Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, includingSupplemental 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 Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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.

The objective of the NIDDK Clinician Scientist Mentoring Award to Promote Workforce Diversity (K05) is to provide salary support for a sustained period of protected time (3-5 years) to outstanding mid-career clinician scientists to devote effort to basic, epidemiological or outcomes research and to focus on the mentoring of post-doctoral level investigators and, preferably, clinical fellows and clinical junior faculty from diverse backgrounds underrepresented in biomedical and behavioral research who are interested in basic, rather than patient-oriented, research. Candidates for the K05 must have independent, peer-reviewed funding and be at the mid-career stage in research relevant to the mission of the NIDDK who have demonstrated a commitment to training and mentoring individuals from underrepresented backgrounds in basic, epidemiological or outcomes research. For candidates engaged in outcomes research, such research must not utilize study designs requiring direct patient interaction, but could include secondary data analyses of established datasets, simulations and ancillary studies that focus on understanding the end results of health care inverventions and practices. For example, a study utilizing a large dataset in order to develop a predictive treatment model for disease management would be appropriate for this program.

The importance of qualified mentors for clinician scientists has been noted at the national level (National Research Council. 2011. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences. Washington, DC:The National Academies Press) and by several clinical societies with mission interests in NIDDK’s disease areas (Gastroenterology, 132:477-480, 2007; CJASN, 9:1144-1147, 2014). There is an additional need to train and mentor investigators from diverse backgrounds (National Research Council and the Institute of Medicine. 2006. Opportunities to Address Clinical Research Workforce Diveristy Needs for 2010. Washington, DC: National Academies Press; Mt Sinai J Med., 79(3):397-411, 2012). The recent report containing recommendations to the NIH Advisory Committee to the Director from the Diversity in Biomedical Workforce Working Group (NIH, Bethesda, MD 2012) specifically recommended the development of mentors and resulted in a national program to build this personnel capacity (National Research Mentoring Network, http://commonfund.nih.gov/diversity/index). Additionally, the strategic plans targeting NIDDK mission interests have stated goals of increasing the involvement of individuals from underrepresented backgrounds in their workforce pipelines (Strategic Plan for NIH Obesity Research, 2012; Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the Diabetes Mellitus Interagency Coordinating Committee, 2011; Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases, 2009). Mid-career individuals with clinical training and engaged in basic research have limited options for obtaining extramural support for career development and mentoring. This program aims to address this by providing protected time and research support to emerging leaders in basic and clinical research that does not involve direct interaction with patients. The existing NIH K24 program (http://1.usa.gov/1nXzN32) is an option for these latter investigators. Additionally, this program will promote the development of workforce diversity by providing support for successful mentors of underrepresented individuals.

The NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; 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 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 basis.

The NIH is particularly interested in encouraging the recruitment and retention of individuals from the following classes of potential mentees:

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, Hispanics or Latinos, American Indians or 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 included in recruitment plans.

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 http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or 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.

Recruitment and retention of individuals from disadvantaged backgrounds (C1 and C2) are most applicable to high school and perhaps undergraduate candidates. Since the focus of the mentoring opportunities should be at the post-doctoral level and, preferably, for clinical fellows or junior faculty who have not yet reached research independence, C1 and C2 are not applicable.

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.

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

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.

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.

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 organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status

Candidates for this award must have a health-professional doctoral degree or its equivalent. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as a doctoral degree in nursing. Candidates with PhD degrees are eligible for this award if they have clinical responsibilities. This may include clinical psychologists, clinical geneticists, speech and language pathologists.

The candidate should be in the mid-career stage at the Associate Professor level or functioning at that level in an academic setting or equivalent non-academic setting and must have an established record of independent, peer-reviewed research grant funding as well as active support at the time of application. If an individual has been expeditiously promoted to Professor based soley on his/her clinical skills, they may still be eligible for this award. Such individuals are encouraged to consult with NIDDK staff named in Section VII to determine eligiblity. A K05 recipient who is promoted to a higher academic position (viz., Full Professor or equivalent) during the award period and continues to have an independent, peer-reviewed research program and continues to provide mentoring to junior investigators can retain the award.

Successful applicants for this award are expected to maintain peer-reviewed independent research support for the duration of the award. Awardees losing this support during the award period must document their efforts to replace this support in their annual continuation reports and demonstrate they meet all the other requirements of the program. Applicants must provide evidence that their administrative or clinical duties will be reduced to accommodate mentoring activities. It is not the intent of this program to support successful applicants in lieu of research effort. Research efforts of the PD/PI in current projects are not expected to be reduced under this program.

The candidate must also have a demonstrated commitment to training and mentoring individuals from underrepresented backgrounds. The focus of the mentoring should be at the post-doctoral level and, preferably, for clinical fellows or junior faculty who have not yet reached research independence. Individuals from diverse backgrounds fall into the categories described under Section I. Funding Opportunity Description.

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

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.

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 be able to demonstrate the need for protected time, 3-6 person months (25-50% of full-time professional effort) for a period ofintensive research focus and to act as a mentor to young investigators. Candidates for the K05 award may not have concurrent applications for any other PHS career award.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

• Present evidence of the candidate’s success as an independent investigator and his/her potential to make future contributions to the chosen field of research.
• Explain how the career award will contribute to career goals, and further the candidate’s research career and ultimate impact on science.
• Document the ability of the candidate to provide mentoring to junior diverse investigators.
• Provide a description of mentoring experience, mentoring role, the number of investigators mentored and the stages of their professional career. Additionally, provide the proportion of individuals mentored by the candidate who remain in academic medicine.
• Provide an explanation as to how relief from clinical and administrative responsibilities will contribute to the development or expansion of the candidate’s research program and increased level of commitment to mentoring diverse new investigators.

Career Goals and Objectives

• Describe the candidate’s career goals and objectives under this award, including prior research and mentoring experience and current research support.

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

• 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 independent scientists.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression as an investigator.

Candidate s Plan to Provide Mentoring

• This required section should include a description of the availability of appropriate junior investigators for mentoring; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate for the career award will serve as a mentor.
• If there is an existing mentoring program (e.g., NRMN award), describe how the mentoring plan will be integrated with those activities. Candidates must also describe a plan for supporting the research of their mentees during the period of the career award.
• This plan should include active research support at the time of application for the career award, and may include research development support.
• Candidates must indicate the proposed person months committed to the mentoring plan.

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:

• Letters of Support from Collaborators, Contributors and Consultants
• Signed statements must be provided by each collaborator and/or consultant 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 that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.

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 well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate.
• Include a description of the facilities and other resources that will be provided to the candidate.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a letter of commitment to the candidate's career goals as 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 the K05 award.
• The letter of commitment from the institution should provide statements concerning the amount of protected time the candidate will receive (3-6 person-months or 25 to 50% full-time professional effort required); the duties from which he/she will be relieved (if clinical duties the institution should describe specific steps that will be taken to cover these duties, such as hiring clinical staff); and the institutional commitment to enhancing the candidate's ability to be a productive, independent investigator.
• Provide assurance that the candidate is an integral part of the institution’s research and academic program.

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

• At the time of application, the K05 candidate should have currently funded research within the mission areas of the NIDDK. The research can be basic, epidemiological or outcomes-based, as long as it does not involve direct patient interaction. The research plan should provide a summary of the funded projects, as well as the planned direction of research activities during the K05 award period.
• Currently supported research: There is no need to provide extensive detail with regard to ongoing, funded research. Enough information should, however, be provided to permit the peer reviewers to evaluate the extent, special features and general quality of the candidate's research activities and opportunities for mentoring.
• Describe how the currently supported research relates the proposed Mentoring Plan and how mentees will be able to benefit from the experience. Outline strategies and approaches employed to facilitate independent projects for the mentees.

Appendix

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

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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 by the Center for Scientific Review and responsiveness by the NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

Reviewers should provide their assessment of the likelihoodthat 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.

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

• Is the candidate an outstanding scientist who is making significant contributions to the field?
• Is there evidence of ongoing, high quality research productivity as evidenced by contributions to the scientific literature and success in obtaining independent funding?
• Has the candidate demonstrated the ability to conceptualize and organize a long-term research approach?
• Is there evidence of the candidate’s capabilities and commitment to serve as a mentor, particularly for those from under-represented groups?
• Is the candidate’s level of training, experience, and competence commensurate with the purposes of the award?
• Does the application demonstrate that the proposed program and protected time will relieve the candidate from non-research patient care and administrative duties and allow him/her to devote additional time and to augment his/her capabilities in patient-oriented research?

Plan to Provide Mentoring

• What is the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate?
• Are the career goals and objectives consistent with the candidate's career goals?
• Is there evidence that the award will enable the candidate to devote full time (at least the required minimum percentage of full-time professional effort) to research and mentoring by release from teaching, administration, clinical work, and other responsibilities?
• Has the candidate described a reasonable strategy to mentor post-doctoral and clinical fellows from diverse backgrounds to research independence?
• Are described plans to integrate the related institutional programs into the mentoring plans adequate?
• Are any activities proposed for the candidate's continued professional development as a mentor appropriate?
• Have past and current mentoring activities, particularly for those from under-represented groups, been adequately described?
• Is an appropriate level of effort proposed for the mentoring component?
• Are the professional development activities proposed consistent with the candidate's career goals and objectives?

Research Plan

• Candidates are expected to have independent, peer-reviewed research support at the time the career award is made. In such instances, reviewers should not re-evaluate the research plan. Rather, the reviewers should evaluate how the research and career development plans together further the candidate’s research career.
• Is the research plan of high quality, and does it have potential for advancing the field of study? Is the scientific and technical merit of the proposed research plan of significance?
• When applicable for the specific candidate and situation, do the letters from consultant(s) and collaborator(s) adequately document their willingness to participate in the independent scientist award program?
• Is the research plan an appropriate vehicle for developing prospective mentees' research skills and capabilities as independent investigators?

Consultant(s), Collaborator(s)

• Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality?
• Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?

Environment & Institutional Commitment to the Candidate

• Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate?
• Is the level of assurance from the institution that they intend the candidate to be an integral part of its research program adequate?
• Are the research facilities, resources and educational opportunities available to the candidate appropriate and adequate?
• Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing research appropriate and adequate?
• Is the level of commitment from the sponsoring institution to provide protected time for the candidate to conduct the research and mentoring program adequate?
• Are the size and quality of the pool of investigators from diverse backgrounds to be mentored by the candidate adequate?
• Is there an adequate commitment from the sponsoring institution to provide protected time for the candidate to conduct the research and mentoring program?

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, 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.

Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases (NDDK) Advisory Council. 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.

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.

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.

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.

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.

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.

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 five years of making awards under this program, NIH 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, NIH 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:

• Continued success of the candidate in mentoring diverse individuals in research as evidenced by number of mentees supervised by the candidate and their subsequent participation in research areas of interest to the NIDDK
• Authorship of scientific publications by the mentees supervised by the candidate in research areas of interest to the NIDDK.
• Subsequent independent research grant support of the mentees supervised by the candidate from NIH or another source

NIDDK will utilize information provided in submitted non-competitive progress reports from successful candidates to capture the above metrics. In addition, successful awardees may be asked to provide NIDDK with data in suggested tabular formats on their mentees subsequent activities on a program-specific website.

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

eRA Commons Help Desk (Questions regarding 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]

Tracy L. Rankin, Ph.D
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email: [email protected]

Terry Rogers Bishop
National Institute of Diabestes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7726
Email: [email protected]

James F. Hyde, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7692
Email: [email protected]

Judith Podskalny, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8876
Email: [email protected]

Barbara Woynarowska, Ph.D
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-7172
Email: [email protected]

Aricia Ajose
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9023
Email: [email protected]

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.

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.