NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required)

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers. Frequently Asked Questions for NOT-HL-23-083 General Questions Q: What is the purpose of the Notice of Special Interest (NOSI) NOT-HL-23-083? The NOSI on Assessing Real-World Effectiveness and Implementation of Telehealth-Guided Provider-to-Provider Communication among Rural Communities (NOT-HL-23-083) aims to support research that generates evidence on the real-world effectiveness of telehealth collaboration among healthcare providers for consultation, second opinions, and other purposes, referred to as provider-to-provider telehealth (PPT). The NOSI is intended to support the use of telehealth interventions and tools for the prevention, management and treatment of heart, lung, blood, and sleep conditions, as well as cancer, in rural communities. Q: Are foreign applications allowed under this NOSI? Yes. Non-domestic entities (Foreign Institutions) and Non-domestic components of U.S. Organizations are eligible to apply under the Notice of Funding Opportunities (NOFOs) relevant to this NOSI (PA-20-185; PAR-22-105; PAR-21-035; PAR-21-341) – additional information regarding eligibility is available in Section III. Eligibility Information of each NOFO. Q: How is “rural” defined for the purposes of this NOSI? Different definitions of “rural” are used by various entities for different purposes. Rurality can be conceptualized based on administrative boundaries, land-use patterns, or economic influence; can reflect several different dimensions, such as population density, population size, and degree of remoteness; and can be delineated at different spatial scales (e.g., zip code, county, census district). Applicants should operationalize “rural” in the way that best serves the aims of their study. However, applicants should clearly state how they are defining rural in their application and provide a justification for the criteria they are using. A few widely used classification systems for defining rural and urban areas are provided below. Additionally, the Health Resources and Services Administration (HRSA) provides a tool on their website that enables users to see whether a specified geographic area is considered “rural” for the purposes of HRSA Rural Health Grant eligibility: https://data.hrsa.gov/tools/rural-healthexternal link. This may be a good starting point for assessing whether an area of interest might be considered “rural”. Census Bureau Urban-Rural Classificationsexternal link - The Census Bureau delineates urban areas by applying specified criteria to the decennial census and other data. For the 2020 Census, an urban area comprises a densely settled core of census blocks that meet minimum housing unit density and/or population density requirements of having at least 2,000 housing units or a population of at least 5,000. This includes adjacent territory containing non-residential urban land uses. Rural areas encompass all population, housing, and territory not included within an urban area. National Center for Health Statistics (NCHS) Urban-Rural Classification Scheme for Countiesexternal link – NCHS has developed a six-level urban-rural classification scheme for U.S. counties and county-equivalent entities. The scheme is based on the Office of Management and Budget’s (OMB) delineation of metropolitan statistical areas (MSA) and micropolitan statistical areas, as well as Vintage postcensal estimates of the resident U.S. population. The scheme has two levels nonmetropolitan counties. USDA Rural Urban Continuum Codes (RUCC)external link - Rural-Urban Continuum Codes are a 9-level classification scheme that categorizes metropolitan counties by the population size of their metro area, and nonmetropolitan counties by their degree of urbanization and adjacency to a metro area. USDA Rural Urban Commuting Area (RUCA) Codesexternal link - RUCA codes categorize census tracts based on measures of population density, urbanization, and daily commuting patterns. This classification system consists of 10 levels that delineate metropolitan, micropolitan, small town, and rural commuting areas based on the size and direction of the primary (largest) commuting flows. These 10 codes are further subdivided based on secondary commuting flows. USDA Urban Influence Codesexternal link (UIC) – Urban influence codes are a 12-level classification scheme that distinguishes metropolitan counties by the population size of their metro area, and nonmetropolitan counties by the size of the largest city or town and proximity to metro and micropolitan areas. There are two metro and ten nonmetro categories. Frontier and Remote Area (FAR) Codesexternal link – Developed by the USDA Economic Research Service, Frontier and Remote Area codes are based on ZIP-codes. The term "frontier and remote" is used to describe territory characterized by some combination of low population size and high geographic remoteness. FAR areas are defined in relation to the time it takes to travel by car to the edges of nearby Urban Areas (UAs)external link. Four levels are necessary because rural areas experience degrees of remoteness at higher or lower population levels that affect access to different types of goods and services. Q: My project focuses on “direct-to-consumer/ direct-to-patient” telehealth, would it still be responsive to this NOSI? No. This NOSI focuses on “provider-to-provider” telehealth (PPT), which is a telehealth modality that fosters collaboration among healthcare providers for consultation, second opinions, and other purposes. Please refer to the “Background” section of the NOSI for some examples of PPT in heart, lung blood, sleep and cancer conditions. Q. My university/institution is located in an urban area, would I still qualify for this NOSI? There is no restriction regarding the location of the Principal Investigator’s university, institution, or center and if it is in an urban or rural area. The limiting factor is the population of interest. The focus of this NOSI is the use of provider-to-provider telehealth (PPT) to benefit rural communities. For the definition of rural areas, please refer to the previous questions “How is “rural” defined for the purposes of this NOSI?” Q. One of the components of my research involves a center or hospital located in an urban center/hospital, would I still qualify for this NOSI? It depends. The focus of this NOSI is the use of provider-to-provider telehealth (PPT) to benefit rural communities. As such, considering a hub-and-spoke telehealth model, the healthcare providers who require consultation and their patients (spoke component) must be in a rural area, assuring that the benefited population served by the PPT intervention is rural. Example 1: If both communicating sides of providers (hub and spoke) are in urban areas, it is not responsive to this NOSI. Example 2: If the provider receiving the consultation or training (spoke) is in a rural area, and the consulted team (hub or hub-less provider) is in an urban area, it is responsive to this NOSI, given that the population of interest benefitted by the PPT intervention is still in a rural area. For the definition of rural areas, please refer to the previous questions “How is “rural” defined for the purposes of this NOSI?” Q. Is the NOSI restricted to telemedicine between physicians? No. The focus of the NOSI is not just telemedicine, but telehealth, which goes beyond the communication between physicians, and would include a series of healthcare providers, allied health providers, and their teams. For some examples, please refer to the “ Background” section of the NOSI. Q: What are some of the research examples that might be responsive to this NOSI? There are a series of research projects that might be of interest for this NOSI. For some examples, please refer to the ones listed in the “Selected Research Examples ” section of the NOSI. Please be aware that these are meant to illustrate some of the projects of interest for this NOSI, and other research projects not exemplified here might still be of interest. Investigators are encouraged to reach out to the Scientific and Research Contacts listed in the NOSI to discuss their research ideas and their relevance to the NOSI as well as institute funding priorities. Q. Who do I contact for more information from specific participating Institutes, Centers, and Offices? To whom should I direct my questions regarding this NOSI? To access the complete list of contacts, please refer to the “Inquiries” Section of the NOSI, which includes Scientific and Research Contacts and Financial/Grants Management Contacts. For programmatic questions at NHLBI, please contact Dr. Fernando P. Bruno fernando.bruno@nih.govmailto:, for programmatic questions at NCI, please contact Dr. Robin C. Vanderpool robin.vanderpool@nih.govmailto:. If you have submission questions, please contact the eRA Service Desk. Application Preparation and Submission Questions Q: NHLBI and NCI are collaborating on this NOSI. If an applicant has a proposal that is relevant to both cancer and to heart, lung, blood, and sleep conditions, which institute will the application be assigned to? Applicants are advised to make use of the Assignment Request Form to request the institute they would prefer to act as the “Awarding Component.” These requests are taken into consideration. Applicants are further advised to consider the institute they plan to choose on the Assignment Request Form when framing their specific aims. The Awarding Component Section of the PHS Assignment Request Form * All assignment suggestions will be considered; however, not all assignment suggestions can be honored. Applications are assigned based on relevance of the application to an individual awarding component mission and scientific interests in addition to administrative requirements. * Applicants may enter up to three preferences for primary assignment in the boxes in the "Suggested Awarding Component(s)" row. Note: the application will be assigned based on the most appropriate match between it, the terms of the FOA, and the mission of each possible awarding component, with your preference(s) taken into consideration when possible. Applicants do not need to make entries in all three boxes of the "Awarding Component Assignment Suggestions" section. Q: If a proposal has aims that might be responsive to more than one eligible Notice of Funding Opportunity (NOFO) – should an investigator submit an application that is targeted at two different eligible funding opportunities, or separate those aims into two different applications and submit one to each corresponding NOFO? Each application in response to this NOSI must target only one of the eligible NOFOs. An applicant can elect to submit two different applications to two different NOFOs as long as the specific aims are sufficiently distinct. If the Division of Receipt and Referral determines there is significant overlap between the two applications, the applicant could be asked to withdraw one of them.