and Human Services (HHS)
EXPIRED
NLM SENIOR INDIVIDUAL BIOMEDICAL INFORMATICS FELLOWSHIPS (F38)
RELEASE DATE: April 18, 2003
PA NUMBER: PAR-03-109 (This PAR has been suspended, see NOT-LM-05-014)
(Scientific review contact change, see NOT-LM-05-013)
(Peer Review contact change, see NOT-LM-05-007)
(Correction to eligibility requirements, see NOT-LM-05-004
and see change NOT-LM-04-005)
This program announcement supersedes PA-92-90
EXPIRATION DATE: November 30, 2005
National Library of Medicine (NLM)
(http://www.nlm.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.879 NLM Medical
Library Assistance
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose
o Training Objectives
o Mechanism of Support
o Eligibility Requirements
o Eligible Sponsoring Institutions
o Allowable Costs
o Stipend Supplementation, Compensation, and Other Income
o Tax Liability
o Payback Requirements
o Leave Policies
o Trainee Terms of Appointment
o Part-Time Training
o Other Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Other Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
NLM senior fellowships in biomedical informatics provide support for
the training of experienced health professionals in informatics.
Training may be for informatics research or for the application of
informatics to any area of biomedicine, including, among others,
clinical medicine, basic biomedical research, education, or.
administration.
These fellowships are intended for experienced scientists, physicians,
and other professionals who wish to make major changes in the direction
of their careers or who wish to broaden their scientific background by
acquiring new capabilities in informatics research and development.
These awards will enable professionally independent individuals with at
least ten years of post-graduate experience to take time from their
regular professional responsibilities for the purpose of receiving
training in informatics. This award can be used in conjunction with
a sabbatical experience. The fellowship is not designed for post-
doctoral level investigators prior to independence or for pre-doctoral
training per se.
The majority of candidates for this award will have a research or
health-professional doctorate, and post-doctoral clinical or research
experience at the time of application. The requirement for a doctoral
degree may be waived for candidates in the following professional
fields: engineering, computer science, library and information
sciences. Applicants without a doctoral degree should contact the
Program Officer named at the end of this announcement for information
regarding eligibility.
RESEARCH OBJECTIVES
Fellowship training is intended to help meet the growing national need
for professionals able to do research in informatics or to apply the
power of computation to the myriad domains of biomedicine. Thus, this
fellowship is suitable for training in informatics specializations
ranging from clinical informatics to the informatics of molecular
biology and other large research datasets. Applications that focus on
building new skills or extending the applicant's existing expertise are
particularly desirable.
Upon completion of training, fellows should be able to conduct basic or
applied research at the intersection of biology and medicine with
computer and cognitive sciences, and are expected to be familiar with
the use and potential of modern information technology. Fellows in
informatics will achieve this goal through an individually tailored
program of formal coursework and research experience, associated with a
project.
Although a canonical set of basic courses for informatics training has
not yet evolved, there is general agreement that the field is
interdisciplinary, and includes, among others, components of computer
science, information science, cognitive science, and knowledge of one
or more domains of biomedicine. The program of coursework should
develop or augment the trainee's basic competency in each of these
areas. This fellowship may lead to a degree, although it is not a
requirement. Whether or not the training is to be used for credit or
certification in an educational program is up to the applicant, the
fellowship sponsor, and the organization involved. The curriculum for
applied research training may be different from that needed for basic
research training, but should provide sufficient theoretical foundation
in the area of application.
An opportunity to carry out supervised research and/or applications
development in informatics is essential to achieve the primary
objective of developing or extending knowledge and skills. The
fellowship must provide hands-on experience obtained via a defined
project. Projects may be in basic informatics research areas or
address an informatics application. An applied informatics project
does not require the form or concepts of a research project, and need
not be hypothesis-driven, but the proposal should provide sufficient
detail to permit reviewers to judge importance of the problem,
feasibility of the approach, and the post-training utility of the
informatics techniques required.
MECHANISM OF SUPPORT
This program announcement for Senior Individual Biomedical Informatics
Fellowships uses the F38 funding mechanism. For NLM, these awards are
authorized by the Medical Library Assistance Act and are not a part of
the National Research Service Awards Program (NRSA) of the Public
Health Service. However, the policies and requirements of the NLM
program are similar in most respects to NRSA awards. Applicants with
fewer than ten years of professional experience are encouraged to
investigate their eligibility for the Individual Informatics fellowship
(F37). The project period may be for one to two years, and awards are
not renewable.
ELIGIBLE INSTITUTIONS
Only domestic non-Federal organizations, public or private, such as
Medical, Dental or Nursing schools or other institutions of higher
education, may accept an award on behalf of an applicant.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
By the date of appointment, applicants must have at least ten full
years of relevant research or other professional experience beyond the
qualifying degree. Relevant postdoctoral experience may include
research experience (including industrial), teaching, internship,
residency, clinical duties, or other time spent in full-time studies in
a health-related field following the date of the qualifying doctoral
degree. All candidates must be willing to spend a minimum of 50
percent of full-time professional effort conducting research and
research career development during the entire award period.
Candidates for the F38, under some circumstances, may have been
principal investigators (PIs) on NIH research or career development
awards, provided the research experience proposed in this application
is in a fundamentally new field of study or there has been a
significant hiatus in their research career because of family or other
personal obligations. Current PIs on NIH career awards are not
eligible. A candidate for the F38 award may not have pending nor
concurrently apply for any other type of NIH career development award.
F38 recipients are encouraged to apply for independent research grant
support during the period of this award.
Postdoctoral Trainees
Postdoctoral trainees must have received a Ph.D., M.D. or comparable
doctoral degree from an accredited domestic or foreign institution.
Eligible doctoral degrees include, but are not limited to, the
following: D.D.S., D.M.D., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D.,
Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. Documentation by an
authorized official of the degree-granting institution certifying all
degree requirements have been met prior to appointment is acceptable.
Professional degrees
The NLM recognizes that graduates of training programs in professions
that do not customarily require a doctoral degree (e.g., library
science and nursing) can make important contributions to Informatics.
The NLM also encourages applications on behalf of individuals without
doctoral degrees, but who have significant professional training and
experience in closely related cognate fields. Nurses, health science
librarians, researchers, educators, administrators, and other health
professionals are eligible, as are computer scientists and engineers
who wish to focus on the health domain.
Applications on behalf of women and other groups underrepresented in
biomedical informatics are strongly encouraged.
Citizenship
By the time of award, individuals must be citizens or non-citizen
nationals of the United States, or must have been lawfully admitted to
the United States for permanent residence (i.e., possess a currently
valid Alien Registration Receipt Card I-551, or other legal
verification of such status). Non-citizen nationals are generally
persons born in outlying possessions of the United States (e.g.,
American Samoa and Swains Island). Individuals on temporary or student
visas are not eligible.
SPECIAL REQUIREMENTS
Before submitting a fellowship application, the applicant must identify
a sponsoring institution and an individual who will serve as a sponsor
(also called mentor or supervisor) and will supervise the training and
research experience.
To apply for support, an institution must submit an application on
behalf of the individual seeking the fellowship. Applications on
behalf of prospective fellows may be submitted by domestic non-profit
organizations, public or private, such as universities, colleges,
hospitals, laboratories, units of State or local government, and
eligible agencies of the Federal government. Applicants proposing
training at their doctorate institution or at the institution where
they have been training for more than a year must document the
opportunities for new training experiences designed to broaden their
scientific background.
Each fellow must have a mentor who provides guidance and oversight for
the training program. The mentor should be expert in an area of
informatics or information science that is pertinent to the proposed
program, and should be an active investigator in the area of the
proposed research who will directly supervise the candidate's research.
The sponsor must document the availability of staff, research support,
and facilities for high-quality research training. The mentor may be
at the applicant's home institution or at another institution. If the
latter, the plan for supervision and interaction must be described.
SPECIAL FELLOWSHIP AT THE LISTER HILL NATIONAL CENTER FOR BIOMEDICAL
COMMUNICATIONS (LHCNBC)
Co-Mentorship Program is available to NLM Individual Informatics
Fellows with project interests that coincide with research and
development ongoing at the NLM. In this program plan option, the
Fellow spends the academic year at the home (sponsoring) institution,
and the three summer months of each fellowship year on site at the
LHNBC in Bethesda doing a relevant research project under the
supervision of an NLM staff scientist.
Applications from underrepresented minorities (African Americans,
Alaskan Native, Hispanic Americans, Native Americans and Pacific
Islanders) and persons with disabilities are encouraged to apply as
applicants and as mentors.
ALLOWABLE COSTS
Stipends
Stipends for NLM Senior Fellows are determined individually at the time
of award. The amount of the stipend shall be based on the documented
salary or remuneration paid to the candidate from the home institution
at the time of award, and shall be based on the normal full-time 12-
month staff appointment at the home institution. However, in no case
shall the NIH contribution to the stipend during the fellowship exceed
the current legislated maximum salary; in Fiscal Year 2002, the maximum
salary provided by a Federal grant is $166,700. For Fellows on
sabbatical, the level of the stipend award will take into account
concurrent sabbatical salary support provided by the home institution
and any other supplementation.
Training awards provide stipends to fellows 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. For fellows sponsored by
domestic non-federal institutions, the stipend will be paid through the
sponsoring institution. For fellows sponsored by Federal institutions,
the monthly stipend payment will be deposited in the fellow's U.S. bank
account or paid directly to the fellow by U. S. Department of Treasury
check. No departure from the established stipend schedule may be
negotiated between the institution and the fellow.
Tuition and Fees
NLM will award 100% of the combined costs of tuition, fees, and health
insurance up to $3,000 and 60 percent of the combined costs above
$3,000. The tuition formula is used for award calculation purposes
only. Actual costs may be higher. Costs associated with tuition and
fees are allowable only if they are required for specific courses in
support of the research training experience supported by the
fellowship. A full description of the tuition policy is contained
within the NRSA Policy Guidelines on the NIH website at
http://grants.nih.gov/training/nrsa.htm
Trainee Travel
Travel for attendance at scientific meetings that are important to the
individual's training is an allowable trainee expense. The base formula
for travel allows up to $1,000 per year per trainee. In their proposed
budgets, applicants for NLM fellowships should request additional
trainee travel funds for a meeting each year, to be held at the
National Library of Medicine in Bethesda or at another site. The
purpose of these meetings will be to exchange information among all NLM
trainees, including those at NLM institutional training program sites,
institutional program directors, NLM program staff, and other selected
participants.
Support for travel by NLM fellows to a research training experience
away from the primary institution is also permitted. Such experiences
are acceptable as a complement to the course work, expertise, and
experiences available at the parent institution. Letters requesting
such training may be submitted to the NLM at any time during the award
period, and should explain the type of opportunities for training
available, how these opportunities differ from those offered at the
parent institution, and the relationship of the proposed experience to
the trainee's career stage and goals. The LHNCBC co-mentorship program
described above is an example of such a program.
Awards for training at a foreign site may include a single economy or
coach round-trip travel fare. No allowance is provided for dependents.
U.S. flag air carriers must be used to the maximum extent possible when
commercial air transportation is available for travel between the
United States and a foreign country or between foreign countries.
Funds are not provided to cover the cost of travel between the fellow's
place of residence and a domestic training institution. However, in
cases of extreme need or hardship, a one-way travel allowance may be
authorized by the sponsoring institution. Such travel must be paid from
the Institutional Allowance.
Health Insurance
In order to adjust policies to facilitate the recruitment of women and
individuals from disadvantaged backgrounds as required by Section 487
of the Public Health Service Act (as amended), NLM will allow costs
associated with family health insurance for trainees who have families
and are eligible for family health insurance coverage at the sponsoring
institution. Self-only health insurance will continue to be an
allowable cost for trainees without families. Institutions may include
the cost of family health insurance for trainees who are eligible for
this coverage in the calculation of the combined cost of tuition, fees,
and health insurance.
Institutional Costs
NLM provides an institutional allowance of $6000 per year per trainee
to defray the costs of other research training expenses, including
consultant costs, equipment, and research supplies. This allowance is
intended to cover training-related expenses for the individual trainee
and is not available until the fellow officially activates the award.
NIH will provide an institutional allowance of up to $3,000 for fellows
sponsored by Federal laboratories for expenses associated with travel
to scientific meetings, health insurance, and books. Funds for fellows
at Federal laboratories will be disbursed from the NIH awarding
institute.
The institution may request additional funds when the training of a
fellow involves extraordinary costs for travel to field sites remote
from the sponsoring institution or for accommodations for fellows who
are disabled, as defined by the Americans With Disabilities Act. The
funds requested for costs of this nature must be reasonable in
relationship to the total dollars awarded under the fellowship and must
be directly related to the approved research training experience. Such
additional funds shall be provided only in exceptional circumstances
that are fully justified and explained by the sponsoring institution.
Consultation with NLM program staff in advance of such requests is
advised.
Facilities and Administrative (F&A, indirect) costs are not allowed on
individual fellowship awards.
Salary for mentors, secretarial, and administrative assistance, etc.,
is not allowed.
STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME
An institution is permitted to provide funds to a fellow in addition to
the stipend paid by the NIH. Such additional amounts may be in the
form of augmented stipends (supplementation) or compensation.
The grantee institution may provide supplementation or additional
support to offset the cost of living on the condition that such
supplementation does not require any additional effort from the
trainee. Federal funds may not be used for supplementation unless
specifically authorized under the terms of both the program from which
such supplemental funds are to be received and the program whose funds
are to be supplemented. Under no circumstances may Department of
Health and Human Services (DHHS) funds be used for supplementation.
An institution may also provide additional compensation to a trainee in
the form of compensation (as salary and/or tuition remission) for
services such as teaching, research, or clinical care. A trainee may
receive compensation for services as a research assistant or in some
other position on a Federal research grant, including a DHHS research
grant. However, compensated services should occur on a limited, part-
time basis apart from the normal research training activities. In
addition, compensation may not be paid from a research grant supporting
research that is part of the research training experience. Under no
circumstances may the conditions of stipend supplementation or
additional compensation interfere with, detract from, or prolong the
trainee's approved training program.
Additionally, compensation must be in accordance with institutional
policies applied consistently to both federally and non-federally
supported activities and supported by acceptable accounting records
determined by the employer-employee relationship agreement.
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.
Concurrent Awards. An NLM fellowship may not be held concurrently with
another Federally sponsored fellowship or similar award that provides a
stipend or otherwise duplicates provisions of the NLM award.
TAX LIABILITY
Section 117 of the Internal Revenue Code applies to the tax treatment
of all scholarships and fellowships. Under that section, non-degree
candidates are required to report as gross income any monies paid on
their behalf for stipends, or any 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 taxability of
stipends, however, in no way alters the relationship between NIH
trainees and institutions. NLM fellowship stipends are not considered
salaries. In addition, trainees supported under these fellowships are
not considered to be in an employee-employer relationship with the NIH
or the awardee institution. It is therefore, inappropriate and
unallowable for institutions to charge costs associated with employment
(such as FICA, workman's compensation, or unemployment insurance) to
the fellowship award. It must be emphasized that the interpretation
and implementation of the tax laws are the domain of the Internal
Revenue Service (IRS) and the courts. The NIH takes no position on the
status of a particular taxpayer, and it does not have the authority to
dispense tax advice. Individuals should consult their local IRS office
about the applicability of the law to their situation and for
information on their tax obligations.
PAYBACK REQUIREMENTS
Because the NLM senior individual informatics fellowships (F38) are not
subject to NRSA policies, there are no service payback requirements.
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 the 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 NLM program staff for an unpaid leave
of absence.
TRAINEE TERMS OF APPOINTMENT
Full-time Fellows
Funded training periods may be for one to two years, and customarily
require a full-time commitment. That is, trainees are typically
required to pursue their research training on a full-time basis,
devoting at least 40 hours per week to the program. Within the 40
hours per week training period, research trainees in clinical areas
must devote their time to the proposed research training and must
confine clinical duties to those that are an integral part of the
research training experience. If the fellowship is proposed at less
than full time, stipends will be adjusted appropriately. The minimum
effort permitted is 50 percent of full-time.
Part-time Fellows
Fellows are typically expected to make a full-time commitment to their
training program. However, under unusual and pressing personal or
professional circumstances, part-time training may be appropriate.
Part-time training program at a level of 50 to 99 percent effort will
be considered on an ad hoc basis with sufficient justification of need.
If part-time training is requested, the application clearly justify the
level of effort proposed, and clearly demonstrate how the research and
program of study will be accomplished with respect to other duties and
responsibilities. A fellow will not be permitted to engage in NLM-
supported research training for less than 50 percent effort.
Individuals desiring to reduce their commitment to less than 50 percent
effort must take a leave-of-absence from NLM fellowship support. The
fellowship notice of award will be reissued and the stipend will be
pro-rated during the period of any approved part-time training.
Stipend levels for part-time trainees will be appropriately pro-rated
according to their level of effort.
Other Appointment Terms
No individual trainee may receive more than 4 years of aggregate NLM
support at the predoctoral level or 3 years of support at the
postdoctoral level, including any combination of support from
institutional training grants and individual fellowship awards.
Any extension of the total duration of trainee support at either the
predoctoral or postdoctoral level requires approval by NIH. Requests
for extension must be made in writing by the trainee, endorsed by the
sponsor and the appropriate institutional official, and addressed to
the NLM Program Officer. The request must include a sound justification
for an extension of the limits on the period of support.
General information about NIH support of fellowships, including those
awarded by the NLM, can be found at
http://grants.nih.gov/training/extramural.htm. Please note that the
"Service Payback" provisions do not apply: NLM's Individual
Informatics Fellowships require no payback. Information about current
NIH stipend levels and other support may be found in NATIONAL RESEARCH
SERVICE AWARD (NRSA) STIPEND INCREASE AND OTHER BUDGETARY CHANGES
EFFECTIVE FOR FISCAL YEAR 2002 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html.
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. Individuals admitted to the United States as
Permanent Residents must submit notarized evidence of legal admission
prior to the award. When support ends, the fellow must submit a
Termination Notice (PHS 416-7) to the NIH. Forms may be found on the
NIH Website at http://grants.nih.gov/grants/forms.htm.
Inventions and Publications. Fellowships made primarily for educational
purposes are exempted from the PHS invention requirements. F38 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 NRSA postdoctoral fellowships. The 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
Government to reproduce, publish, or otherwise use them, and to
authorize others to do so for Federal Government purposes.
WHERE TO SEND INQUIRIES
Inquiries from potential applicants concerning this PA are encouraged.
Inquiries about NLM Fellowships may fall into three areas,
programmatic, peer review, and financial or grants management issues,
and should be directed to the following individuals accordingly.
o Direct your questions about scientific/research issues to: (Contact changed, see NOT-LM-05-013)
Dr. Charles Friedman
6705 Rockledge Drive, Suite 301
Bethesda , MD 20892-7968
Telephone: (301) 594-4882
FAX: (301) 402-2952
Email: [email protected]
o Direct your questions about peer review issues to: (Contact changed, see NOT-LM-05-007)
Dr. Arthur Petrosian
Scientific Review Administrator
6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD 20892-7968
Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 594-4933
FAX: (301) 402-2952
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301, 6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: (301) 402-0421
SUBMITTING AN APPLICATION
Individuals must submit the application form PHS Individual National
Research Service Award (PHS 416-1, rev. 6/02). APPLICATIONS MUST
INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. APPLICATIONS
WITHOUT AT LEAST THREE LETTERS OF REFERENCE MAY BE RETURNED OR DELAYED
IN REVIEW. Applications are available at:
http://grants.nih.gov/grants/funding/416/phs416.htm
Complete Item 3 on the face page of the application indicating that the
application is in response to this announcement and print F38 NLM
SENIOR INDIVIDUAL INFORMATICS FELLOWSHIP.
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 and 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 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.
Submit a signed, typewritten original of the application (including the
Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS,
and all other required materials) and two (2) 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/courier service)
INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED.
Concurrent Applications
An individual may not have more than one individual NRSA fellowship or
comparable application pending review or award at the NIH or other DHHS
agencies at the same time. The CSR will not accept any application in
response to this PA that is essentially the same as one currently
pending initial review unless the applicant withdraws the pending
application. The CSR 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.
Application Receipt Dates and Review Schedule
Fellowship applications undergo a review process that takes between 5
and 8 months. The receipt dates and the three annual review cycles are
as follows:
Application Receipt Dates: Apr 5 Aug 5 Dec 5
Initial Review Dates: Jun/Jul Oct/Nov Feb/Mar
Secondary Review Dates: Aug/Sep Dec/Jan Apr/May
Range of Likely Start Dates: Sep 1-Dec 1 Jan 1-Mar 1 May 1-Jul 1
PEER REVIEW PROCESS
Applications will be reviewed for scientific and technical merit by the
NLM Biomedical Library and Informatics Review Committee (BLIRC) in
accordance with standard NIH peer review procedures. In general, the
merit review criteria customarily employed by the NIH for fellowship
applications will be followed. Additional information may be found at
http://grants.nih.gov/training/nrsa.htm. After the initial merit
review, the NLM program official will forward to each applicant a
written critique and summary of the review of the application prepared
by the Scientific Review Administrator.
After scientific-technical review, staff within the NLM will provide a
second-level review to evaluate relevance to the mission and scope of
NLM. Following the second-level review, the NLM program official will
notify each applicant of the final disposition of the application. Any
questions on BLIRC recommendations and funding possibilities should be
directed to the NLM program official, not the Scientific Review
Administrator.
REVIEW CRITERIA
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.
Sponsor and Training Environment: An assessment of the quality of the
training environment and the qualifications of the sponsor as a mentor
for the proposed research training experience.
Research Proposal: The merit of the scientific proposal and its
relationship to the candidate's career plans.
Training Potential: An assessment of the value of the proposed
fellowship experience as it relates to the candidate's needs in
preparation for a career as an independent researcher.
Additional Review Criteria
In addition to the above criteria, applications will also be reviewed
with respect to the following:
Protections. The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
Inclusion. 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. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
Budget. The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
Training In The Responsible Conduct Of Research. Applications must
include a description of a program to provide instruction in scientific
integrity and the responsible conduct of research. (See the NIH Guide
for Grants and Contracts, Volume 21, Number 43, November 27, 1992.)
OTHER REVIEW CRITERIA
All applications must include in the proposed research plan an outline
and description of the project including specific hypotheses,
objectives, and milestones as appropriate.
Applications with an applied rather than research focus must include a
specific section labeled Milestones following the Research Plan.
Milestones should be well described, quantifiable, and scientifically
justified. A discussion of the milestones relative to the progress of
the project, as well as the implications of successful completion of
the milestones for further investigation or implementation, should be
included. The milestone section should be indicated in the Table of
Contents. The clarity and completeness of the application with regard
to specific goals and feasibility of milestones is critical. The
presentation of milestones that are not sufficiently scientifically
rigorous to be valid for assessing progress will reflect upon the
scientific judgment of the applicant in this application.
Applications for the LHNCBC co-mentorship program must clearly describe
the plan for shared mentorship as well as supervision of the proposed
project(s), and must include a letter of commitment from the proposed
NLM mentor and the Director of the LHNCBC.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data if
applicable
AWARD CRITERIA
Applications will compete for available funds with all other approved
applications assigned to NLM. The following factors will be considered
when making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
Activation
No funds may be disbursed until the fellow has started training under
the award and an Activation Notice (PHS 416-5) has been submitted to
the NIH. An awardee 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 period upon receipt
of a specific request from the fellow.
Terms And Conditions Of Support
Fellowships must be administered in accordance with the current NRSA
Policy Guidelines for Individual Awards and Institutional Grants (see
the NIH Website at http://grants.nih.gov/training/nrsa.htm), the
current NIH Grants Policy Statement (see the NIH Website at
http://grants.nih.gov/grants/policy/policy.htm), and any terms and
conditions specified on the award notice.
Certification and Reporting Procedures
No application will be accepted without the applicant signing the
certification block on the face page of the application. Individuals
admitted to the United States as Permanent Residents must submit
notarized evidence of legal admission prior to the award. When support
ends, the fellow must submit a Termination Notice (PHS 416-7) to the
NIH. Forms may also be found on the NIH Website at
http://grants.nih.gov/grants/forms.htm.
Inventions and Publications
Fellowships made primarily for educational purposes are exempted from
the PHS invention requirements. F38 awards will not contain any
provision giving PHS rights to inventions made by the awardee.
REQUIRED FEDERAL CITATIONS
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
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub- populations must be included in all NIH-supported clinical
research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research. This policy
results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - 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 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 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.
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.
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).
Those who must comply with the Privacy Rule (classified under the Rule
as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This PA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance, Medical Library Assistance, 93.879. Awards
are made under the authority of the Public Health Service Act, Section
472 (42 USC 286b-3) and administered under PHS grants policies and
Federal Regulations, most specifically at 42 CFR Part 61 and 45 CFR
Part 74. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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