Amount: Up to $50,000
For One-Year Grant Period
Deadline Dates:
There are no deadlines
for Letter of Intents (LOIs) or applications. Scientists
are encouraged to submit an LOI prior to preceding to
the application phase. LOIs and applications will be
reviewed as they are received. If an application is
accepted for funding, AFSA will promptly award the funds
(assuming the IRB has been approved).
Welcome!
Interested in
learning more about AFSA’s research granting process?
You are at the right place. While we continue to raise
funds, we currently have enough to award 8 individual
grants that focus on fibromyalgia syndrome (FMS).
Maximum grant award size is $50,000 in U.S. funds.
Please read
through the sections below, and if you have any
questions, e-mail me (Kristin Thorson) at kthorson@afsafund.org.
You may also call me at (520) 733-1570 between 2-5
p.m. weekdays. My role is to assist potential
applicants and facilitate the grant review process. I
look forward to working with you!
Kindest
regards,
Kristin
Thorson
President and Founder of AFSA
This page of
our website contains everything you need to know about
submitting a proposal to AFSA and includes the
following:
Guidelines
for a Letter of Intent
- A Letter
of Intent (LOI) is preferred before submitting a
formal grant application to AFSA. An LOI consists of
a brief synopsis of your proposal that is only one
or two pages long (attachments many be added if
deemed necessary). Understandably, investigators may
not have all of the details worked out at this
stage, however AFSA encourages applicants to include
the following six components in their LOI:
Study
investigators: Name of principal
investigator, degree and area of speciality (as
documented by previous studies), and the names and
degrees of primary people involved in the study.
Also, indicate if this study will be performed
within an institutional environment (such as a
university, hospital, or research center), please
identify the institution.
Study
hypothesis: This consists of a
one-sentence statement with supporting sentences
that may include documented references, clinical
data on a small number of subjects, or whatever else
has led you to your hypothesis.
Study
goals or objectives: Please specify what
you hope to prove by conducting your proposed study.
Study
design: Identify the study population(s),
duration of study, primary testing methods to be
used, and other comments that describe how the study
will be conducted.
Estimated
budget: Include a total dollar amount (in
U.S. funds) as well as a breakdown into the
following sections: (a) principal investigator
salary, if any; (b) technician(s) or other
supportive staff salary, if any; (c) permanent
equipment costs, if any (and identify the
equipment); (d) cost of consumable supplies; and (e)
cost of other expenses (itemize as much as
possible). AFSA realizes that these budget figures
are only estimates, but if possible, please provide
anticipated budget totals for each of the five
categories. The maximum award size is $50,000 in
U.S. funds. Contact AFSA if you are considering a
proposal for a larger sum of money. Exceptions to
the one-time maximum award amount may be made on a
case-by-case basis.
Patient-relevance:
Describe how your study will lead to the improved
well-being of patients with FMS. Please be specific,
and be certain that your project proposal offers
something "new" in terms of guiding treatment
directions. Keep in mind, AFSA does not fund studies
related to behavioral, psychosocial, self-help, or
movement therapies. If you are assessing a
medication that is commonly prescribed for patients,
then your project should provide new insights about
the drug’s mechanism of action.
Note:
No institutional overhead is allowed because all
funds for research are obtained from patients with
FMS and/or CFS. If you are concerned about being
able to meet this requirement, please contact
AFSA. We usually can persuade your institution to
waive its overhead fees should you be approved for
funding by AFSA.
- Response
to your LOI will be provided approximately one month
after we receive it. Responses may also include
recommendations for improving your proposal or
suggestions for modifying your application to make
it more suitable to AFSA's funding priorities.
-
Applications submitted without a "favorable"
response from an LOI may not be formally reviewed if
the proposal does not meet AFSA's funding needs or
if it duplicates an "in progress" project that has
been funded. Please review our website section on
"Research Projects Funded" prior to submitting (even
before an LOI), and be aware that the website may
not include projects awarded during the past 6-8
months.
- In its
14-year existence, AFSA has yet to turn down a
project due to lack of funds. We have surpassed $1.7
million in fund raising for research, and welcome
patient-relevant, "budget-appropriate," proposals
related to AFSA's research funding priorities (see
section below for a description of priority funding
areas).
- If you
are unsure about what to do, just contact AFSA (ask
for Kristin Thorson). We are eager to discuss AFSA's
application process with any investigator meeting
our application requirements and wishing to propose
a project that is related to our research funding
priorities.
- You may
contact AFSA by any of the following methods:
Phone: (520) 733-1570 (preferably between 2 and 5
p.m. MST)
Fax: (520) 290-5550
E-mail: kthorson@afsafund.org
Your LOI should be e-mailed to the above address.
Priority
Areas for Research Funding
Proposals
submitted for review should be relevant to AFSA's
research priorities. By investigating the areas
described below, AFSA believes that better diagnostic
tools and treatments will be made available to
patients with fibromyalgia syndrome (FMS) and its
overlapping conditions.
In the past,
AFSA’s focus has been on pain mechanisms and
treatment. While advances have been achieved in these
areas, little progress has been made toward
characterizing the sleep disturbances in FMS patients.
This is why AFSA is putting aside $300,000 for studies
pertaining to sleep. The purpose of AFSA’s sleep
research initiative is to gain a better understanding
of the relationship between the neurobiology of sleep
in people with FMS and the various symptoms of this
condition.
In addition
to sleep, AFSA strongly encourages investigators to
submit proposals that address the “other important
priorities” listed in the second section. AFSA
currently has $300,000 available to fund grants up to
$50,000 for each proposal that addresses these other
priorities. Depending upon AFSA’s fund-raising
success, additional funds may be available to study
these other areas of priority.
Investigator
qualifications, guidelines for LOIs and full grant
applications (submitted after a favorable review of
your LOI), and conditions of award are explained on
AFSA’s website at www.afsafund.org.
If you reside outside the United States, AFSA still
welcomes your LOI as long as you are fluent in
English.
Keep in mind, AFSA does not fund studies related to
behavioral, psychosocial, self-help, or movement
therapies. If you are assessing a medication that is
commonly prescribed for patients, then your project
should provide new insights about the drug’s mechanism
of action.
Sleep-Related
Priorities:
- Identify
sleep polysomnography (PSG) characteristics
(particularly EEG brain patterns and anomalies in
sleep architecture) that may be specific to FMS
and/or correlate with symptoms.
- Evaluate
the occurrence of sleep disorders, such as upper
airway resistance syndrome, obstructive sleep apnea
or restless legs syndrome (the latter can be
diagnosed with clinical interview; PSG not
required). Tag-on proposals to ongoing epidemiologic
studies involving larger patient populations or
community-based samples are welcomed.
- Test
effectiveness of interventions for improving sleep,
either pharmacologic agents or therapies designed to
enhance airflow, to determine if they lead to
improvements in pain, fatigue, dyscognition,
function, or other measures.
- Correlate
sleep PSG characteristics (including brain wave
patterns and sleep architecture) with
neuro-endocrine-immune abnormalities or specific
physiologic measures in FMS patients.
(All
sleep proposals must be of a clinical nature and
involve FMS patients who meet the 1990 American
College of Rheumatology (ACR) criteria.
Budget-conscious proposals exceeding $50,000 may be
considered on a case-by-case basis. Include in your
LOI a budget outline with justification.)
Other
Important Priorities
- Test
therapeutic interventions for FMS pain, particularly
medications that are effective with minimal side
effects. In particular, evaluate medications
approved for other indications or those currently
being tested in Phase III clinical trials for other
conditions.
- Identify
the chronic pain mechanisms in FMS. This includes
brain imaging studies that build upon the recent
findings of gray matter loss (or altered gray matter
densities), as well as therapeutic manipulations
that may elucidate the cause of the findings.
-
Investigate the role of neuro-endocrine-immune
modulators and their receptors in the central
nervous system and the peripheral systems. Proposals
to test medications to alter or correct documented
abnormalities in the above neuro-endocrine-immune
modulators would be of interest to AFSA.
-
Identify/develop potential lab markers, genetic
indicators, or other test measures for use as
diagnostic and clinical evaluation purposes.
- Explore
the physiologic mechanisms responsible for the
symptom of fatigue and test pharmacological
treatments to alleviate this symptom.
- Evaluate
neurocognitive deficits (or dyscognition) in people
with FMS by correlating it to neuro-endocrine-immune
abnormalities, brain imaging findings, or PSG. This
symptom is often the most disabling and deserves
special attention.
NOTE:
If the mechanisms of fatigue or the role of
dyscognition will be evaluated in relationship to
improvements in sleep architecture or sleep
therapies, such a study proposal would fall into our
sleep research initiative. Again, all proposals must
be of a clinical nature and involve FMS patients who
meet the 1990 American College of Rheumatology (ACR)
criteria.
Keep in mind, AFSA does not fund studies related to
behavioral, psychosocial, self-help, or movement
therapies. If you are assessing a medication that is
commonly prescribed for patients, then your project
should provide new insights about the drug’s mechanism
of action.
Grant
Application Requirements
Potential
applicants for AFSA funding should meet the following
requirements and budget constraints:
- The
Principal Investigator (PI) must be fluent in
English and, ideally, published in peer-reviewed
English language medical journals. If applicant
resides outside the United States, please indicate
the budget in U.S. dollars.
- The PI
must be a board certified "M.D.", "D.O.", or
"D.D.S." or a Ph.D. with applicable basic science
research experience. If the applicant has not
previously published in a peer-reviewed medical
journal, AFSA strongly recommends that the applicant
team up with a co-PI with research experience.
- An
application may be submitted with an institutional
review board (IRB) pending, but the IRB must be
approved before the project can be funded.
- All
funded projects must be capable of testing your
hypothesis without reliance upon another funding
source. AFSA is open to funding tag-ons to
NIH-funded projects, but the AFSA portion must be
clearly defined with a study hypothesis.
- The
methodology used to determine the required sample
size for the proposed study must be provided.
- No
institutional overhead or other indirect costs will
be paid and should not be included as part of any
grant request. A letter to your institution
explaining this condition can be requested if
needed.
- Beware
that substantiative equipment costs or salaries for
the PI and co-PI may jeopardize project funding.
AFSA awards are intended for the collection of
preliminary data needed to assist investigators with
obtaining much larger sums of money from the NIH or
other financial institutions.
- AFSA does not fund studies related to behavioral,
psychosocial, self-help, or movement therapies. If you
are assessing a medication that is commonly prescribed
for patients, then your project should provide new
insights about the drug’s mechanism of action.
Conditions
of Award
In addition
to the above application requirements, the following
conditions must be met:
- All funds
awarded shall be used in accordance with the
submitted and approved proposal and accompanying
budget. Any unused portion thereof shall be returned
to the American Fibromyalgia Syndrome Association,
Inc. (AFSA). If an unforseen problem occurs with the
study design (e.g., you find out that the proposed
medication dosage is too high or too low, or that a
planned assay has been accidently contaminated,
etc.), please notify AFSA immediately. Potential
changes to the study design with additional
financial assistance from AFSA could salvage the
study and still lead to a favorable outcome.
- A
one-year grant period is assumed, unless otherwise
specified in the application. At the midpoint of the
grant period (6 months) a progress report indicating
the number of study participants and/or assays
completed as well as a financial report must be
submitted. A final report must be submitted within
90 days of the completion of the project (i.e., 15
months after award is made). This report shall
include a project summary or scientific abstract, a
financial summary, and a less technical lay language
article (4-5 paragraphs) to be used in certain AFSA
publications. Confidential data that could
jeopardize formal publication in a peer-reviewed
journal should not be disclosed in the lay article.
If a delay in project completion of more than 3
months duration is anticipated, AFSA should be
notified promptly with a brief explanation. All
investigators are encouraged to communicate and work
with AFSA for the best possible outcome of their
study.
- The
principal investigator must assure AFSA of his or
her intended work location. AFSA must be advised at
the time of application of all moves, contemplated
or real. Even address, phone number, fax number and
e-mail changes within the same institution should be
promptly conveyed to AFSA. The institution at which
the proposed project will be completed must be
stated at the time of application. A project can be
moved during a funded period only with the expressed
permission of AFSA.
- All
publications resulting from AFSA-funded research
must include AFSA in a footnote/credit
line/disclosure, and copies of such publications
must be provided to AFSA. This includes scientific
abstracts for conference posters. All publicity and
information disseminated about such research must
acknowledge AFSA support. This is an essential part
of AFSA's conditions of award. Publicity or
information about the project is used to keep
patient-contributors to AFSA informed about how
their donations are being spent. This condition does
NOT involve disclosure of any information that might
jeopardize the applicant's ability to formally
publish their findings.
- AFSA-funded investigators should avoid discussing or
writing about their project for other organizations or
media as it causes confusion about the funding source
and adversely affects contributions. Principal
investigators need to submit their findings to AFSA
and the research should be published before being
released to other entities.
- The
recipient of any research grant awarded must certify
that all research will be conducted according to the
rules and regulations of the United States
Department of Health and Human Services (HHS). The
recipient must agree to hold AFSA harmless from any
and all claims that may arise from such research.
- All work
involving human subjects must show documented
compliance with HHS and NIH guidelines for human
subjects as provided by the sponsoring institution's
committee for clinical investigation. All work
involving animal experimentation should comply with
NIH guidelines for care and use of laboratory
animals (applicants outside the United States need
to comply with similar guidelines set forth by their
country). Grant applications may be submitted to
AFSA with the Institution Review Board (IRB) pending
approval, but no awards can be issued until a
favorable letter certifying IRB approval has been
sent to AFSA. This can be faxed to AFSA at (520)
290-5550.
- Any
grants awarded by AFSA are for one time only. If the
applicant desires further assistance, a new
application must be submitted at such time as
additional grant funding may be available. In the
past, however, we have approved the funding of a
two-part project - all pending on the success of the
first part of the project. Applicants must consult
AFSA if a two-part application is being considered.
- Any
discovery made under a program supported by AFSA
must be reported promptly to AFSA, and application
for a patent may not be made without the prior
written notice to AFSA.
- All human
subjects studied must be assessed to determine
whether they meet the ACR criteria for FMS and the
CDC criteria for CFS/ME. The overlap between these
two syndromes is substantial and it is in the best
interest of the patients that both syndromes be
acknowledged because the findings may be relevant to
both FMS and CFS/ME.
Grant Application and Instructions
Please download the following PDF files. Both of these
files need to be signed independently and returned
together as a package for formal submission.
- Conditions of Award/Instructions
- Research Grant Application
(Submissions that do not contain both
the Conditions of Award and Research Grant Application
could result in a delay of the grant review.)
You will need Adobe Acrobat Reader to
view the Grant Application.
