Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute on Aging (NIA) |
|
Funding Opportunity Title |
Independent Scientist Award (Parent K02) |
Activity Code |
K02 Research Scientist Development Award Research |
Announcement Type |
Reissue of PA-11-191 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-14-045 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.242; 93.113; 93.279; 93.273; 93.121; 93.866; 93.173; 93.853; 93.865 |
Funding Opportunity Purpose |
The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three, four, or five years of salary support and protected time for newly independent (see IC provisions) scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate. Prospective candidates are encouraged to contact the relevant Institute or Center (IC) staff for IC-specific programmatic and budgetary information: Table of IC-Specific Information, Requirements and Staff Contacts. |
Posted Date |
December 19, 2013 |
Open Date (Earliest Submission Date) |
January 12, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, with the first due date on February 12, 2014 Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Standard AIDS dates apply, with the first AIDS due date on May 7, 2014 Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
New Date: May 10, 2016 (previously January 8, 2017) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the 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 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. Information about all NIH Career Development programs may be found at the NIH Extramural Training Mechanisms website.
The NIH Independent Scientist Award (K02) is intended to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. It provides three, four, or five years of salary support and protected time for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers.
Candidates must hold a doctoral degree, independent peer reviewed research support at the time the award is made, and commit a minimum of 9 person-months (75% of full-time professional effort) conducting research and relevant career development activities during the period of the award. Depending on the sponsoring Institute or Center (IC), scientists whose work is primarily theoretical may apply for this award in the absence of external research grant support. Receipt of prior support may have an impact on eligibility for the K02 award. Each independent scientist career award program must be tailored to meet the individual needs of the candidate. The sponsoring institution must demonstrate a commitment to provide the environment, resources and the protected time required for the candidate to perform the activities included in the proposed research and career development plans.
Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Award budgets are composed of salary and other program-related expenses, as described below. |
Award Project Period |
The total project period may not exceed 5 years. |
Salary |
The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). The total salary requested must be based on a full-time 12 months staff appointment. Career awards require the candidate to devote a minimum of 9 person-months (75% of full-time professional effort) to conducting health-related research. The remaining effort may be devoted to other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. 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. If full-time, 12-month salaries
are not currently paid to comparable staff members, the salary proposed must
be appropriately related to the existing salary structure. Confirmation of
salary may be required prior to the issuance of an award. Fringe benefits,
based on the sponsoring institution’s rate and the percent of effort, are
provided in addition to the salary. |
Other Program-Related Expenses |
It is expected that candidates for a K02 award will have research support at the time of the award. There are some research specialties, however, in which only minimal research support is needed, i.e., theoreticians, statisticians, and computer scientists. In such cases, depending on the participating IC, applicants may request in their application additional funds to cover incidental research expenses. When provided, these funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical and computational services including personnel and computer time. In no case may funds be requested that duplicate funds already being provided by other research support. For IC-specific information, see Table of IC-Specific Information, Requirements and Staff Contacts). Salary for secretarial and administrative assistance, etc., is not allowed. |
Indirect Costs |
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. |
NIH grants 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
- 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 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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 Principal Investigators 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). Individuals on temporary or student visas are not eligible.
Candidates for this award must have a doctoral degree and newly independent, peer-reviewed support at the time the award is made. Some of the participating NIH ICs require the candidate to have an NIH research grant at the time of application and that the support be from their IC. Other NIH ICs will accept candidates with peer-reviewed, independent research support from other sources.
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.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for 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 applicant institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Candidates with VA appointments should contact the 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.
Depending on the policies of the awarding IC, K02 awardees may apply for a one-time renewal for an additional three to five years of support if the K02 recipient continues to have independent peer-reviewed research support at the time of submission of the renewal application. Candidates should clearly demonstrate their continuing need for protected time to expand their research programs.
Depending on the policies of the sponsoring IC, candidates are expected to continue to hold independent peer-reviewed research support for the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the K02 award.
Institutional Environment
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.
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 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 forms package associated with this FOA includes all applicable components, required 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 components.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (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
- Describe the candidate’s commitment to a career in biomedical, behavioral or clinical research. Include a description of all of the candidate’s professional responsibilities in the grantee institution and elsewhere and show their relationship to the proposed activities of this K02 award.
- Present evidence of the candidate's ability to interact and collaborate with other scientists.
- 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.
- Describe the candidate’s immediate and long-term career objectives. Explain how the K02 award will contribute to these goals, and further the candidate’s research career and ultimate impact on science.
- Describe how this award will relieve the candidate of current duties so that a greater portion of the candidate’s effort (at least 9 person-months, equivalent to 75% full-time professional effort) may be devoted to research and related career development activities.
Career Goals and Objectives
- Describe the candidate’s career goals and objectives under this award, including prior experience, and current research support. Candidates are encouraged to provide a timeline for accomplishing these goals.
Candidate's Plan for Career Development/Training Activities During Award Period
- 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 to achieve independence as an investigator.
- The candidate should describe any new or enhanced research skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research programs as an independent scientist.
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 - may fulfill the requirement for instruction in RCR by participating as lecturers and discussion leaders; 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 and Consultants
- Signed statements must be provided by each consultant and/or collaborator 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 consulting/collaboration. 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 strong, 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.
- Describe the facilities, supplies, equipment, and human resources that will be available to the candidate.
- Describe how the research environment of the institution is particularly suited to enhance the development of the candidate's research career as an independent scientist and proposed career and research plans.
Institutional Commitment to the Candidate’s Research Career Development
- The sponsoring institution must provide a statement of commitment to the candidate's career goals to be 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 K02 award.
- In a clear statement, provide assurance that the candidate will be released from other duties and be able to devote a minimum of 9 person-months (75% of full-time professional effort) in the development of his/her research program, with the remaining percent effort being devoted to activities related to the development of his/her career as a research scientist.
- 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
- A sound research project that is consistent with the candidate s level of research development and the objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
- Describe plans for the recruitment and retention of subjects (when applicable) and plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide..
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). 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.
Add additional information about funding restrictions. If any of these
restrictions become part of the terms of award that must be stated in Section
VI.1.
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, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Important Update: See
NOT-OD-16-006
for updated review language for applications for due dates on or after January 25, 2016.
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.
For this particular announcement, note the following: Reviewers should evaluate the candidate’s potential for continuing an independent research program that will make important contributions to the field, taking into consideration the years of research experience, and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
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
- Has the candidate demonstrated the capacity to carry out independent research?
- Does the candidate have potential to become an outstanding scientist who will make significant contributions to the field?
- Is there evidence of past and present 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 current independent, peer-reviewed research support?
- Is the candidate’s level of training, experience, and competence commensurate with the purposes of the award?.
Career Development Plan/Career Goals and Objectives
- 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 of 75% of full-time professional effort) to research and related duties by release from teaching, administration, clinical work, and other responsibilities?
Research Plan
- Candidates are expected to have an 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?
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 commitment from the sponsoring institution to provide adequate protected time for the candidate to conduct the research program adequate?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3)
potential benefits to the subjects and others, (4) importance of the knowledge
to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 - may fulfill the requirement for instruction in RCR by participating as lecturers and discussion leaders; 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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
- Will receive a written critique.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Because of the difference in individual Institute and Center
(IC) program requirements for this FOA, prospective applications are strongly
encouraged to consult the Table
of IC-Specific Information, Requirements and Staff Contacts, to
make sure that their application is responsive to the requirements of one of
the participating NIH ICs.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Phone: 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
TTY: 301-451-5936
Email: [email protected]
See Table of IC-Specific Information, Requirements and Staff Contacts
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
See Table of IC-Specific Information, Requirements and Staff Contacts
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.
