CF Foundation/NIH K-Unfunded Award

Overview

About the Cystic Fibrosis Foundation

The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, partnering with the CF community, and advancing high-quality, specialized care. To achieve this mission, various types of grants and awards are offered to support meritorious research in CF.

CF Foundation/NIH K-Unfunded Award

Program and Award Overview

The objective of this Request for Applications (RFA) is to support excellent CF-related research projects performed by applicants with an intent to pursue a career in CF-related research that have been submitted to and approved by the NIH but cannot be supported by available funds. CFF does not intend to assume the role of the NIH or other governmental funding agencies, but instead wishes to ensure that the momentum in CF research and development of a cohort of CF-focused researchers are not irreversibly slowed due to budget constraints. The CFF/NIH K-Unfunded Award offers a temporary mechanism for supporting highly meritorious K-award applicants until NIH funding can be obtained. The CFF will continue to vigorously encourage the NIH to assume support of meritorious CFfocused projects and investigators

The maximum award amount is $80,000 per year for up to two years (Direct Costs Only); indirect costs are not allowable

Eligibility

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Application Details

For application technical support, please contact ewarnke@cff.org
Program Name: 2025 CFF/NIH K-Unfunded Award
Brief Program Overview/Description: In an effort to assure that all meritorious CF-focused research and early
career investigators are supported, CFF has developed the CFF/NIH K-Unfunded Award mechanism to provide
bridge funding. The objective of this Request for Applications (RFA) is to support excellent CF-focused
researchers whose projects have been submitted to and approved by the NIH but cannot be supported by
available funds.
Funding Amount: The maximum award amount is $80,000 per year for up to two years (Direct Costs Only);
indirect costs are not allowable. Note: the level of funding will be determined by CFF following review by the
designated medical/scientific advisors.
Eligibility:
• Candidates must be U.S. citizens or U.S. permanent residents (must have obtained permanent residency
prior to the time of application).
• The application must have been reviewed by an NIH study section within 12 months of applying for CFF
support.
• Applications must have been submitted to NIH as a K01, K08, K22, K23, K24, K25 or K99/R00 application. If
an application has been submitted to NIH multiple times, the most recent submission must have been
scored to be considered.
• Applicants must be from a non-profit or academic institution; for-profit entities are not eligible to apply.
For-profit entities should visit Industry Funding Opportunities for more information.
• Additional eligibility requirements are outlined below in Section IV.
Key Dates:
Published February 26, 2025
Full Application Deadline Rolling through November 13, 2025
Notification to Applicants 12 to 16 weeks post submission
Project Start Date As determined by applicant
Table of Contents:
I. About the Cystic Fibrosis Foundation
II. Program and Award Overview
III. Funding Amounts
IV. Eligibility
V. Mentorship Requirements
VI. Goals of Research Currently of Interest to CFF/Priority Areas
VII. Review and Award
VIII. Submission Information
IX. Letter of Intent Guidelines
X. Full Application Guidelines
XI. Resources and Other Information
XII. Contact Information
XIII. Electronic Application Checklist

I. About the Cystic Fibrosis Foundation
The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF the
opportunity to lead long, fulfilling lives by funding research and drug development, partnering with the CF
community, and advancing high-quality, specialized care.
To achieve this mission, various types of grants and awards are offered to support meritorious research in
CF.
II. Program and Award Overview
CFF has developed its research programs to complement work at the National Institutes of Health (NIH).
Support from CFF, through various mechanisms, is intended to provide support for the development of
sufficient preliminary data to make CF-focused investigators highly competitive in the NIH review process.
However, as a result of funding constraints on the NIH, coupled with the growing interest in CF research,
occasions arise in which highly meritorious grantees are favorably reviewed by the NIH but not funded. In
an effort to assure that all meritorious CF-related research is supported, and to support the career
development of CF-focused researchers, the CFF has developed the CFF/NIH K-Unfunded Award
mechanism to provide bridge funding for well qualified applicants. The objective of this Request for
Applications (RFA) is to support excellent CF-related research projects performed by applicants with an
intent to pursue a career in CF-related research that have been submitted to and approved by the NIH but
cannot be supported by available funds.
CFF does not intend to assume the role of the NIH or other governmental funding agencies, but instead
wishes to ensure that the momentum in CF research and development of a cohort of CF-focused
researchers are not irreversibly slowed due to budget constraints. The CFF/NIH K-Unfunded Award offers a
temporary mechanism for supporting highly meritorious K-award applicants until NIH funding can be
obtained. The CFF will continue to vigorously encourage the NIH to assume support of meritorious CF-
focused projects and investigators.
III. Funding Amount
The maximum award amount is $80,000 per year for up to two years (Direct Costs Only); indirect costs are
not allowable. Note: the level of funding awarded will be determined by CFF following review by the
designated medical/scientific advisors.
IV. Eligibility
• Candidates must be U.S. citizens or U.S. permanent residents (must have obtained permanent
residency prior to the time of application).
• The application must have been reviewed by an NIH study section within 12 months of applying for
CFF support.
• Applications must have been submitted to NIH as a K01, K08, K22, K23, K24, K25 or K99/R00. If an
applicant has submitted for another K program and wants to know if it qualifies for this award, please
contact the Program Officer, Elizabeth Yu (eyu@cff.org) and grants@cff.org.
• Applicants must be from a non-profit or academic institution; for-profit entities are not eligible to
apply. For-profit entities should visit Industry Funding Opportunities for more information.
• The original NIH application must be clearly relevant to advancing the CFF mission.
• The investigator should not be receiving other funding for this work. If other funding is obtained at
any point (through NIH or other funding bodies) for this work, the CFF award must be relinquished.
• If awarded, a revised application must be submitted to the NIH within one (1) year of receiving the CFF
award. Failure to do so will result in the loss of support. Documentation showing resubmission must
be provided to CFF as part of the final scientific report.
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V. Mentorship Requirements
Not applicable to this RFA
VI. Goals of Research Currently of Interest to CFF/Priority Areas
Proposed research must be relevant to the CFF’s mission and to the health and well-being of CF patients.
Applicants are encouraged, but not required, to address a research priority outlined below, and in further
detail on https://www.cff.org/key-research-priorities-applicants
All applications are reviewed and scored not only on scientific merit but also on relevance to the CFF’s
mission.
Research Priorities:
• Treat the underlying cause of CF for all people with the disease and drive progress toward a cure. In
particular, research related to evaluating genetic-based therapies that may have clinical impact for
people with CF, developing therapies that address the underlying cause of CF for individuals with
nonsense and rare mutations, and improving and better understanding cystic fibrosis
transmembrane conductance regulator (CFTR) modulator therapies.
• Understand the biological mechanisms of, and advance new and improved treatments to address the
many complications of CF, including:
 Mental health;
 Infections affecting people with CF;
 Inflammation, impaired airway hydration, and mucus clearance;
 Serious complications of CF outside the lungs, such as GI complications (including in the liver,
the pancreas, and the impact of nutritional deficiencies), endocrine system dysfunction
(including CF related diabetes and CF bone disease);
 Sinus disease;
 Lung transplant and advanced lung disease;
 Sexual and reproductive health – applicants with an existing hypothesis and interest in
research in this space are encouraged to connect with the Sexual Health, Reproduction, and
Gender Research (SHARING) Working Group for additional mentoring: Raksha Jain is the
working group chair (Raksha.Jain@UTSouthwestern.edu), and Traci Kazmerski is the co-chair
(Traci.Kazmerski@chp.edu).
• Characterize the best CF care and treatment regimens to provide optimal, individualized care as the CF
treatment landscape evolves.
• Improve understanding of system-level and societal barriers to optimal CF care and explore
opportunities to minimize their effects, including racial disparities and socioeconomic barriers to
equitable care.
• Ensure that the CF care model adapts to meet the future needs of people with CF across their lifespan.
This includes considerations for the aging CF population and the increasing utilization of remote care.
• Research related to biomarker or outcome measure development in support of research and
development of genetic-based therapies
Funding priority will be placed on those projects that will lead to a better understanding of disease
mechanisms, pathophysiology, and prevention, and treatment strategies.
VII. Review and Award
Since applications to this program have already been reviewed and scored by an NIH study section, CFF
medical/scientific advisors will focus on the following points:
• Potential for future support by the NIH or other similar funding entity
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• Commitment of the applicant to pursue a career in CF research
• Training environment and mentoring team to provide high quality training in CF research
• Relevance of the proposed study to issues in CF
• Adequacy of the budget
All awards are subject to observance of CFF policies and Terms and Conditions in addition to applicable
Federal regulations or equivalent regulations in the Awardee Institution’s country, based on the type of
research involved. All awards and ongoing support are also contingent upon the availability of CFF funds.
Applications may be resubmitted through this mechanism after they have gone through another round of
review by NIH.
VIII. Submission Information
Application Deadline (rolling): through Thursday, November 13, 2025 at 5:00 PM (EST)
Submit online through: https://awards.cff.org
An application will be considered incomplete if it fails to comply with the instructions, or if the submitted
material is insufficient to permit adequate review. CFF reviews applications electronically, and only
documents submitted online at https://awards.cff.org will be reviewed.
General Timeline:
Published February 26, 2025
Full Application Deadline Rolling through November 13, 2025
Notification to Applicants 12 to 16 weeks post submission
Project Start Date As determined by applicant
IX. Letter of Intent Guidelines
Not applicable to this RFA
X. Full Application Guidelines
Applications must be submitted online at https://awards.cff.org
Documents should be typed using:
• Font: Times New Roman 12 or Arial 11
• Margins: No less than a half inch on each side
Note: When all the documents have been uploaded to awards.cff.org, the system will compile them into a
single PDF file. You may preview this file by selecting “Application Full Print”, as well as exporting the
compiled PDF file.
To login, please visit: https://awards.cff.org
For all first-time applicants in the new Grants Management System, we ask that you pre-register to create
a username and password for “http://awards.cff.org” and complete a profile prior to submitting an
application. We also request that as you begin your application, you enter the title of your project, if
available. If you are registered and cannot remember your password, click on the “Forgot Password?” link
below the “Login” fields.
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Once logged in, the award opportunities, including this Request for Applications (RFA), will be listed in the
Funding Opportunities tab on the opening screen.
Locate the listing for the “2025 CFF NIH K-Unfunded Award” program. Click on the “Apply” button in the
column on the far right to open the application form.
Applicants may stop at any point but must click the “Save” button at the bottom of each page before
exiting in order to save their progress. When you wish to return to your draft application, please do not go
through the “Funding Opportunities” tab. Instead, go to the “My Applications” tab in the right corner of
the main page. When you are in the “My Applications” tab you will be able to find all your draft
applications by clicking on the “Draft Applications” module.
The following sections are displayed as tabs across the application screen. Click on each section and follow
the directions. Click “Save” as you complete each section.
Please note: Only select the “Sign & Submit to AIO” button after the application has been fully completed.
This will trigger validation on all required fields and send the application to your Authorized Institutional
Official “AIO” for review and signature through Adobe Sign.
GENERAL
Enter the title of your project, enter the project start and end dates, and complete any additional
questions.
*Please ensure that you review and comply with the Organizational Assurances and Certifications as
cited below.
CONTACT PROFILE
If a profile was completed upon registration, the fields in this section will already be populated with the
information entered in your Professional Profile. If you need to make any changes, you may update your
profile in this section. Once updated you must “Save and Validate” prior to returning to continue your
submission.
INSTITUTION
If a profile was completed upon registration, the applicant’s/principal investigator’s institution will be
preloaded as the Lead Institution. Domestic applicants must verify their institution by entering the
Employer Identification Number (EIN) or Tax Identification Number (TIN) to search the system for the
correct institution. If the EIN/TIN is not located, you may add the legal institution. Please also confirm if
the project site is the same as the legal institution.
Verification of Applicant Institution’s Tax Status (upload as PDF documents):
The CFF Grants & Contracts Management and Administration (GCMA) Office must have a copy of the
applicant institution’s current W-9 and 501(c)3 letter, or other documentation verifying its Federal tax
status and will not issue Award Letters to Awardees if these documents are not received and on file.
• Applicants from for-profit organizations must submit a copy of the applicant institution’s W-9 and IRS
documentation verifying the organization’s Federal tax status. Awards are not issued prior to having
these documents on file with the CFF GCMA Office.
International Applicants (if applicable):
Not Applicable to this RFA
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CONTACTS
Please note: The INSTITUTION tab must be completed prior to adding internal contacts to ensure that the
contacts are properly associated with the applicant institution.
Complete the required contact fields by searching by name for existing contacts at your institution for each
role. If the desired institutional contact is not available in the system, you may select “Add Internal
Contact” to create a basic contact profile in order to add the individual to your application.
Additional contacts not associated with the applicant institution may also be added. These contacts are
considered additional contributors involved in the proposed research plan. These may include consultants,
collaborators, or subcontractors. In order to add contacts external to the applicant institution, please
select the appropriate “Add Subcontractors” or “Add Consultants/Collaborators” button(s) and add the
contacts in the table, then click “Save”.
ABSTRACTS/RELEVANCE
In the space provided online for abstracts, provide a statement of no more than 2,000 characters
(including spaces) explaining the subject of the research proposal and its relationship to CF. Two different
abstracts are required, as follows:
• Lay Abstract: This statement will be used to inform the non-scientific departments of CFF and the
general public of the nature of this work. Applicants should not include any confidential or proprietary
information, including intellectual property, in the lay abstract.
• Scientific Abstract: This statement will be used to inform the scientific community.
• Summary of Relevance to CFF mission: All applications are reviewed and scored not only on scientific
merit but also on relevance to CFF’s mission:
The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people
with CF the opportunity to lead long, fulfilling lives by funding research and drug development,
partnering with the CF community, and advancing high-quality, specialized care.
Provide a statement of no more than 3,000 characters (including spaces) summarizing the relevance of
the proposed research to the health and well-being of CF patients, for a scientific audience who may or
may not have a background in the subspecialty of the proposed research.
BUDGET
Select the “Edit Budget” button under Application Budget, to enter and begin completion of the
application’s budget detail for each year of funding being requested. CFF NIH K-Unfunded Awards
approved through this RFA are for a maximum of two (2) years. The total budget request cannot exceed
$80,000 per year (indirect costs are not allowable).
The following budget categories are offered under this program:
Salaries & Benefits - List the names and positions of all professional and non-professional personnel
involved in the project, whether or not salaries are requested. Indicate the percent effort on the project
for all personnel. For each individual, be sure to complete all fields on the Budget Detail in full on the
template provided. In accordance with National Institutes of Health (NIH) policy, salary requests may not
use an institutional base salary in excess of the current federal salary cap of $225,700 (FY2025). Fringe
benefits may be requested if they are treated consistently by the applicant institution as a direct cost to
all funding agencies and foundations.
Consultant Expenses - Give the name and institutional affiliation of any consultant who has agreed to
serve in this capacity, including statisticians and physicians in connection with acquiring patient samples if
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they are not listed under personnel. In the budget justification, briefly describe services to be performed,
the number of days, rate of compensation, per diem and any other associated costs.
Travel - Describe the purpose of any CF-relevant travel. Please note: expenses for travel outside the North
American continent, including travel to Hawaii, Puerto Rico, and other U.S. territories are not allowable
expenses without prior written approval from the CFF GCMA Office. Travel expenses may not exceed
$2,000 per person, per year. Registration fees associated with conferences should be listed under “Other
Expenses.”
Consumable Supplies – Itemize supplies e.g. glassware, chemicals, animals, in separate categories and give
the estimated cost of each category. If animals are involved, state the number, unit purchase cost, and
unit care cost.
Major Equipment - List all items of equipment greater than $5,000 requested and the cost of each item. If
funds are requested to purchase equipment that is equivalent to items listed under “Facilities Available”,
justify the duplication. Justify any item of equipment for which the need may not be obvious.
Patient Research Costs – Funds may be requested for patient research costs specifically related to the
proposed research. The basis for estimating funds requested in this category must be justified and
applicants must provide detailed information regarding the proposed costs (e.g., number of procedures,
cost per procedure, ancillary costs). The scientific need for patient research costs will be considered in the
review. Negotiation of these costs are between the applicant institution and the service provider.
If approved as part of the application, patient research costs are capped at the amount requested in the
budget and under no circumstances is CFF responsible for any costs that are later determined non-covered
by third party insurers. Applicants and applicant institutions acknowledge that CFF is solely a provider of
funding for the research performed under an approved award and not a sponsor of the research as
defined by the FDA (21 CFR §312.3(b)).
Other Expenses - Itemize other expenses by major categories, such as subcontracts, duplication costs,
publication costs, computer charges, conference registration fees, etc. Tuition costs are not allowable.
Subcontractors Summary – - If applicable, detailed budgets and budget justifications for each
subcontract, including indirects, must be provided for each year of support. Subcontractors are added in
the prior section entitled CONTACTS. The lead/prime applicant (PI) and/or Grants Officer can
initiate/complete the subcontract budget. After adding Subcontractor(s), in order to access the
subcontract budget activity, please select the “BUDGET” tab of the application and click the “Open”
button next to each listed subcontractor. After completing the subcontract budget activity, please select
“Pending PI Acceptance”, as well as “Submit” to ensure the subcontractor budget is included as part of
the main application budget.
Budget Detail – Indirect Costs
Indirect costs are not allowable.
FULL APPLICATION UPLOADS
Download the available templates applicable to the project, upload the completed templates, as well as
the additional application components as outlined below. All documents must be uploaded in PDF format
to the corresponding attachment types within this section. Templates available for download include:
• Budget Justification
• Copy of NIH (or other governmental funding agency) Unfunded Application
• Copy of NIH Summary Statement (or equivalent)
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• Response to NIH Summary Statement
• NIH Biographical Sketch
• Research Plan – Revised
• Other Support
• Letter(s) of Support
• Letter of Institutional Commitment
• Facilities Available
• CFF Patient Registry Data Request
• Data Safety Monitoring Plan
BUDGET JUSTIFICATION
Describe costs listed in the Budget Detail. Use major categories, such as Salary & Benefits, Consultant
Costs, Major Equipment, etc. Justify all items and make sure amounts and figures listed in the narrative
are consistent with those listed in the Budget Detail(s).
COPY OF NIH (OR OTHER GOVERNMENTAL FUNDING AGENCY) UNFUNDED APPLICATION
A PDF copy of the entire unfunded grant application should be uploaded to awards.cff.org of the online
application.
COPY OF NIH SUMMARY STATEMENT (OR EQUIVALENT)
A PDF copy of the entire NIH Summary Statement associated with the unfunded grant application must be
uploaded. Applications that were submitted to governmental funding agencies in other countries should
submit the reviewer critiques provided by the funding agency.
RESPONSES TO NIH SUMMARY STATEMENT
Please provide a point-by-point response to the critiques noted in the NIH Summary Statement (or
reviewer critiques provided by the funding agency) and specific plans to address identified weaknesses.
There is no page limit to the responses; however, be as concise and succinct as possible.
BIOGRAPHICAL SKETCH(ES) OF KEY PERSONNEL
Complete and upload an NIH Biographical Sketch for all key project personnel, beginning with the
Applicant/Principal Investigator. International applicants can upload a biosketch that is equivalent in
content to the NIH template provided. (CFF defines “key personnel” as any individual with an advanced
degree that will play an instrumental role in the accomplishment of the research project.) Do not exceed
five (5) pages per person.
RESEARCH PLAN – REVISED
• Key figures and legends must be included in the Research Plan and should be of sufficient quality and
size to be evaluated by the reviewer(s). If uploaded as Appendices, they will NOT be reviewed.
• Type the PI’s name in the space available in the header of the document. The template available will
track page numbers at the bottom.
• Page limit: Ten (10) single-sided pages, not including the Literature Cited. Applications exceeding this
page limit will not be reviewed. Include sufficient information to permit effective review without
reference to previous applications. Information should be presented in a clear and concise manner,
while being specific and informative.
The Revised Research plan should not be a copy of the submitted NIH-unfunded application. Instead, this
section should highlight the scope of work and experiments that will be completed using the funds from
CFF if the award is funded. This section should specifically address weaknesses noted in the
NIH Summary Statement as well as the reduced CFF budget. The Revised Research Plan must also include a
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clear strategy for resubmission of the original application to the NIH. The plan may include the following
components:
a. Hypothesis and Specific Aims: State concisely and realistically the intent of the proposed research and
the hypothesis to be tested. The specific aims should be clearly relevant to the mission of the Cystic
Fibrosis Foundation. Do not exceed one page.
b. Background and Significance: Briefly describe the background. Critically evaluate existing knowledge
and specifically identify the gaps that the project is intended to fill. Concisely state the importance and
rationale of this research by relating the specific aims to longer-term objectives. This section should
also show the potential importance of the proposed work to CF. In addition, describe the relationship
of the proposed work to your long-term career goals. Preference will be given to applicants who
express an interest in a long-term career in CF-related research.
c. Preliminary Results: If applicable, provide a detailed discussion of any preliminary results.
d. Experimental Design and Methods: Provide a detailed discussion of the experimental design and
procedures to be used to accomplish specific aims. Please discuss: study hypothesis; primary and
secondary outcome measures; study sample-inclusion and exclusion criteria; sample size estimates*;
subject enrollment including age range; pubertal status (if applicable); sex distribution; randomization
scheme (if applicable); description of experimental procedures and schedule including a study time-
line; drugs and dosage; measures of compliance; follow-up schedule including a study time-line for full
project up to three years; efficacy and safety evaluation, data monitoring and quality control; and a
description of your proposed data analysis and statistical procedures for your hypothesis testing.
Although no page limit is specified for this section, make every attempt to be concise and succinct.
*For sample size estimates, please provide all estimates of means, standard deviations, rates or
proportions used to calculate each of your sample size or power estimates. Please include in the
statistical section whether you will use a one or two-tailed test, the power selected for such a test (if
making a sample size calculation), and the reference for your sample size or power calculation. In
instances of pilot studies where some of these parameters are unknown, we will accept your best
estimates of the unknown parameters if preliminary data are not available, and if your calculation is a
preliminary estimate before formal sample size can be calculated for a larger study. Please identify if
you are making estimates from data or from personal estimates. This section must document access to
adequate numbers of subjects. If the Sponsor(s) is not a CF Center Director or Co-Director, a letter of
support from the Center Director is required (upload as a PDF document as an Appendix).
e. Limitations and Potential Pitfalls: Discuss potential difficulties and/or limitations of the proposed
procedures and alternative approaches to achieve aims. Point out any procedures, situations or
materials that may be hazardous to personnel or patients and the precautions to be exercised.
f. Consultant Arrangements: If the proposed project includes consultant arrangements and/or
collaboration with other individuals outside the applicant's group, describe the working relationships
and support this description by letter(s) of intent signed by collaborating individual(s). If clinical
material required by this award is to be furnished by other individuals, include a letter from these
individuals agreeing to their participation and precautions taken to ensure anonymity of patients.
g. Literature Cited: References should be numbered in the sequence that they appear in the text and
listed at the end of the Research Plan. Each citation must include the names of authors, the name of
the journal or book, volume number, page number and year of publication (titles are optional).
OTHER SUPPORT
Complete and upload the Other Support form for all key project personnel, beginning with the
Applicant/Principal Investigator. There is no page limitation. Information on other support assists CFF in
the identification and resolution of potential sources of overlap. Scientific and budgetary overlap should
be minimized. Commitment of an individual’s effort greater than 100 percent, is not permitted.
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LETTER(S) OF SUPPORT
Letters of support should specifically speak to CF priorities and research commitment. Applicants may
provide up to two (2) additional letters not already included in the original NIH K Award
application. Investigators are strongly encouraged to consult or collaborate with an established CF
investigator/clinician either at their own institution or another. A letter of support from the
collaborator/consultant should be included with the application (either within the original NIH submission
or uploaded here), explicitly describing how the proposed work is relevant to CF and how the
collaborator/consultant will assist the investigator (such as providing scientific expertise or CF-relevant
samples and reagents).
LETTER OF INSTITUTIONAL COMMITMENT
A letter of institutional commitment must be provided from the Chair of the applicant’s Department at the
applicant institution – The letter should clearly describe the institution’s commitment to the professional
growth and research career of the applicant.
FACILITIES AVAILABLE
Describe the facilities and equipment available at the applicant’s institution that will be used for this
project, such as laboratory, clinical, animal, computer, office, etc. Provide any additional information about
the environment, including any support services available that will be utilized. Describe their pertinent
capabilities, proximity and anticipated extent of use. If facilities or equipment at a consultant’s or
collaborative site will be used, they should be identified and clearly described. There is no page limit. Use
continuation pages, if necessary.
CFF Patient Registry Data Request (template available for download, upload if applicable)
Researchers who wish to request Registry data for their proposed clinical research study must complete
and submit the “Application for CFFPR Data and Confidentiality Agreement” application to
datarequests@cff.org prior to submitting their full application to CFF. The formal application for CFF
Patient Registry Data Requests can be found at https://www.cff.org/Research/Researcher-
Resources/Tools-and-Resources/Patient-Registry-Data-Requests/
Note: The application must be submitted using the online system available from the link above and the
email from the system indicating receipt of the application must be uploaded to the submission. Funding is
contingent upon approval to access registry data.
CFF Biorepository Clinical Specimen Confirmation Letter (if applicable)
Since 2006, the Cystic Fibrosis Foundation has collected and stored samples from a variety of clinical trials.
The CF Foundation has developed a database that combines information from these samples with data
from CF clinical trials and the CF Foundation Patient Registry to create a unique and specific sample profile.
To request clinical samples to use in the proposed study, download and complete the template from
https://www.cff.org/Research/Researcher-Resources/Tools-and-Resources/CFFT-Biorepository/.
Applicants must supply a letter from the clinical research program manager confirming samples are
available for their use with their LOI submission.
Note: Applicants must upload the confirmation letter provided by the CFF Clinical Research Program
Manager to the application. Funding is contingent upon approval and availability to access clinical
specimens.
DATA SAFETY MONITORING PLAN (UPLOAD IF APPLICABLE)
In compliance with Federal regulations, all applicants must submit a general description of the Data Safety
Monitoring Plan (DSMP) for any proposed study that places human subjects at more than minimal risk. A
DSMP helps to ensure subject safety, as well the validity and integrity of the data. Furthermore, a DSMP
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allows for the monitoring of study data to assess whether or not an early termination is necessary for
safety or efficacy reasons.
The extent of monitoring required for a study is dependent on the level of risk involved for the subjects, as
well as the size and complexity of the study. Large, multi-center CFF-funded interventional clinical trials
may be required to utilize a Data Safety and Monitoring Board (DSMB). In addition, because its members
are CF clinicians and clinical trial experts, CFF strongly encourages and may require that investigators
utilize the CFF DSMB for any other interventional CF clinical trial that meets one or more of the following
criteria:
• Multi-center;
• Randomized;
• Conducted in an emergency setting;
• Use high-risk interventions, such as gene therapy, gene transfer, or bronchoscopy; or include
particularly
• Use high-risk interventions, such as gene therapy, gene transfer, or bronchoscopy; or Include
particularly vulnerable study populations, such as pediatric patients.
Note: On the available template, please check whether a DSMP is required and upload the template
regardless of the response.
Address the following areas in the DSMP: Assessment of Risk – Describe the level of risk the proposed
research presents to subject participants and provide a detailed justification for the level of risk. Discuss
who will monitor the study.
Level of Risk
• Minimal Risk
o Study poses no more risk than expected in daily life (blood draw, physical exam, etc.)
o Observational studies
o Survey or questionnaire studies
• Low Risk
o Post-marketing study Phase IV drug or device, as defined by FDA
• Moderate Risk
o Substantial risk (>5%) of a Serious Adverse Event (SAE) originating from the underlying
condition of the enrolled subject
o Phase I or II study with available safety data in humans
• High Risk
o Involves an intervention or invasive procedure with substantial risk
o Involves the use of a new chemical or drug for which there is little or no toxicology data
in humans
o A gene therapy study or research involving recombinant DNA or RNA molecules (gene
transfer)
o Involves vulnerable populations (pediatric, pregnant, etc.)
Anticipated Adverse Events and Grading Scale – Describe anticipated adverse events (AEs), including
expected frequency and the grading scale to be used. Discuss plans for addressing AEs.
Reporting of AEs – Detail the plan for reporting AEs, including who shall be notified in the event an AE
should occur.
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Safety Monitoring Plan – Describe all tests, evaluations, and exclusion criteria that will be implemented to
ensure and monitor the safety of human subjects. Discuss stopping rules for the study subjects or for the
overall study if necessary.
Safety Reviews – Describe the process for monitoring and reviewing subject safety data, including the
frequency of such reviews. Include details as to who will perform the monitoring and plans for reporting. If
utilizing the CFF DSMB, provide the frequency of meetings, the reporting requirements, including AEs and
SAEs, and the procedure for interim reporting as necessary. If this information is not available at the time
of submission of the application, note that CFF will not release awarded payments until it is provided.
Registrations for Investigator-Initiated Clinical Trials:
• Clinicaltrials.gov (United States): Applicants are required to register all non-exempt human subject
studies in the ClinicalTrials.gov database to ensure information is freely available on CFF-funded trials
within the community. The registration should be no later than twenty-one (21) days after the first
subject is enrolled. CFF requires copies of documentation confirming this registration, when
applicable.
• EudraCT Registration (European Union): For interventional clinical trials with medicinal products
conducted in the European Union, the Institution must provide documentation to CFF confirming
registration of the clinical trial when applicable.
APPENDICES
Appendices are restricted to the following categories:
• Certification of organization assurances (i.e. IRB, IACUC and IBC approvals).
• Up to three (3) reprints of the applicant’s work relating to the general area of research in the proposal
may be uploaded in PDF format.
• Additional NIH (or equivalent) Biographical Sketches, that are not already included in the original
application, should be completed/uploaded for any new key personnel named in the CFF
application. Note: CFF defines “key personnel” as any individual with an advanced degree that will plan
an instrumental role in the accomplishment of the research project.
*Organization Assurances & Certifications
CFF requires, as applicable, that all U.S.-based awardees obtain Institutional Review Board (IRB) approvals
for human subject research, Institutional Biosafety Committee (IBC) approval for recombinant or synthetic
nucleic acid research, and Institutional Animal Care and Use Committee (IACUC) approval for animal
research, (see additional information regarding these approvals below). Copies of these approvals, if
available at the time the application is submitted, must be uploaded with the application as appendices.
CFF will not release payments to awardee institutions until these documents are received and on file with
the CFF GCMA Office.
Awardees based outside of the U.S. must comply with the applicable equivalent regulations in their
respective countries and provide copies of approvals as soon as they are available. CFF will not release
payments until these documents are received and on file with the CFF GCMA Office.
Research Involving Human Subjects: CFF policy pertaining to the protection of individuals as research
subjects requires that for each proposal awarded, the awardee institution certify in writing that an
Institutional Review Board (IRB) has reviewed and approved the procedures for the use of human
subjects, or human organs, tissues and body fluids, in the proposed research, in accordance with the
Department of Health and Human Services policies found at https://www.hhs.gov/ohrp/regulations-and-
policy/index.html. In the event the IRB has determined a study is exempt, documentation demonstrating
the exempt status must also be submitted to the CFF GCMA Office.
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Research Involving Recombinant or Synthetic Nucleic Acid Molecules: All research involving recombinant
or synthetic nucleic acid and human gene transfer studies supported by CFF must meet the requirements
contained in the document NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid
Molecules (updated April 2019). This publication and announcements of modifications and changes to the
NIH Guidelines are available from the Office of Science and Policy, National Institutes of Health, 6705
Rockledge Drive, Ste 750, MSC 7985, Bethesda, MD, 20892-7985 or online at https://osp.od.nih.gov/wp-
content/uploads/NIH_Guidelines.pdf.
Research Involving Animals: Applications submitted to CFF involving the use of animals must meet the
guidelines of the National Institutes of Health found at https://grants.nih.gov/grants/olaw/olaw.htm,
which require that all proposed studies be reviewed and approved by an Institutional Animal Care and
Use Committee (IACUC). In addition, CFF awardee institutions and laboratories must be accredited by the
American Association for Accreditation of Laboratory Animal Care (AAALAC) and/or have other verifiable
assurances that the institution and laboratory meet appropriate standards.
Validation and Submission
Prior to selecting “Sign & Submit to AIO”, please complete a thorough review of the entire application.
The “Sign & Submit to AIO” button will trigger validation on all required fields and identify any upload
errors or incomplete fields. Upon selecting Sign & Submit to AIO, the ability to edit the application will be
locked pending review and approval by your AIO.
After selecting Sign & Submit to AIO, the applicant will receive an email asking them to sign the
application FacePage electronically using Adobe Sign. Once signed by the PI, the FacePage will then be
routed to the AIO contact that is listed on the application for review and signature.
To ensure the application is fully signed and submitted ahead of the Application Deadline for this
program, please be sure to complete the application, and begin the Sign & Submit to AIO process in
advance of the 5:00 PM EST deadline. The status of your application will display “Submitted” once fully
signed, to indicate that your application has been received by CFF.
XI. Resources and Other Information
• CFF Funding Opportunities Newsletter
• Grants Management System – How to User Guides
XII. Contact Information
For technical support and program/content information:
Primary CFF GCMA Office contact Erik Warnke at ewarnke@cff.org or 301-841-2614
For scientific questions:
Elizabeth Yu, Ph.D. eyu@cff.org
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XIII. Electronic Application Checklist
Application Deadline (rolling): through Thursday November 13, 2025 at 5:00 PM (EST)
Submit online at https://awards.cff.org
Face Page which includes:
 Signatures
 Applicant
 The Official authorized to sign on behalf of the Applicant Institution
 Applicant information (online)
 Complete Institution and Applicant Contact Information, including correct mailing address (online)
 Organization Assurances (check those that apply online/complete the required information)
 Human Subjects Certification
 Research Involving Recombinant or Synthetic Nucleic Acid Molecules information
 Research Involving Animals Information
 Key Personnel (online)
Research Plan & Supporting Documents:
 Budget Justification for each year of support requested - (upload)
 Copy of NIH-Unfunded (or other governmental funding agency) Application - (upload)
 Copy of NIH Summary Statement (or equivalent) - (upload)
 Responses to NIH Summary Statement (or reviewer critiques provided by the funding agency) -
(upload)
 Revised Research Plan - (upload)
 Hypothesis and Specific Aims
 Background and Significance
 Preliminary Results
 Experimental Design and Methods
 Literature Cited (not included in Research Plan page limitation)
 Other Support – (upload)
 Verification of Applicant Institution’s Tax Status - (upload)
 W-9
 Federal (IRS) tax status letter or equivalent tax status letter
 Appendices (upload as PDF documents, if applicable)
 Certification of organization assurances (i.e. IRB, IACUC and IBC approvals), if available at the time
of application.
 Up to three (3) reprints of the applicant’s work relating to the general area of research in the
proposal
 Signed Letter(s) of Support and/or Collaboration. Note: Letter of Support is required for
Investigators New to CF Research - (upload)
 Additional NIH (or equivalent) Biographical Sketches not already included in the original unfunded
application - (upload)
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