All applications are received as Office of the Director (OD) applications. The OD funds the majority of awards, but other NIH institutes and center are invited to fund applications that within their mission and they deem meritorious. Regardless of who funds the application, all Early Independence Awards remain in the OD with an OD Program Officer. However, the most scientifically relevant NIH institute or center (as determined by the High-Risk, High-Reward Research program working group) select an "affiliate" Program Officer from that institute or center to provide additional guidance for the awardee. Awardees are strongly encouraged to get to know their "affiliate" Program Officers. They have in-depth knowledge of the science being conducted and can:

• Provide advice on future research and funding strategies
• Help navigate NIH and institute/center administrative channels
• Provide career advice

"Affiliate" Program Officers are asked for their assessment on awardees' annual reports, invited to attend the awardee site visit, and encouraged to attend the annual High-Risk, High-Reward Research Symposium.

The Notice of Award (NoA) provides information on the project's start and end dates, terms and conditions of award, and how much money will be received for current and future years. A NoA is issued for every budget period of the award.

You can find the NoA in eRA Commons using the Status module or Notice of Award query. Note that grants management staff may issue a revised NoA to reflect any of the following changes:

• Increase or decrease of funds
• Lifting of a restriction
• Change in budget period
• Carryover or offset

NIH requires grantees to submit annual Research Performance Progress Reports (RPPR) through eRA Commons. The progress report must be approved by NIH to fund the next budget period. Late, incorrect, or incomplete progress reports will delay awards until all reporting elements are complete.

The RPPR asks grantees about accomplishments towards the goal of the project, plans for the next year of the project, manuscripts and publications produced, personnel who have worked on the project, changes to level of effort of key personnel on the project, actual or planned challenges or delays in the projects and plans for resolving them, significant changes regarding human or animal subjects, inclusion enrollment reports for clinical studies, and more.

The Program Officer reviews each progress report to determine whether funding for the project will continue, and the Grants Management Specialist evaluates the grant's administrative and fiscal status. Both must approve a progress report before an award can be issued.

There may be times when adjustments are needed to your project or budget. Some of the adjustments can be made by the grantee without NIH approval due to “expanded authorities” laws, which gives greater autonomy and flexibility to grantees.

Without NIH approval, you can:

• Extend a project period for up to 12 months without additional funds (called a no-cost extension).
• Carry over unobligated balances from one budget period to the next.
• Transfer work to a third party through a consortium agreement, contract, or other means, as long as you retain a substantive role in the research.
• Make cost-related changes, including rebudgeting of funds, as long as the scope of the research remains the same.
  • Spend money up to 90 days before the grant's start date with your institution's permission.

Actions that require NIH preapproval include:

• Taking an action that changes the scope of the approved research.
• Reducing PD/PI effort by 25 percent or more.
• Changing the grantee organization.
• Taking a second no-cost extension of a final budget period.
• Changing the award terms and conditions, or undertaking any activities disapproved or restricted as a term of award.
• Adding, removing, or transferring a foreign subaward or foreign site.

The request must be endorsed by your Authorized Organization Representative and sent to the Grants Management Specialist at least 30 days before your proposed change. Contact your Grants Management Specialist with questions on preapprovals.

There may be times when your research plans need adjustment because of a new research path or a dead end. Talk with your Program Officer about whether it makes sense to modify your research. You will need approval from your Grants Management Specialist to change the scope of your research.

Actions that may change the scope of your research include:

• Changing the Specific Aims
• Shifting the research emphasis from one disease area to another
• Changing any aspects of research involving animals or human subjects
• Using a new technology
• Purchasing equipment that costs more than $25,000
• Rebudgeting funds in or out of a budget category by more than 25 percent of the total costs of the award

For a list of all actions that constitute a change in scope, see Section 8 of the NIH Grants Policy Statement.

If you wish to change institutions, you must ask the awarded institution to relinquish the award to your new one. The new institution must be a U.S. domestic institution capable of supporting the research and must fulfill all the requirements in the funding opportunity.

Your new institution must submit a new application in response to the Change of Grantee Organization (Type 7 Parent) announcement. NIH staff will review the application to ensure all the requirements in the funding opportunity are met.

For more information, see:

• NIH Change of Institutions/Relinquishing Statements FAQs
• Section 8 of the NIH Grants Policy Statement

If your institution does not agree to transfer your grant or the new institution cannot meet all the requirements in the funding opportunity, the grant must be terminated.

The High-Risk, High-Reward Research Symposium is held annually in June in Bethesda, MD. The symposium brings together recipients of the NIH Director's Pioneer, New Innovator, Transformative Research, and Early Independence awards to share their groundbreaking research and discoveries. The symposium is free and open to the public. Symposium attendees enjoy:

• Scientific talks and posters from High-Risk, High-Reward Research program awardees
• Networking with some of the most creative scientists in the U.S.
• Scheduled one-on-one meetings with NIH staff during "Office Hours"

High-Risk, High-Reward Research award recipients are strongly encouraged to attend the symposium annually. Awardee lab members, NIH staff and fellows, and members of the general public are also welcome to attend. NIH does not pay for or make travel arrangements for symposium attendees and presenters.

Every Early Independence awardee receives a site visit from NIH staff around the end of the first year of their award. Site visits are used to assess the progress of awardees in establishing an independent research program and to ensure they are receiving the support and resources from their institution as described in their application. Below are common questions regarding site visits.

What are site visits?

Every Early Independence awardee will meet with NIH staff to assess their progress and ensure they are receiving the institutional support and help needed to successfully transition to research independence. At the site visit, NIH staff will come to your institution to meet with you, your colleagues, and institution officials, as well as view facilities and discuss your research and career progress. Awardees will have a chance to ask questions, get advice, and get to know NIH staff.

Are site visits audits?

Site visits are not audits and don't fulfill any statutory requirements. They are used to ensure the awardee is getting the support needed to grow a successful independent research program. It is also a good way to build relationships with NIH staff, get questions answered, and get advice. The site visit is a good time for awardees to bring up any concerns they have about their institution's support or environment; NIH staff can bring those concerns up during their meetings with other faculty and institution officials and work towards a resolution.

When and where will the site visit occur?

Site visits are typically scheduled around the end of the first year of the Early Independence Award (usually between August and December). The site visit may be done virtually or in-person at the awardee's institution. Whether or not a site visit happens virtually or in-person depends on NIH priorities.

How long is the site visit?

Site visits will last for one day during regular business hours.

Who will attend from the NIH?

The Program Officer attends and conducts all site visits. Additionally, each awardee has an "affiliate" Program Officer from the most scientifically relevant NIH Institute or Center. They are there to help advance the awardee's scientific program, offer guidance about transitioning to other sources of NIH support, provide insights into navigating NIH administrative channels, and is a great overall resource. The awardee's affiliate Program Officer is invited to attend the site visit as well, but attendance will depend on their availability.

What happens during the site visit?

NIH staff will gather information on lab infrastructure/physical space, progress on establishing an independent research program, integration into the institutional culture and faculty community, and institutional support. NIH staff will need to do the following activities to get a comprehensive view of the support received:

• Meet with the awardee (must be the first meeting of the day for 1.5 hours)
• View the facilities (5-15 minutes)
• Meet with lab personnel (30 minutes)
• Meet with faculty mentors (30 minutes)
• Meet with non-mentor faculty colleagues (30 minutes)
• Meet with the department/division chair (30 minutes)
• Meet with an institutional representative (30 minutes)

Who should be included in the site visit meetings?

NIH staff will want to meet with people involved in the awardee's research and mentorship to better understand the community and support for the awardee. NIH staff should meet with the following people during the site visit:

• Awardee
• Lab members and personnel
• Faculty mentors helping integrate the awardee into the community
• Non-mentoring faculty members (colleagues not involved in the awardee's research or mentorship) to provide insight into the department and its culture
• Department or division chair to learn more about the department or division and the support it has in place for the awardee
• Institutional representative (such as the dean of research) to learn more about the institution's strategy for supporting early career scientists and their research

The awardee will only be present during their designated meeting, facility tour, and wrap-up meeting. The awardee will not be present in any of the other meetings.

Who schedules the meetings at the institution and sets the site visit agenda?

It is the responsibility of the awardee to schedule the meetings and set the site visit agenda. The NIH Program Officer may request modifications to the agenda to ensure that programmatic needs of the site visit are met. If possible, awardees are asked to schedule and organize a seminar at their institution for a presentation on the High-Risk, High-Reward Research program. Broad dissemination of the seminar at the awardee's institution and other local institutions is appreciated.

What information is needed for the agenda?

The agenda should include the time, activity, meeting link (for virtual meetings), and the name, title, and department/organization of the people NIH staff will meet with. Include location and contact information if NIH staff will be traveling to and from in-person meetings unescorted. Please also remember to leave time for lunch. For in-person visits, a working lunch can be scheduled where NIH staff meet with the awardee and perhaps other High-Risk, High-Reward awardees or potential applicants. Or the time can be left open for NIH staff to find lunch on their own. An example site visit agenda is available for further guidance.

Does the awardee attend all the scheduled meetings during the site visit?

No. The awardee should not attend meetings outside their own scheduled meeting, facility tour, and a wrap-up meeting. NIH staff should meet with the other groups without the awardee present.

Should the awardee update the NIH on his/her research progress during their meeting?

Yes. NIH staff will want an update on the awardee's research progress. This is often done with a presentation.

When does the agenda need to be set by?

A draft of the agenda is asked a month before a virtual site visit and at least three months before an in-person site visit so NIH can get travel approvals. It is understood that agendas may change; send an updated version as soon as possible.

For in-person visits, who makes travel and lodging arrangements for NIH staff?

NIH staff will make all their own travel and lodging arrangements and pay for their own meals and expenses.

When and how will site visit dates be scheduled?

Awardees will receive an email from NIH staff with more information and possible site visit dates in February or March after their award is made. The awardee should discuss suitable dates with those at their institution who will participate in the site visit meetings and select the most convenient date that is available. Awardees should respond quickly to requests to select the site visit date as they are given on a first-come, first-serve basis.

What happens if the awardee changes institutions before a site visit?

If an awardee changes or will be changing institutions before a site visit occurs, the site visit can be delayed until the awardee has had time to establish themselves at the new institution.

Will NIH staff complete an official report on the site visit, and will I receive a copy?

Yes. The Program Officer will complete an official report on the findings of the site visit. Affiliate Program Officers are not required to submit a report. The report is not shared with the awardee or institution, but general findings are disclosed to the awardee during the wrap-up meeting at the end of the site visit.

What happens if issues are identified at the site visit?

The site visit is meant to ensure adequate support is being provided to the awardee so they can succeed in their transition to independence. If issues are identified, NIH staff will discuss them with the awardee and institutional officials. The goal is to bring up concerns early so they can be discussed and resolved before the problems become entrenched and more difficult to correct. Institutions are expected to provide the support outlined in the application. Failure to provide independence and/or support to the awardee may lead to NIH actions, including reduction of funds.