Ruth L. Kirschstein National Research Service Awards, NRSAs, NRSA, eRA commons registration, letters of reference, responsible conduct of research, concurrent applications, receipt dates, individual fellowship

11.2.3 Application Requirements and Due Dates

11.2.3.1 Application

Each fellowship applicant must submit an application based on the application package provided as part of the FOA. Individual fellowship applications are submitted electronically through Grants.gov using an application package that combines form components from the SF424 (R&R) application with the PHS Fellowship Supplemental Form.

The major emphasis of the application should be the research training experience and broadening of scientific competence. The AOR of the sponsoring institution agrees to secure and retain, but need not submit to NIH, the assurance signatures of the fellowship applicant and sponsor. For postdoctoral fellowship applicants, the assurance of the fellowship applicant includes certification that he or she has read the payback information and will meet any payback provisions required under the law as a condition for accepting the award.

Fellowship applicants and sponsoring institutions must comply with policies and procedures governing such requirements as civil rights; the protection of human subjects, including data and safety monitoring requirements; research misconductFabrication, 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.; the humane care and use of live vertebrate animals; the inclusion of women, minorities and children in study populations; human embryonic stem cells; and recombinant or synthetic nucleic acid research. (For a complete list of applicable requirements, see Exhibit 4, Public Policy Requirements, Objectives and Appropriation Mandates in IIA.)

11.2.3.2 eRA Commons Registration

All fellowship applicants and sponsoring institutions must be registered in the eRA Commons. The fellowship applicant must be assigned the "PI Role" in the eRA Commons. Only the PI Role will provide the fellowship applicant with the appropriate access in the eRA Commons to the application and review information. When a prospective fellowship applicant is submitting an application through a sponsoring institution that is different than their current institution, that individual must be affiliated with the sponsoring institution. Additional information on eRA Commons registration and affiliating individuals with different institutions can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.

11.2.3.3 ORCID iDs

The requirement for ORCID iDentifiers will be enforced at the time of application for individual fellowship and career development awards, including the following: F05, F30, F31, F32, F33, F37, F38, F99/K00, FI2, 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.

At this time, prospective applicants for individual fellowship and career development awards are encour- aged to follow the ORCID link from their Personal Profiles in the eRA Commons, where they can either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them back to the eRA Commons.

11.2.3.4 Letters of Reference

As part of an application submission, at least three (but no more than five) letters of reference on behalf the fellowship applicant also must be submitted. Electronic submission of the fellowship application incorporates a separate, yet simultaneous electronic submission process for reference letters through the eRA Commons. Reference letters are submitted directly by the referee through the eRA Commons and not as part of the electronic application submitted through Grant.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. Applicants must carefully follow the instructions provided in Part I, Section 5.4 of the Individual Fellowship Application Guide found at: http://grants.nih.gov/grants/funding/424/index.htm. The Application Guide includes specific instructions to be sent to prospective referees.

11.2.3.5 Responsible Conduct of Research

All fellowship applicants must include a plan to obtain instruction in the responsible conduct of research. This plan should document prior instruction in responsible conduct of research during the applicant's current career stage (including the dates of last occurrence) and propose a plan to receive instruction in responsible conduct of research. The plan must address the five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained below. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant's understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. Further, applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. For additional instructions, see the specific FOA.

  1. Format. Substantial face-to-face discussions between the fellow, other individuals in a similar training status and sponsors plus a combination of didactic and small-group discussions (e.g. case studies), are highly encouraged. While on-line courses can be a valuable supplement to instruction in responsible conduct of research, online instruction is not considered adequate as the sole means of instruction. A plan that employs only online coursework for instruction in responsible conduct of research will not be considered acceptable.
  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
    2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
    3. sponsor/fellow responsibilities and relationships
    4. collaborative research including collaborations with industry
    5. peer review
    6. data acquisition and laboratory tools; data management, sharing and ownership
    7. research misconductFabrication, 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
    8. responsible authorship and publication
    9. 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.

  1. Faculty Participation. Sponsors 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. Sponsors may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors.
  2. Duration of Instruction. Instruction should involve substantive contact hours between the fellow, sponsor 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.
  3. Frequency of Instruction. Reflection on responsible conduct of research should recur throughout a scientist's career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels. Individual fellows are strongly encouraged to consider how to optimize instruction in responsible conduct of research for their particular career stage. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. It is highly encouraged that initial instruction during predoctoral training occurs as early as possible in graduate school. Senior fellows may fulfill the requirement for instruction in responsible conduct of research by participating as lecturers and discussion leaders. To meet the above requirements, instruction in responsible conduct of research may take place, in appropriate circumstances, in a year when the award recipient is not actually supported by an NIH grant. This instruction must be documented in the submitted plan.

Information on the nature of the instruction in the responsible conduct of research and the extent of fellow and faculty participation also must be provided in the annual progress report submitted as a prerequisite to receiving non-competing continuation support.

11.2.3.6 Concurrent Applications

An individual may not have two or more competing Kirschstein-NRSA individual fellowship applications pending review concurrently. In addition, CSR will not accept for review any application that is essentially the same as one already reviewed.

11.2.3.7 Receipt Dates

Kirschstein-NRSA individual fellowship applications undergo a review process that takes 5 to 8 months. The annual schedule for application receipt, review, and award can be found in a specific Funding Opportunity AnnouncementA publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts. and at http://grants.nih.gov/grants/funding/submissionschedule.htm.