NIAID Physician-Scientist Pathway to Independence Award (K99/R00 Clinical Trial Required)

NIAID Physician-Scientist Pathway to Independence Award (K99/R00 Clinical Trial Required) is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Aims to increase and maintain a strong cohort of new and talented independent physician-scientists, facilitating their transition from mentored postdoctoral research to independent faculty positions, including support for independent clinical trials.

Pathway to Independence Awards Parent K99/R00 and NIAID Physician-Scientist K99/R00 SOP | NIAID: National Institute of Allergy and Infectious Diseases Resources for Researchers Division of Intramural Research Labs Research at Vaccine Research Center Intramural Scientist & Clinician Directory Research Rules & Policies Allergy, Immunology & Transplantation Resources for Researchers Antimicrobial (Drug) Resistance Antimicrobial Resistance Threats Information for Researchers Risk Factors & Prevention Research Immune Tolerance Processes Disease-Specific Research Information for Researchers Autoimmune Lymphoproliferative Syndrome (ALPS) Basic & Preclinical Research Information for Researchers Information for Researchers Shiga Toxin-Producing E.

coli (STEC) Researching Ebola in Africa Information for Researchers Information for Researchers Why Food Allergy is a Priority for NIAID Characterizing Food Allergy & Addressing Related Disorders Information for Researchers Diagnosis & Management Guidelines Disease-Specific Research Information for Researchers Genomics & Advanced Technologies Pathogen-Based Initiatives Information for Researchers Information for Researchers Group A Streptococcal Infections Disease-Specific Research Information for Researchers Overview of the Immune System Features of an Immune Response Information for Researchers Information for Researchers Leprosy (Hansen's Disease) How NIAID is Addressing Lyme Disease Information for Researchers Parasite, Mosquito & Human Host Prevention, Treatment & Control Strategies Strategic Partnerships & Research Capacity Information for Researchers Information for Researchers Neglected Tropical Diseases Information for Researchers Translational & Clinical Research Cross-cutting Preparedness Molecular & Genetic Research Primary Immune Deficiency Diseases (PIDDs) Information for Researchers Animal Prion Diseases and Humans Information for Researchers Respiratory Syncytial Virus (RSV) Schistosomiasis (Bilharzia) Research in Endemic Regions Sexually Transmitted Infections (STIs) NIAID's Research Approach Information for Researchers Disease-Specific Research Information for Researchers Information for Researchers Disease-Specific Vaccines Information for Researchers Translational & Clinical Research Information for Researchers Biology, Genetics & Clinical Research NIAID's Approach to Women's Health Research Sex-Specific Health Challenges Facing Women Biennial Report (FY 2019-2020) Information for Researchers Why NIAID Is Researching Zika Virus Information for Researchers Find a Funding Opportunity Opportunities & Announcements NIAID Research Priorities Plan Your Budget & Personnel Additional Application Elements Research with Special Considerations After You Submit an Application Funding Policies and Considerations Understand the Review Process Respond to Pre-Award Requests Negotiation & Initial Award Become a Healthy Volunteer Participant's Guide to Clinical Trials HIV and Emerging Infectious Diseases Laboratory of Infectious Diseases Primary Immune Deficiency Clinic Vaccine Research Center Clinical Studies Fill Out the Volunteer Form Q&A: Vaccine Clinical Studies Vaccine Clinical Studies Safeguards Clinical Trial Publications NIAID-Funded Research News Division of Allergy, Immunology, and Transplantation Division of Microbiology and Infectious Diseases Division of Extramural Activities Division of Clinical Research Division of Intramural Research Dr. Joseph J.

Kinyoun: Father of the NIH Dr. Joseph Kinyoun The Indispensable Forgotten Man Dr. Joseph Kinyoun: Selected Bibliography NIAID 60th Anniversary Timeline Research Training at NIAID Campuses Grant Programs that NIAID Funds AIDS Research Advisory Committee AIDS Vaccine Research Subcommittee Board of Scientific Counselors Members Advisory and Peer Review Committees Autoimmune Diseases Committee Website Policies and Notices External Link Icon and Disclaimers Freedom of Information Act (FOIA) Voluntarily Submitted Information Pathway to Independence Awards Parent K99/R00 and NIAID Physician-Scientist K99/R00 SOP This standard operating procedure (SOP) includes the following sections: Purpose , Procedure , Contacts , and Links .

Some links will work for NIAID staff only. To help scientists and physician-scientists (PS) begin independent research earlier in their careers. Pathway to Independence Awards (K99/R00s) support salary (up to $100,000 plus fringe benefits per year) and research expenses (up to $50,000 per year) in the mentored, postdoctoral K99 phase for new investigators.

The R00 phase provides salary and fringe benefits to continue the research project independently. In this phase, the investigator must have plans to apply for a tenure-track (or equivalent), full-time assistant professor position.

For non-U.S. citizen and permanent residents, the applicant institution is responsible for determining and documenting in the application that the applicant investigator's visa will allow him or her to remain in this country long enough to be productive on the research project in the United States for the duration of the proposed independent research (R00) phase.

An NIH institution/center's intramural laboratory may use its funds to support the applicant during the K99 phase. Intramural K99 recipients who want to continue into the R00 phase must obtain an extramural institution position.

NIAID will accept only K-series applications proposing to conduct new, independent clinical trials through the NIAID Physician-Scientist Pathway to Independence Award (K99/R00, Clinical Trial Required) notice of funding opportunity (NOFO). Eligible applicants for the PS K99/R00 who are proposing clinical trial research must use the clinical trial NOFO.

Those not proposing a clinical trial must use the nonclinical trial NOFO, NIAID Physician-Scientist Pathway to Independence Award (K99/R00, Clinical Trial Not Allowed) . NIAID encourages applications requesting up to 2 years for the K99 and 3 years of support for the independent R00 phase of the award. This also applies to intramural K99 recipients at NIAID and other NIH institutes and centers (ICs).

The transition from a K99 to an R00 is not automatic. As with other K awards, investigators may request part-time appointments and other adjustments. For more information, see the Career Development Grants SOP .

Eligibility is restricted to people with a doctoral degree, or equivalent and no more than 4 years of postdoctoral biomedical research training as of the relevant application due date regardless of whether the application is new or a resubmission. To be eligible to apply, you must be in a mentored, postdoctoral or equivalent training position.

NIAID may grant exceptions or extensions to the 4-year postdoc rule for exceptional circumstances, such as family care responsibilities, childbirth, disability, illness, or active military duty. Also, time spent conducting postgraduate clinical training not involving research or time spent gaining select agent approval or BSL-4 training do not count toward the 4-year eligibility limit.

To request an extension, contact Research Training Officer . The mentored, postdoctoral (K99) phase is for a minimum of 12 months and up to 24 months. During the initial K99 phase, you must secure a tenure-track, full-time assistant professor position or equivalent at a U.S. academic institution.

Submit applications electronically. Read the appropriate Pathway to Independence Award (K99/R00) NOFO and supplemental instructions for K awards in the SF 424 Application Guide . Note: Address rigor and reproducibility.

Learn more at NIH’s Guidance: Rigor and reproducibility in Grant Applications page. Include an eRA Commons username for your primary mentor, and report it on the R&R Senior/Key Person Profile (Expanded) form, as follows: List the primary mentor under the Profile for Senior/Key Person 1. Insert "Other" or "Other Professional" in the Project Role field, and enter "Mentor" in the Other Project Role Category field.

Provide a valid eRA Commons username in the Credential field. If the primary mentor does not have an eRA Commons account, he or she should ask your business office to create one using any role (e.g., Project Personnel, Scientist).

The direct costs requested for each year may include the following: Associated fringe benefits Research development support (e.g., supplies, equipment, travel) up to $50,000 The indirect costs [also known as facilities and administrative (F&A) costs] are reimbursed at 8 percent of modified total direct costs. Note that K99 recipients cannot transition to the R00 phase until they have completed 12 months in the K99 phase.

K99 awardees must secure a qualified tenure-track faculty position and ask officials to submit their R00 Phase II application according to instructions that NIAID sends candidates. NIAID will consider R00 applications received after July 1 for potential funding the next fiscal year. Read the appropriate Pathway to Independence Award (K99/R00) NOFO and supplemental instructions for K awards in the SF 424 Application Guide .

Note: Address rigor and reproducibility. Learn more at NIH’s Guidance: Rigor and Reproducibility in Grant Applications page. Include an eRA Commons username for your primary mentor, and report it on the R&R Senior/Key Person Profile (Expanded) form, as follows: List the primary mentor under the Profile for Senior/Key Person 1.

Insert "Other" or "Other Professional" in the Project Role field, and enter "Mentor" in the Other Project Role Category field. Provide a valid eRA Commons username in the Credential field. If the primary mentor does not have an eRA Commons account, he or she should ask your business office to create one using any role (e.g., Project Personnel, Scientist).

The total cost amount (direct plus F&A) for each of the 2 years may not exceed $249,000. Use the currently effective F&A rate. Office of Research Training and Special Programs (ORTSP) Monitor Council-reviewed K99 applications and work with DEA's Office of the Director and the Budget and Financial Management Branch (BFMB) to establish funding plans each fiscal year.

Review initial R00 applications against the NIH-established criteria documented in the appropriate Pathway to Independence Award (K99/R00) NOFO. Document approval or disapproval of the R00 application on the face page.

Deliver the reviewed R00 applications to the Grants Management Career Award Coordinator Contact for NIAID Staff , who will then identify the grants management specialist and forward it for award processing or notification of disapproval. After the Center for Scientific Review creates an IMPAC II record, email BFMB Contact for NIAID Staff documenting approval of the R00 applications and requesting a Release List authorizing funding.

Complete the Program Officer Checklist for K99 applications released for funding. Assist PIs during the K99 mentored award (e.g., when PIs are attempting to submit their R00 application early, determine whether the staff position is appropriate for the R00 phase, and resolve any scientific issues in the K99 or R00 phase).

Complete a Program Officer Checklist for each Type 4 (extension) R00 application that is approved for funding by ORTSP. Review Type 5 (noncompeting) R00 applications and complete the Program Officer Checklist. Work with the grants management specialist on prior approval requests, e.g., change of mentor (K99 phase) or institution (usually only in the R00 phase).

Grants Management Career Award Coordinator Create a K99 tracking spreadsheet for each fiscal year and enter K99 applications released for funding. Email the updated spreadsheet to the BFMB Contact for NIAID Staff , NIAID's Research Training Officer , and the Grants Management Program (GMP) management team and team leaders.

Monitor the R00 application receipt due dates and ensure that specialists are following up with the PIs regarding submission of the R00 applications. Check the status of each R00 application (e.g., funded, pending receipt of application, carried over to next fiscal year for funding once application is received and approved).

Email the updated spreadsheet to BFMB Contact for NIAID Staff , NIAID's Research Training Officer , and the Grants Management Program management team and team leaders. Budget and Financial Management Branch Issue Release Lists for Type 1 (new) K99 applications within the NIAID-established K99 payline.

Create Type 4 (extension) R00 IMPAC II records and issue Release Lists for Type 4 R00 applications approved and recommended for funding by the ORTSP Director. Grants Management Specialist Issue the mentored award after receiving a Release List. Adjust the K99 funding if the R00 application is submitted and funded before the K99 award has ended.

NIAID may allow a no-cost extension for the following reasons: We will not fund the R00 application. There is a reasonable cause for delay between the end of the K99 and the submission of the R00 application, and the PI remains at the K99 awardee institution.

If the K99 application is from an NIAID intramural investigator, do the following: Work with the NIAID Administrative Office to assure that salary is funded according to provisions of the K99 program. Send the investigator a letter advising him or her of the award.

If the K99 application is from an intramural investigator from another IC, do the following: Work with the IC's intramural administrative office to assure that salary is funded according to provisions of the K99 program. Once you've confirmed salary with the funding IC, send the investigator a letter advising him or her of the award. Six months before the end of the K99 award, email the PI about submitting the R00 application.

For applications from another IC's intramural investigator, work with the other IC's administrative office about the timing of the R00 submission so that funding responsibility can move to NIAID. Award Type 4 R00 applications approved by the ORTSP Director and released by BFMB for funding. In an NIAID R00 application, the maximum number of years an investigator can request is 2.

Create a record in IMPAC II, then ask NIAID's Research Training Officer to request a Release List from BFMB. Note: all requests for Release Lists must come from ORTSP. If the R00 application is not approved for funding, send written notification to the PI within 60 days of receiving the R00 application.

The notification must provide the rationale for the disapproval. Work with NIAID's Research Training Officer to draft the notification. If the R00 application is approved for funding, based on the estimated balance of funds, revise the budget, the budget end dates, and project period end dates.

Type 5 R00 applications are subject to the NIH noncompeting research project grant funding plan (e.g., 97. 1 percent of the committed total costs). Applicants with questions should read Contacting Program Officers and Grants Management Specialists .

AITrainingHelpDesk@mail. nih. gov , Research Training Officer, ORTSP Contact for NIAID Staff —Grants Management Career Award Coordinator Contact for NIAID Staff —NIAID Budget and Financial Management Branch NIAID Research Career Development (K) Awards Career Development Grants SOP Research Training at NIAID NIH Research Career Development Awards Content last reviewed on March 21, 2025