and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
NCCAM INTERNATIONAL POSTDOCTORAL FELLOWSHIP
RELEASE DATE: January 6, 2003
PA NUMBER: PA-03-050
APPLICATION RECEIPT DATES: April 5, 2003; December 5, 2003; December 5,
2004; December 5, 2005
EXPIRATION DATE: December 6, 2005
National Center for Complementary and Alternative Medicine (NCCAM)
(http://www.nccam.nih.gov)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose
o Mechanism(s) of Support
o Eligibility Requirements
o Eligible Sponsoring Institutions
o Allowable Costs
o Salary Supplementation, Compensation, and Other Income
o Taxes
o Leave Policies
o Other Special Requirements
o Where To Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
o Supplemental Application Instructions
PURPOSE
This program announcement has several interrelated goals. The main goal is
to support training of foreign scientists in rigorous scientific research
methodology at a clinical or basic research facility in the United States.
The purpose of this training is to prepare these scientists to successfully
conduct high-quality research in complementary and alternative medicine
(CAM) when they return to their home countries. NCCAM defines CAM as
medical or health-related therapies practiced in the United States but not
presently considered an integral part of conventional medicine in the United
States (from NCCAM Five-Year Strategic Plan 2001-2005:
http://nccam.nih.gov/about/plans/fiveyear/index.htm). As stated in NCCAM's
strategic plan, CAM can be divided into five major domains. These domains
are alternative medical systems, mind-body interventions, biologically based
therapies, manipulative and body-based methods, and energy therapies.
This NCCAM International Postdoctoral Fellowship specifically focuses on the
domain of alternative medical systems, defined as complete systems of theory
and practice that have evolved independently of, and often prior to,
conventional biomedical approaches. Many of these alternative medical
systems are actually traditional medical systems practiced in, as well as
originating in, cultures throughout the world. Examples include, but are
not limited to, traditional oriental medical systems, Ayurvedic medicine,
Unani, and homeopathy. Fellows may focus their research on whole alternative
medical systems common to or originating in their home country, or
components of such systems. Components of such systems could include, but
are not limited to acupuncture, herbal medicine, or forms of meditation.
Through this international training initiative, NCCAM aims to increase the
number and improve the quality of research and the competitiveness of its
international research grant applications; to foster lasting collaborations
between United States scientists and foreign scientists interested in CAM
research; to build CAM research capacity and infrastructure in other
countries; and, most importantly, to promote research in alternative medical
systems or components of such systems by foreign scientists who reside in
the countries where these medical systems originated and/or are practiced.
MECHANISM OF SUPPORT
This International Postdoctoral Fellowship is supported through the F05
mechanism, which is designed to "provide collaborative research
opportunities for qualified non-immigrant alien scientists who hold a
doctoral degree or its equivalent in one of the biomedical or behavioral
sciences." The proposed postdoctoral training must be within the broad
scope of biomedical, behavioral, or clinical research as it relates to
alternative medical systems or components of such systems, and must offer an
opportunity to enhance the fellow's understanding of the health-related
sciences and extend his/her potential for a productive research career.
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
while at the U.S. research site. Research clinicians must devote full-time
to their proposed research training and must restrict clinical duties within
their full-time research training experience to activities that are directly
related to the research training experience. This fellowship may not be used
to support studies leading to the N.D., D.C., M.D., D.O., D.D.S., D.V.M., or
other similar health-professional degrees. Neither may this award be used to
support the clinical years of residency training.
However, NCCAM recognizes the critical importance of training clinicians to
become researchers and encourages them to apply. Moreover, for those who
have a health professional degree, the proposed training may be used to
satisfy a portion of the degree requirements for a master's degree, a
doctoral degree or any other advanced research degree program. Women,
minorities, and individuals with disabilities are encouraged to apply.
ELIGIBILITY REQUIREMENTS
VISA REQUIREMENTS: Foreign nationals who apply for the fellowship must have
a visa that permits training or employment in the United States at the time
that an award is made. One of the following visas is acceptable:
o J-1 (exchange visitor)
o F-1 (Student–for post-completion practice training after award of doctoral
degree)
o H-1B (nonimmigrant worker in a specialty occupation)
o 0-1 (extraordinary ability in the sciences)
CITIZENSHIP: Non-immigrant alien scientists are eligible for this award.
U.S. citizens, non-citizen nationals, or persons with U.S. permanent
resident status are not eligible for this award. Individuals in the latter
three categories should consult the training information on the NCCAM
website for descriptions of other fellowship and career development awards
for which they may be eligible (http://nccam.nih.gov/training/).
DEGREE REQUIREMENTS: Before this fellowship award can be activated, the
individual must have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M.,
O.D., O.M.D, D.P.M., Sc.D., Eng.D., Dr.P.H., D.N.S., N.D., Pharm.D., D.S.W.,
Psy.D., or equivalent foreign degree in one of the biomedical or behavioral
sciences from an accredited U.S. or foreign institution. The applicant must
provide a photocopy of his/her diploma (and translation if not in English)
or a letter from a university dean or registrar stating when the degree was
awarded. Certification by an authorized official of the degree-granting
institution that all degree requirements have been met is also acceptable.
Scientists at all career levels who meet the degree requirements must also
meet the following additional requirement. The applicant must have at least
4 years of relevant experience beyond the doctoral degree (or equivalent
foreign degree) at the time the award is issued. Relevant experience may
include research (including industrial research), teaching, internship,
residency, clinical duties, or other time spent in full-time studies in a
health-related field beyond the qualifying degree.
DURATION OF SUPPORT: Individuals may receive a minimum of 1 year and up to 3
years of support to conduct research at a basic or clinical research
facility within the United States (referred to as the U.S. Sponsoring
Institution). During this support period, the fellow may spend up to one-
fourth of the time per year at the institution in his/her home country (also
referred to as the Foreign Institution) to which he/she plans to return to
continue this research. This time at the Foreign Institution must be devoted
totally to furthering the CAM research collaboration initiated at the U.S.
Sponsoring Institution, and not to other responsibilities at the Foreign
Institution such as teaching or clinical duties. Acceptable activities at
the Foreign Institution could involve planning activities for setting up
infrastructure so that clinical and/or basic research can continue upon
return.
SPONSOR: Before submitting a fellowship application, the applicant must
identify a sponsoring institution in the United States and a research
scientist at that institution who will serve as a sponsor (also called
mentor or supervisor) and will supervise the training and research
experience during the 1 to 3 years the applicant is supported through NCCAM
by the U.S. Sponsoring Institution.
The applicant's U.S. sponsor should be an active independent investigator in
the area of the proposed research who will directly supervise the
candidate's research. The sponsor does not necessarily need to be an expert
in CAM research. However, his/her research expertise must be relevant to
the CAM research that the applicant wishes to pursue. For example, an
applicant who wishes to explore the effect on the immune system of a
particular alternative medical system or component of such system, may chose
a sponsor who has expertise in immunology and not CAM, as long as the
sponsor agrees to support the applicant's research and continue a
collaboration after the fellow returns to the Foreign Institution. The
sponsor must document the availability of research support and facilities
for high-quality research training at the U.S. Sponsoring Institution. In
addition, the sponsor must demonstrate a commitment to continue a
collaboration with the fellow once he/she returns to the Foreign
Institution. A collaboration plan should be described in the section
"Training Plan, Environment, Research Facilities," which is Item 34 in the
sponsor's portion of the fellowship application.
ELIGIBLE SPONSORING INSTITUTIONS
U.S. SPONSORING INSTITUTION REQUIREMENTS: The U.S. Sponsoring Institution
may be anyone of the following.
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of state and local governments
o Eligible agencies and laboratories of the Federal government, including
NIH intramural laboratories.
FOREIGN INSTITUTION REQUIREMENTS: No application will be accepted without an
accompanying letter from the Foreign Institution to which the applicant
plans to return. This letter should be sent in the same package with the
copies of the completed application. This letter must be signed by the
appropriate institutional business official, by the appropriate academic
official (such as a university dean responsible for the applicant's
appointment), and co-signed by the applicant. It must contain the following
information: 1) The title and description of the applicant's appointment at
this institution; 2) the guaranteed duration of the appointment; 3) a
description of the research facilities/equipment at the institution,
including a description of the research facilities/equipment available to
the applicant.
Applicants for this NCCAM International Postdoctoral Fellowship must have a
guaranteed appointment of no less than 4 years at the institution in their
home country to which they plan to return. This guaranteed appointment must
be documented in the letter from this institution described above.
ALLOWABLE COSTS
STIPEND: This fellowship award provides a stipend to the postdoctoral
fellowship awardee to help defray living expenses during the research
training experience at the U.S. Sponsoring Institution. The awards are not
provided as a condition of employment with either the Federal government or
the U.S. Sponsoring Institution. NCCAM will provide stipend support in
addition to an institutional allowance, described below, to enable the
awardee to participate as a postdoctoral research fellow on a research
project funded by the sponsor through the U.S. Sponsoring Institution.
Examples of funding support by the sponsor through the U.S. Sponsoring
Institution include NIH research grant awards, awards from another Federal
funding agency, or grant awards from private foundations.
The fellowship awardee's requested stipend must be in accordance with the
salary structure of the U.S. Sponsoring Institution, consistent with the
level of effort, which is 100 percent effort based on a 40 hour week, and
may not exceed the maximum National Research Service Award (NRSA) yearly
stipend level based on years of postdoctoral experience. While this is not
an NRSA fellowship, NRSA stipend levels will be used as a guide. Amounts
requested above current NRSA stipend levels must be justified. The NRSA
stipend schedule is updated nearly every year and applicants are advised to
check for the posting of the current stipend schedule on the NIH website at
http://grants.nih.gov/training/nrsa.htm. NCCAM will adjust awards on the
anniversary date of the fellowship award to ensure consistency with the
stipend schedule in effect at that time.
TUITION AND FEES: NCCAM will offset the combined cost of tuition and fees at
the following rate: 100 percent of all costs up to $3,000 and 60 percent of
costs above $3,000. Costs associated with tuition and fees are allowable
only if they are required for specific courses in support of the research
training experience of the fellow at the U.S. Sponsoring Institution.
Tuition and fees for courses must be requested from and approved by NCCAM.
A full description of the tuition policy is contained within the NRSA
section of the Grants Policy Statement at
http://grants.nih.gov/grants/policy/policy.htm.
INSTITUTIONAL ALLOWANCE AT THE U.S. SPONSORING INSTITUTION: NCCAM will
provide an institutional allowance of $10,000 per 12-month period to
nonprofit U.S. Sponsoring Institutions to help defray such awardee expenses
as research supplies, equipment, health insurance (either self-only or
family as appropriate), and travel to scientific meetings and/or the Foreign
Institution. NCCAM will provide an institutional allowance of up to $8,000
for fellows sponsored by for-profit U.S. institutions or Federal
laboratories. This allowance may be used for expenses associated with travel
to scientific meetings and/or the Foreign Institution, health insurance, and
books.
These institutional allowances are intended to cover training-related
expenses for the individual awardee. The allowance is not available until
the fellow officially activates the award and must be used during the 1 to 3
years that the applicant is training at the U.S. Sponsoring Institution. If
an individual fellow is enrolled or engaged in training for less than 6
months for any given 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 NCCAM.
OTHER TRAINING COSTS: Additional funds may be requested by the U.S.
Sponsoring Institution 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
for circumstances that are fully justified and explained by the U.S.
Sponsoring Institution.
INSTITUTIONAL ALLOWANCE AT THE FOREIGN INSTITUTION: One of NCCAM's goals in
issuing the NCCAM International Postdoctoral Fellowship is to increase the
number and improve the quality of research and competitiveness of its
international research grant applications; and at the same time, foster
lasting collaborations between U.S. scientists and scientists from other
countries interested in CAM research in alternative medical systems. To
these ends, after successful completion of training at the U.S. Sponsoring
Institution, NCCAM will provide the Foreign Institution, through a change in
institution mechanism, with up to $32,000 per year for 2 years. This amount
will not be released until the awardee returns to the Foreign Institution
immediately after his/her training in the United States. These funds are to
be used only by the awardee to support ongoing research initiated at the
U.S. Sponsoring Institution in order to continue the collaborative research
training effort and to enhance the applicant's ability to apply for an NCCAM
regular research grant (R01) or exploratory/developmental grant (R21) in
collaboration with the U.S. sponsor. These funds are limited to personnel
costs, purchase of supplies and equipment, and travel. The plans for use of
these funds at the Foreign Institution will be reviewed and approved by
NCCAM before they are released.
FACILITIES AND ADMINISTRATIVE COSTS: F&A; (indirect) to the U.S. Sponsoring
Institution: F&A; costs are not allowed for the U.S. Sponsoring Institution.
FACILITIES AND ADMINISTRATIVE COSTS: F&A; (indirect) to the Foreign
Institution: F& A costs of eight percent can be requested by the Foreign
Institution. However, the F&A; costs must be included as part of the $32,000
per year provided by NCCAM. More information about F&A; costs for foreign
and international organizations can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html
SALARY SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME
The U.S. Sponsoring Institution is allowed to provide funds to the fellow in
addition to the stipend and institutional allowance paid by NCCAM while the
fellow is training at the U.S. institution. Such additional amounts may be
in the form of augmented salary (supplementation). Supplementation should
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.
The U.S. Sponsoring Institution may not provide funds in addition to the
stipend in the form of compensation, such as salary or tuition remission for
services provided, such as teaching. The fellow should spend 100 percent
effort on activities related to this research training award and not be
required to perform additional paid services while at the U.S. Sponsoring
Institution.
CONCURRENT AWARDS: The NCCAM International Postdoctoral Fellowship may not
be held concurrently with another U.S. federally sponsored fellowship or
similar Federal award that provides a stipend/salary or otherwise duplicates
provisions of this award.
TAXES
All fellowship awardees must pay U.S. income taxes, unless they are exempted
by an income tax treaty between the United States and their country of
residence (for tax purposes). Although the tax assessment differs according
to stipend/salary level (higher levels are taxed at higher rates),
fellowship awardees can expect to pay at least 20 percent of their
stipend/salary in U.S. Federal income tax. (Those that are exempt due to a
tax treaty may have to pay taxes to their home country, depending on the
country/treaty). All fellows, including those exempt from U.S. Federal tax,
must pay state income taxes, depending on their state of residence.
Individuals holding an H-1B or 0-1 visa also must pay Social Security tax.
Employees who hold J-1 status will begin to pay Social Security tax at the
start of their third calendar year in the United States.
LEAVE POLICIES
In general, during the years of support at the U.S. Sponsoring Institution,
fellows may receive a stipend 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 stipend for up to 15 calendar days of sick
leave per year.
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.
OTHER SPECIAL REQUIREMENTS
CERTIFICATION AND REPORTING PROCEDURES: No application will be accepted
without the applicant signing the certification block on the face page of
the application. When support ends, the fellow must submit a letter of
termination to the NIH.
LETTER FROM THE FOREIGN INSTITUTION: As described under Eligibility
Requirements, no application will be accepted without an accompanying letter
from the Foreign Institution to which the applicant plans to return. This
letter must be signed by the appropriate institutional business official, by
the appropriate academic official (such as a university dean responsible for
the applicant's appointment), and co-signed by the applicant. It must
contain the following information: 1) The title and description of the
applicant's appointment at this institution; 2) the guaranteed duration of
the appointment; 3) a description of the research facilities/equipment at
the institution, including a description of the research
facilities/equipment available to the applicant.
Applicants for this NCCAM International Postdoctoral Fellowship must have a
guaranteed appointment of no less than 4 years at the Foreign Institution to
which they plan to return. This guaranteed appointment must be documented in
the letter from this institution described above.
POLICY OF THE NCCAM ON QUALITY OF NATURAL PRODUCTS: Applicants must follow
NCCAM's policy on the quality of natural products in research described on
the NCCAM website http://nccam.nih.gov/research/policies/naturalproducts.htm
NCCAM CLINICAL RESEARCH REQUIREMENTS: In addition to the clinical research
requirements listed below under REQUIRED FEDERAL CITATIONS, clinical
research performed as part of this NCCAM International Postdoctoral
Fellowship must conform to the NCCAM TERMS OF AWARDS FOR CLINICAL TRIALS
found at http://www.nccam.nih.gov/research/policies/terms-of-awards.htm.
INVENTIONS AND PUBLICATIONS: Fellowships made primarily for educational
purposes are exempted from the PHS invention requirements. F05 awards will
not contain any provision giving PHS rights to inventions made by the
awardee.
DATA SHARING: It is the policy of the DHHS that the results and
accomplishments of all funded activities should be made available to the
public. This policy also applies to individuals supported by individual
postdoctoral fellowships. The U.S. Sponsoring Institution should place no
restrictions on the publication of results in a timely manner.
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 U.S. Government to reproduce,
publish, or otherwise use them, and to authorize others to do so for Federal
Government purposes.
WHERE TO SEND INQUIRIES
As indicated above, applicants are strongly encouraged to contact the
individuals designated below, in advance of preparing an application, for
additional information concerning the areas of research, receipt dates, and
other types of pre-application instructions.
Nancy J. Pearson, Ph.D.
Program Officer
National Center for Complementary and Alternative Medicine
Two Democracy Plaza, Suite 401
6707 Democracy Boulevard MSC 5475
Bethesda, MD 20892-5475 (0vernight express use 20817)
Telephone: 301-594-0519
Email: pearsonn@mail.nih.gov
Direct questions about NCCAM financial or grants management matters
to:
Marc Pitts, M.B.A.
Grants Management Specialist
National Center for Complementary and Alternative Medicine
Two Democracy Plaza, Suite 401
6707 Democracy Boulevard MSC 5475
Bethesda, MD 20892-5475 (Overnight express use 20817)
Telephone: (301) 594-9095
Fax: (301) 480-3621
Email: pittsm@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 416-1 application. The PHS 416-
1 is available at http://grants.nih.gov/grants/forms.htm in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-
0714, Email: GrantsInfo@nih.gov.
APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. THESE
LETTERS MUST BE IN ENGLISH. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF
REFERENCE MAY BE RETURNED OR DELAYED IN REVIEW.
The PHS 416-1 application is used for several different types of fellowship
awards. Therefore, not all statements in the PHS 416-1 form may be
applicable to the NCCAM International Postdoctoral Fellowship Award.
Supplemental application instructions are given at the end of this Program
Announcement to assist applicants in completing the PHS 416-1 application.
Please contact the NCCAM program official listed under WHERE TO SEND
INQUIRIES if you have questions specific to the NCCAM International
Postdoctoral Fellowship when completing the application form.
The applicant should identify the number of this Program Announcement in
Item 3 of the application.
INSTRUCTIONS 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. No award will be
made if an application lacks this component.
CONCURRENT APPLICATIONS: An individual may not have more than one individual
fellowship or comparable application pending review or award at the NIH or
other DHHS agencies at the same time.
APPLICATION RECEIPT DATES AND REVIEW SCHEDULE: The NCCAM International
Postdoctoral Fellowship applications will undergo a review process that
takes between 5 and 8 months. The receipt dates are as follows:
Application Receipt Dates: Apr 5, 2003 Dec 5, 2003,2004,2005
Initial Review Dates: Jun/Jul Feb/Mar
Secondary Review Dates: Sep/Oct May/June
Range of Likely Start Dates:December July
Submit a signed, typewritten original of the application (including the
Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS in
English, and all other required materials) and one (1) 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
Bethesda, MD 20817 (for express mail/courier service)
All applications submitted to the Center for Scientific Review must come via
United States Postal Service or a recognized delivery/courier service.
Individuals may not personally deliver packages to the building on Rockledge
Drive. For further information please see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html
A copy of the application should also be sent to:
Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
Two Democracy Plaza, Suite 401
National Institutes of Health
6707 Democracy Boulevard MSC 5475
Bethesda, MD 20892-5475
Bethesda, MD 20817 (for express mail/courier service)
PEER REVIEW PROCESS
Complete applications will be assigned to NCCAM for potential funding and to
a suitable Scientific Review Group (SRG) for review. Applicants will be
notified by mail of their application's assignment to NCCAM and assignment
to an appropriate SRG.
Applications receive two sequential levels of review. The first level is an
assessment of the merit of the research training by an 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 and forwards it to the appropriate NCCAM Staff. The second level
of review is conducted by the National Advisory Council for Complementary
and Alternative Medicine.
REVIEW CRITERIA
The review criteria will focus on five main components:
o Candidate: An assessment of the candidate's previous academic and research
performance and the potential to become an important contributor to
biomedical, behavioral, or clinical science related to complementary and
alternative medicine.
o Sponsor and Training Environment at the U.S. Sponsoring Institution: An
assessment of the quality of the training environment at the U.S. Sponsoring
Institution, including qualifications of the sponsor as a mentor for the
proposed research training experience.
o Research Proposal: The merit of the scientific proposal and its
relationship to the candidate's career plans to continue research in
alternative medical systems or components of such systems. An assessment of
whether the number of years requested (a minimum of 1 and up to 3 years) is
an appropriate amount of time for the candidate to develop the skills
necessary to continue this collaborative research once he/she returns to the
Foreign Institution.
o Training Potential: An assessment of the overall value of the proposed
fellowship experience as it relates to the candidate's research training
needs and the extent to which this training experience will allow the
candidate to continue research, in collaboration with the U.S. sponsor, in
his/her home country after the fellowship in the United States is ended.
o Other Review Criteria: An assessment of the Foreign Institution's ability
to support the candidate's continued research in collaboration with the U.S.
sponsor, once the NCCAM supported training at the U.S. Sponsoring
Institution has ended. This should be based on the candidate's and
sponsor's description of plans for continuing research collaboration and on
the letter sent by the Foreign Institution that should include: 1) The title
and description of the applicant's appointment at this institution; 2) the
guaranteed duration of the appointment; 3) a description of the research
facilities/equipment at the institution, including a description of the
research facilities/equipment available to the applicant.
NOTIFICATION: Shortly after the SRG meeting, each applicant will be notified
by mail of the SRG recommendation and the name and phone number of the NCCAM
program official responsible for the application. When the NCCAM program
official receives the written summary of the review, prepared by the SRA
after the review meeting, a copy will be forwarded to the applicant.
Following the second-level review, the NCCAM program officer will notify
each applicant of the final disposition of the application. Any questions on
SRG recommendations and funding possibilities should be directed to the
appropriate NCCAM program officer, not the Scientific Review Administrator
of the SRG.
AWARD CRITERIA
NCCAM staff use the following criteria in making awards:
o Eligibility of the applicant;
o The SRG recommendation of the overall merit of the application;
o The relevance of the application to the NCCAM's research and research
training priorities and program balance, including investment in
international research; and
o The availability of funds.
ACTIVATION: No funds may be disbursed until the fellow has started training
under the award and a letter of activation has been submitted to the NIH.
An awardee has up to 6 months from the issue date on the award notice to
activate the award. Under unusual circumstances, NCCAM may grant an
extension of the activation period upon receipt of a specific request from
the fellow.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: NIH specifically
requires the establishment of Data and Safety Monitoring Boards (DSMBs) for
multi-site clinical trials involving interventions that entail potential
risk to the participants, and generally for Phase III clinical trials.
Although Phase I and Phase II clinical trials may also use DSMBs, smaller
clinical trials may not require this oversight format, and alternative
monitoring plans may be appropriate. A detailed Data and Safety Monitoring
Plan must be submitted to the applicant's IRB and subsequently to the NIH
funding Institute or Center for approval prior to the accrual of human
subjects. For further information see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.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 AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide for
Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons not
to include them. This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
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 that is available at
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 proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for
Grants and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. For
individual fellowships, the Institute/Center funding the fellowship will
request the necessary information prior to issuing the award. Further
information is available at
http://grants.nih.gov/grants/policy/hs_educ_faq.htm.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 (see
http://escr.nih.gov). It is the responsibility of the applicant to provide
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.
PUBLIC 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 public 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.
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 NCCAM International Fellowship award is described in the Catalog of
Federal Domestic Assistance No. 485D (NCCAM). Awards are made under
authorization of Sections 307 and 402 of the Public Health Service Act as
amended and administered under NIH grants policies and Federal Regulations
42 CFR 63a. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
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.
SUPPLEMENTAL APPLICATION INSTRUCTIONS
Below are instructions related to information requested in numbered items in
the PHS 416-1 application where the information is specific for the NCCAM
International Postdoctoral Fellowship Award.
PART I – Applicant
Item 2. Level of Fellowship: Postdoctoral
Item 3. Program Announcement/Request for Applications: Enter the PA number
of this announcement: NCCAM International Postdoctoral Fellowship
Item 23: Scholastic Performance: For applicants who have received their
doctoral degree or equivalent within the past 7 years, follow the
instructions for postdoctoral applicants. For applicants who received their
doctoral degree or equivalent more than 7 years ago, omit this item.
Item 30d: Sponsor and Institution: Parts (1) and (2) refer to the U.S.
Sponsoring Institution. In part (3) briefly describe the plans for
continuing the collaborative research at the Foreign Institution that was
initiated at the U.S. Sponsoring Institution (two pages maximum
length).
PART II - Sponsor and Sponsoring Institution Officials
Item 34: In addition to the requested description of the training plan for
the applicant at the U.S. Sponsoring Institution, the U.S. sponsor should
also describe the plan for future research collaboration with the awardee
once he/she returns to the Foreign Institution.
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