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 Center for Complementary and Alternative Medicine (NCCAM), ( http://www.nccam.nih.gov/)

Title: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowship Training in Complementary and Alternative Medicine (F31)

Announcement Type
This is a reissue of PAR-00-023, which was previously released on December 9, 1999.

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-07-384

Catalog of Federal Domestic Assistance Number(s)
93.213  

Key Dates
Release Date:  June 13, 2007
Letters of Intent Receipt Date(s): Not required
Application Receipt or Submission 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://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(s): please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: New Date July 3, 2009 (per of NOT-AT-09-005) Original Exp. Date: May 8, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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 and 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
  6. Other Submission Requirements

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 Training Objectives

Background and Objectives

About NCCAM: The National Center for Complementary and Alternative Medicine (NCCAM) is one of the 27 Institutes and Centers that comprise the National Institutes of Health (NIH).  NCCAM is dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training complementary and alternative medicine (CAM) researchers, and disseminating authoritative information to the public and professionals. 

In “Expanding Horizons of Health Care: Strategic Plan 2005-2009” (http://nccam.nih.gov/about/plans/2005/), NCCAM defines complementary and alternative medicine (CAM) as medical practices that are “unproven by science and not presently considered an integral part of conventional medicine (also referred to as biomedicine, or mainstream or allopathic medicine).”  These medical practices can be divided into four domains:  mind-body medicine; biologically-based practices, manipulative and body-based practices; and energy medicine.  A fifth domain, whole medical systems, incorporates aspects of several of these domains.  Examples of whole medical systems include Ayurveda, traditional Chinese medicine, healing practices indigenous to the Americas, and homeopathy.  NCCAM is interested in sponsoring research and research training in all five of these areas.

As stated in its 2005-2009 Strategic Plan, NCCAM’s four primary areas of focus are: research; research training and career development; outreach; and integration. The mission of NCCAM’s research training and career development program is to prepare highly qualified individuals for productive, independent careers in CAM research.  Predoctoral candidates for this award are encouraged to visit the NCCAM website (www.nccam.nih.gov) to learn about NCCAM research priorities and also to contact the appropriate NCCAM program officer (also listed in Section VII of this announcement) for advice.

NCCAM recognizes that there are several potential career pathways leading to a productive, independent CAM research career and that a fellowship candidate could pursue a period of predoctoral research training not directly related to a CAM therapy.  For example, a fellow could choose to be trained in pharmacology to provide part of the expertise required to study herbal medicines.  Alternatively, predoctoral research training in bioengineering or orthopedic research could be appropriate preparation for an independent research career in chiropractic manipulation.  NCCAM’s overall objective in issuing this Funding Opportunity Announcement (FOA) is to provide individual research training fellowships to promising predoctoral applicants from a range of career backgrounds, including those trained in CAM practices, who have the desire and potential to become productive and successful independent CAM research investigators.  Applicants must hold a baccalaureate degree (such as B.A. or B.S.) and be enrolled in a doctoral training program at the time the application is submitted.

The proposed training must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his/her potential for a productive CAM research career.  As such, predoctoral candidates for this award should address all the review criteria described in this announcement in their application to demonstrate that the proposed training will meet the goals of this fellowship program. This Program Announcement is one component of NCCAM’s 2005-2009 Strategic Plan commitment to training CAM investigators. 

NCCAM’s goals for its individual predoctoral fellowship program: The purpose of this NCCAM National Research Service Award (NRSA) Individual Predoctoral Fellowship is to help ensure that diverse pools of highly trained scientists will be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical, behavioral and clinical research agendas in complementary and alternative medicine.

NCCAM and NIH recognize the critical importance of training clinicians, including clinicians trained in CAM healing practices, to become researchers, and encourages them to apply for appropriate NCCAM fellowship programs.  However, this award may not be used to support training leading to either a conventional or CAM clinical or health professional doctorate such as an M.D., D.O., D.C., D.A.O.M, O.M.D., D.D.S., D.V.M., or N.D.(Doctor of Naturopathy).  Those individuals in a formally combined, accredited research/clinical doctoral program, such as an M.D./Ph.D program, are eligible to apply.

Individuals from diverse racial and ethnic groups and individuals with disabilities and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

Predoctoral applicants and their sponsors must include a research training proposal that documents the need for the research training, the expected value of the proposed fellowship experience as it relates to the individual’s career goals, and how the proposed research training will serve as a solid foundation and prepare them for a productive career in CAM research.

Research Training Program

Fellowship awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.  The duration of research training supported by this award is two to five years.  The sponsoring institution must have adequate faculty and facilities available to provide a suitable environment for the high-quality research training experience.  The applicant’s research training should be guided and supervised by a committed primary sponsor who is an active, established, and productive investigator in the area of the applicant’s proposed research.  Co-sponsors may also participate in the research training of the fellow.  The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant.  The research training should also be guided and supervised by an individual with an appreciation of CAM, or training and experience in CAM research and/or a CAM modality. 

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 Ruth L. Kirschstein NRSA individual predoctoral fellowship (F31) award mechanism.   As an applicant, the candidate together with his/her sponsor and institution are jointly responsible for planning, directing, and executing the proposed project.   Information for NCCAM contacts may be found in Section VII. Agency Contacts.

This FOA supports predoctoral research training for individuals enrolled in research doctoral programs.  It does not support study leading to a clinical or health professional doctoral degree such as an M.D., D.O., D.C., D.A.O.M., O.M.D., D.D.S., D.V.M., or N.D.(Doctor of Naturopathy). However, those enrolled in a formally combined, accredited research/health professional doctoral degree program are eligible to apply for the research training portion of their program.

2. Funds Available

Although the financial plans of NCCAM provide support for this program, awards pursuant to this funding opportunity are contingent upon the receipt of a sufficient number of meritorious applications, the program priorities of NCCAM, and the availability of funds.

The NRSA mechanism provides a stipend, tuition and fees and an institutional allowance.  For information, see: http://grants.nih.gov/training/nrsa.htm, and NIH Notice NOT-OD-07-057 released March 14, 2007, and NIH Notice NOT-OD-06-093 released August 18, 2006.

Stipends

Ruth L. Kirschstein-NRSA awards provide stipends to predoctoral fellows as a subsistence allowance to help defray living expenses during the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. The current stipend level can be found on 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 or foreign 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

The NIH will offset the combined cost of tuition and fees costs at the rate in place at the time of the award.  The rate currently in place, as indicated in the NIH Guide announcement NOT-OD-06-093 released August 18, 2006, will provide an amount per fellow equal to 60% of the level requested by the applicant institution, up to $16,000 per year.  If the program supports formal combined and accredited dual degree training (e.g., M.D.-Ph.D.) the amount provided will be 60% of these costs up to $21,000 per year. The current policy can be located at: NOT-OD-06-093 or http://grants2.nih.gov/training/extramural.htm.

Institutional Allowance

The NIH provides an institutional allowance to help offset expenses such as research supplies, equipment, health insurance (either self-only or family as appropriate), and travel to scientific meetings. At the time of publication of this funding opportunity announcement (and as indicated in the NIH Guide Notice NOT-OD-06-093 and can also be found at  http://grants2.nih.gov/training/extramural.htm.  F31 fellows receive an institutional allowance of $4,200 per 12-month period to non-federal, or nonprofit or foreign sponsoring institutions.  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.  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 returned to the NIH.

NIH will currently provide an institutional allowance of up to $3,100 for F31 fellows sponsored by Federal or for-profit institutions for expenses associated with travel to scientific meetings, health insurance, 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 awarding IC.

Funds are not available to cover the costs of travel between the fellow’s place of residence and a domestic 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 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 exceptional circumstances.  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.

Facilities and Administrative (F&A) Costs

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 in accordance with its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar status, regardless of the source of funds. 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 full-time research training activities. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.

A full description of the policy for stipend supplementation and compensation is located in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.

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.   An applicant must include in the application the name of his/her sponsor who will supervise the training and research experience.

Applicants requesting fellowship support for foreign research training must demonstrate in the application that the foreign institution and sponsor offer unique opportunities and clear scientific advantages that are not currently available in the United States.  Only if there is a clear scientific advantage will foreign training be supported. 

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 support.

Citizenship

By the time of award, the individual applicant applying for the Kirschstein-NRSA fellowship award must be a citizen or non-citizen national 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 F31 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

At time of application, an applicant must have a baccalaureate degree (e.g., B.S. or B.A.) and be currently enrolled in a Ph.D. or equivalent research doctoral degree program, a formally combined M.D./Ph.D. program, or other formally combined, accredited health professional doctorate/research Ph.D. graduate program in the biomedical, behavioral, or clinical sciences at an accredited domestic or foreign institution.  With the exception of the combined degree programs such as those described above, the F31 may not be used to support studies leading to a clinical or health-professional doctorate (e.g., M.D., D.O., D.C., D.A.O.M., O.M.D., D.D.S., D.V.M., and N.D.(Doctor of Naturopathy).

Individuals with a clinical or health-professional doctorate such as an M.D., D.O., D.C., D.A.O.M., O.M.D., D.D.S., D.V.M., or N.D.(Doctor of Naturopathy) who are interested in pursuing predoctoral research training leading to a research doctorate in the biomedical, behavioral, or clinical research sciences are eligible to apply for this award.  Such individuals may also want to consider applying for the NCCAM Ruth L. Kirschstein National Research Service Awards for Postdoctoral Training in Complementary and Alternative Medicine (F32), PAR-07-319, as this program may better match the individual’s career goals. Candidates are encouraged to contact the NCCAM program officer listed in Section VII – Agency Contacts for advice about NCCAM-supported research training opportunities appropriate for different career stages.

2. Cost Sharing or Matching

Cost sharing is not required

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

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

Duration of Support

Individuals may receive up to five years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from institutional training grants (T32) and an individual fellowship award. However, it is not possible to have concurrent NRSA support (e.g., F31 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.  The target length of support for this FOA is between two and five years.

Individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. Continuation of the fellowship award for each subsequent year beyond the first award period is based upon evidence of satisfactory progress in the graduate program.

Sponsor

Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also referred to as mentor or supervisor) who will supervise the training and research experience. The sponsor should be an active investigator in the area of the proposed research who is committed to the research training of the individual and who will directly supervise the candidate's research. Co-sponsors may also participate in the research training of the fellow.  The research training should also be guided and supervised by an individual with an appreciation of CAM, or training and experience in CAM research and/or a CAM modality.  The sponsor must also document the availability of sufficient staff, research support, and facilities for a high-quality research training experience. The applicant must work with his/her sponsor in preparing the application.

Sponsoring Institution

The sponsoring institution must have appropriate faculty and facilities available on site to provide a suitable environment for high-quality research training.

Training at Foreign Organizations

Applicants requesting foreign research training are required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training at a U.S. domestic institution. 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 unique opportunities and the scientific and research training advantages are clear.   Applicants seeking training abroad are encouraged to contact NCCAM prior to preparing an application.  Additional information regarding foreign grants is available in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_T0c54600260). 

Section IV. Application and Submission Information


1. Address to Request Application Information

The fellowship application instructions are available at PHS 416-1 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Note that the PHS 416-1 has been restructured (Rev. 10/05), and the instructions have been significantly modified.  See the NIH Notice NOT-OD-07-002 released October 5, 2006.

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(Rev. 10/05). 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 13b of the face page of the PHS 416-1 form (Rev. 10/05)

The title and program announcement 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.

Additionally, the following must be included with the application at the time of submission.  Failure to include any of these items may delay review of the application:

3. Submission Dates and Times

Applications must be mailed on or before the receipt dates as described in section Section IV.3.A .

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): not required
Application Receipt or Submission 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://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(s): please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the most recent  PHS 416-1 research training fellowship application as described above.

The applicant must follow the instructions stated in the PHS 416-1 for submitting the application and Appendix materials, and letters of reference  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).

Certification Procedure

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/submission 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 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. 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.

Information on the status of an application should be checked by the applicant in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

These awards are also subject to the NRSA policies (see http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm)

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 and 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.

Service Payback

There are no payback requirements for predoctoral NRSA support.  

Future Year Support

Funds for continuation beyond the initial year are determined by the progress described in the continuation application (PHS 416-9, Rev. 10/05), the timely submission of all 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 (Rev. 10/05).  Please note several important changes and reminders on pages 1 and 2, and the new biographical sketch format page. Applicants should follow the most up-to-date PHS 416-1 application form and instructions at the time of application.

Sponsor

The applicant’s sponsor, who will directly supervise the applicant’s research, should be an active investigator in the area of the proposed research and meet the eligibility requirements in Section III.  The sponsor must describe in detail his/her commitment to and proposed role in guiding the individual applicant during the research training experience and describe the research training plan for the applicant and how it will contribute to the applicant’s career as an independent investigator in CAM research.

Training Plan

The sponsor must provide a tailored research training plan for the applicant.  The plan must list experiences that are specifically planned for the fellow including 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 aspirations.

Additionally, the availability and quality of the facilities and related resources necessary for the proposed research training experience (e.g., equipment, laboratory space, computer time, research support, etc.) must be described.

If the sponsoring institution is a foreign institution, information must be provided in the application describing how the institution and sponsor offer special and unique opportunities for research training not currently available in the United States.

Research Proposal

A description of the broad, long-term objectives and specific aims, making reference to the health relatedness of the research proposal must be included (page 2 of the application PHS 416-1, Rev. 10/05). 

Other Research Experiences

Follow the special instructions for predoctoral fellows for item 27, form page 5.  Note that advanced graduate students (ONLY) must include a narrative of their doctoral dissertation (may be preliminary) in item 27, Form Page 5.  However, all graduate students should include a description of any research experience they have.

Training Potential

The application must include statements addressing the planned value of the proposed fellowship experience and research training program, and how these relate to the applicant’s needs in preparation for a career as an independent researcher in CAM research.

Instruction in the Responsible Conduct of Research

Applications must include the sponsoring institution’s plans to provide and 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.

Special NCCAM Requirements on Research Using Biologically Active Agents

Applicants who use biologically derived substances must follow the NCCAM policy and applicant guidance for studies of biologically active agents as stated on the NCCAM website, http://nccam.nih.gov/research/policies/index.htm.  Instructions are provided on the type of information that should be included in the application, as well as the type of information that NCCAM may request after review but before grant award.

Questions regarding Investigational New Drug (IND) applications should be addressed to the Food and Drug Administration (FDA).  If an IND is required, it is the sole responsibility of the applicant to obtain all necessary clearances from the FDA. The applicant should present a plan for IND submission, evidence that an IND application is in process or that the FDA has allowed an exemption.

NCCAM Policy on Terms of Award for Clinical Trials

In addition to the required Federal Citations listed below related to clinical research, applicants submitting applications in response to this announcement should also follow the NCCAM Policy on Terms of Award for Clinical Trials http://nccam.nih.gov/research/policies/terms-of-awards.htm, where applicable.

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 that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCCAM in accordance with the review criteria stated below.

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 Administrator (SRA), a designated Federal official who coordinates the review of applications for the SRG, prepares a written summary of the review of each application for the second level of review.  The National Advisory Council of Complementary and Alternative Medicine (NACCAM) provides a second level of review.

As part of the initial merit review, applications:

The following will be considered in making funding decisions:

The goal of the NCCAM Training in Complementary and Alternative Medicine National Research Service Award (NRSA) F31 program is to provide individual research training fellowships to promising predoctoral applicants from a range of backgrounds who have the desire and potential to become productive and successful independent CAM research investigators.  Regardless of their training background, the applicant must have earned a baccalaureate (e.g. B.S. or B.A.) degree and be enrolled in a research doctorate training program or formally combined, accredited professional doctoral/research doctoral degree program. The proposed training must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his/her potential for a productive, independent CAM research career.

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 the above stated 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. Sponsor and Training Environment

3. Research Training Plan

In evaluating the scientific proposal and research training plan, the stage of graduate career should be considered.  For example, students in the earlier years of graduate training may be expected to have more emphasis on didactic training and less emphasis on the research proposal, whereas more senior graduate students who have passed their qualifying exam and started their dissertation research are likely to have a more detailed research proposal and perhaps less emphasis on didactic training.

4. Training Potential

 What is the value of the overall proposed fellowship experience as it relates to the candidate's needs in preparation for a career as an independent CAM researcher?  In answering this question, in addition to the scientific research proposal, sponsor and research environment, reviewers should assess any additional proposed research training experiences such as coursework, seminars, journal clubs, or participation in scientific meetings, as appropriate, to the specific training goals of the candidate.

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:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate?  Are the improvements in the resubmission application appropriate?

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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 sponsoring institution’s plans to provide and 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.

Requested Period of Support: Reviewers should comment on the reasonableness of the requested period of support in relation to the proposed research training.  However, the priority score should not be affected by the evaluation of the length of the requested period of training support.  The duration of research training should be between two and five years.

Research in CAM:  The proposed predoctoral research training does not need to be research directly on a CAM therapy to be appropriate for the NCCAM F31 NRSA Fellowship program, as long as it contributes to the career development of the fellow as a CAM investigator. 

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 fellow 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 to the eRA Commons Help Desk at: commons@od.nihl.gov 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.  A request for just-in-time information should not be interpreted as indicating that an award will be issued.

A formal notification in the form of a Notice of Research Fellowship Award (NRFA) will be provided to the electronically to the designated sponsoring organization business official listed on the face page of the application.  The NRFA may also be retrieved by the institution through its eRA Commons account. The NRFA 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. An awardee has up to six months from the issue date on the NRFA 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, Rev. 10/05) has been submitted to the NIH.  A fellow has up to 6 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 date upon receipt of a specific request from the fellow, countersigned by the sponsor and an institutional official.

In accordance with NCCAM’s policy and applicant guidance for studies of biologically active agents used in CAM (http://nccam.nih.gov/research/policies/index.htm), after peer review, applicants with a better likelihood of being supported will be notified by NCCAM to submit product integrity information http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html. The product integrity information will be evaluated.

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 Research Fellowship 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 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

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 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 NCCAM 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 Ruth L. 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 notice of research fellowship 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.

Inventions

Fellowships made primarily for research educational purposes are exempted from the PHS invention requirements. F31 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 further development of discoveries and inventions for furthering research and benefiting the public. 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

All forms were revised in October 2005 for immediate use, see NIH Notices: NOT-OD-06-017 and NOT-OD-06-018 which were released December 9, 2005 for additional details. As indicated in NIH Notice NOT-OD-07-002 released October 5, 2006, revised instructions and Form pages have been posted on the NIH Forms Page at: http://grants1.nih.gov/grants/funding/416/phs416.htm.

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, Rev. 10/05) 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, Rev. 10/05, 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 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, Rev. 10/05) 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:

Partap S. Khalsa, DC, PhD, DABCO
Program Officer, Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
National Institutes of Health (NIH)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Office: (301) 594-3462
Fax: (301) 480-1587

2. Peer Review Contacts:

Martin Goldrosen, Ph.D.
Acting Director
Division of Extramural Activities
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594-2014
FAX: 301-480-2417
Email: goldrosm@mail.nih.gov

3. Financial or Grants Management Contacts:

Cornice Martin
Grants Management Specialist
Office of Grants Management
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-6059
FAX: (301) 480-1552
Email: martincor@mail.nih.gov

Section VIII. Other Information


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).

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 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 priority score.

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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 PAR 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.  Awards are made under the authorization of Sections 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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