The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences. Award budgets are composed of salary and other program-related expenses, as described below. The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development website.

The objective of the Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge. The purpose of this FOA is to provide such investigators with support for an intensive period of mentored research experience to acquire new research capabilities in research areas supported by the sponsoring NIH Institute(s)/Center(s). Such experiences will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; and/or 2) redirect their research programs in new trajectories; and/or 3) catalyze research collaborations in new research directions. It is expected that this initiative will lead to new and/or augmented research programs competitive for NIH funding.

The objective of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to provide support for experienced scientists to remain current in state-of-the-art techniques, evolving technologies, and the fundamental, translational, and clinical research frontiers related to the hearing, balance, smell, taste, voice, speech, and language sciences. Established investigators often express an urgent need for compensated protected time and mentored training to augment their research capabilities and to keep their research programs in-step with emerging technologies and evolving scientific frontiers and, thereby, competitive for continued NIH funding. This initiative provides candidates with protected time and mentored guidance to augment or redirect their research career trajectories within the NIDCD research mission. It focuses on established investigators holding the academic rank of Associate Professor or Professor, or the equivalent in non-academic research settings, who have records of scientific accomplishment and independent research support (past and/or present). The purpose of this NOFO is to provide such investigators with support for short-term, intensive periods of mentored research experience over a period of six- to twenty-four months to acquire new research capabilities in the study of hearing, balance, smell, taste, voice, speech, or language sciences. Such experiences, typically undertaken during an academic sabbatical year, will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; 2) redirect their research programs in new trajectories within the NIDCD scientific mission; and/or 3) catalyze research collaborations in new research directions. It is expected that this initiative will lead to new and augmented research programs competitive for NIH funding. In addition to serving as a short-term career development vehicle for investigators within the NIDCD Extramural research community, this program is also intended for investigators working outside of the hearing, balance, smell, taste, voice, speech, and language sciences who wish to add research direction within the NIDCD scientific mission to their overall research programs.

The research career enhancement experience shall take place in a host laboratory, whether in the applicant institution (i.e., in which the candidate holds his/her primary appointment) or in another institution with the appropriate resources to provide the proposed research career development experience. In both cases, the tutelage of a well-qualified host/mentor (or team of mentors/hosts) is required. In most cases, the applicant and proposed mentor(s) and host laboratory will not have had previous research collaborations.

The research career development experience proposed must have the potential to substantially augment the research capabilities of the candidate at the applicant institution, and provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s). The research career enhancement experience should be tailored to the individual needs and level of experience of the candidate, and will generally incorporate two components: 1) didactic (e.g., directed study/tutorials, semester-long courses, short courses, seminar series, journal clubs) and/or laboratory-based instruction in the new discipline, techniques or technologies; and, 2) a small-scale research project at the host site. The research enhancement experience may comprise translational or clinical/patient-oriented research (including epidemiologic, outcomes and health services research).

All applications submitted to this Notice of Funding Opportunity must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” that fall within the NIH definition of a clinical trial and also meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” (32 CFR 272.3).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this NOFO, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this NOFO.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate NOFO for the type of study.

Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the a 'Clinical Trials Required' or Clinical Trial Optional’ NOFO, but not under this NOFO.