plan must include details on compliance, the IRB serving as record, and communication strategies between sites.
How do I submit the sIRB Plan?
The sIRB Plan is submitted as part of the FORMS-E application to NIH.
Is a Letter of Support necessary?
Yes, Letters of Support from the sIRB and participating sites are essential for the application.
What if there are delays in multi-site research?
A delayed-onset justification must be provided if there is no detailed human subjects involvement plan at submission.
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