NIH/NCI Cancer Research Grants (e.g., R01, R21, K08, K23)

NIH/NCI Cancer Research Grants (e.g., R01, R21, K08, K23) is sponsored by National Cancer Institute (NCI) - National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-12-052: NCI Mentored Patient-Oriented Research Career Development Award to Promote Diversity (K23) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title NCI Mentored Patient-Oriented Research Career Development Award to Promote Diversity (K23) K23 Mentored Patient-Oriented Research Career Development Award December 09, 2014 - This PAR has been reissued as PAR-15-62 . supersedes instructions in Section III.

3 regarding applications that are essentially the same. November 27, 2013 ( NOT-OD-14-027 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

May 31, 2012 - See Notice NOT-OD-12-113. This Notice clarifies instructions under Section III. Eligibility Information.

Funding Opportunity Announcement (FOA) Number PAR-12-051 , K08 Mentored Clinical Scientist Research Career Development Award to Promoted Diversity Applicants may only have one individual Career Development Award Application pending peer review at any time. See Section III. 3.

Additional Information on Catalog of Federal Domestic Assistance (CFDA) Number(s) The purpose of the NIH 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 NCI's Diversity Training Branch (DTB) and the 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 currently underrepresented on a national level in the biomedical, clinical, behavioral, and social sciences.

The NCI recognizes a unique and compelling need to promote diversity in the patient-oriented research workforce. Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply , by 5:00 PM local time of applicant organization. AIDS Application Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

New Date: December 10, 2014. This PAR has been reissued as PAR-15-062 .

January 8, 2015 Required Application Instructions It is critical that applicants follow the instructions in 424 (R&R) Application Guide , especially 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. Part 1. Overview Information Part 2.

Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts 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 are available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

1. Research Career Objectives The Diversity Training Branch (DTB) of the NCI's Center to Reduce Cancer Health Disparities (CRCHD) expects efforts to diversify cancer research workforce to lead to the recruitment of the most talented researchers from all groups, thereby capitalizing on the discoveries of new technologies being developed for the diagnosis/treatment of cancers and the predictions of cancer risk.

The overall objective of the NCI Research Career Development Award program is to prepare qualified individuals for careers that have a significant impact on the health-related research workforce needs of theNational The objective of the NCI Mentored Patient-Oriented Research Career Development Award (K23) program is to ensure a future cadre of well-trained scientists working in Patient Oriented Research (POR) areas who will become competitive for NIH research project (R01) grant support.

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.

The goal of the NCI DTB K23 is to diversify the pool of clinical researchers 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 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 at ( PAR-12-051 ).

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. 6 million men and women will be diagnosed with cancer, and approximately 0.

5 million of deaths from cancer are projected to occur in the United States in 2011. Past patterns of cancer incidence and mortality predict that the disproportionate increase in U.S. cancer incidence and mortality will be experienced by both minority and underserved populations. Barriers to Cancer Treatment.

Contributing to the cancer mortality of U.S. minorities is their limited access to treatment by culturally competent physicians. This factor is largely due to the small numbers of U.S. patient-oriented clinical oncologists from diverse backgrounds. A reduction in the overall cancer mortality rate in minority and underserved populations would substantially impact known cancer statistics.

Cultural 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 minority 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 culturally sensitive issues such as prophylactic surgery for family members and/or major changes in lifestyle, possibly even 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 minority groups 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 It is therefore imperative that a sufficient number of clinical scientists in oncology from diverse backgrounds be trained and available so that access to care is not limited by the number of clinical scientists in oncology who are sensitive to cultural issues.

Additionally, 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 Specific Research Objectives This FOA has been part of an important NCI initiative to attract talented individuals from diverse backgrounds underrepresented in biomedical science on a national level.

The Diversity Training Branch, CRCHD will provide successful candidates with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required for preparing competitive research project grants. The NCI is especially interested in increasing the number of clinicians from diverse groups, trained to conduct high-quality, patient-oriented clinical research.

The K23 provides the awardee, through multidisciplinary didactic training, the opportunity to obtain both the knowledge and the research skills necessary to compete for independent support in patient-oriented research.

The purposes of Encourage individuals with a health professional doctoral degree from diverse backgrounds currently underrepresented in the biomedical, clinical, behavioral, and social sciences on a national level to develop independent research skills and gain experience in advanced methods and experimental approaches needed to conduct patient-oriented research; Capture those diverse health professionals 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 other clinical research areas for less than 2 years, to re-direct their research focus to clinical cancer 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.

Clinical Research. For the purposes of this award, and in agreement with the recommendations of the NIH Director's Panel on Clinical Research, ( http://www. nih.

gov/news/crp/97report/index. htm ), 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 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 The objective of the NIH Mentored Patient-Oriented Research Career Development Award (K23) program is to provide salary and research support for a sustained period of protected time (3-5 years) to ensure a future cadre of well-trained scientists from diverse backgrounds working in Patient-Oriented Research (POR).

The K23 award is expected to help research-oriented clinicians to develop research skills and gain experience in advanced methods and experimental approaches needed to become an independent investigator conducting POR.

Glossary and the SF 424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations, the submission of a sufficient number of meritorious applications and the availability of funds. Award budgets are composed of salary and other program-related expenses, as described below. The total project period may not exceed 5 years.

NIH will contribute up to $100,000 per year toward the salary of the career award recipient. The total salary requested must be based on a full-time staff appointment.

The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale.

However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses NIH will contribute $30,000 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.

Salary for mentors, secretarial and administrative assistants, etc. is not Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are Foreign components, as defined in the NIH Grants Policy Statement , are not allowed.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal 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 diversify and expand the pool of independent and talented cancer research investigators: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce.

The NCI expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently 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.

Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following 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. disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

disadvantaged backgrounds who are defined as: 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.

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, but would be more difficult to justify for individuals beyond that level of achievement. must be submitted by the applicant Institution in a letter certifying that the applicant belongs to one of the above groups. The letter should be inserted in the application immediately before the Checklist as a PDF file.

Application processing may be delayed or the application may be returned if it does not comply with this requirement.

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.

Nomination: The candidate must be nominated by institutions on the basis of qualifications, interests, accomplishments, and motivation, and based upon the candidate's intent to conduct a research project highly relevant to cancer biology, cancer health disparities, etiology, pathogenesis, prevention, diagnosis, and/or treatment that has the potential for establishing an independent research program.

Accordingly, the NCI continues to encourage institutions to diversify their student and faculty populations and to identify candidates who will increase diversity on a national basis. of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award.

The remaining 3 person-months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K23 Award, i.e., the candidates development into an independent investigator in POR. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056 .

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. 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 NCI prior to preparing an application to discuss their eligibility.

Former principal investigators 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 principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

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.

Career Stage : The intent of the K23 program is to support clinical scientists in their early career stages (i.e. postdoctoral positions or early stage of faculty positions such as Assistant professors with = 2 yrs of appointments). Clinicians (including those with MD, DDS.

DVM, and other licensed health professionals) in clinical faculty position that denotes independence in clinical responsibilities but not in research are also eligible It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent positions.

Candidates in such positions are strongly encouraged to contact the NCI program official for confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that the position he/she is in complies with the intent of this eligibility requirement. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application that is essentially the same as one already reviewed.

An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

A candidate for an NIH K23 award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K22, K23, K25), a research project grant (R01), or any PHS award that duplicates any of the provisions of the K23 award.

Ineligible individuals include current and former principal investigators on NIH research project grants, comparable individual career development awards (e.g., K01, K07, K08, K23, K25) equivalent non-PHS peer-reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.

Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application.

K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution.

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.

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 . Candidates must have at least two mentors.

The candidate must name a primary sponsor/mentor, who, together with the applicant is responsible for the planning, direction, and execution of the clinical program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators in patient-oriented research.

A second basic research mentor in the proposed research area should have a proven record of success in training independent investigators. The mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program.

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

The institution must demonstrate a commitment to the development of the candidate as a productive investigator and be willing to allow the protected time needed by the candidate. The candidate, mentor(s), and institution must describe a career development program that will maximize the use of this environment, including available facilities and resources.

and Submission Information 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 (R&R) Application Guide , 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 Required and Optional Components The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA.

Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

PHS 398 Career Development Award Supplemental Form All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate’s Background (Component of Describe the candidate's commitment to an academic career in Patient-Oriented Research (POR).

Include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career 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 Provide evidence of the candidate's potential to develop into an independent investigator. Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the POR program and related career development activities.

The mentor or department chair must agree and provide a statement in the application documenting that this percent of the candidate’s time will be protected.

Career Goals and Objectives (Component of Candidate Information) Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur; (2) justifies the need for further career development to become an independent investigator; and (3) utilizes the relevant research and educational resources of Career Development/Training Activities During Award Period (Component of Candidate Information) 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 the 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 other research projects) beyond the minimum required 9 person-months (75% 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.

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 Less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely didactic in nature and is followed by a period of intense, supervised research.

The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a Training in the Responsible Conduct of Research (Component of Candidate Information) Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in