Department of Health and Human Services

Part 1. Overview Information

Key Dates

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

1. Part 1. Overview Information
2. Part 2. Full Text of the Announcement
   1. Section I. Funding Opportunity Description
   2. Section II. Award Information
   3. Section III. Eligibility Information
   4. Section IV. Application and Submission Information
   5. Section V. Application Review Information
   6. Section VI. Award Administration Information
   7. Section VII. Agency Contacts
   8. Section VIII. Other Information

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. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Purpose

The purpose of the NCI Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented cancer research (POR). The Diversity Training Branch (DTB) of the NCI's Center to Reduce Cancer Health Disparities (CRCHD) announce the availability of the "Mentored Patient-Oriented Research Award to Promote Diversity" for career development of individuals with a health professional doctoral degree from groups nationally underrepresented in the biomedical, clinical, behavioral, and social sciences.

According to the Physician-Scientist Workforce Working Group report of June 2014 (http://acd.od.nih.gov/reports/PSW_Report_ACD_06042014.pdf;), nearly three-quarters of the MD RPG awardees were white and another one in five were Asian. Although there has been significant growth for Asian and Hispanic awardees over the past decade, there has been less growth for African-Americans and Native Americans. Seventy-eight percent of the NCI's Center for Cancer Training career development (K) recipients are non-Hispanic whites and Asians. African Americans, Hispanic whites, and Native Americans together comprise less than five percent (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3608862/;

http://www.cancer.gov/researchandfunding/cancertraining/KAward-Evaluation-Report.pdf ). Similar findings have been reported by others (http://acd.od.nih.gov/bmw_report.pdf; http://biomedicalresearchworkforce.nih.gov/ ). The lack of diversity of the physician-scientist workforce is a source of very serious concern to the NIH and to the professions. Contributing to the challenges confronting the physician-scientists are: 1) the increasing length of training required to obtain competency in clinical and scientific research, 2) finding mentors who can support and guide early career investigators, and 3) the decreasing NIH funding resulting in the increasing demand on physician-scientists to support a higher percentage of their income by seeing patients.

The National Cancer Institute (NCI) is committed to building a diverse workforce for the biomedical, behavioral, and clinical sciences - a critical step in reducing the burden of cancer for an increasing diverse America. Providing a smoother path towards careers in science and medicine is an important means to attract and engage the nation's most talented individuals, especially those from backgrounds traditionally underrepresented in cancer research and care. The resulting workforce, reflecting diverse cultural and research perspectives, can best ensure that our science addresses the health needs of all Americans. To ameliorate the challenges confronting the physician-scientist workforce, this K23 mechanism establishes a pathway of recruiting, training, and retaining investigators from underrepresented backgrounds in research fields that address problems pertinent to the diagnosis, control, and treatment of human cancer and who can conduct independent competitive cancer research programs.

The NCI Mentored Patient-Oriented Research Career Development Award (K23) program represents the continuation of a long-standing NIH program that provides support and protected time to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical, clinical, behavioral, and social sciences. The objective of the NCI Mentored Patient-Oriented Research Career Development Award (K23) program is to provide salary and research support for a sustained period of protected time to ensure a future cadre of well-trained scientists conducting NIH-supported POR. The expectation is that through this sustained period of research career development and training, awardees will develop enhanced research capabilities for cancer research careers and be better prepared to compete for research project grants (e.g. R03, R21, or R01) funding.

The specific objectives of the Mentored POR-Career Development Award are to:

• Encourage research-oriented clinicians to develop independent research skills and gain experience in advanced methods and experimental approaches needed to become an independent investigator conducting patient-oriented research.
• Increase the pool of clinical researchers who can conduct patient-oriented studies, capitalizing on the discoveries of biomedical research and translating them to clinical settings.
• Support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research.

For the purposes of the K23 award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials; and 4) the development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects research are not included in this definition. See also the NIH Directors Panel on Clinical Research Report.

The goal of the NCI DTB K23 is to enhance the diversity of NCI-funded pool of clinical investigators who are available to conduct cancer focused patient-oriented studies, capitalizing on the discoveries of biomedical research and translating them to clinical settings. This award forms an important part of the NCI initiative to recruit the most talented researchers from all groups and to promote diversity in the patient-oriented research workforce.

Related Funding Opportunity: Clinically trained professionals or individuals with a clinical degree who are representative of groups underrepresented in biomedical research and are interested in further career development in laboratory- or field-based research that is not patient-oriented should consider the NCI Mentored Clinical Scientist Career Development (K08) Award, which can be found in the FOA PAR-15-060.

Background

Substantial national and local efforts are directed toward a reduction in cancer morbidity and mortality in the general population. However, in spite of these efforts, the American Cancer Society estimates that approximately 1.7 million men and women will be diagnosed with cancer, and approximately one-third of them will succumb to cancer metastases in 2014. Past patterns of cancer incidence and mortality predict that the disproportionate increase in U.S. cancer incidence and mortality will be experienced by both underrepresented and underserved populations (http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/ ). Specifically, cancer rates for stomach, liver, gall bladder, and cervix are higher in Hispanics than in non-Hispanic whites (http://www.cancer.org/research/cancerfactsfigures/cancerfactsfiguresforhispanicslatinos/ ). Stomach and liver cancer incidence and death rates are more than twice as high in Asian American/Pacific Islanders as in Caucasians, and cancer mortality rates from prostate, stomach, and cervical cancers among African Americans are more than twice those in Caucasians.

Barriers to Cancer Treatment. A factor contributing to the cancer in health disparity populations is their limited access to patient-oriented clinical oncologists from diverse backgrounds. A reduction in the overall cancer mortality rate in underserved populations would substantially impact known cancer statistics. Barriers to cancer diagnosis/treatment and to advice regarding preventive health care will take on added importance as the techniques of molecular epidemiology are increasingly applied to identify underserved individuals and family members at high risk for cancer. As a result of this new technology, physicians will increasingly be called upon to deal with sensitive issues such as prophylactic surgery for family members and/or major changes in lifestyle, possibly even including childbearing.

Need for Diversity among Clinician Scientists. There is abundant evidence that not only patients, but the biomedical enterprise will directly benefit from broader inclusion. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from underserved populations into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings.

The clinical scientist in oncology must have an understanding of the new technologies being developed that will assist in the diagnosis/treatment of cancers and the predictions of cancer risk. This understanding can best be provided by a research and career development experience in the development and/or application of these technologies.

Specific Research Objectives

This FOA has been part of an important NCI initiative to attract individuals from diverse backgrounds nationally underrepresented in biomedical science to clinical research .. The NCI is especially interested in enhancing the pool of clinicians from nationally underrepresented backgrounds , trained to conduct high quality, patient-oriented clinical research. The K23 provides the awardee with the opportunity to obtain both the knowledge and the research skills necessary to compete for independent support in patient-oriented research.

The purposes of this award are to:

• Encourage individuals with a health professional doctoral degree from backgrounds nationally underrepresented in biomedical, clinical, behavioral, and social sciences to develop independent research skills and gain experience in advanced methods and experimental approaches needed to conduct patient-oriented research;
• Capture health professionals from underrepresented backgrounds with variable backgrounds in clinical practice and limited or no clinical research experience to re-direct their careers toward clinical cancer research by acquiring critical research skills in a mentored clinical research environment;
• Provide an opportunity for clinicians engaged in non-cancer related clinical research who wish to receive mentoring to re-direct their research focus to cancer-related clinical research; and
• To build a diverse cadre of clinical researchers who can conduct patient-oriented studies, capitalizing on the discoveries of biomedical research and translating them to clinical settings.

Section II. Award Information

Other Award Budget Information

NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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 not 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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• 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/Principal Investigators (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.

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

The overarching goal of this FOA is to enhance the pool of independent and talented cancer research investigators from backgrounds nationally

underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, therefore given the purpose of this funding opportunity announcement this category is ineligible for support.

Candidates for this award should have broad clinical training, must demonstrate competence in clinical activities, must document a serious intent for a research career in patient-oriented clinical oncology, and must document sensitivity to cultural issues impinging upon the practice of medicine among the major U.S. ethnic populations.

Candidates for this award must have a health-professional doctoral degree. Such degrees include but are not limited to the MD, DO, DD.S, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice. Candidates with PhD degrees are eligible for this award if the degree is in a clinical field and they usually perform clinical duties. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline but who are certified to perform clinical duties should contact the appropriate Institute concerning their eligibility for a K23 award. Candidates also must have completed their clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training.

Former PDs/PIs on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K awards), or the equivalent are not eligible. Former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

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 career development and research training 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 NCI Scientific/Research Staff listed under Section VII Agency Contact prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Mentor(s)

Before submitting the application, the candidate must identify mentor(s) who will supervise the proposed career development and research experience. The mentor(s) 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(s) must document the availability of sufficient independent research support and facilities for high-quality research to cover the costs of the proposed research project in excess of the allowable costs of this award. 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 principal mentor who will coordinate the candidate’s research. Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. Appropriate mentors include, but are not limited to, NIH-supported investigators involved in POR. The mentor(s) should also be sensitive to the individual needs of the candidate, have a proven record of success in training independent investigators, demonstrate a strong, continuous commitment to the candidate throughout the period of training and should have sufficient independent research support to absorb the costs of the proposed research project in excess of the allowable costs of this award.

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.

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except 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 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (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, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

Other Project Information

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed

Other Attachments:

Eligibility information must be submitted by the applicant Institution in a letter certifying that the applicant belongs to category A or B, above. Name the PDF formatted letter EligibilityCertification.pdf . Application processing may be delayed or the application may be returned if it does not comply with this requirement.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate’s Background

• Describe the candidate's commitment to an academic career in Patient-Oriented Research (POR). Describe all of the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career development award.
• Present evidence of the candidate's ability to interact and collaborate with other scientists.
• Describe prior training and how it relates to the objectives and long-term career plans of the candidate.
• Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
• Provide evidence of the candidate's potential to develop into an independent investigator.

Career Goals and Objectives

• Describe the candidate’s career goals and objectives under this award. Candidates are encouraged to provide a timeline for accomplishing these goals.
• Describe a systematic plan that: (1) shows a logical progression from the candidate’s prior research and training experiences to the research and career development experiences that will occur during the Development Award period and then to independent investigator status; (2) justifies the need for further career development to become an independent academic investigator; (3) includes didactic (if appropriate) and research components; and (4) utilizes the relevant research and educational resources of the institution.

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. A timeline is often helpful. The sponsor/mentor may form a mentoring team (or an advisory committee) to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's 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.
• Describe the professional responsibilities/activities including involvement in other research projects beyond the minimum required 9 person-months (75% effort full-time professional effort) commitment to the K23 award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator conducting patient-oriented research.
• The candidate should describe any new or enhanced research skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research programs as an independent scientist conducting patient-oriented research.
• Provide details and the duration of planned structured activities, such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc. essential to develop the necessary knowledge and research skills in scientific areas relevant to the candidate’s career goals.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent research career conducting patient-oriented research. The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher conducting patient-oriented cancer research.

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).
• The plan must address the five, required instructional components outlined in the NIH policy: 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 instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
• Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), 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 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(s) 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.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• Include a statement that the candidate will commit at least 9 person-months (75% 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 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. Collaborators and consultants generally 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. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• 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. These
• individuals generally do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

Description of Institutional Environment

• The sponsoring institution must define and 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.

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 assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to POR and related career development activities. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent clinician-scientist, e.g. clinic responsibilities, teaching and administration, and/or additional research activities.
• Provide assurance that the candidate will have appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, if necessary) to carry out the proposed research plan.
• Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), 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 not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
• The research strategy for the application must have aspects that the applicant can take with him/her after the mentored period of the training. The mentor must ensure that this is stated in his/her statement in the application and designate the "portable aspects of the project" to this section.
• While the focus of the K23 award is on POR, complementary laboratory research directly related to patient-oriented research may be proposed in the application, thereby providing an opportunity for a career development experience in translational research.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the NOT-OD-11-079). 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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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.

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 (SAM). 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 NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-012 and NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

• Does the candidate have the potential to develop as an independent and productive researcher?
• Are the candidate's prior training and research experience appropriate for this award?
• Is the candidate’s academic, clinical (if relevant), and research record of high quality?
• Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in patient-oriented research?
• Do the letters of reference address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan/Career Goals and Objectives

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Are there adequate plans for evaluating the candidate's research and career development progress?

Research Plan

• Are the proposed research question, design, and methodology of significant scientific and technical merit?
• Is the research plan relevant to the candidate’s research career objectives?
• Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?

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

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
• Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
• Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
• Is there evidence of the mentor s, consultant s, and/or collaborator’s previous experience in fostering the development of independent investigators?
• Is there evidence of the mentor's current research productivity and peer-reviewed support?
• Is active/pending support for the proposed research project appropriate and adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
• Are the combined expertise, roles and responsibilities of any involved co-mentors, consultants, and/or collaborators likely to enhance the candidate’s career development?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
• Is the institutional commitment to the career development of the candidate appropriately strong?
• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is the environment for scientific and professional development of the candidate of high quality?
• Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children

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 children 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 five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Renewals

Not Applicable

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.

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).

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) Genome Wide Association Studies (GWAS).

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 NCI 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory 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.

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part 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 at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ("K") Awardees section of the NIH Grants Policy Statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final progress report, 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 agreements are 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.

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.

Within ten years of making awards under this program, NCI will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NCI will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Scientific/Research Contact(s)

John O. Ojeifo, M.D., Ph.D., M.B.A.
National Cancer Institute (NCI)
Telephone: 240-276-6186
Email: [email protected]

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Financial/Grants Management Contact(s)

Arina V. Kramer
National Cancer Institute (NCI)
Telephone: 240-276-6327
Email: [email protected]

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 Parts 74 and 92.