FIRST/SECOND YEAR CLINICAL FELLOWSHIP AWARD POLICIES & GUIDELINES TABLE OF CONTENTS AWARD OVERVIEW….…………………………………………………………………………….….…….1 ELIGIBILITY & REQUIREMENTS .............................................................................2 SUBMISSION INFORMATION & GENERAL TIMELINE ............................................2 AWARD DETAILS...................................................................................................2 APPLICATION REVIEW..........................................................................................3 ONLINE APPLICATION PRELIMINARY STEPS….......................................................3 Registration & Log In Start & Continuation Templates & Instructions Face Page Designating Access to Another

LETTERS OF SUPPORT & REFERENCE………………………………..…………….……………….4 Applicant’s Instructions for Letters Applicant’s List Of Sponsors & Reference Letters of Support Letters of Reference

OTHER DOCUMENTS FROM SPONSORS…..………………………………………………………5 Sponsor’s List of Outcomes of CFF/CFFT Support Sponsor’s List of Previous Fellows

BUDGET DETAILS, JUSTIFICATION & SUMMARY……………………………………………….5 CFF PAYBACK AGREEMENT…………………………..…………………………………………………6 TRAINING PLAN & RELATED INFORMATION….…..…………………………………………….6 Previous Training & Future Plans Proposed Training Plan

SECOND YEAR RESEARCH PLAN (if research is included)….…..………………………….6 ORGANIZATION ASSURANCES & CERTIFICATION……….…………………………………….6 Appendix Materials OTHER DOCUMENTS TO UPLOAD…………………………………………………………………….7 Biographical Sketch (NIH Format) Other Support (NIH Format) Proof of Citizenship

FINAL STEPS OF THE APPLICATION…………………………………………………………………..8 CONTACT INFORMATION………………………………………………………………………………….8 APPLICATION CHECKLIST ………………….……….........................................................9

FIRST/SECOND YEAR CLINICAL FELLOWSHIP AWARD OVERVIEW The mission of the Cystic Fibrosis Foundation (CFF) is to cure cystic fibrosis and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment, and ensuring access to high-quality, specialized care. To meet this mission, various types of grants are offered to support meritorious research ranging from basic laboratory investigation to clinical management of cystic fibrosis (CF). For all awards, proposals are encouraged that involve collaboration between an approved CFF Care Center and an institution with basic and/or clinical research programs. The Cystic Fibrosis Foundation (CFF) invites applications for the First and/or Second Year Clinical Fellowship award from physicians interested in chronic pulmonary and gastrointestinal diseases of children, adolescents, and adults with cystic fibrosis (CF). The intent of this program is to encourage specialized training in the early career development stage and to prepare young, wellqualified candidates for careers in academic pulmonary or gastrointestinal medicine related to CF.

CFF generally prefers that the first year of training provides intensive experience in patient management, diagnostic, and therapeutic procedures. The second year’s award is contingent upon on the basis of a renewal progress report indicating satisfactory performance for the portion of the first year that will have been completed at the time of application. A minimum of 30% of the trainee's total training time over a three-year period must be spent in research, and so documented in the application. The second year clinical fellowship may be requested in the same application as for the first year, and may include a research project for which additional funding is provided. The third, fourth and fifth year clinical fellowships (see CFF Funding Opportunities) each include funding for a research project.

ELIGIBILITY & REQUIREMENTS 

Applicants must have completed at least three years of training in an approved pediatric or internal medicine program by the time the fellowship begins.

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Adult caregivers in CF are encouraged to apply.

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The applicant’s institution must be accredited in pulmonary or GI medicine.

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Applicants must have either US citizenship or a permanent resident visa. Proof of citizenship or is required in the application.

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Applicants must describe career goals related to a long-term commitment to CF research and care.

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The institutional status of a fellow must correlate with the CFF fellowship award. e.g. Applicants who are not yet fellows in an accredited pulmonary or GI medicine program should apply for a first and second year clinical fellowship for the upcoming two years. Likewise, a first year fellow in an institutional training program should apply for a second year fellowship from CFF; a second-year fellow should apply for a third-year fellowship, and so on.

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Training must take place in one of the CFF recognized CF Care Centers or a Center-affiliated adult CF program, and should provide a thorough grounding in diagnostic and therapeutic procedures, comprehensive care, and clinical research. Two types of fellowship training are generally offered: Pulmonary and Gastrointestinal.

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Every fellow must have a Sponsor who will be responsible for the fellow's training and research activities. If the CF Center Director is not the Sponsor, then s/he must be listed as the Co-Sponsor. CFF can fund only one fellowship per subspecialty, per year, per Center. If more than one applicant is qualified to apply for this award, the Sponsor/Center Director must determine which applicant should apply.

SUBMISSION INFORMATION & GENERAL TIMELINE Application Deadline: January 6, 2016 at 5:00pm (Eastern) Submit online at ProposalCENTRAL: https://proposalcentral.altum.com/

Email the signed face page to [email protected] on the same date. Review Committee Meeting…………………….……………………….February Applicant Notified…………………………………………………………… April Earliest Start date………………………………...…………………….......July 1, 2016

AWARD DETAILS First Year Fellowship The maximum level of support is $61,250 (direct costs only). This total includes: Base salary support: $60,000 Auxiliary training opportunities: $1,250 (e.g. travel to educational meetings or purchase of materials.) 2 CFF 1st & 2nd Year Fellowships 2015

Second Year Fellowship The maximum level of support is either $66,250 (direct costs only) without a research project, or $68,750 with a research project. Base salary support: $65,000 Auxiliary training opportunities: $1,250 (e.g. travel to educational meetings or purchase of materials.) Research: Up to $2,500 may be requested. (If requested, a research plan must be included in the application) In addition, CFF fellows may later request student loan interest reimbursement of up to $7,000 per year of CFF support. Fellowship payments are made to the sponsoring institution on a quarterly basis in arrears. No indirect costs are paid to the sponsoring institution. The final payment is made only after the final progress report and the final expense report are received.

APPLICATION REVIEW Basic science projects are reviewed by the CFF Professional Education Committee (PEC). Funding decisions are based on the priority score awarded to each application. All fellowships awarded are subject to the observance of the regulations, policies and objectives of CFF related to that category of research support, and are contingent upon the availability of funds. Chief causes for low priority scores include the following: 

Insufficient information or documentation.

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Inadequate statement of hypothesis, experimental design or methods.

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Failure to demonstrate awareness of and plans for coping with key problems and pitfalls associated with the proposed research. Such pitfalls may include insufficient numbers of potential study subjects, insufficient project duration to accomplish aims, or lack of documentation of access to necessary databases.

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Insufficient or improper controls, especially in human clinical studies.

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Failure to describe potential relevance of the proposed study to issues in CF.

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Failure to document the necessary skills/training to accomplish the proposal’s goals.

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Failure to meet all of the criteria described in the policy statement for a given award.

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Failure to describe career development goals as they may be related to a long-term commitment to CF research.

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Insufficient evidence of Sponsor’s involvement in the development of the research plan.

ONLINE APPLICATION PRELIMINARY STEPS REGISTRATION & LOG IN Register at ProposalCENTRALhttps://proposalcentral.altum.com if you are a first time user. If you have registered before, and cannot remember your password, click on the Forgot Password button. Grant opportunities, including this, are listed on the opening screen, but you must log in first, then click on the gray tab labeled GRANT OPPORTUNITIES in order to see the APPLY NOW button appear next to the program name. Click on that button to begin.

START & CONTINUATION Application Sections are listed in the gray menu box to the left of the screen. The sections need not be complete sequentially. Click the red SAVE button after completing each section. 3 CFF 1st & 2nd Year Fellowships 2015

You may stop at any point in the application, each time remembering to SAVE your entries, and return to continue, revise, and upload until you have actually hit the SUBMIT button. When you log in to continue, click on the blue tab, MANAGE PROPOSALS, and then the Edit button next to your application’s title. Do not start a new application.

Designating Access to Another Complete Section 3 online if you wish to designate access to another individual, such as an assistant who has registered on ProposalCENTRAL. Enter the full name and email address and in the Permissions column, then use the pulldown menu to select the type of access you wish to give. Face Page The data you enter in your profile, together with demographic information entered in the forms in various sections, will be system-generated into the Face Page that you can download as one of the final steps. Note that the “Project Title” you enter in the Title Page will become part of your official documentation so please enter either “CFF First Year Fellowship” or a formal descriptive title including that program name. Templates & Instructions Download the templates and instructions in Section 2 of the application. Complete the forms offline and upload in Section 9. The applicant or his/her designated person (see Section 3 of the application) must upload the documents.

LETTERS OF SUPPORT AND REFERENCE Applicant’s Instructions for Letters of Reference (template) Use the downloaded template to list the sponsors and referees, and upload a PDF in Section 9, together with other documents.

List of References (template) Use the template to list (1) Sponsor and (2) Center Director and/or (3) Program Director who will provide Letters of Support; and of those individuals who have been requested to provide Letters of Reference. At least two referees should be individuals who were closely associated with the applicant during his/her medical training.

Section 6. Letters of Support & Reference (online form) Note: Complete this section early. These letters are weighted heavily in the review, and at least five (5) letters must be uploaded before you can submit your application. Enter online the name and email address of the Sponsor, the CF Center Director at the center nearby, and Division/Section Chief (if that person is not the Center Director), and at least two other individuals. If there are potential collaborators/partners in the research project, enter their name and email addresses. (These can be revised later, if necessary.) A system-generated email will request each of those individuals to submit a letter of support/reference, and provide instructions on what to include in the confidential letter and how to upload it online into your application. You may generate email reminders from this section. Letters of Support  The Sponsor is requested to describe the types of CF learning experiences to which the applicant will be exposed. If the application includes a research project, the letter should detail how the Sponsor(s) will provide the fellow with the tools and resources necessary for her/him to develop into a CF-focused independent investigator.  The CF Center Director(s) at the sponsoring/ nearby) institution if s/he is not a Sponsor, should be listed as Co-Sponsor) and requested to describe the types of CF learning experiences, tools and resources to support the fellow.  The Applicant’s Division or Section Chief (if s/he is not the Center Director) is requested to describe career and faculty development plans and opportunities, as well as institutional resources available and relevant to the applicant. Letters of Reference At least two letters of reference are required from other individuals who were closely associated with the applicant during his/her medical training. 4 CFF 1st & 2nd Year Fellowships 2015

OTHER DOCUMENTS FROM SPONSORS Sponsor’s Outcomes of CFF/CFFT Support (For the applicant to upload) Use the template provided for your Sponsor/Co-Sponsors to identify the outcomes of past and current CFF/CFFT funding they have received in the past three to five years, such as subsequent funding from other sources, journal articles, and invited presentations. If a Sponsor has never received CFF/CFFT support, please indicate that on the form, and upload as instructed.

Sponsor’s List of Previous Fellows (For the applicant to upload) Download the provided template for the Sponsor(s) to list all previous fellows under his/her supervision over the past 10 years, including the fellows’ source(s) of support. The applicant should upload this document.

BUDGET DETAILS, JUSTIFICATION & SUMMARY Detailed Budget: Use the template provided. (This is different from Section 9. Budget Summary that must be entered online.) The maximum level of support for a First Year Fellow is $61,250; for a Second Year Fellow without a research project the maximum is $66,250; and $68,750 with a research project. CFF does not provide indirect costs on fellowship grants. Note that the online budget includes a column for each year, and a combined total is given as the maximum. Personnel – Enter the applicant’s name and title. Enter dollar amounts separately for salary and fringe benefits. Fringe benefits may be requested if they are treated consistently by the applicant institution as a direct cost to all grant sponsors. The total salary and benefits cannot exceed $60,000 for the first year, and $65,000 for the second year. Equipment - Up to $400 for the first year, and up to $500 for the second year may be requested for auxiliary training opportunities. Computers, laptops, and/or other computer equipment are not allowable expenses on a fellowship grant. Supplies - Second Year only: Up to $2,500 may be requested for supplies to support a research project. Justify all items. Itemize supplies, such as glassware, chemicals, animals, etc., 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. Travel - If travel is requested, the purpose must be stated, and the cost can be no more than $1,250. Travel outside the North American continent is not an allowable cost. Other Expenses - Itemize other expenses by major categories, such as duplication costs, publication costs, etc. Justify all items.

Budget Justification: Use this page (attached to the above template), to describe the costs listed in the Detailed Budget, by major categories, e.g. Personnel, Supplies.

Section 7. Budget Summary (online forms) In the online forms in this section, enter the dollar amounts for each year requested, either the first or second year, or both years.

CFF PAYBACK AGREEMENT The applicant is required to sign a payback agreement provided online, and upload it in the application. CFF expects that upon completion of a CFF fellowship, the recipient will engage in biomedical research, teaching, and patient care, or a combination of these activities, in an academic environment. Failure to commence these activities or sustain them for a period equal to that of CFF support will incur payback obligations for every fellowship year beyond the first. The payback amounts are $23,500 for the second year of support, and $33,000 additional for each year beyond. Length of Support Payback Amount 2 years $23,500 3 years $56,500 4 years $89,500 5 years $122,500 5 CFF 1st & 2nd Year Fellowships 2015

TRAINING PLAN & RELATED DOCUMENTS Upload your completed templates in Section 9, together with the following documents your training information:

Previous Training & Future Plans (No page limit) Upload a brief description of the first four years of the applicant’s clinical fellowship and a summary of future plans in CF-related research and/or clinical care. The personal statement is weighed heavily in the review.

Proposed Training Plan (Maximum 5 pages) Upload the training plan that has been completed by the applicant in conjunction with the Sponsor(s). The plan should include the anticipated clinic and rounds schedule, as well as information on participation in supplemental course work and special seminars. Delineate estimates of time dedicated to research/scholarly pursuits and clinical care.

SECOND YEAR RESEARCH PLAN If research funding is requested, a research plan must be uploaded. (Maximum 3 pages) Up to $2,500 may be requested to support research in a second year fellowship. Enter in the downloaded template a description of the research project, and upload to your application. Provide sufficient information to permit effective review without reference to previous applications. A. Abstract (Scientific): No more than 250 words (up to 2,000 characters max, including spaces) . B.

Hypothesis and Specific Aims: (Maximum one page). State concisely and realistically the intent of the proposed research and the hypothesis to be tested, and how they relate to CFF’s mission.

C.

Background and Significance: 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. Describe the relationship of the proposed work to long-term career goals.

D. Literature Cited: Number references in the sequence that they appear in the text, and list them at the end of the Research Plan. (This list does not count in the 3-page limit for the Research Plan.)

ORGANIZATION ASSURANCES & CERTIFICATIONS (Complete the forms in Section 8 online on IRB, IACUC approvals, etc.) Research Involving Human Subjects CFF policy pertaining to the protection of individuals as research subjects requires that for each proposal submitted, the applicant 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 Department of Health and Human Services policies. This certification should accompany the application and must be received before activation of any grant. If approval does not accompany the application, there should be a statement in the application indicating that such approval is pending and the date when such approval is expected. The IRB application must be submitted to the applicant institution BEFORE the CFF application deadline. The approved certification should be submitted as soon as it is available. Research Involving Recombinant DNA All research involving recombinant deoxyribonucleic acid (DNA) techniques and human gene transfer supported by CFF must meet 6 CFF 1st & 2nd Year Fellowships 2015

the requirements contained in the document NIH Guidelines for Research Involving Recombinant DNA Molecules (revised October 2011). This publication and announcements of modifications and changes to the NIH Guidelines are available from the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD, 20892-7985 or online at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html. The purpose of the NIH Guidelines is to specify practices for the construction and handling of: (i) recombinant deoxyribonucleic acid (DNA) molecules, and (ii) organisms and viruses containing recombinant DNA molecules. As defined by these guidelines, recombinant DNA molecules are either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (ii) molecules that result from the replication of those described in (i) above. Many types of studies involving recombinant DNA are exempt from the NIH Guidelines while others are prohibited. The applicant organization is required to establish and implement policies that provide for the safe conduct of the research in full conformity with the NIH Guidelines. This responsibility includes establishing an Institutional Biosafety Committee to review all recombinant DNA research to be conducted at or sponsored by the applicant organization, and to approve those projects it finds are in conformity with the Guidelines. CFF policy pertaining to recombinant DNA research requires that the applicant institution certify in writing that an institutional committee has reviewed and approved the procedures involving recombinant DNA in accordance with the NIH Guidelines. Applicants that do not have institutional committee approval must submit a recombinant DNA application to the applicant institution BEFORE the CFF application deadline. Certifications need not accompany the application, but applicants must provide copies of all required certifications upon request by CFF. Research Involving Animals Grant applications submitted to CFF involving the use of animals must meet the guidelines of the National Institutes of Health, U.S. Public Health Service, which require that all proposed studies be reviewed and approved by an Institutional Animal Care and Use Committee (IACUC). In addition, CFF grantee 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. Applicants who do not have institutional committee approval must submit an IACUC application to the applicant institution BEFORE the CFF application deadline. Certifications need not accompany the application, but applicants must provide copies of all required certifications upon request by CFF.

APPENDIX MATERIALS Appendices are restricted to the following three (3) categories: 1. 2. 3.

For clinical research, certification of IRB approval, or a statement that it is pending approval and the approximate date available. Up to three (3) reprints of the applicant’s work related to the proposed research. Other materials pertinent to the grant proposal, not already described.

Applications containing Appendices outside of the above-listed categories will be administratively declined. Figures and/or legends uploaded as in this section will NOT be accepted. Do not submit an incomplete application. An application is considered incomplete if it fails to comply with instructions, or if the material is insufficient to permit adequate review. Requests to submit supplemental data must be received within a week of the deadline at [email protected], and even if accepted, review of these items is not guaranteed.

OTHER DOCUMENTS TO UPLOAD BIOGRAPHICAL SKETCH (Maximum 5 pages per Biosketch) A sample NIH Biosketch is provided. Complete and upload a Biosketch for each key project personnel, i.e. any individual with an advanced degree who will play an instrumental role in the accomplishment of the research project. *Note – both new and old 7 CFF 1st & 2nd Year Fellowships 2015

versions of the NIH Biosketch will be accepted during this application cycle.

OTHER SUPPORT (No page limit.) A sample NIH Other Support format page is provided to enter other funding support received by each of the key project personnel. Upload all to your application.

PROOF OF CITIZENSHIP CFF fellowships are restricted to individuals who are United States citizens or Permanent Residents. Upload a legible PDF copy of US citizenship, e.g. birth certificate or passport; or a permanent resident visa or card.

FINAL STEPS OF THE APPLICATION 1.

Validate: Upon completing your application, click on the blue VALIDATE button on the main screen. Attend to any omissions/errors as prompted onscreen, if prompted, and VALIDATE again.

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Print face page: After validation, follow the prompts to print the system-generated face page.

3. Submit: Click on the gray button with blue lettering. CFF will not receive your application until and unless you have submitted it. You will receive an email confirmation from proposalCENTRAL (not from CFF) that your application has been successfully uploaded. This email will be your only acknowledgment. If you do not receive it, please contact ProposalCENTRAL immediately to ensure that the application is properly submitted. 4.

Sign, scan and email the face page to [email protected] by the deadline date. The Applicant (Principal Investigator), the applicant’s Sponsor, and the official authorized to sign on behalf of the institution are all required to sign. No hardcopy is necessary.

CONTACT INFORMATION

For all technical questions concerning the online application, contact ProposalCENTRAL: [email protected] 1-800-875-2562 during business hours (Mon.-Fri., 8:30 a.m. – 5:00p.m. Eastern). For program questions, contact CFF Grants and Contracts: 301-841-2667 [email protected] Please write “Fellowship Application Inquiry” in the Subject line and, mark urgent.

8 CFF 1st & 2nd Year Fellowships 2015

ELECTRONIC APPLICATION CHECKLIST Application Deadline: January 6, 2016 at 5:00pm (Eastern) Applications must be submitted at Proposal Central: https://proposalcentral.altum.com/

A PDF copy of the signed Face Page should be emailed to [email protected] on the same date. No hardcopies are required.

Face Page (system-generated) Signatures Principal Investigator (PI)/Fellow Sponsor(s) The Official authorized to sign on behalf of the Sponsoring Institution Applicant/PI Professional Profile (online) Enter online: Lead Institution, Signing Official, and Sponsor(s) contact information Organization Assurances (online) Human Subjects Certification Recombinant DNA Biosafety information Research Involving Animals information Research Plan, Supporting Documents and Appendix Material Abstracts, Summary of Relevance, Keywords Outcomes of Past and Current CFF/CFFT Support (For Sponsors Only) Budget and Budget Justification Facilities Available Biosketches for all key personnel (NIH Format) Other Support for all key personnel (NIH Format) Proof of Citizenship Letters of Support/Reference Names and Addresses of Sponsor(s) & References Letters submitted online by each Sponsor/Referee at the ProposalCENTRAL one week prior to application deadline List of Previous Fellows of Sponsors (For Sponsors to complete) Description of Previous Training/Future Plans Training Plan Research Plan Hypothesis and Specific Aims Background and Significance Preliminary Results Experimental Design and Methods Literature Cited (not included in Research Plan page limitation) CFF Payback Agreement with Signature Appendix Material Certification of IRB approval, or statement indicating that such approval is pending and the date when such approval is expected (when applicable) Up to three (3) reprints of the applicant’s work relating to the general area of research in the grant proposal Other materials pertinent to the grant proposal, not already described