Research career development K award, CDA, application, letters of reference, concurrent applications, environment and institutional commitment to the candidate, training in the responsible conduct of research, budget, submission dates

12.4.1 Application

Before applying for a CDA, applicants should carefully review the guidelines in the NOFO for the specific career award(s) of interest, noting especially the eligibility requirements, award provisions, requirements for a mentor, and review criteria. The participating ICs may have distinctive guidelines, requirements, and funding amounts for each NOFO in order to accommodate the career needs of researchers working in fields related to their specific research missions. Candidates are therefore strongly encouraged to contact the staff person in the relevant IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. listed in the NOFO prior to preparing an application to discuss any specific provisions of the award.

The specific NOFO provides links to the application forms package as well as the appropriate application instruction guide. As with all NIH programs using electronic submission, a CDA application uses a combination of SF424(R&R) and PHS398 forms. A separate section (Section I.7) of the SF424(R&R) Application Guide is included that provides supplemental instructions for preparing a CDA application. Further information is available from the NIH Grants & Funding website.

Applications must contain Candidate Information, Statements of Support, Environment and Institutional Commitment to the Candidate, as well as a Research Plan. The Candidate Information section includes required information about the candidate and must justify the need for the requested period of support, be tailored to the prior research experience and career development needs of the candidate, and for mentored CDAs be designed to move the candidate from a mentored phase to an independent status. The research plan must have intrinsic research importance as well as serve as a suitable vehicle for learning the methodology, theories, and skills necessary for a well-trained independent researcher. For mentored award programs, the research plan must also include a description of the relationship between the mentor's research and the candidate's proposed research plan.

Other than the K22 application from an unaffiliated candidate, all applications require documents describing the Environmental and Institutional commitment to the candidate.

For mentored award programs the career development application also must include Statement by Mentor(s), Co-Mentor(s), Consultant(s) and Contributor(s) as well as a statement describing the institution's commitment to the candidate's development.

The requirement for ORCID identifiers will be enforced at the time of application for individual career development awards, including the following: K01, K02, K05, K07, K08, K18, K22, K23, K24, K25, K26, K38, K43, K76, and K99/R00.

eRA system validations will check whether applicants have ORCID iDs and applications will not be accepted unless an ORCID iD is linked to the PD/PI's eRA Commons Personal Profile.

To either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them back to the eRA Commons. Prospective applicants for individual career development awards may follow the ORCID link from their Personal Profiles in the eRA Commons.

12.4.1.1 Letters of Reference

At least three (but no more than five) letters of reference are required for all new and resubmission mentored CDA applications. The letters should be from individuals not directly involved in the application, but who are familiar with the candidate's qualifications, training, and interests and include advisory committee members (if applicable). However, the candidate's mentor(s) of the application must not submit a separate letter of reference because a mentor's statement is required as part of the application. The letters of reference should address the candidate's competence and potential to develop into an independent biomedical, behavioral, or clinical investigator.

Electronic submission of CDA applications requires electronic submission of reference letters as well. However, reference letters are submitted directly by the referee through the eRA Commons and not as part of the electronic application that goes through Grants.gov. Reference letters will be joined with the electronic application within the eRA system once an application completes the submission process. Applications that are missing the required letters may be delayed in the review process or not accepted at all. Complete instructions for candidates and referees are found in Part I, Section 7.3 of the SF424(R&R) Application Guide for Adobe Applications.

12.4.1.2 Concurrent Applications

NIH will not accept any application in response to an NOFO that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial resubmission of an application already reviewed, but such applications must include an Introduction addressing the previous critique.

12.4.1.3 Environment and Institutional Commitment to the Candidate

The applicant organization 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 staff capable of productive collaboration with the candidate. The institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of the award. The institution should indicate how the necessary facilities and other resources will be made available for career enhancement as well as the research proposed in the application. The applicant should describe opportunities for intellectual interactions with other investigators, including courses offered, journal clubs, seminars, and presentations.

The institution should provide a document on institutional letterhead that describes its commitment to the candidate and the candidate's career development. The document should include the institution's agreement to provide adequate time and support for the candidate to devote the proposed protected time to research and career development for the entire period of the proposed award. The institution should provide the equipment, facilities, and resources necessary for a structured research career development experience. It is essential to document the institution's commitment to the retention, development, and advancement of the candidate during the period of the award.

Because of the diverse types of CDAs, applicants should contact the appropriate awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award. scientific/research contact named in the specific NOFO to determine the level of commitment required for the application. Institutional commitment to the candidate may not be contingent upon the receipt of the CDA.

Off-Site Training Experience. A candidate may propose a career award experience that involves sites beyond the applicant organization, provided that the goals of the total experience are encompassed and supported under the appointment with the applicant organization.

12.4.1.4 Training in the Responsible Conduct of Research

All CDA applicants (mentored and non-mentored) must include a description of the formal and informal activities related to instruction in the responsible conduct of research planned for the proposed research program. Specifically, applicants must include a description of a plan for instruction in responsible conduct of research. This description should document prior instruction in or the nature of the applicant's participation in responsible conduct of research instruction (lecturer, discussion leader, etc.) during the applicant's current career stage (including the dates of last occurrence) and propose plans to receive or participate in instruction in responsible conduct of research. Such plans must address the five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined below. Applications lacking a plan for instruction or participation in responsible conduct of research will be considered incomplete and may be delayed in the review process. Plans and past record will be rated as acceptable or unacceptable and the summary statement will provide the consensus rating of the review committee. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. For additional information see the specific NOFO.

1. Format. Discussion-based instruction in the responsible conduct of research is expected to remain a key feature of RCR training and to include substantive face-to-face interaction among participants and faculty. However, recognizing that advances in video conferencing now allow for effective "face-to-face" discussions to occur electronically, institutions may wish to consider incorporating video conferencing options into their RCR instruction, provided that those options are utilized in a way that fosters discussion, active learning, engagement, and interaction among the participants. At the same time, video conferencing should not be the sole means for meeting the requirement for RCR instruction, and a plan that employs only video conferencing will not be considered acceptable, except in special instances of short-term training programs (see below), or unusual and well-justified circumstances.

2. Subject Matter. While there are no specific curricular requirements for instruction in responsible conduct of research, the following topics have been incorporated into most acceptable plans for such instruction:

1. conflict of interest - personal, professional, and financial - and conflict of commitment, in allocating time, effort, or other research resources
2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
3. mentor/mentee responsibilities and relationships
4. safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability and other forms of discriminatory harassment)
5. collaborative research including collaborations with industry and investigators and institutions in other countries
6. peer review, including the responsibility for maintaining confidentiality and security in peer review
7. data acquisition and analysis; laboratory tools (e.g., tools for analyzing data and creating or working with digital images); recordkeeping practices, including methods such as electronic laboratory notebooks;
8. secure and ethical data use; data confidentiality, management, sharing and ownership
9. research misconduct Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion. and policies for handling misconduct
10. responsible authorship and publication
11. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

While courses related to professional ethics, ethical issues in clinical research, or research involving vertebrate animals may form a part of instruction in responsible conduct of research, they generally are not sufficient to cover all aspects of responsible research conduct.

3. Faculty Participation. Mentors and other appropriate faculty are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. For institutional Career Awards, training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors. Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.

4. Duration of Instruction. Instruction should involve substantive contact hours between the career recipient/scholars, mentors and other appropriate faculty. Acceptable programs generally involve at least eight contact hours. A semester-long series of seminars/programs may be more effective than a single seminar or one-day workshop because it is expected that topics will then be considered in sufficient depth, learning will be better consolidated, and the subject matter will be synthesized within a broader conceptual framework.

5. Frequency of Instruction. Existing policy and guidance call for RCR instruction to be undertaken at least once during each career stage, and at a frequency of no less than once every four years. As institutions consider how to optimize the timing and delivery of instruction in the responsible conduct of research, they are encouraged to bear in mind the value of ongoing and discipline-specific training as individuals progress in their research careers. For example, while broad-based instruction in the responsible conduct of research is often appropriate early in graduate school; a more tailored, discipline-specific approach may better fit the needs of advanced graduate students and those who have transitioned to postdoctoral status. If advanced students and postdoctorates have been exposed to the full range of topics traditionally included in RCR instruction early in their scientific training, it may make sense for their ongoing and/or subsequent RCR training to focus on subjects most relevant to their fields, and institutions may wish to consider this approach, where applicable.

12.4.1.5 Budget

CDAs provide limited costs, generally covering only applicable salary and fringe benefits for the candidates, as well as a fixed amount for research development support. Costs requested and awarded for CDA programs must be consistent with applicable Federal cost principles The government-wide principles, issued by OMB (or, in the case of commercial organizations, the Federal Acquisition Regulation [48 CFR 21], or, in the case of hospitals, 45 CFR 75, Appendix IX, "Principles For Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals"), on allowability and unallowability of costs under federally sponsored agreements. See Cost Considerations-The Cost Principles for additional details.. Salary amounts as well as the research development costs can vary by CDA program and then within a particular program even by each participating NIH IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.. Applicants are advised to consult the relevant NOFO for guidelines on allowable costs and budget limitations.

The transition to electronic submission included a change in business process with respect to budget information. Detailed budget information is now required as part of the initial application; however it is limited to the senior/key person information for only the candidate and then the total amount of requested research development support in budget section F.1. Other Direct Costs/Materials and Supplies. A budget justification is also required and should be used to provide a detailed description for the specific research development support costs. Instructions are provided in the applicable Application Guide and specific NOFOs.

As with all NIH training programs, Facilities and Administrative costs for CDAs are provided at a rate of 8% of modified total direct costs Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy..

12.4.1.6 Submission Dates

For all parent CDA NOFOs, NIH receives applications three times each year using standard submission dates. For a list of the standard submission dates and review cycle are posted on NIH's web site. IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.-specific NOFOs may use special submission dates instead of the standards dates, but the NOFO will clearly indicate if standard or special submission dates are used.