EXPIRED
June 30, 2020
July 8, 2020
Not Applicable
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard dates apply
Not Applicable for Fellowships
Standard dates apply
New Date October 26, 2020 per issuance of PA-21-049. (Original Expiration Date: May 8, 2023)
Not Applicable
It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide 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 Ruth L. Kirschstein National Research Service Award (NRSA) 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. NRSA fellowships support the training of pre-and postdoctoral scientists, dual-degree investigators, and senior researchers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.
This Funding Opportunity Announcement (FOA) will support students at institutions with NIH-funded institutional predoctoral dual-degree training programs. These include institutions with NIH-supported Medical Scientist Training Programs (MSTP), or Dental Scientist Training Programs (DSTP), or similar predoctoral dual-degree training programs. In a companion FOA, NIH is also seeking F30 applications from students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The intent of this two-FOA approach is to ensure equitable review of applications from these two kinds of institutions, as well as better tracking of fellowship awardees future progress in establishing independent careers as physician/clinician-scientists.
There is a critical need for physician-scientists and other clinician-scientists to investigate human health and disease through rigorous research. The complexity of biomedical, behavioral, and clinical science poses a challenge in the integration of research training into the standard course of study at most medical schools and other health professional schools. To address this challenge, a variety of programs have been developed to combine training for the MD or other health professional degrees (e.g., DO, DDS, AuD, DVM) with extensive research experience leading to a second, advanced degree. It is expected that graduates of these dual degree programs will play will play a vital role in advancing knowledge across the full spectrum of health-related research.
The purpose of the Kirschstein-NRSA Individual Predoctoral MD/PhD or Other Dual-Doctoral Degree Fellowship (F30) is to support highly promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), during their mentored dissertation research training and clinical training under the guidance of outstanding faculty sponsors. This program thus contributes to efforts to increase the pool of highly trained physician/clinician-scientists in the biomedical research workforce.
Candidates for the Kirschstein-NRSA F30 award are expected to propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The integrated program of research and training should enhance the individual’s potential to develop into a productive, independent physician/ clinician-scientist. The training plan should document the need for, and the anticipated value of, the proposed mentored training in relationship to the individual’s career goals. The training plan should also facilitate transition to a residency or other postdoctoral program appropriate to the candidate’s career goals and particular clinical degree.
It is expected that the mentored training experience will provide:
The Kirschstein-NRSA program may provide up to six years of support for research and clinical training that leads to the MD/PhD degree or another dual-doctoral degree. Because the F30 program is intended to support individuals matriculated in an integrated, dual-degree program during both their graduate research training and clinical training, the F30 cannot be used to support only the clinical training years.
Note: This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.
Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements, and Staff Contacts , to make sure that their application is appropiate for the requirements of one of the participating NIH ICs.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
Renewal: Individual fellowship awards are generally not
renewable. In rare cases in which fellowship awardees require further
fellowship support, they should consult with NIH staff to obtain advice
regarding submission of a Renewal application
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose independent clinical trials.
Note: Candidates may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.
Individuals may receive up to 6 years of aggregate Kirschstein-NRSA support at the predoctoral level for dual degree training, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award. Over the total duration of F30 support, at least 50% of the award period must be devoted to graduate research training leading to the doctoral research degree.
Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences.
NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award.
The application should request a Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings.
NIH does not separately reimburse indirect costs (also known as Facilities & Administrative [F&A] Costs) for fellowships. Costs for administering fellowships are part of Institutional Allowance.
Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Eligibility is limited to institutions with NIH-funded institutional predoctoral dual-degree training programs. These include institutions with NIH-supported Medical Scientist Training Programs (MSTP), or Dental Scientist Training Programs (DSTP), or similar predoctoral dual-degree training programs. This eligibility criterion applies to institutions with currently active institutional training programs supporting the same dual degree, at the time the F30 fellowship application is submitted for review.
Before submitting a fellowship application, the candidate must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the candidate. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. All institutions with the appropriate resources and commitment are encouraged to apply.
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 allowed.
An individual may request support for training abroad. In such cases, the candidate is required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.
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.
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. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCiD. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Any candidate fellow 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 sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
A Kirschstein-NRSA F30 award does not support studies leading to the MD, DO, DDS, AuD or similar professional degrees, or studies that are part of residency training leading to a medical specialty. The F30 program is specifically designed to support combined, dual-degree training leading to award of both a health professional doctoral degree (e.g., MD, DO, DDS, AuD, DVM, PharmD) and a research doctoral degree (e.g., PhD, DrPH) from an accredited program.
The candidate must have a baccalaureate degree or equivalent, show evidence of high academic performance in the sciences, and commitment to a career as an independent physician-scientist or other clinician-scientist.
For all MD/PhD and DO/PhD degree candidates: To be eligible, a candidate 1) must have matriculated into a dual-degree program no more than 48 months prior to the due date of the initial (-01) application; and 2) must have identified a dissertation research project and sponsor(s). Exceptions to the first eligibility criterion will be considered when the candidate has taken an official leave of absence from the dual-degree program. In addition, over the total duration of F30 support, at least 50% of the award period must be devoted to full-time graduate research training leading to the doctoral research degree.
Because dentist-scientist, audiologist-scientist, and veterinarian-scientist dual-degree programs are highly variable in their phasing and integration, the eligibility parameters for these dual-degree candidates are different, as follows:
For all DDS/DMD-PhD, AuD-PhD, DVM-PhD, and VMD-PhD degree candidates: To be eligible, a candidate 1) must have matriculated into a dual-degree program; and 2) must have identified a dissertation research project and sponsor(s). In addition, over the total duration of F30 support, at least 50% of the award period must be devoted to full-time graduate research training leading to the doctoral research degree.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information).
Because individuals may receive a maximum of 6 years of aggregate Kirschstein-NRSA support at the predoctoral level for dual-degree training, candidates must consider any prior NRSA research training in determining the duration of support requested. Information about previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award. The F30 fellowship is generally not intended to support dual-degree students after year 8 of dual-degree training. Over the total duration of F30 support, at least 50% of the award period must be devoted to research training leading to the doctoral research degree; award durations may be adjusted accordingly.
At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.
Before submitting the application, the candidate must identify a sponsor(s) who will supervise the proposed mentored training experience. Candidates are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the candidate’s overall training.
A clinical training sponsor, in an area of clinical interest to the candidate, may also be appropriate. This individual would meet regularly to help collaboratively mentor the candidate during the tenure of the award.
The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate s research training and to direct supervision of his/her research. The primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The primary sponsor, or a member of the sponsor team, should have a successful track record of mentorship. The candidate must work with the primary sponsor(s) in preparing the application.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution
It is critical that applicants follow the Fellowship (F) 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.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
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 must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship applicant) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
The PHS Fellowship Supplemental Form is comprised of the following sections:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Fellowship Applicant Section
Candidate s Background and Goals for Fellowship Training
The candidate’s research and clinical training plan, i.e. the activities planned under this award, should be individually tailored and well integrated with his/her research project. Describe the skills and techniques that the candidate intends to learn as well as any planned, non-research activities (e.g. those relating to professional development and clinical activities) during the award period. The candidate should provide a timeline for the entire duration of the dual-degree program in which he/she is matriculated. On the timeline, indicate the estimated percentage of time that will be devoted to clinical- and research-related activities each year and indicate where, on this timeline, the candidate is at the time of application. This timeline will complement the candidate s description of how he/she expects to divide his/her time between research and clinical training during each year of the award period.
Research Training Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Sponsor(s), Collaborator(s), and Consultant(s)
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The Sponsor should also describe the roles and responsibilities that both he/she and the fellow are undertaking, including contributions to the research plan, the portion of the research ideas and plan that originated with the candidate, and the relationship
between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.
Institutional Environment and Commitment to Training Section
Description of Institutional Environment and Commitment to Training
Educational Information
Appendix
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. If gaining research experience in a clinical trial led by a sponsor/co-sponsor, provide the sponsor s ClinicalTrials.gov identifier (i.e., NCT number).
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.
Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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. The National Research Service Award (NRSA) policies apply to this program. A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.
Pre-award costs are generally not allowable for Fellowships.
Over the total duration of F30 support, at least 50% of the award period must be devoted to graduate research training leading to the doctoral research degree. After an award is made, award duration may be adjusted to ensure that at least 50% of the total award duration is devoted to research training leading to the research doctorate.
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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important
reminders:
All PD(s)/PI(s) and sponsor(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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy Any instructions provided here are in addition to the instructions in the policy. .
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.
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.
Fellowship Applicant
Sponsors, Collaborators, and Consultants
Institutional Environment & Commitment to Training
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 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
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..
Renewal: Individual fellowship awards are generally not renewable. In rare cases in which fellowship awardees require further fellowship support, the committee will consider the progress made in the last funding period.
Not Allowed
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 candidate, including any prior instruction or participation in RCR as appropriate for the candidate’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 sponsor(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.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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).
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) Genomic Data Sharing Plan.
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:
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. Following initial peer review, recommended applications will receive a second level of review by the appropriate NIH Institute or Center. The following will be considered in making funding decisions:
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.
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.
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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 MUST 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. Prior consultation with NIH staff is strongly encouraged.
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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
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).
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.
Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship and career development awards are encouraged to apply for an extramural LRP award.
Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.