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2008 Research Grant
Submission Instructions
OVERVIEW
Purpose
The National Osteoporosis Foundation
seeks to expand the understanding of
osteoporosis through the funding of
research projects in
translational/clinical research
investigating the epidemiology,
pathogenesis, prevention, diagnosis, and
treatment of osteoporosis and which
support the mission and goals of the
National Osteoporosis Foundation.
Clinical/ translational research
includes human or animal research in
these areas.
Translational research is defined as the
process of applying ideas, insights, and
discoveries generated through basic
scientific inquiry to the treatment or
prevention of human disease. Clinical
research is conducted with human
subjects (or on material of human origin
such as tissues, specimens and cognitive
phenomena) for which an investigator
directly interacts with human subjects.
Also included are epidemiological and
behavioral studies as well as outcomes
research and health services research.
Eligibility
Applications for research grants may be
submitted by investigators who have been
granted an M.D., Ph.D. or equivalent
degree, and must have U.S. citizenship
or permanent resident status. They must
be less than 4 years beyond
completion of graduate or fellowship
programs that follow successful
completion of an M.D., Ph.D. or
equivalent degree. NOF grants are
awarded to not-for-profit institutions
located within the United States, its
territories, and the Commonwealth of
Puerto Rico. Federal agencies and their
employees are not eligible.
Funding
Applications for both pilot and research
projects supplemental to an ongoing
funded project will be considered for
funding under this grant program. NOF
will also consider innovative projects
which do not meet the criteria for NIH
or other traditional grant programs.
Depending on funding, a minimum of three
grants of $50,000 each will be awarded
for one-year research projects. In
addition, institutional overhead of 14%
or $7,000 will be provided with the
grant award for a total maximum grant
amount of $57,000.
Background
According to the United States Surgeon
General, osteoporosis is a major public
health threat for an estimated 44
million Americans or 55 percent of the
people 50 years of age and older. In the
U.S. today, 10 million individuals are
estimated to already have the disease
and almost 34 million more are estimated
to have low bone mass, placing them at
increased risk for osteoporosis.
Osteoporosis is characterized by low
bone mass and microarchitectural
deterioration of bone tissue, leading to
bone fragility and increased fracture
risk. Although any bone can be affected,
most fractures occur in the hip, spine
and wrist.
In the United States, the cost of
osteoporosis in terms of human suffering
and health care dollars is enormous. In
2005, more than two million incident
fractures occurred at a cost of $17
billion. Total costs, including
prevalent fractures are more than $19
billion. Annual fractures and costs are
projected to rise by almost 50% by 2025.
The most rapid growth is estimated for
people 65-74 years of age, with an
increase exceeding 87%. Increases of
nearly 175% are projected for Hispanic
and other subpopulations.
NOF has estimated that one out of every
two Caucasian women will experience an
osteoporotic fracture at some point in
her lifetime. Although Caucasian women
are most commonly affected by
osteoporosis, other ethnic groups
including African-American,
Asian-American, and Latino women, as
well as men, are also at risk.
While progress has been made in recent
years in expanding the understanding of
the disease in postmenopausal Caucasian
women, a great deal is still unknown
about the primary prevention of this
disease, how best to achieve peak bone
mass in children, as well as the
epidemiology, pathogenesis, prevention,
diagnosis, and treatment of the disease
in other populations, including men,
minority women, and premenopausal women.
Program Implementation
A brief letter of intent (no more than
one page in length) detailing the goals,
methods, and scope of the proposed
research project, the qualifications of
the applicant and his/her institution to
perform this work, and institutional
support for the project must be
submitted in advance of the grant
application. Letters of Intent are
reviewed by the NOF Science and Research
Committee; full grant proposals will be
requested from investigators whose
letters best address NOF’s research
priorities. Selected applicants will be
directed to the application
submission instructions to submit a full
proposal.
Grant Cycle Timeline
NOF’S RESEARCH AGENDA
NOF invites qualified investigators to
present clinical or translational
research related to the epidemiology,
pathogenesis, diagnosis and treatment of
osteoporosis, for example:
Clinical syndromes of abnormal bone
remodeling causing skeletal fragility
Bone quality studies in humans
Studies to improve the ability to
predict risk of fracture
Clinical studies of the mechanisms of
regulation of bone remodeling rates
Clinical studies of targeted
(mechanically driven), and untargeted
(non-mechanically driven remodeling)
The impact of hormone replacement
therapy in prevention and treatment of
osteoporosis in diabetic women
Optimal calcium intake in minority
women
Genetic factors affecting bone mass
and bone metabolism
New preventive/treatment approaches
based on molecular biology
Cost-benefit analyses of osteoporosis
prevention, diagnostic, and treatment
techniques
Hip fracture rates in minority men and
women
Prevention and treatment of
osteoporosis in men
The intensity, duration, frequency,
and type of exercise effective for
prevention of osteoporosis or
osteoporotic fracture
Effective measures of screening for
and treating risk factors for falling
Means for maximizing peak bone mass in
children, adolescents, and young adults
RESEARCH GRANT
PROGRAM POLICIES
1. AUTHORITY FOR MAKING GRANTS: Research
Grants are awarded by the Board of
Trustees of the National Osteoporosis
Foundation (NOF), acting upon the
recommendations of scientific reviewers
and the Science and Research Committee
of the National Osteoporosis Foundation.
Members of the Board of Trustees are
prohibited from voting on grant awards
to individuals at institutions with
which they are affiliated.
2. SCIENTIFIC REVIEW OF APPLICATIONS:
Each research grant proposal is reviewed
by at least two scientific reviewers
with expertise in the technical and
methodological areas addressed in the
grant application. Conflict of interest
disclosure is required of each reviewer.
This information is made known to the
Review Committee and NOF staff.
Reviewers are expected to decline
reviewing any grant proposals if doing
so may give the appearance of conflict
of interest.
The scientific reviewers evaluate: (a)
the overall scientific merit of the
application; (b) the qualifications,
experience and productivity of the
investigator (s); (c) the resources
available; (d) research environment and
mentoring opportunities; (e) human and
animal welfare issues; (f) the
appropriateness of the budget; and (g)
the applicability to the specific goals
of NOF and the particular solicitation.
The Research Grant Committee of the
Scientific Advisory Council appraises
the scientific reviewer’s evaluations
and determines recommendations to be
taken to the NOF Board of Trustees.
3. TO WHOM GRANTS ARE MADE: The grants
are intended for investigators at the
beginning or early stages of their
faculty careers and within 4 years of
their postdoctoral or medical fellowship
training period. Research grants are
awarded to not-for-profit institutions
located within the United States, its
territories, and the Commonwealth of
Puerto Rico. Grant applications will not
be accepted from for-profit institutions
or agencies of the federal government.
Grants are not made to an individual
investigator. Accordingly, an
application for a grant must bear the
signature of the official head of the
institution or that of his designee.
Investigators who have received previous
NOF grants are eligible, but preference
will be given to those who have not
previously been funded. Investigators
who hold a current NOF grant are
ineligible. The National Osteoporosis
Foundation does not assume any
responsibility for the conduct of the
investigation or the acts of the
investigator since both are under the
direction and control of the grantee
institution and subject to its medical
and scientific policies.
4. TERM AND DESCRIPTION OF GRANTS: NOF
Research Grant Awards are made in
accordance with the NOF Research Grant
award policies herein. When a request
for support of a research project is
submitted to more than one granting
agency, such proposals will be awarded
provided that the support requested from
NOF does not duplicate funding provided
by another funding source. The grantee’s
proposed budget must designate which
budget items are to be funded by the NOF
grant and which will not. The NOF
support cannot be accepted in
duplication of other support for the
same expenses on the same project.
Research grants are made for a term of
one year. If the study can be completed
in less than one year, grants may be
made for shorter periods if so requested
by the investigator or so determined by
the scientific reviewers and the Science
and Research Committee.
5. APPLICATIONS FOR GRANTS: Selected
applicants will be directed to the
application submission
instructions in order for them to submit
a full proposal.
Grant Cycle Timeline:
|
Call for Letters of Intent
|
October 15th |
|
Letters of Intent Submission
Deadline |
December 1st |
|
Call for Grant Applications |
December 20th |
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Grant Application Submission
Deadline |
February 20th |
|
Award Announcement |
June 1st |
|
Award Activation Date |
September 1st |
6. PAYMENTS: Payments on grants will be
made quarterly in equal amounts in
September, December, March, and June.
Acknowledgement of payment is not
required.
7. EXPENDITURES: The primary
investigator may make minor alterations
within the approved budget with written
approval from the NOF Staff
Administrator.
8. FINANCIAL RECORDS: A separate account
must be maintained for the NOF grant.
The account, with substantiating
invoices and payrolls, should be
available at all times for audit by
representatives of the Foundation.
Reports of expenditures are to conform
to the instructions herein and the NOF
Research Program Guidelines. All
financial reports must be signed by the
responsible financial officer of the
institution and the principal
investigator.
The Foundation is not responsible for
the over-expenditure of grant funds, for
commitments against a grant not paid
within sixty (60) days after termination
or for expenditures made before the
starting date of a grant.
An annual report of expenditures must be
submitted by September 1 of the year
following the award period and a final
report with budget within ninety days
after termination of a grant, together
with the refund of any unexpended
balance. Unexpended funds from an
existing grant cannot be carried forward
to any other grant.
9. REPORTS: Recipients of research
funding are required to provide a final
report within ninety (90) days following
completion of the grant. Reports of
unpublished research are considered
confidential.
INTERIM REPORTS: Recipients of research
funding are required to send NOF an:
1. Interim expense budget report in
December (2nd quarter).
2. Interim progress report in March (3rd
quarter).
3. Interim progress report and budget in
June (4th quarter).
10. NO-COST EXTENSIONS: may be made
under certain circumstances subject to
approval by the Science and Research
Committee. Requests will be considered
on a case-by-case basis. If necessary,
submit your written no-cost project
extension request to NOF in July (4th
quarter). At least 30 days prior to the
end of the award period, describe:
a. The current progress or status of
your project
b. The reason for the request
c. The projected timeline for completion
11. PUBLICATIONS: Publications resulting
from research supported by the National
Osteoporosis Foundation should contain
an acknowledgement, such as: “Supported
by a grant from the National
Osteoporosis Foundation.” The awardee is
requested to submit a copy of all
publications to NOF.
12. PATENTS: Grantees shall promptly
report to NOF the results of research
performed under an NOF grant, including
any inventions that are conceived or
reduced to practice under an NOF grant.
NOF expects Grantees to make the results
and accomplishments of their activities
available to the research community and
to the public at large. NOF recognizes
that certain research findings may
result in patentable inventions.
Grantees have the prerogative to protect
these inventions. Grantees should abide
by applicable provisions of the Bayh-Dole
Act of 1980 as codified in 37 CFR Part
401 in protecting these inventions. This
act encourages certain researchers to
patent and market their inventions by
permitting them to retain patent rights.
Consistent with the Bayh-Dole Act of
1980, NOF agrees that Grantees that are
not-for-profit institutions with
established patent policies shall retain
rights to inventions conceived or first
reduced to practice in the performance
of work under an NOF grant. NOF will
defer to the established patent policy
of such Grantees providing the following
requirements are met:
a. Grantee will elect, in writing,
within two years after an invention is
conceived or first reduced to practice in the performance
of work under an NOF grant, and prior to
any to
publication of research results or other
disclosure of such invention, whether or
not to
retain title to the invention.
b. Grantee will file a patent
application within one year of election
title, or will notify the
NOF, in writing, upon the earlier of the
expiration of such one-year period or
nine (9) a months after any publication of research
results or other disclosure of such
invention, if patent application will not be filed on
the invention.
c. Grantee will give the NOF reasonable
prior written notice if any patent
application that Grantee has filed for an invention that
is conceived or first reduced to
practice in the
performance of work under an NOF grant
will be abandoned.
d. Grantee will make reasonable efforts
to attract licensees.
e. If Grantee does not notify the NOF of
its election to retain title to any
invention within the period referenced in item (a), or if
Grantee abandons any patent application
for an invention that is conceived or first
reduced to practice in the performance
of work under
an NOF grant, the NOF may elect to file
and prosecute a patent application on
the
invention, and in that event the Grantee
will, at NOF expense, cooperate in the
patent
application process.
13. CANCELLATION: The Foundation has the
right to cancel the grant for
non-performance. In the event of
cancellation of a grant, the Foundation
cannot assume responsibility for
expenditures in excess of payments
already made to the grantee institution
prior to the effective date of
cancellation, and all unexpected funds
must be returned to the Foundation. In
the event of any such cancellation, the
grantee will be entitled to retain only
such funds as shall represent a
reasonable expenditure of work actually
performed and any funds theretofore
transferred to the grantee in excess of
such amount shall be refunded by the
grantee to the Foundation.
14. TRANSFER: Grants may be considered
for transfer from one institution to
another, but not from one principal
investigator to another. When transfer
is from one institution to another, the
National Osteoporosis Foundation must
receive written acceptance by an
authorized official of the new
institution and a “letter of release”
from the original institution. Payments
will not be initiated until a final
accounting has been received from the
original institution. The report must be
submitted within ninety (90) days of the
termination date.
APPLICATION
GUIDELINES
Applicants must complete the
Grant Application Cover Page.
Applicant should prepare applications in
the following format:
PROPOSED RESEARCH PLAN TITLE
(Number and title paragraphs as outlined
below)
Please include the following in the
header of every page: name, credential,
institution, grant number, email address
1. Aims of the Research Program -- 200
words or less
Provide a clear, concise paragraph
listing the aims of the work proposed
and their relation to your long-term
goals.
2. Previous Work Done on Same or Related
Problems – Limit 2 pages
(Use appendix for figures and tables)
a. By applicant (if none, write “none”).
Completely describe previous work and
preliminary studies related to the
proposed research.
b. By other investigators. Summarize
important results outlined by others in
the same field.
3. Methods of Procedure – Limit 3 pages
Describe methods and procedures
concisely, explicitly, and sufficiently
to allow adequate evaluation. Describe
any experimental problems that must be
overcome in order to successfully
accomplish the goals of this research
project.
4. Significance of the Research – Limit
200 words
Briefly explain:
a. Why the results of the research
program may be important.
b. How the proposal is likely to produce
new and useful information.
c. How the information relates to
age-related bone loss and osteoporosis.
5. Ethical Aspect of Proposed Research –
Limit 200 words
Describe in detail any special
consideration you have given to all
ethical issues involved in your proposed
investigations, identifying risks and
management, indicating the nature of the
informed consent that will be obtained.
Use of Human and Animal Subjects:
In all research involving human
subjects, submit a clearly marked copy
of the informed patient consent form
with your grant application. If you are
using humans or animals please check
“yes” on the
application title page. Research
involving biohazards, radioactive drugs
or chemicals in human subjects or animal
requires the approval of the Human
Ethics Committee or Institutional Animal
Care and Use Committee (IACUC). The
human ethics committee or IACUC review
approval form is due at NOF after you
have been notified you are a grant
recipient.
APPLICATIONS WILL BE REVIEWED WITHOUT
APPROPRIATE INSTITUTIONAL ENDORSEMENT
AND PATIENT CONSENT FORMS.
GRANT AWARD MONEY WILL NOT BE DISBURSED
WITHOUT APPROPRIATE INSTITUTIONAL
ENDORSEMENT AND PATIENT CONSENT FORMS.
6. Publications of the Principal
Investigator:
The bibliography should not exceed three
pages. Provide a chronological list of
the pertinent articles or those most
representative of publications. List the
authors in the same order as they appear
on the paper, the full title, and the
complete reference as these usually
appear in journals.
List under the following headings:
a. Relevant published articles and books
b. Relevant articles accepted for
publication
c. Relevant abstracts (do not include
abstracts subsequently published in
full)
7. Publications of the Co-Investigators
If Co-Investigators are named in the
application, list the bibliography in
the same format as the Principal
Investigator’s.
8. Lay Research Summary
On a separate page, provide a
non-technical summary (250 words or
less) of the research proposed,
expressing significance attached to the
project and reasons for undertaking it.
This summary will be used for public
information and should be written in
terms that nonscientists can easily
understand.
9. Reprints/Supplemental Materials
Submit three (3) reprints of the three
(3) most pertinent publications by the
applicant. (If none are pertinent to the
research project, submit three (3)
reprints of other publications that best
represent your work). Abstracts are not
acceptable.
If an investigator feels that
supplemental material (protocols,
evaluation instruments, examples of
program materials, etc.) would be more
relevant to the proper consideration of
the application, send three
(3) copies of supplemental material in
lieu of three (3) reprints of other
publications. However, these should be
of reasonable length and clearly
referenced in the body of the
application.
10. Budget
Salary for Principle Investigator and
Co-Investigator(s) may be submitted for
coverage as direct cost. Grant
applications may include salaries and up
to 14% in overhead costs not to exceed
total grant amount of $57, 000.
a. Personnel – List all positions for
which salary support is requested –
Principle Investigator or Co-Investigator(s)
technical support, secretarial, clerical
and others. Identify each position by
name and degree, if known, or by
required qualifications if not yet
employed, and indicate estimated percent
of time and effort on project.
b. Equipment –Equipment costing $500 or
more must be itemized for each year of
support requested.
c. Supplies – Itemize the cost of
supplies by major categories, such as
animals, radioactive drugs or chemicals,
glassware, expendable equipment costing
less than $100, etc. In the case of
animals indicate number to be used, unit
cost per animal and cost for daily care.
d. Direct Cost – Can not exceed $50,
000.
e. Overhead Cost- Can not exceed $7,000
(14% of $50,000).
f. The NOF Research Grant Program will
not support the following:
Institutional overhead above the 14%
level
Hospitalization costs for human
subjects
Payment of dues to organization or
societies
Salaries for students using the grant
as a part of their thesis
Foreign travel
Construction or renovation of
buildings
g. Justification of Budget – It is
important that you defend the itemized
budget if you believe that this will be
helpful to the reviewers of your
application. For instance, if you are
requesting major items of equipment,
funding for professional salaries, or
part-time or consultative services from
individuals with doctorate degrees, this
should be described in detail.
h. Relationship of Proposed Budget to
Other Support – Describe in detail the
relationship of this budget request to
other support, and state whether this
request is for a new project for which
no other funds will be available.
11. Other Support
All Active or Approved – List all
research project support available to
the Principal Investigator and define
your role. Applicants must list
explicitly all research support
available to them (active or
approved for funding, excluding
applicant’s salary), NIH project grants,
portions of NIH program projects, SCOR
or Center grants, NIH contracts,
Veterans Administration funds, NSF
grants, NASA, grants or contracts from
industry, grants from other non-federal
health agencies and institutional
support. If the Principal Investigator
is a participant in a program project or
any other award, list source and amounts
available. A non-technical summary
describing the work in each grant should
be included. It is recommended that the
abstract submitted with the application
be used.
12. Pending or Planned Applications
Include requests now being considered as
well as any proposals that the Principal
Investigator plans to submit to any
granting agency for funding of the same
project. An application MUST be
identified as ALTERNATIVE if submitted
to more than one granting agency for the
same project and in which there are
duplicated budgetary requests.
13. Facilities Available
Accurately describe facilities available
to applicant, including laboratory
space, animal rooms and major equipment
at Principal Investigator’s disposal to
carry out the procedures outlined.
Include details of any collaborative
arrangements with other institutions.
14. Curriculum Vitae for the Principal
Investigator and Co-Investigators
This should be in the same format as in
NIH grant applications, and the
bibliography limited to 2 pages. Include
publications but not abstracts.
15. Submission Instructions
Applicants must submit three (3) paper
copies and three (3) CD copies of the
grant proposal and three (3) copies of
attachments. All pages must be properly
collated. Grant proposals that do not
meet this standard will not be reviewed.
All documents must be labeled with your
name and grant number; also label the CD
with this information.
16. Late Submissions
NOF Research Grant proposals that are
received in the Foundation offices after
the specified date of submission will
not be reviewed.
17. Request for Additional Funding
No funds in addition to initial grant
amounts will be awarded to NOF Research
Grant recipients during the period for
which they have been funded. No requests
for additional funding will be
considered.
NOF
Research Grants
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