Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD/NIH), (http://www.nidcd.nih.gov)
National Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS/NIH), (http://www.ninds.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
Office of Dietary Supplements (ODS/NIH), (http://ods.od.nih.gov)

Title: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30)

Announcement Type
This is a reissue of PA-99-089 that was previously released April 20, 1999 and replaces PA-01-100, and PA-01-122.

Note: The PHS 416-1 (rev. 9/2008) must be used for December 2008 application receipt dates. See also: NOT-OD-09-004.

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PA-05-151

Catalog of Federal Domestic Assistance Number(s)
93.272, 93.173, 93.278, 93.894, 93.282, 93.853, 93.866, 93.847

Key Dates
Standard dates for Individual Kirschstein-NRSA Awards apply. See http://grants.nih.gov/grants/funding/submissionschedule.htm for details. Applications must be mailed on or before the receipt dates for individual Kirschstein-NRSA fellowships.
Release Date: August 8, 2005
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm 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: http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Expiration Date: New Date June 12, 2009 (per issuance of PA-09-207) Original Date: September 2, 2008 - (New Expiration Date January 8, 2010 per NOT-OD-08-069)
(now September 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The NIA, NIAAA, NIDCD, NIDA, NIEHS, NIMH, NINDS, and the ODS are interested in supporting individual predoctoral fellowships for combined MD/PhD training in research areas relevant to the mission of the participating Institutes.

Table of Contents

Part I. Overview Information

Part II. Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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 to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Dietary Supplements (ODS) provide Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to individuals for combined MD/PhD fellowship training. The participating Institutes award 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 their scientific mission areas. 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.

Each NIH Institute and Center has a unique scientific purview and different program goals and initiatives that evolve over time. Prior to preparing an application, it is critical that all applicants consult the appropriate Institute website (listed with each Institute's name at the beginning of this announcement) for details of research areas supported by that Institute and contact the appropriate Institute representative listed below in Section VII, to obtain current information about each Institute's program priorities and policies. This action is of utmost importance because applications with marginal or no relevance to the participating Institutes or ODS programs will not be accepted for review or possible funding.

Research Training Objectives

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. NIA, NIAAA, NIDA, NIDCD, NIEHS, NIMH, NINDS, and ODS recognize the critical importance of training physicians to become physician-scientists including those conducting translational research and patient-oriented research.

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 services research settings. There is a critical need in the aging, mental health, drug abuse and addiction, alcohol abuse, neuroscience, deafness and other communication disorders, and environmental medicine 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 services investigations.

There is a critical need for investigators conducting translational research. Recent developments have made it possible to study etiological and pathophysiological mechanisms underlying mental disorders, neurological disorders, drug abuse and addiction, and alcohol-related disorders. For example, clinical and epidemiologic research now involves linkage studies to determine the genetic locus of abnormal genes in a mental disorder, differential hybridization methods to detect possible abnormalities in genomic regulation, and other basic science methods in clinically and epidemiologically driven research. As another example, MRI measures can be used to correlate the pathology of drug abuse with its underlying circuitry and function.

Major changes in research direction and paradigms have led to a strong public health focus in clinical intervention, health services and prevention research at many of the participating Institutes. 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 including (but not limited to) public health, epidemiology, economics, bioethics, computer science and pharmacy.

Applicants are strongly advised to consult with NIH staff listed below in Section VII, to obtain current information about each Institute's program priorities and policies before preparing an application to determine if their research topic falls within the mission of one of the participating Institutes. Information regarding special interests and instructions of participating Institute and Centers can be found at: (http://grants.nih.gov/archive/grants/guide/contacts/pa-05-151_contacts.htm)

The research training experience must provide: a strong foundation in research design, methods, and analytic techniques; the development or enhancement of the applicant's ability to conceptualize and think through research problems with increasing independence; experience in conducting, presenting, and publishing independent research; the opportunity to interact with members of the scientific community at meetings and workshops (including NIH-sponsored meetings); and a well-conceived career plan to increase the applicant's ability to secure federal support for his/her research. 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 that is demonstrably committed to research training in the particular program proposed by the applicant.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Kirschstein-NRSA F30 individual award mechanism. As an applicant, the candidate and his/her sponsor are jointly responsible for planning, directing, and executing the proposed project.

2. Funds Available

Although the financial plans of the IC(s) 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 participating Institutes.

Stipends. Kirschstein-NRSA awards provide stipends at the predoctoral level to fellows as a subsistence allowance to help defray living expenses during the research and clinical training experience. 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 the NIH website at http://grants.nih.gov/training/nrsa.htm. The awarding NIH Institute 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.

Tuition and Fees. At the time of publication of this program announcement, The NIH will reimburse 100 percent of the cost of tuition up to $3,000 and 60 percent of that cost above $3,000 for the fellow. Tuition, for the purposes of this policy, means the combined cost of tuition, fees, and health insurance (see below). A full description of the current tuition policy is contained within the NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm.

Health Insurance. Self-only health insurance (available to fellows without families) or family health insurance (available to fellows with families) is an allowable cost for fellows at the awardee or sponsoring institution only if such self or family health insurance is required of all persons in a similar training status regardless of the source of support. Health insurance for fellows who are eligible for this coverage is included in the calculation of the combined tuition, fees, and health insurance.

Institutional Allowance. At the time of publication of this program announcement, F30 fellows receive an institutional allowance of $2,750 per 12-month period to non-federal, or nonprofit sponsoring institutions to help defray such awardee expenses as research supplies, equipment, books, and travel to scientific meetings. This allowance is intended to cover training-related expenses for the individual awardee 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 Research Fellowship Award will be revised, and the balance must be refunded to NIH.

At the time of publication of this program announcement, NIH will provide an institutional allowance of up to $1,650 for F30 fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with travel to scientific meetings, health insurance, and books. For fellows at for-profit institutions, the $1,650 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the NIH awarding Institute.

The Institutional Allowance is adjusted from time-to-time. Prospective applicants are advised to check for the current Institutional Allowance in the most recent documentation related to NRSA stipends at http://grants.nih.gov/training/nrsa.htm.

Other Training Costs. Additional funds may be requested by the institution when the training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution, or for accommodations for fellows who are disabled, as defined by the Americans With Disabilities Act. The funds requested for costs of this nature 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.

Facilities and administrative costs are not allowed on individual 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 NIH. 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.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The PhD phase of the program may be conducted outside the sponsoring institution, e.g. a Federal laboratory including the NIH intramural laboratories. This training, however, must be part of a combined MD/Ph.D program.

Foreign Institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training is invited to work with their sponsor and institution 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 programs. Although a Kirschstein-NRSA award is not usually made for study leading to the MD, DO, DDS, or similar professional degrees, or for study that is part of residency training leading to a medical specialty, the F30 program is specifically designed to support training in an accredited, combined MD/PhD program. Fellowship awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program.

Citizenship. By the time of award, candidates for the Kirschstein-NRSA MD/PhD fellowship award must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card 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 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 participating Institutes. When the application is submitted, the applicant must be enrolled in an accredited MD/PhD program at a medical school, accepted in a related scientific PhD program, and supervised by a mentor in that scientific discipline. Applications are generally submitted during the first two years of medical school, but may be submitted at any stage of medical school provided that at least one year of dissertation-stage research training will remain at the time of the expected award date.

2. Cost Sharing or Matching

There is no required cost sharing.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Duration of Support. Individuals may receive up to six years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F30). However, it is not possible to have concurrent NRSA support (e.g., F30 and T32). Applicants must consider any prior NRSA predoctoral research training in determining the duration of support requested. Accurate information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

Training beyond the 6-year aggregate limit may be possible under rare and exceptional circumstances, but a waiver from the NIH-awarding component is required. Individuals seeking Kirschstein-NRSA support beyond the sixth year are strongly advised to consult with relevant NIH staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. Waiver requests should be discussed with the program officer at the sponsoring NIH Institute at least six months prior to the termination date of the fellowship and should be submitted to the program officer prior to the termination date of the fellowship.

Sponsor. Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also called mentor or supervisor) and who will supervise the training and research experience. The applicant's sponsor should be an active investigator in the area of the proposed research who is committed to the research training of the candidate and who will directly supervise the candidate's research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training.

Sponsoring Institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training.

While the sponsoring institution must be domestic, an individual may request support for training abroad. In such cases, the applicant is required to provide detailed justification for the foreign training, including the reasons why the facilities, the mentor, 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. Applicants seeking training abroad are encouraged to contact the relevant participating Institute prior to preparing an application.

See (http://grants.nih.gov/archive/grants/guide/contacts/pa-05-151_contacts.htm) for contact information.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 416-1 application instructions are available at http://grants.nih.gov/grants/funding/416/phs416.htm#forms in an interactive format. Applicants must use the currently approved version of the PHS 416-1. 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

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Form (PHS 416-1). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 12 of the face page of the PHS 416-1 form.

The title and number of this funding opportunity must be typed on line 3 of the face page of the application form.

If the applicant has been lawfully admitted to the United States for Permanent Residence, the appropriate item should be checked on the face page of the application. Applicants who have applied for but have not yet been granted admission as a permanent resident should check the Permanent Resident block on the face page of the PHS 416-1 application, and should also write in the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award.

At least three completed, sealed references must be submitted with the application or it may be delayed in review or returned to the applicant without review.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Dates: Standard dates for individual Kirschstein-NRSA applications apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Institute Second Level Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form as described above. Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, at least three, sealed reference letters, and all other required materials) and two exact, clear, single-sided photocopies of the signed application, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

Because the NIDCD reviews and awards its fellowship applications on an expedited schedule, applicants submitting applications that are within the scientific purview of the NIDCD must send, at the time of submission, one of the two application copies and all sets of appendix materials, if any, to:

Chief, Scientific Review Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
Attn: NRSA F30 fellowship

Owing to its expedited review schedule, the NIDCD will not accept fellowship application materials or supplemental information after the application receipt date.

Certification and Reporting Procedures : No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed. At least three, sealed letters of reference must be submitted with the application.

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3.Reporting).

These awards are also subject to the NRSA policies (see http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187).

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. We must 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 ad implementation of the tax laws are 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 any required forms, and the availability of funds.

6. Other Submission Requirements

Applicants are advised to pay special attention to the following important items in the PHS 416-1:

Part I (Applicant Information)

Item 3. The applicant should identify the number of this Program Announcement (PA).

Item 5. Training Under Proposed Award. Identify the PhD discipline according to the NIH Lexicon of NRSA disciplines found in the PHS 416-1 instructions.

Item 23. Scholastic Performance. In addition to the information requested in the application, applicants should provide scores for MCAT, GRE, and other exams relevant to medical and graduate school that they have taken recently.

Item 30a. Activities Under Award. Typically, an MD/PhD student spends the first two years of the program in medical school courses with a limited amount of time devoted to PhD work; the third and fourth years of support are spent on PhD research; and the last 2 years are used to complete medical school. Applicants should provide a detailed description of their institution's combined MD/PhD program and the sequencing of the applicant's graduate research and medical school training within this program. Applicants should describe how they expect to divide their time between medical 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. A minimum of 40 hours/week is required for support under the NRSA program.

Item 30b. Research Training Proposal. All applicants should provide a research plan, including a description of a research proposal in which they will be involved as part of their training. The plan should include substantive detail that adds to the information about time allocations requested in Item 30a. Note that Subsections (1) through (3) of this item are not to exceed 10 pages including all tables and figures. Applicants must follow the format in the PHS 416-1 instructions.

Part II (Sponsor Information)

Items 33 and 34. Sponsor's Previous Fellows/Trainees, Training Plan, Environment, and Research Facilities. The sponsor 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 chairman of the graduate committee for the PhD program must also describe the department's commitment to and proposed role in guiding the individual applicant and any modifications to the department's usual PhD requirements that are necessary to facilitate this trainee's special needs. Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.

The sponsor must describe the research training plan for the applicant. Include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Describe the research environment and available research facilities and equipment. Indicate the relationship of the proposed research training to the applicant's career. Describe the skills and techniques that the applicant will learn. Relate these to the applicant's career.

Instruction in the Responsible Conduct of Research. Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. Although the NIH has not established specific curriculum or format requirements for this training, it is suggested that the following topics be covered: conflict of interest, data sharing, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applications without plans for training in responsible conduct of research will be considered incomplete and may be returned without review. No award will be made if an application lacks this component.

Human Subjects Research. If the proposed research involves human subjects, the applicant must be responsive to the instructions in the current version of the PHS 416-1. 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 the exemptions that apply: http://grants.nih.gov/grants/peer/tree_children_hs.pdf.

Care and Use of Vertebrate Animals in Research. If vertebrate animals are to be used in the project, the applicant must be responsive to the instructions in the current version of the PHS 416-1. The adequacy of plans for the care and use of vertebrate animals is assessed as part of the fellowship evaluation.

Biohazards: The investigator and the sponsoring institution are responsible for protecting the environment and research personnel from hazardous conditions. If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, please describe the procedures to be taken in order to ensure adequate protection.

Plan for Sharing Research Data
Not Applicable

Sharing Research Resources
Sharing Model Organisms: If the development of model organisms is anticipated, include a description of a specific plan for sharing and distributing unique model organism research resources or state appropriate reasons why such sharing is restricted or not possible. For many individual fellowships it is anticipated that plans of this nature would have already been reported to the NIH by your sponsor in his/her research application. When this has occurred, indicate so in this section and include the appropriate grant number. For additional information on this policy, see Sharing Model Organisms Policy (PHS 416-1). 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.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

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.

As part of the initial merit review, applications:

The following will be considered in making funding decisions:

The goal of the F30 individual MD/PhD fellowship program is to train future generations of outstanding physician-scientists committed to pursuing research careers relevant to the missions of the participating NIH Institutes. 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, weighting them 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 priority score. The final priority score will reflect the overall evaluation of the entire application.

Review Criteria:

1. Candidate

2. Research Training Proposal

3. Sponsor and Training Environment

4. Training Potential

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see criteria included in the section on Federal Citations, below).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see inclusion criteria in the section on Federal Citations, below).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described on page 21 of the PHS 416-1 fellowship application instructions (rev. 6/2002) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Responsible Conduct of Research. Every NRSA fellow must receive instruction in the responsible conduct of research (http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, an application with an unacceptable plan will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Sharing Model Organisms: For many individual fellowships it is anticipated that plans for sharing model organisms would have already been reported to the NIH by the sponsor in his/her research application. When this has occurred, applicants will indicate so 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 state appropriate reasons why such sharing is restricted or not possible.

The reviewers will assess the adequacy of plans for sharing model organisms, and will describe their assessment of the sharing plan in an administrative note, but will not include their assessment in the overall priority score. The adequacy of the resources sharing plan will be considered by Program staff of the funding IC when making recommendations about funding applications.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the applicant will receive a written critique called a Summary Statement.

A formal notification in the form of a Notice of Research Fellowship Award (NRFA) will be provided to the applicant organization. This notification signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. 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.

The Notice of Research Fellowship 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 through its NIH eRA Commons account.

2. Administrative and National Policy Requirements

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.

Service Payback. Recipients of Kirschstein-NRSA F30 awards do not incur service payback.

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 30 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 paid leave for this purpose and the use of parental leave is approved by the program director.

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. Under unusual and 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 awarding NIH Institute or Center 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.

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 awardee.

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.

3. Reporting

Activation Notice. An awardee has up to six months from the issue date on the Notice of Research Fellowship Award to activate the award using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (PHS 416-5) available at http://grants.nih.gov/grants/forms.htm. Under unusual circumstances, an NIH Institute 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. An awardee will be required to submit the form PHS 416-9, Continuation of an Individual National Research Service Award, annually (http://grants.nih.gov/grants/forms.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 related to the current year's progress as well as the plans for the coming year.

Termination Notice. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH within 30 days following termination. Forms may be found at http://grants.nih.gov/grants/forms.htm.

Section VII. Agency Contacts

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:

Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-05-151_contacts.htm) or information for each IC's scientific/research contact for the F30 program.

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-05-151_contacts.htm) for information regarding each IC's grants management contact for this NRSA F30 program .

Section VIII. Other Information
Applicants are strongly encouraged to visit the following NIH Web site to gain a better understanding of the use of this program (F30) by the participating NIH Institutes and Centers:
(http://grants.nih.gov/archive/grants/guide/contacts/pa-05-151_contacts.htm).

Required Federal Citations

Use of Animals in Research:
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 (45CFR46) 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).

Inclusion of Women And Minorities in Clinical Research:
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 new PHS Form 398; 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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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 PA 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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 Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 PA 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 or Health Systems Agency review. 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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