Mentored Research Scientist Development Award (Parent K01 – Independent Clinical Trial Required) (PA-20-176)

National Cancer Institute (NCI)

Scientific Program Contact:   
Sergey Radaev, PhD 
Phone: 240-276-5630  
Email: sradaev@mail.nih.gov

Grants Management Contact:

Amy Bartosch 
amy.bartosch@mail.nih.gov

NCI Specific Information

Career Stage: The NCI only uses the parent K01 funding opportunities to support cancer control and prevention cancer researchers in their early career stages. Candidates must have completed at least two, but usually not more than five years of research training/experience beyond a doctoral degree at the time of submitting a K01 application. Early career-stage faculty, including assistant professors (or equivalent), may apply if within the eligibility window. Exceptions will be considered by the program contact on a case-by-case basis.

Candidates still within postdoctoral non-independent, mentored positions are strongly encouraged to apply for a K99/R00 award if within the K99/R00 eligibility window.

Research Areas of Interest: NCI will only accept K01 applications that are submitted in response to one of the following Notices

• NOT-CA-24-022: Notice of Special Interest: National Cancer Institute Supports Applications for the Mentored Research Scientist Development Awards (K01) Within the Mission of the Division of Cancer Control and Population Sciences.

More information about potentially relevant research areas can be found by examining the mission and scientific scope of the Division of Cancer Control and Population Sciences.

• NOT-CA-24-023: Notice of Special Interest: National Cancer Institute Supports Applications for the Mentored Research Scientist Development Awards (K01) Within the Mission of the Division of Cancer Prevention.

More information about potentially relevant research areas can be found by examining the mission and scientific scope of the Division of Cancer Prevention.

Applicants are strongly encouraged to discuss their proposal with the NCI scientific program contact before preparing an application. 

Additional Information:

• All NCI K01 applicants must justify the need for additional mentored training and explain how the training will facilitate their ability to conduct cutting-edge research in one of these topic areas. 
• Applicants must appropriately justify the duration of support, taking into consideration prior research experience and the proposed mentored career development goals that are essential for developing an independent, NCI-funded research program. 
• An application must include a strong and credible plan for the candidate’s transition to research independence, including milestones, and evidence of significant institutional commitment to the continued development of the K01 candidate as an independent researcher at the applicant institution. Applicants are expected to plan to apply for independent research support during the later years of their mentored career award.
• Award project period: Up to 5 years with justification for a mentored training award for the requested duration.
• Salary Support: Up to $100,000 plus fringe benefits per year.

• Research support: Up to $50,000 per year.

  Review additional details about the NCI Mentored Research Scientist Development Award (K01).

  For information about Career Development Awards to Promote Diversity, please visit the NCI Center to Reduce Cancer Health Disparities (CRCHD).

NHLBI Specific Information:

The NHLBI only uses the K01 for highly innovative research in humans only in the following areas: 

• Epidemiological research that elucidates the mechanisms, etiology, pathogenesis, prevention, diagnosis and treatment of heart, lung, blood, sleep (HLBS) diseases, including chronic HLBS disorders resultant of infectious diseases and associated treatment complications (e.g., HIV/AIDS).
• Biostatistics research leading to the development of innovative methods for designing studies and analyzing data in clinical and population-based research (e.g., Clinical trials and epidemiologic, genomic, proteomic, or metabolomic studies) in HLBS diseases, including chronic HLBS disorders resultant of infectious diseases and associated treatment complications (e.g., HIV/AIDS).
• Outcomes research involving the comparison of screening, diagnostic, preventive or treatment strategies for HLBS diseases, including chronic HLBS disorders resultant of infectious diseases and associated treatment complications (e.g., HIV/AIDS).
• Implementation research that addresses strategies for sustained adoption of proven, effective multilevel interventions for HLBS diseases, including chronic HLBS disorders resultant of infectious diseases and associated treatment complications (e.g., HIV/AIDS).
• State of the art research studies reflected above that use large data sources and electronic health records are encouraged.
• Data science disciplines, including but not limited to Artificial Intelligence, Machine Learning, Deep Learning, Healthcare Data Analytics, Public Health Data Analytics, Imaging Analytics, Predictive Analytics, and Bioinformatics, for the creation, management, analysis, and integration of complex, large data sets in support of data-driven discovery in heart, lung, blood, and sleep health and disease.

 NHLBI has a 6-year limit of cumulative support on institutional and mentored Ks (e.g., K12 or KL2 plus the K01).

The NHLBI does not support Re-Entry research applications through the K01 mechanism. Re-Entry opportunities are available at: Re-Entry Administrative Supplement
 
Salary Support: Up to $100,000 plus fringe benefits per year. Please see /grants/guide/notice-files/NOT-HL-16-309.html
Research Support: Up to $30,000 per year.

National Human Genome Research Institute (NHGRI)

Scientific Program Contact:

Heather A. Colley
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2332
Email: heather.colley@nih.gov

 
Grants Management Contact:
Deanna Ingersoll
Phone:  (301) 435-7858
Email:  Deanna.Ingersoll@nih.gov

NHGRI Specific Information:

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the ethical, legal, and social implications of genomic advances; the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; and the impact of genomic advances, technology, and implementation on health disparities and health equity. Within these areas, approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or functions may be in scope for NHGRI. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

All K01 applicants must justify the need for additional training and explain how the training will facilitate their ability to conduct cutting-edge research in the research areas outlined above. 

Prospective applicants are strongly encouraged to contact a Scientific Program Contact to discuss their concept for this initiative during the development stages of the application.

Salary Support: Commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank.

Research Support: Up to $40,000 per year.

In addition to Research Support, awardees are strongly encouraged to attend at least one NHGRI Research Training and Career Development Annual Meeting while supported on the K01.  Travel may be requested up to $1500 each per NHGRI meeting.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Scientific Program Contact:

Kristy Nicks, Ph.D.
Phone: 301-594-5055
Email: kristy.nicks@nih.gov

 
Grants Management Contact:
Yen Thach
Phone: (301) 594-3505
Email: thachy@mail.nih.gov

NIBIB Specific Information:

NIBIB uses the K01 only to support individuals who wish to obtain experience and skills in an area significantly different from their doctoral and/or post-doctoral research focus. NIBIB will only support individuals who are within 10 years of the completion of their PhD. The duration of support can be 3 or 4 years.

Under this FOA, NIBIB will only support applications proposing early stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Before preparing an  application, prospective applicants are encouraged to fill out the NIBIB K01 Eligibility Inquiry Form and forward it along with the requested attachments to the Scientific Program Contact in order to verify eligibility, determine if the application is appropriate for a K01 award through NIBIB, and ensure that the application is submitted to the appropriate FOA.

Applicants whose applications include human subjects research are especially encouraged to contact the NIBIB Scientific Program Contact for guidance in advance of submitting an application, to ensure their proposed project is in compliance with NIH human subjects research and clinical trials’ policies (/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.

More information on this and other NIBIB Career Awards can be found here.

Salary Support: Up to $90,000 plus fringe benefits per year.

Research Support: Up to $40,000 per year.

NICHD Specific Information:

The NICHD accepts K01 applications from eligible individuals in only the following subject areas.  Applications on other research topics will be withdrawn without review.
 
Medical Rehabilitation Research: Applicants must have clinical training in a rehabilitation-related profession (e.g., P.T., O.T., R.N., or Speech and Language pathologist), possess a doctoral level degree (e.g., Ph.D., D.Eng., Ed.D.), and be committed to a career as an independent investigator in medical rehabilitation.

Child Abuse and Neglect: Applicants must be committed to developing careers as independent investigators in child abuse and neglect research.

Population Research: Population research is defined as demographic, behavioral, and social scientific research on fertility, family and household structures, mortality and morbidity, migration, immigration, population and the environment, and population distribution and characteristics. NICHD supports research that addresses the intersection of demographic processes and health, examines health from a population perspective, and/or integrates demographic or social scientific approaches to understanding health with behavioral or biomedical approaches.  The K01 award in Population Research is intended to provide mentored training experiences for: 

1. Investigators in demography or other areas of population research who require additional technical and scientific inquiry skills in order to launch independent research careers;
2. Investigators in demography or population research who seek research experience in different disciplines (e.g., anthropology, geography, biological sciences, epidemiology, public health, medicine);
3. Investigators in other disciplines (e.g., anthropology, geography, biological sciences, epidemiology, public health, medicine) who propose new training in demography or population research.

The K01 program in Population Research generally is limited to individuals at the Assistant Professor level.  However, recent Associate Professors in the latter two categories are also eligible, as are Associate Professors who initially applied as Assistant Professors and are submitting a revised application (resubmission). For further details on the Population Research K01, see /grants/guide/notice-files/NOT-HD-07-010.html.
 
Research related to Down syndrome:  NICHD will temporarily accept K01 applications for projects related to Down Syndrome as described in NOT-OD-20-021 – “Mentored Career Development Awards to Foster the Careers of Investigators Pursuing Research Related to Down syndrome as Part of the INCLUDE Project.”  Applications in response to this Notice should be aligned with the overall INCLUDE Project Research Plan, which consists of three components:

• Component 1: Targeted, high risk-high reward, basic science studies in areas highly relevant to Down syndrome
• Component 2: Cohort Study to connect existing resources and expand to inclusion of individuals with Down syndrome
• Component 3: Inclusive clinical trials research for co-occurring conditions in individuals with Down syndrome

All K01 applicants must justify the need for additional training and explain how the training will facilitate their ability to conduct cutting-edge research in one of these topic areas. NICHD has a 6-year limit of cumulative support on institutional and individual mentored Ks.

Salary Support: Up to $75,000 plus fringe benefits per year.
Research Support: Up to $25,000 per year

NIDCD Specific Information: 

NIDCD uses the K01 program to support new and junior basic research investigators in supervised career development experiences through a formal structured program to enhance the skill sets of the applicant by mentor(s) with established research lines and expertise in the field or technique that the applicant intends to develop or acquire; and a research project based on preliminary data that fits the applicant career development level and serves to incorporate the skills or technique he/she aims to acquire in the career development plan. NIDCD also uses the program to support investigators who need protected time in supervised career development experiences to train in a new field.

• Application must demonstrate its contribution to NIDCD and its fit to NIDCD's Mission, Research Priorities, and Strategic Plan.
• Applicants are strongly encouraged to provide clear evidence that adequate resources are available at the institution for the successful completion of the proposed research project.
• Applications should include explicit statements from the institution and the mentor(s) addressing the following:
  • Detailed information about who will provide the necessary resources;
  • Funding source and amount of additional funding (as needed);
  • Support staff available and committed to the project;
  • Availability of biostatistical support for the duration of the study - including the planning period; and
  • A contingency plan (for the institution and mentor) for completion of the study in the event the awardee leaves the institution earlier than the end date of the award.

 
Salary Support: Up to $75,000 plus fringe benefits per year.
Research Support: Up to $30,000 per year.

NIDDK Specific Information:

The purpose of the NIDDK K01 award is to provide an intensive, supervised, research and career development experience for nonclinical, doctoral researchers as they transition to independent research careers.  NIDDK encourages K01 applications in all areas of research supported by the NIDDK (see below). NIDDK limits support to a maximum of 6 years of combined institutional K (K12 or KL2) plus K01 funding.  Information on the NIDDK K01 can be found at K01. The NIDDK provides further information on all K-award programs on our training and career development web site: K-Awards.

NIDDK has a major interest in diabetes and its complications, but research on most organ-specific diabetes complications, with the exception of diabetic nephropathy, is within the mission of other NIH ICs.  For example, research on diabetic retinopathy is not within NIDDK’s mission interests. Research on cardiovascular disease, cardiomyopathy, cardiac autonomic neuropathy, hypertension or dyslipidemia are also not within NIDDK’s mission interests. Research on endocrine cancers and research focusing on the primary prevention or treatment of gestational diabetes directed at the immediate pregnancy outcomes of women or their newborns are not within NIDDK’s mission interest. Reproductive endocrinology is not within the mission of NIDDK and studies on this topic will not be supported.

NIDDK has a major interest in obesity research, but research on obesity-related endpoints outside of the mission of NIDDK should be submitted to other NIH ICs.  For example, research on the pathogenesis, prevention, or treatment of obesity-related cardiovascular disease, hypertension, asthma, or heart failure is not within NIDDK’s mission interest.  Research on obesity-related musculoskeletal disorders and research on use and abuse of alcohol after bariatric surgery is not within NIDDK’s mission interest.  NIDDK is also interested in nutrition studies that aim to treat diseases within the mission of NIDDK or improve health.

NIDDK is interested in research studies with translational potential and clinically meaningful endpoints for diseases of the alimentary tract, liver, and pancreas.  Studies on cancer progression and outcomes are not within NIDDK’s mission interest.

NIDDK is also interested in supporting research studies leading to the identification and evaluation of possible treatments to prevent the development and progression of kidney diseases and benign urological conditions.  Trials focused solely on non-renal outcomes and endpoints in populations with kidney disease are not supported by the NIDDK and should be submitted to the appropriate IC.  Studies involving malignant diseases of the kidney and urologic organs are also not within the NIDDK’s mission interest.

NIDDK supports research studies investigating (1) hematopoietic stem cell biology and myeloid fate determinants, (2) erythroid cell biology and erythropoiesis, (3) the molecular biology of heme and hemoglobin, (4) acquired and congenital disorders of red blood cell production and survival leading to chronic anemia or bone marrow failure, (5) the uptake, utilization, storage, and transport of iron in health and disease, (6) myeloid cell biology and myelopoiesis. Research applications directed at understanding hematologic malignancies and their pathogenesis or management are not within the scope of the NIDDK Hematology program.

Applicants for the K01 (new and resubmission) at NIDDK must have:

• a research-based doctorate (usually a Ph.D.) or comparable nonclinical doctoral degree. Individuals who have a clinical doctorate from another country and are not board-eligible in the United States are eligible for the K01
• completed at least 2 years, but no more than 7 years, of postdoctoral research training

Prospective applicants are strongly encouraged to contact NIDDK program staff to discuss relevance of the proposed studies to NIDDK's research interests and appropriateness of the K01 for accomplishing their overall career development goals; providing Specific Aims and current NIH biosketches for yourself and your proposed primary mentor will expedite this process.

Salary Support: Up to $90,000 plus fringe benefits per year.
Research Support: Up to $25,000 per year.

K01 awardees are strongly encouraged to attend the NIDDK K Awardees’ Workshop while supported on the K01 (one-time attendance for this biennial meeting).  Up to $1500 will be provided for K01 awardees to attend this meeting (in addition to the above-listed Research Support).

National Institute of Mental Health (NIMH)

Scientific Program Contact:
 NIMH Training Contacts

Grants Management Contact:
Rita Sisco
Phone: (301) 443-2805
Email: siscor@mail.nih.gov

NIMH Specific Information: 

The NIMH supports a broad spectrum of basic and translational research, including basic neuroscience, human genetics, adult and developmental translational research, services and intervention research, and AIDS-related research (NIMH Extramural Research Programs). 

• Eligibility for the K01 is limited to individuals with no more than 6 years of postdoctoral research experience at the time of application (either the initial or resubmission application). NIMH encourages applicants to limit the requested support to no more than four years. The requested duration of support should be appropriately justified, taking into consideration prior research experience and the proposed mentored career development goals that are essential for developing an independent, NIMH-funded research program. See NOT-MH-22-310 and K-Series​ for further details about NIMH’s support for K programs.
• An application must include a strong and credible plan for the candidate’s transition to research independence, including milestones, and evidence of significant institutional commitment to the continued development of the K01 candidate as an independent researcher at the applicant institution. Applicants are expected to plan to apply for independent research support during the later years of their mentored career award.
• It is recommended that NIMH mentored K applicants proposing clinical trials review the following guidance: (Career Development Programs K-Series).
• Prospective applicants are strongly encouraged to contact Institute career development staff (Research Training and Career Development Programs) before preparing an application to discuss the relevance of the proposed research to the Institute’s current research priorities and for guidance on the proposed research and career development plans.

Salary Support: Up to $90,000 plus fringe benefits per year.
Research Support: Up to $50,000 per year. 

National Institute on Minority Health and Health Disparities (NIMHD)  

Scientific Program Contacts:

For initial inquiries contact:
NIMHDtraining@nih.gov
 

Grants Management Contact:

Priscilla Grant, JD
Phone: 301-594-8412
Email: pg38h@nih.gov

NCCIH Specific Information:

NCCIH uses the K01 program to support new and junior investigators in supervised career development experiences that lead to research independence. It also supports investigators who need protected time in supervised career development experiences to train in a new field.

• Before the application receipt date, investigators are strongly encouraged to discuss their proposed research interest with an NCCIH Program Officer in the specific scientific area and/or intervention that is closely related to the proposed project to confirm its relevance to NCCIH 's mission and research priorities. A list of NCCIH program officials can be found at NCCIH Grants Contacts. 
• Applications proposing the use of natural products or devices in an interventional research project should explicitly describe the status of the Investigational New Drug (IND) or Investigational Device Exemption (IDE). Applicants interested in natural products research are encouraged to review NCCIH's Natural Product Integrity Policy.
• NCCIH will not fund applications proposing a clinical trial to test efficacy or effectiveness through this mechanism. Applicants are encouraged to discuss their proposed scope of work with an NCCIH program officer, and to review resources available at NCCIH’s Clinical Research Toolbox.
• Applicants are strongly encouraged to provide clear evidence that adequate resources are available at the institution for the successful completion of the proposed research project. Applications should include explicit statements from the institution and the mentor(s) addressing the following:
  • Detailed information about who will provide the necessary resources;
  • Funding source and amount of additional funding (as needed);
  • Support staff available and committed to the project;
  • Allocation of sufficient protected time for the K awardee to conduct the research;
  • Availability of biostatistical support for the duration of the study - including the planning period; and
  • A contingency plan (for the institution and mentor) for completion of the study in the event the awardee leaves the institution earlier than the end date of the award.

Salary Support: Up to $75,000 plus fringe benefits per year.
Research Support: Up to $25,000 per year.