US National Institutes of Health (NIH)

The NIH has 27 institutes and centres (ICs), each focused on a specific disease area, body system, health priorities or life stage and each provides funding primarily through grant programs. The NIH provides uniform guidance for proposals and submission procedure via their Application guide. 

Find funding opportunities using NIH matchmaker enter abstracts or other scientific text to find potential Program Officials and ICs for your research.

Key dates are located within each Funding Opportunity Announcement (FOA).

The Macquarie University submission date is 4 weeks prior to the funding agency due date and requires the full draft application to be submitted via PURE.

Beginning 25 January 2023

NIH requires researchers to submit a Data Management and Sharing Plan. This policy applies to all research, funded or conducted in whole or in part by the NIH, that results in the generation of scientific data. A Plan will be submitted with any grant application. Plans should include the following elements:

• Data Type
• Related Tools, Software and/or Code
• Standards
• Data Preservation, Access, and Associated Timelines
• Access, Distribution, or Reuse Considerations
• Oversight of Data Management and Sharing

NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.

Once a grant has been awarded, the Plan becomes part of the award's terms and conditions. NIH expects researchers and institutions to implement data management and sharing practices as described in their approved Plan. Compliance with the Plan, including any Plan updates, may be reviewed during regular reporting intervals.

To learn more about the NIH Policy for Data Management and Sharing and the support available, please visit the pages linked below.

• Final NIH Policy for Data Management and Sharing
  The National Institutes of Health (NIH) is issuing this final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research.
• Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
  This supplemental information outlines the Elements to be addressed in a Plan within two pages or less.
• Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing
  The National Institutes of Health (NIH) recognizes that making data accessible and reusable for other users may incur costs. To assist individuals and entities subject to the final NIH Policy for Data Management and Sharing, this supplemental information outlines categories of allowable NIH costs associated with data management and sharing.
• Macquarie University has a comprehensive Research Data Management Framework to assist applicants.
• NIH provide three data sharing plan scenarios and sample data share plan

1. Complete the MQ Notification Of Intent (NOI)

Complete a Notification of Intent to inform the Grant Development team of your intention to submit an application.

2. Communicate with the Funding Scheme Program Director 

The program director (also referred to as program manager or program officer) is an excellent resource to clarify something contradictory or ambiguous in the funding guidelines, guidance on whether your project is a good fit for the funding agency or scheme, or getting to know and understand the process overall. When contacting the program director, it is important not to ask questions which are provided in the material or inundate them with questions. You can find contact information for the program managers on the FOA under Grantor Contact Information. Note that it is quite common to get funding from the NIH without program director contact.

If you would like some tips on contacting a program officer and what to include in your correspondence follow this link.

3. Setup an eRA commons account: If you want to apply to the NIH as a Principal Investigator (PI) or co-investigator, you need a valid eRA Commons username (Commons ID). The Grant Development Team need to create this account for you before you can apply for NIH funding.

4.Complete the Application

The application has multiple forms and are completed in the NIH Assist portal. Login to Assist using your eRA Commons username and password.  Use the Initiate Application   feature and your Funding Opportunity Number to get started on your application.

Use the tabs across the top of the screen to move between forms. Add optional forms as needed (e.g. subaward budget form if you are including partner institutions). More details on how to submit can be found on the NIH website .

For your sub-awardees (applications led by another institution) it is recommended that you download and send the forms directly to them to complete. They will need to complete the budget (R&R Subaward Budget Attachment(s) Form).

5. Foreign Justification

When considering applying for a US based grant, it is important to consider the expertise of the team and the research being proposed, as a justification for funding to be conducted outside of the USA. Areas to be considered are the expertise of the team, the resources available at MQ as well as partner organisations, and if appropriate, the populations you will be researching.

6. Submit application in PURE

A PURE record must be created, all forms must be uploaded into the PURE record and the record submitted for Faculty checking no later than 4 weeks prior to the funding agency due date. During these 4 weeks, your application will receive a strategic review and two compliance checks (if submitted on time).

7. Submission to funder

• ‘Validate application’ action  - to ensure your application is free of any system identified errors.
• ‘Preview application’ action – to ensure you’re satisfied with the assembled application
• ‘Update submission status’ action – when you’re ready, you’ll use this action and select ‘Ready for submission’ from the drop down options. finalise your application for submission.
• Assist will do a final validation check on your application before changing the status, you will need to amend any errors flagged.

The Grant Development Team will be notified that your application is ready for submission. They will submit your application to the NIH agency through grants.gov (the US federal grants portal).  For sub-awardees (applications led by another institution), the MQ co-PI must submit completed documentations via PURE for HoD and DDRI approval, see below.

For sub-awardees (applications led by another institution), the MQ co-PI must submit completed documentations via PURE for HoD and ADR approval, see below.

If Macquarie University is a sub-awardee and the application is led by another institution, the process is:

1. Complete the MQ Notification Of Intent (NOI) Complete a Notification of Intent to inform the Grant Development team of your intention to submit an application.
2. Complete the Application forms, as directed by the lead institution
3. The Grant Development Team will provide a compliance and eligibility check no later than 2 weeks prior to the deadline, given the complexity of US grants it is highly recommended that you complete them earlier to avoid last minute complications.
4. Submit application in PURE, with a note indicating when the lead institution has requested for the forms to be submitted to them
5. Submit to the lead institution when HoD and DDRI approvals have been obtained in PURE.

How-To Guides

• How to Apply – NIH Application Guide
• Preparing your application using ASSIST
• How to develop your budget

Annotated Forms

• Annotated NIH forms

MQ Related Policies

• US Public Health Service Financial Conflicts of Interest Disclosure Procedures
• US Public Health Service Financial Conflicts of Interest Disclosure Statement

Resources

• NIH Budget Template for Applications Led by Macquarie University
• NIH Budget Template for Sub-Awardees
• R&R Budget Form - Content Guide
• MQ Salary Rates including on-costs
• NIH Formatting guide
• Biosketch - Content Guide
• Facilities and Resources - Content Guide
• MQ Letter of Organisational Support Template