Department of Health and
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
Title: NHLBI Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30)
This is a reissue of
Update: The following updates relating to this announcement have been issued:
Program Announcement (PA) Number: PA-09-232
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Individual Fellowship Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.837, 93.838, 93.839, 93.233
Release Date: July 13, 2009
Opening Date:July 8, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): N/A
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Receipt Date(s): Standard dates for Individual Kirschstein-NRSA awards apply: see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for details.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Expiration Date: New Date January 8, 2011 (per issuance of NOT-OD-11-018), Original Date: August 9, 2012
Due Dates for E.O. 12372
Additional Overview Content
Table of Contents
Section I. Funding Opportunity Description
1. Research Training Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
1. Research Training Objectives
The objective of NIH-supported Ruth L. Kirschstein National Research Service Awards (NRSA) programs is to ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.
The National Heart, Lung, and Blood Institute (NHLBI) provides Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to individuals for combined MD/PhD fellowship training. The NHLBI awards this Kirschstein-NRSA individual fellowship (F30) to promising applicants with the potential to become productive, independent, highly trained physician-scientists, including patient-oriented physician-scientists (see http://www.nih.gov/news/crp/97report; http://books.nap.edu/catalog/10823.html) in its scientific mission area. The Institute plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects. Research is related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The NHLBI plans and directs research in development and evaluation of interventions and devices related to prevention, treatment, and rehabilitation of patients suffering from such diseases and disorders. It also supports research on clinical use of blood and all aspects of the management of blood resources (http://www.nhlbi.nih.gov/about/org/mission.htm).
This funding opportunity supports individual predoctoral F30 fellowships with the expectation that these training opportunities will increase the number of future investigators in basic, translational and clinical research who are physician scientists. The NRSA legislation requires that the Nation's overall need for biomedical research personnel be taken into account by giving special consideration to training physicians who propose to become active biomedical researchers. The NHLBI recognizes the critical importance of training physicians and scientists to become physician-scientists including those conducting translational research and patient-oriented research.
NHLBI Programmatic Need
The enormous complexity of biomedical and behavioral science today prevents the standard course of study at most medical schools from providing the experience necessary to develop researchers. Integrated curricula that combine training for the MD degree with extensive research experience have been developed, because scientists who are both medical doctors and trained scientists play a vital role in helping to bring the highest scientific standards into basic, clinical, translational, epidemiologic, prevention, and health services research settings. There is a critical need in the cardiovascular, pulmonary and hematological disorders and sleep research arenas for physician-scientists to investigate problems of disease in humans. Graduates of MD/PhD programs differ from most other clinicians in having had intensive research experience in basic science to foster fundamental scientific knowledge and insight into basic, clinical, translational, epidemiologic, prevention, and health services investigations.
Research Training Objectives
The research training experience must provide:
The applicant's experience should be guided and supervised by a committed sponsor who is an active and established investigator in the area of the applicant's proposed research. The research training should occur in a research-intensive environment that has appropriate human and technical resources and one that is demonstrably committed to research training in the particular program proposed by the applicant.
Training under this award is designed to provide a foundation for a career as a physician-scientist in the areas of interest to the NHLBI. Recent developments in many different areas have made it possible to increase our understanding of the etiologic and pathophysiologic mechanisms underlying cardiovascular, lung, blood-related and sleep disorders. For example, techniques of systems biology are increasingly important to understand alterations in regulatory networks within cells as well as cell-cell communication that lead to disease. The ability to regulate the temporal expression of individual genes in specific cells of transgenic animals allows dissection of their role in normal and pathological function. Proteomic and genomic analysis are increasingly able to identify changes in gene expression in single cells. Clinical and epidemiologic research now involves genome-wide association studies to determine the role of genetic polymorphisms in the etiology of human disease. Advances in imaging techniques are increasingly applied to investigate protein-protein interactions and signaling in living organisms.
Major changes in research direction and paradigms have led to a strong public health focus in clinical intervention, health services, and prevention research at the NHLBI. Because of an acute shortage of physician-scientists in these critical research areas, potential applicants who are interested in such careers are especially encouraged to apply. A wide-range of disciplines is appropriate for research training in cardiovascular, lung, blood-related and sleep diseases including (but not limited to) public health, clinical trials, epidemiology, biostatistics, bioinformatics, statistical genetics, health economics, bioethics, computer science and pharmacy.
Potential applicants may be interested in viewing the NHLBI Strategic Plan located at http://apps.nhlbi.nih.gov/strategicplan. The strategic plan is intended to provide the NHLBI with a guide for its research and training programs over the next five to ten years. Among the areas of emphasis, but not limited to, in research training are Computational Biology, Bioinformatics, Systems Biology or Network Biology, and Interdisciplinary Research.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity will use the Kirschstein-NRSA F30 individual fellowship award mechanism. As a Fellowship Applicant, the individual, together with his/her sponsor and institution, are jointly responsible for planning, directing, and executing the proposed research training program.
2. Funds Available
Although the financial plans of the NHLBI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, the receipt of a sufficient number of meritorious applications, and the program priorities of the NHLBI.
2.A. Allowable Costs
Stipends: Kirschstein-NRSA F30 awards provide stipends to fellows as a subsistence allowance to help defray living expenses during the research and clinical training experiences. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For the current stipend levels, see: NOT-OD-09-725. The NHLBI will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend level in effect at that time.
For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U.S. Department of Treasury check. Fellows in the NIH intramural program will be supported for their PhD research by NIH intramural funds.
Tuition and Fees: The NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Currently, the NIH will provide an amount per individual fellow equal to 60% of the level requested by the applicant institution, up to $21,000 per year for those individuals enrolled in a dual degree (e.g., MD/PhD) program. Tuition, for the purposes of this policy, means the combined costs of tuition and fees. For additional information, see: NOT-OD-06-093.
Institutional Allowance: Predoctoral fellows sponsored by nonfederal or nonprofit institutions (domestic or foreign) will receive an institutional allowance of $4,200 per 12-month period to help defray fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. Self-only health insurance (available to fellows without families) or family health insurance is an allowable cost for fellows at the sponsoring institution only if such self or family health insurance is applied consistently to all persons in a similar training status and regardless of the source of support. This allowance is intended to cover training-related expenses for the individual fellow and is not available until the fellow officially activates the award. If an individual fellow is enrolled or engaged in training for less than six months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Award will be revised and the balance must be returned to the NIH.
NIH will currently provide an institutional allowance of up to $3,100 for fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with health insurance, travel to scientific meetings and books. For fellows at for-profit institutions, the $3,100 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the NHLBI.
Funds are not available to cover the costs of travel between the fellows place of residence and a training institution. However, in an individual case of extreme hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the Institutional Allowance.
The Institutional Allowance is adjusted occasionally. Prospective applicants are advised to check for the current Institutional Allowance in the most recent documentation related to Kirschstein-NRSA stipends at http://grants.nih.gov/training/nrsa.htm.
Other Training Costs: As part of this award, additional funds may be requested. In all cases, the additional funds requested must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution in the application.
Indirect Costs: These costs, also known as Facilities and Administrative (F&A) costs, are not allowed for fellowship awards.
Supplementation of Stipends, Compensation, and Other Income: The sponsoring institution is allowed to provide funds to the fellow in addition to the stipend paid by the NHLBI. Such additional amounts either may be in the form of an augmented stipend (supplementation) or in the form of compensation, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved Kirschstein-NRSA training program. See also: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600200.
Stipend Supplementation: Supplementation, or additional support to offset the cost of living, may be provided by the sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.
Compensation: The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.
Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.
NIH Grants Policy: NIH grants policies as described in the PA-09-209).
Citizenship: By the time of award, the individual applicant 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). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the Kirschstein-NRSA F30 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.
Degree Requirements: An applicant must have a baccalaureate degree and show evidence of both high-academic performance in the sciences and substantial interest in research in areas of high priority to the NHLBI. In addition when the application is awarded, the applicant must be enrolled in an accredited combined MD/PhD program at a medical school, accepted in a related scientific PhD program, and be supervised by a funded sponsor conducting research related to the goals of the NHLBI. Applications are generally submitted during the first two years of medical or graduate school, but may be submitted at any stage of predoctoral training provided that at least one year of dissertation-stage research training will remain at the time of application.
2. Cost Sharing or Matching
This program does not require cost sharing as
defined in the current SF424 (R&R)
Individual Fellowship Application Guide for completing the SF424 (R&R)
forms for this FOA, use the Apply for Grant Electronically button in this FOA
or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
The PD/PI (Fellowship Applicant) should work with their institution/organization to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1. Organizational/Institutional Registration in Grants.gov/Get Registered
3. Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
The PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several of the steps of the registration process could take four weeks or more. Therefore, the Fellowship Applicant should immediately check with his/her business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
NOTE: Fellowship Applicants who are submitting an Individual Fellowship application with a different sponsoring organization should refer to NIH Notice Number: NOT-OD-07-003 Guidance to Applicant Organizations about Registering Research Fellows in the eRA Commons for guidance; see http://grants.nih.gov/grants/guide/notice-files/not-od-07-003.html. Additional instructional information is in the SF-424 (R&R) Individual Fellowship Application Guide for NIH and other PHS Agencies, 2.2 Registration Process.
Fellowship Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Individual Fellowship Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able touse any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Individual Fellowship Application Guide for this FOA through Grants.gov/Apply. Note the PHS Supplemental Form Pages that must be included in the application.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. In addition to these components, NIH and AHRQ Fellowship Applicants must also complete supplemental components listed as the PHS Fellowship Supplemental Form in the table below: A completed application in response to this FOA includes the data in the following components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person Profile(s)
PHS Fellowship Supplemental Form
PHS398 Cover Letter
Specific instructions related to each of the components are included in the Individual Fellowship Application Guide located at Grants.gov/APPLY.
3. Submission Dates and Times
See Section IV for details.
Submission, Review, and Anticipated Start Dates
Opening Date:July 8, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): N/A
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application
Electronically to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
These awards are also subject to the NRSA Policies. For more information see: http://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
Citizenship:Fellowship Applicants must meet the citizenship/residency requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.
Concurrent Awards: 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.
Tax Liability:Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. Note that the NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are within the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.
Future Year Support: Funds for continuation beyond the initial year are determined by the progress described in the continuation application (PHS 416-9), the timely submission of all required forms, and the availability of funds.
Service Payback:Recipients of Kirschstein-NRSA predoctoral support do not incur service payback.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI (i.e. Fellowship Applicant) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS: The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Cover Letter: The cover letter must include information regarding the type of expertise needed to review the application; names of suggested reviewers should not be included.
6.A. Fellowship Applicant Information and Research Training Plan
The following information must be included in the application in accordance with the Application Guide Instructions for Individual Fellowships in the SF424 (R&R).
Sponsor(s): The sponsor(s) must currently be funded to conduct independent research (e.g., Principal Investigator on an R01 or equivalent) and must describe past experience in the guidance of other research trainees and fellows. The sponsor must describe in detail his/her commitment to and proposed role in guiding the individual applicant. The sponsor should provide a detailed description of the institution's combined MD/PhD program and the sequencing of the applicant's graduate research and medical school (or other health professional degree) training within this program. The sponsor should describe the research training plan for the applicant (coordinated with the applicants own research training plan; see below). The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged. The description should also elaborate on the research environment and available research facilities and equipment, and discuss the relationship of the proposed research training to the applicant's career.
Note: The Sponsor(s) section must be attached as part of Other Attachments under Other Project Information Component.
Research Training Plan: The fellowship applicant should describe how he/she expects to divide time between medical (or other health professional) and graduate school, e.g., medical school courses, graduate school courses, research, research training, etc., during both the academic year and the summer for each year of the program. Applicants must provide a research training plan, including a description of the research in which they will be involved as part of their training. The applicants plan should be coordinated with the sponsors plan (see above), and should include substantive detail that adds to the information about time allocations requested. The applicant must describe concisely the Specific Aims, the background leading to the proposed research, the significance of the research, the Approach for achieving the Specific Aims, the rationale, and expected/alternative outcomes of the proposed studies. It is beneficial to include pertinent preliminary data obtained by the applicant in the dissertation laboratory.
Note: Item 3 of the Research Training Plan is limited to 6 pages.
Training Potential:The application must include statements that address the planned value of the proposed fellowship experience and research training program, and how these relate to the applicants needs in preparation for a career as an independent physician scientist. Applicants should provide evidence of their potential for a productive and successful research career based upon the quality of their previous research training and academic record.
Note: Training Potential section must be attached as part of Other Attachments under Other Project Information Component.
Institutional Environment and Commitment to Training: The Director of the graduate program must describe the department's or programs commitment to, and proposed role in, guiding and advising the applicant, and any modifications to the department's or programs usual PhD requirements that are necessary to facilitate this trainee's special needs in progressing through the combined degree program. Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.
Note: Institutional Environment and Commitment to Training section must be attached as part of Other Attachments under Other Project Information Component.
Additional Educational Information Required: In additional to the information requested in the application, F30 applicants should provide scores for MCAT, GRE, and other exams relevant to medical and graduate school that they have taken recently.
Note: Additional Educational Information Required section must be included as part of the Biographical Sketch. See Section 4.5 Senior/Key Person Profile (Expanded) Component.
Human Subjects Research: If the proposed research involves human subjects, the applicant must be responsive to the instructions in the SF 424 (R&R) Application Guide. The adequacy of plans to include appropriate human subjects is included in the fellowship evaluation (see Additional Review Criteria below). Note that NIH defines children as individuals under 21 years of age. Consult the Decision Tree for Inclusion of Children in Human Subjects Research for the exemptions that apply: http://grants.nih.gov/grants/peer/tree_children_hs.pdf
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.Training in the Responsible Conduct of Research: Applications must include a plan to obtain instruction in the responsible conduct of research. This section should document prior instruction in responsible conduct of research during the applicants current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research. Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicants 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. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.
Note: Instruction in the Responsible Conduct of Research section must be attached as part of Other Research Training Plan Section under PHS Fellowship Supplemental Form.
Biohazards: The investigator and the sponsoring institution are responsible for protecting the environment and research personnel from hazardous conditions. It materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the procedures to be taken in order to ensure adequate protection must be described (see Additional Review Criteria below).
Select Agents Research: If any of the activities proposed in the application involve the use of Select Agents at any time during the proposed project period, either at the applicant organization or at any other Project/Performance Site, refer to application instructions for addressing this item.
6.B. Letters of Reference
Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Individual Fellowship Application Guide for specific instructions (Part 5.4). Letters of reference are an important component of the application for fellowship support. Applicants for this fellowship must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the Fellowship Applicant as well as his/her potential to develop research skills needed in preparation for a productive research career as a physician-scientist in scientific areas related to the mission of the NHLBI. These letters should be from individuals not directly involved in the application, but who are familiar with the candidates qualifications, training, and interests, including advisory committee members (if applicable). Resubmission applications will require new letters of reference.
Letters of reference may be submitted any time after the FOA opens and no later than 5 business days after the application due date.
Applications that are missing the required letters of reference may be delayed in the review process or not accepted.
6.C. Citizenship and Certification Procedures
If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the PHS Fellowship Supplemental form. Applicants who have applied for and have not yet been granted admission as a permanent residentshould check the Permanent Resident of U.S. Pending block. A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. Individuals admitted to the United States as Permanent Residents will be required to submit notarized evidence of legal admission prior to the award.
All application instructions outlined in the SF 424 (R&R) Individual Fellowship Application Guide are to be followed.
6.D. Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
For many individual fellowships, it is anticipated that plans of this nature would have already been reported to the NIH by the sponsor in his/her research application. When this has occurred, indicate so in this section and include the appropriate grant number. However, if the development of a new model organism is anticipated, applicants will include a description of a specific plan for sharing and distributing unique model organism research resources or will state appropriate reasons why such sharing is restricted or not possible. For additional information on this policy, see Sharing Model Organisms Policy. If model organisms are not part of the planned research training plan, omit this section. This description is not included in the Research Training Plan page limits.
(c) Genome Wide Association Studies: Not Applicable.
Applicants must follow the specific instructions on Appendix materials as described in the SF 424 (R&R) Individual Fellowship Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Training Plan. An application that does not comply with the required page limitations may be delayed in the review process.
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the participating ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training by a Scientific Review Group (SRG), composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to the application. After the SRG meeting, the Scientific Review Official (SRO), a designated Federal official who coordinates the review of applications for the SRG, prepares a written summary of the review of each application and forwards it to the appropriate NIH Institute. Staff within the assigned funding Institute provides a second level of review.
As part of the initial merit review, applications:
The following will be considered in making funding decisions:
The purpose of the individual MD/PhD F30 fellowship program is to train future generations of outstanding physician-scientists committed to pursuing research careers relevant to the mission of the NHLBI. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of this goal. Each of these criteria will be addressed and considered in assigning the overall score, and weighed as appropriate for each application. The scientific review group will use information in the letters of reference in consideration of the review criteria. Note that an application does not need to be strong in all categories to merit a high overall impact/priority score. The overall impact/priority score will reflect the overall evaluation of the entire application.
Individual Fellowship Review Criteria
Overall Impact/Merit: Reviewers will provide an overall
impact/priority score to reflect their assessment of the likelihood that the
fellowship will enhance the candidates 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.
Remember that the F programs are training awards and not research awards. Major considerations in the review are the candidate's potential for a productive career, the candidate's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy those needs.
Core Review Criteria: Reviewers will consider each of the five criteria below in determining scientific and technical merit and will give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major impact.
Sponsor(s), Collaborator(s), and Consultant(s):
Research Training Plan:
Institutional Environment and Commitment to Training:
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.
Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
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.
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.
Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), 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 Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact /priority score.
Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration of Instruction, and Frequency of Instruction) as detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
Select Agents 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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period of Support: Reviewers will assess the appropriateness of the requested period of support in relation to the proposed fellowship training.
3. Anticipated Announcement and Award Dates
1. Award Notices
After the peer review of the application is completed, the Fellowship Applicant will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons. Refer to the NIH eRA Commons System (COM) Users Guide for additional information regarding registration in the NIH eRA Commons. Direct questions regarding Commons registration to the eRA Commons Help Desk at: firstname.lastname@example.org or by telephone: 301-402-7469 or 866-504-9552 (Toll Free).
If the application is under consideration for funding, NIH will request just-in-time information from the applicant. Applicants are advised to submit just-in-time information only when requested by the awarding component. Guidance for submitting this information will be provided at the time of the request. Alternatively, this information may be submitted using the Just-In-Time feature of the eRA Commons found in the Status section. For information on the Commons see: https://commons.era.nih.gov/ commons/index.jsp.
A formal notification in the form of a Notice of Award (NoA) will be provided to the sponsoring organization. This notification signed by the grants management officer is the authorizing document. The Notice of Award will be sent electronically to the designated institutional business official listed on the face page of the application or may be retrieved by the institution and the Fellowship Applicant through the eRA Commons. The NoA signed by the grants management officer is the authorizing document indicating that an award has been made.
Selection of an application for award is not an authorization to begin performance. A fellow has up to six months from the issue date on the NoA to activate the award.
Activation: No funds may be disbursed until the fellow has started training under the award, and an Activation Notice (PHS 416-5) has been submitted to the NIH. A fellow has up to six months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow, countersigned by the sponsor and an institutional official.
All NIH grants and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions of Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).
Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the Notice of Grant Award.
Leave Policies:In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 60 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to the same paid leave for this purpose and the use of parental leave is approved by the program director. (see NOT-OD-08-064 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-064.html)
A period of terminal leave is not permitted, and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.
Part-Time Training: While Kirschstein-NRSA awardees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under pressing personal circumstances, a fellow may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the NHLBI in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in Kirschstein-NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from Kirschstein-NRSA fellowship support. The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training.
Certification Requirements:Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
Service Payback: Recipients of Kirschstein-NRSA F30 awards do not incur service payback.
Inventions: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F30 awards will not contain any provision giving PHS rights to inventions made by the fellow.
Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, fellows should make the results and accomplishments of their Kirschstein-NRSA fellowship activities available to the research community and to the public at large. The grantee organization should assist fellows in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results in a timely manner.
Fellows are encouraged to submit reports of their findings for publication to the journals of their choice. Responsibility for direction of the project should not be ascribed to the NIH. However, NIH support must be acknowledged by a footnote in language similar to the following: This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number). In addition, federal funding must be acknowledged as provided in Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.
Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.
Forms may be found at http://grants.nih.gov/grants/forms.htm.
Activation Notice: The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, the NHLBI may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
Application for Continued Support:The fellow will be required to submit the form PHS 416-9, Continuation of an Individual National Research Service Award, annually (http://grants.nih.gov/grants/funding/416-9/phs416-9.htm) as required in the NIH Grants Policy Statement. 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. Note that the instructions request a listing of all courses and publications completed during the past year.
Termination Notice: When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH within 30 days following termination.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Drew Carlson, Ph.D.
Division of Cardiovascular Science, NHLBI
Rockledge II Building, Room 8142
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Telephone: (301) 435-0535
FAX: (301) 480-7404
2. Peer Review Contacts:
3. Financial or Grants Management Contacts:
Ms. Denise Payne
Senior Grants Management Specialist
Office of Grants Management, DERA, NHLBI
Rockledge II Building, Room 7155
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 594-9529
FAX: (301) 451-5462
Required Federal Citations
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.
Policy for Genome-Wide Association
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as
Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the
Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of
Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Kirschstein-NRSA 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). All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40-hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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