Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Basic Behavioral and Social Science Opportunity Network (OPPNET)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
Mid-Career Enhancement Awards to Integrate Basic Behavioral, Biomedical, and/or Social Scientific Processes (K18 Basic Experimental Studies with Humans Required)
Activity Code
K18 Career Enhancement Award
Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-20-226
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.121, 93.398, 93.213, 93.271, 93.846, 93.281

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications from investigators who strive to expand their research trajectories through the acquisition of new knowledge and skills in the areas of basic psychological processes, sociological processes, and/or biomedical pathways—expertise that is beyond and enhances their current areas of expertise. The program will support career development experiences and a small-scale research project that will provide experienced investigators with the scientific competencies required to conduct independent research projects that more thoroughly investigate interrelationships among behavioral, biological, endocrine, epigenetic, immune, inflammatory, neurological, psychological, and/or social processes. Eligible candidates are independent investigators at mid-career faculty rank or level.


Applicants may propose research career development projects that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena (see, NOT-OD-18-212). These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA 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.Applicants who plan to gain research experience within an existing clinical trial or basic experimental study with humans led by another investigator, or who propose to gain research experience in purely basic human or model animal research, or in data sciences, must apply to companion FOA, PAR--20-211,Independent Clinical Trials Not Allowed.

This Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to inNOT-OD-18-212as “prospective basic science studies involving human participants.” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA 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.

Key Dates

Posted Date

June 3, 2020

Open Date (Earliest Submission Date)
February 16, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)
March 17, 2021, March 17, 2022, March 17, 2023,

by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)
March 17, 2021, March 17, 2022, March 17, 2023,

by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review
June 2021, June 2022, June 2023
Advisory Council Review
August 2021, August 2022, August 2023
Earliest Start Date
September 2021, September 2022, September 2023
Expiration Date
March 18, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions
It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applicationsthat do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 Extramural Training Mechanisms 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.

bout OppNet

OppNet is a trans-NIH initiative that accelerates discoveries in the underlying mechanisms and processes that inform health behaviors through deepened understanding of basic social-behavioral mechanisms and processes, and enhanced synergies in biopsychosocial processes that influence outcomes in health, illness, recovery, and overall wellbeing. All OppNet initiatives invite investigators to propose projects that will advance basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of behavioral and biomedical health research. All NIH Institutes and Centers that fund research and Program Coordination Offices within the NIH Office of the Director (ICOs) collectively manage OppNet's scientific direction yet may not participate in every OppNet FOA. Consequently, applicants should review the list of ICOs in this FOA's Components of Participating Organizations. For more information about OppNet, visit https://oppnet.nih.gov.

OppNet strives to ensure that proposed projects focus primarily on basic social, behavioral, and biopsychosocial sciences. Though OppNet defers from imposing a definition on the field, OppNet uses the following statement to guide the concepts it develops toward funding opportunity announcements: basic behavioral and social sciences research (b-BSSR) furthers our understanding of fundamental mechanisms and patterns of behavioral and social functioning, relevant to the Nation's health and wellbeing, and as they interact with each other, with biology, and with the environment. OppNet acknowledges that disease-, risk-, and wellness-contexts can provide opportunities to study basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or methodology and measurement relevant to b-BSSR.

Program Objective

The objective of this Career Enhancement Award for Mid-Career Investigators (K18) is to provide support for experienced scientists who wish either to expand their scientific capabilities or to change their research careers by acquiring new research knowledge or skills. In addition to preparing the awardee to apply for future independent funding in areas beyond her/his current expertise, it is expected that this career development activity also will lead to new research collaborations that could be competitive for future NIH funding, particularly projects that account for biopsychosocial interrelationships that impact behavior change and adherence related to health, recovery, and overall wellbeing.

Applicants are expected to identify one or more research mentors with relevant expertise in applicant knowledge-gap areas. The mentor(s) must be established, well-qualified, and willing to support the applicant's short-term research career development experience. The candidate and the proposed mentor(s) should not currently have established, longstanding collaborations at the time of the application. Candidates are expected either to establish new collaborative arrangements or to strengthen and enhance relatively new or developing collaborations on a research project.

Examples of novel skill combinations that might result from the mentored career development experience include, and are not limited to:

1. Development of career expertise and collaboration among researchers with expertise in animal models of basic behavioral and social processes and those studying similar or related processes in human subjects. For example, a researcher who studies human neurobiological mechanisms involved with social cognition might propose to work with an expert who studies neurobiological circuitry in social cognition among model animals.

2. Increased collaboration among basic and applied sciences and researchers to facilitate basic-applied translations. Innovative approaches to change individual health-related behaviors and/or social systems begin with basic (or fundamental) research that illuminates mechanisms and targets involved with attitudes, decision-making, and behavior change and maintenance. Applied (or intervention) research can identify intractable unhealthy behaviors or efficacious interventions whose original designs did not include sufficient basic measures to explain the intervention's efficacy--thus suggesting basic research questions. For example, an applied researcher who repeatedly has found that a setting-based social-network intervention results in sustained healthier behaviors might propose to seek mentorship from a basic sociologist with expert knowledge in social network nodes and ties.

3. Interactions among biological, behavioral, and social processes. Examples include and are not limited to, behavioral cardiology, cell biology, economic neuroscience, genetics, (self-) management of chronic conditions, neurolinguistics, live and virtual social networks, and the spread of disease or wellness. For example, a behavioral or cognitive neuroscientist may propose to extend her expertise with a mentor in in the field of computational sciences; a disease-specific researcher might seek mentoring in cognitive, social, and/or decision-making processes for more comprehensive future research approaches.

4. New approaches to research design and data collection, measurement, and analysis. Sample projects include research tools that could be used in behavioral and social sciences, engineering and technological sciences, in biomedical sciences, or interactions of multiple disciplines. Big data collection and analysis also is appropriate for this announcement. For example, a computational scientist who designs and analyzes mobile health applications might propose to be mentored by a cognitive or developmental neuropsychologist; a neuroscientist might seek additional expertise in behavioral and/or systems science and vice versa.

This short-term (up to 12 months) period of mentored research experience should expand the investigator's current expertise and lead to new knowledge and skills and potential new collaborators. The research career enhancement experience may be conducted in a different department within the candidate's home institution or in a different institutional setting from the location where the candidate holds her or his primary appointment. Mentoring may occur in-person, virtually, or in combination. The research experience proposed must have the potential to augment the candidate’s research capabilities substantially 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. The career enhancement plan may include (1) a didactic academic enrichment plan, e.g., coursework, seminars, journal clubs, etc., and (2) a small-scale research project. The research project is expected to expand the candidate's desired expertise.

ICs participating in this FOA may have specific interests. OppNet strongly encourages researchers to discuss their interests with Scientific/Research contacts well in advance of submitting applications. IC-specific interests appear below:

National Cancer Institute (NCI)

NCI has a specific interest in expertise development and collaboration among researchers with expertise in animal models of biobehavioral cancer-related processes and those who study cancer-related outcomes in humans. Examples may include, but are not limited to the following:

  • Career expertise development and mentoring opportunities that will help to elucidate the multi-factorial individual-level factors that influence adherence and decision-making: cognitive factors, affective factors, biological factors, and motivational factors,
  • Expertise development opportunities in the development and implementation of biopsychosocial interventions,
  • Career expertise and collaboration among researchers with expertise in animal models of social (e.g., isolation, loneliness) and biopsychosocial (e.g., stress, emotion) processes and cancer-related outcomes with those who study these processes and cancer-related outcomes in humans.
  • Career expertise development and collaboration among neuropsychologists, cognitive scientists and/or clinical oncologists, and
  • Career expertise development and collaboration among radiologists with cancer imaging expertise and scientists with expertise in cognition and perception.

National Center on Complementary and Integrative Health (NCCIH)

The National Center for Complementary and Integrative Health (NCCIH) strongly encourages investigators to discuss their plans with NCCIH program staff prior to submitting their application. NCCIH interests include

  • Career expertise development and collaboration among basic and applied complementary and integrative health (CIH) researchers to facilitate basic-applied translation of mind-body interventions (e.g., yoga, tai chi, meditation, mindfulness, hypnosis, manual therapies, and complex interventions such as music and art-based approaches)
  • Expertise development among CIH researchers studying mind-body approaches in biological, behavioral, and social science fields, or vice versa; expertise development to enhance careers of researchers with expertise in animal models of basic behavioral and social processes with relevance to pain research, and those studying similar or related processes in human subjects
  • Enhanced expertise development of CIH researchers studying mind-body interventions in new approaches to research design and data collection, measurement, and analysis. Investigators are strongly encouraged to discuss their plans with NCCIH program staff prior to submitting their application.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA interests include but are not limited to:

  • Career expertise development and collaboration among researchers with expertise in animal models of basic behavioral and social processes associated with alcohol use disorder (AUD) and those studying similar or related processes in human subjects.
  • Mentoring and expertise development and opportunities that will help to elucidate factors that influence adherence and decision-making (e.g., cognitive and affective factors) leading to alcohol use, addiction, or cessation of consumption.
  • Career expertise development and collaboration among researchers with expertise in animal models of social (e.g., isolation, loneliness) and biopsychosocial (e.g., stress, emotion) processes with those who study these processes in humans as they relate to alcohol abstinence and relapse.
  • Development of expertise in research skills focusing on a better understanding of the basic, psychosocial, environmental and behavioral mechanisms that influence disparities in onset of alcohol use related illness, treatments and recovery in the general population as well as among racial, ethnic and gender minorities.

National Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences (NIEHS) strongly encourages investigators to discuss their interests with NIEHS program staff prior to submitting their application. The mission of NIEHS is to discover how the environment affects people in order to promote healthier lives. NIEHS supports research to understand how exposures to toxic environmental insults alter biologic processes, are linked to disease initiation, progression or morbidity, and the development of prevention and intervention strategies to mitigate the effect of these exposures. Examples of environmental agents which are considered of primary interest for NIEHS include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, both indoor and outdoor. Further information is available in the NIEHS Strategic Plan https://www.niehs.nih.gov/about/strategicplan/index.cfm. Areas of interest to NIEHS in this announcement include, but are not limited to:

  • Career expertise development and collaboration opportunities between environmental health scientists with skills in the areas of basic science and/or biomedical pathways, and behavioral and social scientists with backgrounds in health communication, sociology, psychology and anthropology, to understand the interrelationship between biological, psychological and sociocultural factors as they relate to environmental exposures.
  • Promotion of translational research (see NIEHS Translational framework https://www.niehs.nih.gov/research/programs/translational/framework-details/index.cfm) to enable basic and applied researchers to collaboratively design and/or adapt interventions to prevent or mitigate environmental exposures.
  • Expertise development and collaboration opportunities to enhance in informatics or other quantitative sciences to integrate behavioral and social science research methods with data science to develop or adapt tools and methods to more fully understand the processes by which environmental exposures impact communities. Developing expertise in crowd sourcing or other data collection methodologies to collect data on community impact is also included.
  • Collaboration and career development opportunities among researchers with expertise in the effects of the environment on biological systems and processes and those with expertise in communication, outreach and engagement to share research findings with affected community groups and promote environmental health literacy.
  • Career expertise development and collaboration opportunities in computational, informatics, and quantitative approaches for basic researchers, with the goal of integrating diverse data sets, either from animal or human studies, to enhance understanding of the effects of environmental exposures on basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or to develop informatics tools for methodology and measurement of behavioral and social processes.

National Institute of Mental Health (NIMH)

NIMH strongly encourages investigators to discuss their plans with NIMH program staff prior to submitting their application. NIMH interests include, but are not limited to:

• Career development and collaboration between experts in behavioral task development, validation, and/or measurement and experts in neurobiological measures. Projects in human, animal, clinical, and basic populations are of interest.. Measurement of brain and behavior in lab-based or real-world contexts are of interest. Investigators are encouraged to align their proposals with NIMH’s priorities and domains of function as articulated in https://grants.nih.gov/grants/guide/notice-files/NOT-MH-19-053.html and https://grants.nih.gov/grants/guide/pa-files/PAR-18-930.html.

• Opportunities for career expertise development and collaboration that will help elucidate the contribution of social processes (e.g., emotion contagion, communication, social dynamics and/or social network structure, bullying, etc) in the etiology and trajectory of mental illness. Innovative and advanced statistical techniques and methodologies for analyzing network data are encouraged.

• Expertise development in computational, mathematical and engineering approaches for basic and clinical mental health researchers, with the goals of establishing causal links across diverse data sets to enhance understanding of mental illnesses and mental health outcomes.

• Career expertise development and opportunities between translational researchers and social scientists (e.g experts in the fields of economics, sociology, public health, and decision-science) to understand the mechanisms by which societal, cultural, and community factors mediate risk or resilience for mental illnesses. Research on suicide is of particularly high priority, but other mental health areas also welcome.

• Collaboration and career expertise development opportunities between basic and behavioral researchers to understand the biological, behavioral, and psychosocial mechanisms of mood disorders in people living with HIV, particularly the role of the neuroimmune system, and to understand how interventions to improve mood disorders impact these mechanisms and outcomes.

National Institute on Minority Health and Health Disparities (NIMHD)

The National Institute on Minority Health and Health Disparities (NIMHD) seeks to increase and maintain a strong cohort of investigators in minority health and health disparities research. Applications are accepted for all areas of research including biomedical, clinical, population health, behavioral and social sciences. Projects must include a focus on one or more NIH-designated health disparity populations in the United States, which include African Americans, Latinos/Hispanics, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, less privileged socioeconomic groups, underserved rural residents, and sexual and gender minorities (SGMs).

NIMHD supports the study of many aspects of minority health and health disparities— from genetic, molecular, and biologic science to clinical, behavioral, and translational research, as well as research on health care services and systems, and research workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. For more information on specific areas of research please see: https://www.nimhd.nih.gov/programs/extramural/

NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information).

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Required - Basic Experimental Studies with Humans: Only accepting applications that propose independent clinical trial(s) that also meet the definition of basic research.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period
The total project period may not exceed 1year.

Other Award Budget Information

Salary
NIH will contribute 6-9 person months per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094.

The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

Other Program-Related Expenses

NIH will contribute $35,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession
Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/PrincipalInvestigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCiD. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
Candidates for the K18 award must have a research or health-professional doctoral degree. This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)
Level of Effort
At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.

Mentor(s)


Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed career development experience.

Institutional Environment
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Project Summary/Abstract

Include a description of your current research and the research you propose to continue in the independent phase.

SF424(R&R) Senior/Key Person Profile Expanded
  • All instructions in the SF424 (R&R) Application Guide must be followed.

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (candidate) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix

All instructions in the SF424 (R&R) Application Guide must be followed.

Candidate Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Candidate Information and Goals for Career Development

Candidate’s Background

  • Describe the candidate's commitment to a career as a health related research scientist.
  • Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research support.
  • Present evidence of the candidate's potential to augment his/her research career and to ultimately advance scientific progress through this career enhancement plan.
  • Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines.

Career Goals and Objectives?

  • Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed research career development enhancement program.
  • Justify the need for further career enhancement in order to achieve the candidate's future research goals.
  • Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.
  • The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period

  • The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team.
  • Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent of the K18 program.
  • Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities.
  • Explain how the career development plan will enhance the candidate’s independent research career trajectory, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.
  • Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.

Research Plan Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

  • A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
  • Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.

.

  • Applicants proposing basic experimental study with humans should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.
  • Describe the proposed timelines for the proposed study, including any potential challenges and solutions (e.g., enrollment shortfalls).
  • Does the project contribute to furthering to the integration of basic behavioral, biomedical, and/or social scientific processes
  • Is the design of the research project justified and relevant to the career development plan?
  • Is the design of the research project justified and relevant to the hypothesis(es) being tested?
  • Are planned analyses and statistical approach appropriate for the proposed project design?

Training in the Responsible Conduct of Research

  • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

  • The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
  • The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
  • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
  • Include a statement that the candidate will commit at least 6 person-months (50% of full-time professional effort) to the career development program and related career development activities.
  • The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence.
  • Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
  • The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
  • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Description of Institutional Environment

  • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
  • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
  • Describe the resources and facilities that will be available to the candidate.
  • Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate’s Research Career Development

  • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
  • Provide assurances that the candidate will be able to devote the required effort to activities under this award.The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
  • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
  • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

The following additional instructions apply:
  • Applications to this FOA must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1.4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through K awards may be sufficient to support only small feasibility studies.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

  • Has the candidate provided evidence of excellence as an independent investigator, including a record of research support and peer-reviewed publications?
  • Does the candidate show evidence of a high level of commitment to meeting the program's career enhancement objectives?
  • Does the candidate have high potential for successfully augmenting his/her research career capabilities and becoming an outstanding contributor to the research field relevant to the proposed research enhancement experience?
  • Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?  
  • Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

Career Development Plan

  • Is the career development plan appropriate in its content, scope, duration, and phasing for the candidate's stated career development goals?
  • Is there a high likelihood that the proposed program will contribute substantially to the research career enhancement of the candidate?
  • Is an appropriate level of the candidate's professional effort to the career development plan documented in the application?
  • If proposed, will the Basic Experimental Study with Humans clinical trial experience contribute to the applicant's research career development?

Research Plan

  • A sound research project that is consistent with the candidate’s level of research development and objectives of her/his career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
  • Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.
  • Is the scientific rationale for a career development research project well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
  • Is the study design justified and relevant to the hypothesis(es) being tested?
  • Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
  • Are planned analyses and statistical approach appropriate for the proposed study design and methods used?
  • For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

  • Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality?
  • Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
  • Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed Basic Experimental Study with Humans clinical trialand help him/her to meet timelines?

Environment & Institutional Commitment to the Candidate

  • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration, available to the candidate?
  • Is there clear commitment from the institution(s) to ensure that the candidate will devote the requisite effort directly to the research career enhancement activities described in the application?
  • Is there strong institutional commitment to fostering the candidate’s advanced research career development? Are there unique features of the scientific environment of the institution(s) that will benefit the proposed research and career development plan (e.g., useful collaborative arrangements, special equipment or analytic methods, unique subject populations)?
  • Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
  • Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
  • If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline for Clinical Trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by the Center of Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Specific to applications proposing clinical trials, ancillary or feasibility studies

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include theNIH Grants Policy Statementas part of the NoA. For these terms of award, see theNIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: GeneralandPart II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided atAward Conditions and Information for NIH Grants. More specifically, for K Awards, visit theResearch Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.
Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov

Scientific/Research Contact(s)

The Office of Behavioral and Social Sciences Research (OBSSR) facilitates OppNet on behalf of NIH but cannot accept assignment of applications or manage awards that are funded. Please contact one of the IC-based contacts below for inquiries regarding the suitability of the proposed project for this FOA and the IC's research portfolio.

William Elwood, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-402-0116
Email: william.elwood@nih.go

Lanay Mudd, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: lanay.mudd@nih.gov

Susan Perkins, Ph.D.
Center for Cancer Training
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email:susan.ciolino@nih.gov

Gina Tesauro, MSW
Behavioral Research Program
National Cancer Institute (NCI)
Telephone: 240-276-6786
Email: gina.tesauro@nih.gov

Ivana Grakalic, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7600
Email: igrakalic@mail.nih.gov

Ashlee Van't Veer, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-917-5036
Email: ashlee.van'tveer@nih.gov

Nadra Tyus, Dr.P.H., MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: nadra.tyus@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Alicia Heslip
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4907
Email: alicia.heslip@nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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