American Lung Association Awards and Grants Program Application Guidelines

Transcription

1 INTRODUCTION The American Lung Association offers annual funding opportunities as a part of its Awards and Grants Program. The Awards and Grants Program supports basic, clinical and behavioral/policy research through training and investigator-initiated peer-review proposals. The goals of the Awards and Grants Program are as follows: 1. to foster laboratory, patient-centered and social-behavioral research designed to prevent and relieve the suffering associated with all lung diseases and corresponding risk factors 2. to fund researchers at important crossroads of their careers to gain long-term commitment to lung disease research We invite qualified scientists in all areas of lung health and associated risk factors/behaviors to submit an application for the grant cycle and join us in our mission to save lives by improving lung health and preventing all lung diseases. The deadline for full submissions is November 12, GUIDELINES IMPORTANT NOTES PRINT AND RETAIN A COPY OF THIS DOCUMENT FOR FUTURE REFERENCE. APPLICANTS ARE STRONGLY ADVISED TO READ COMPLETELY THROUGH THE PROGRAM DESCRIPTIONS AND GUIDELINES BEFORE STARTING AN APPLICATION. APPLICANTS FOUND INELIGIBLE FOR AN AWARD OR FOUND TO BE NONCOMPLIANT WITH THESE GUIDELINES WILL BE ADMINISTRATIVELY WITHDRAWN. APPLICANTS ARE LIMITED TO SUBMITTING ONLY ONE APPLICATION PER REVIEW CYCLE. ONCE AN APPLICATION IS SUBMITTED ON proposalcentral, IT CANNOT BE CHANGED FROM ONE AWARD TYPE TO ANOTHER. FOR HELP WITH THE ELECTRONIC APPLICATION PROCESS, PCSUPPORT@ALTUM.COM OR PHONE (TOLL-FREE): FOR QUESTIONS REGARDING PROGRAMS, ELIGIBILITY, POLICIES, TERMS AND CONDITIONS OR APPLICATION GUIDELINES, RESEARCH@LUNG.ORG. 1) TITLE PAGE To initialize your application, enter a title for your project. If you are resubmitting the same or similar proposal previously reviewed, but not funded, by the American Lung Association, select the appropriate application from the list of prior submissions. An applicant who is unsuccessful in a competition may resubmit the same or similar application up to two times. Applicants are also asked to provide the first year monetary amount requested. Refer to the individual Program Descriptions for maximum award allocation. The project start and end dates are automatically entered for you as we do not allow flexible start dates. The American Lung Association award period is July 1, 2014 to June 30, Once complete, press the red SAVE button and then press NEXT or use the gray Proposal Navigation box on the left portion of your screen to move to another section. Page 1 of 16

2 2) DOWNLOAD TEMPLATES & GUIDELINES All downloadable files are located on this page. These files consist of instruction files and Word.doc templates. Click the DOWNLOAD link for each file, and SAVE to your local workstation. Go to the Research Plan and other Supporting Documents menu option in the gray navigation menu to upload your completed template files. 3) ENABLE OTHER USERS TO ACCESS THIS PROPOSAL This section allows you to give other users access to your grant application. When you give a person access to your grant application, you can give them one of three levels of permissions: View (cannot change any details), Edit (can view and change information in the grant application, but cannot Submit or view the Access Permission page), or Administrator (can view, edit and submit the application, as well as give access rights to others). 4) APPLICANT CONTACT INFORMATION The person who creates the application is the default Applicant. Contact information from this person s Professional Profile, including primary institution affiliation, is automatically loaded to this section of the application. As all American Lung Association correspondence occurs with the individual Applicant, please provide the correct contact information for the applicant. The Sponsored Research Program Office is NOT acceptable. To change the Applicant and the institution affiliation, choose from the list of available names and institutions. For privacy reasons, the list contains only the following: the name and institution of the person who created the application and the names of individuals who included you in the Access Permissions section of their Professional Profile (such as administrators at the institution). If, after changing the Applicant you need to update the contact information that appears below it, you can click EDIT PROFESSIONAL PROFILE to go directly to your Professional Profile. You can exit this screen and select the PROFESSIONAL PROFILE tab from the proposalcentral management window and changes will be automatically uploaded to the Applicant screen. Contact information and institution affiliation from the selected Applicant s Professional Profile is preloaded to the Applicant s contact information section below. Complete all the required fields that are marked with a red asterisk. If the required fields are incomplete or incorrect, changes must be made in the Applicant s Professional Profile. You can go directly to the selected Applicant s Professional Profile by clicking the button EDIT PROFILE. Alternatively, you may exit the Applicant s section and use the Professional Profile tab in your proposalcentral management window which is usually located in a different proposalcentral browser window than the application. The percent of Applicant's total effort currently devoted to each of the listed activities must be indicated before going on to the next section. 5) INSTITUTION AND CONTACTS The lead institution is the institution that will have primary contractual responsibility for the grant if awarded. The institution of the Applicant was selected as the default Institution. Institution information, from this institution s Institution Profile, is pre-loaded to this section of the application. Complete all the required fields that are marked with a red asterisk. NOTE: If the required fields are incomplete or incorrect, changes must be made in the Institution Profile. To change the Institution choose from the list of institutions and press the button CHANGE INSTITUTION. Initially, the list contains only the following: the current institution, the institutions that you listed in your Professional Profile, and any other institutions that include your UserID in their Access list. Use the SEARCH option to search the other institution profiles available in proposalcentral. Results of the Search will be added to the list of Page 2 of 16

3 institutions. To change the Institution choose from the new list of institutions and press the button CHANGE INSTITUTION. If, after changing the Institution you need to update the contact information that appears below it, contact the Grants and Contracts office of your institution to update the Institution Profile or call Customer Service at proposalcentral at for assistance. The table below lists the contacts requested by the grant-maker for the particular grant program; (*) indicates a required contact. There are two ways to enter contact information for the requested contact. First, you can select from the available LIST OF INSTITUTION OFFICIALS. This list is provided from the Institution Profile of the Institution that you selected at the top of this page. When you have selected the appropriate institution official for the designated contact, click the red ADD button. The contact information is loaded into your proposal and the contact will be shown in the table below. Click EDIT next to the contact name to edit the information for your proposal. NOTE: This will not change the contact information for their profile. Contact your institution administrator if the listed official s information needs to be updated. The other way to enter a contact s information is to enter the address of the contact, then click the ADD button. Complete the contact form and then click SAVE to add the contact to your proposal. Be advised that the contact form may be pre-filled with some information if the you entered is already associated with a proposalcentral user. 6) KEY PERSONNEL The applicant is responsible for listing all personnel who will have a significant role with the research project (i.e., will have impact on project content, data collection, data interpretation). Sponsors and mentors must be listed as Key Personnel regardless of their role with the research project. DO NOT list the applicant in this section. Steps for the Applicant to Submit Key Personnel: Enter the address of the key personnel in the text box provided and click ADD. A window will open; enter the requested information. Complete all the required fields that are marked with a red asterisk. If the person is already registered in proposalcentral, some information will be pre-loaded into the contact form. Click the red SAVE button and CLOSE WINDOW. NOTE: All edits and deletions to key personnel must be done in the Key Personnel table. Changes will be for this proposal only. Permanent changes must be made in the person s Professional Profile. *** Remember to delete any previously submitted versions of the file. *** Remember to include sponsors and mentors as key personnel. 7) LETTERS OF RECOMMENDATION All applicants must provide 3 letters of recommendation. This is in addition to the Department Chair and/or Sponsor Statement requirement found in Part VIII of Section 10 Research Plan. Duplicate letters from the same person are not accepted and may be grounds for withdrawal. FOR TRAINING AWARDS (LH, RT) and JUNIOR LEVEL INDEPENDENT INVESTIGATOR GRANTS (RG, DA, CG, SB), the required letters of recommendation required are as follows: 1. From an individual who has not directly worked with the applicant but who can provide an independent evaluation of the applicants abilities. 2. From an individual who is currently working, or has worked, with the applicant. 3. From the applicant s Mentor (please label as such). Page 3 of 16

4 Please note that an exception to this requirement is when the Mentor is also the Sponsor/Department Chair. When this occurs, the applicant is required to obtain another Letter of Recommendation from an individual who is currently working, or has worked, with the applicant. FOR ALL OTHER RESEARCH AWARDS (AI, LCD): 1. From an individual who has not directly worked with the applicant but who can provide an independent evaluation of the applicants abilities. 2. From an individual who is currently working, or has worked, with the applicant 3. From an individual who is currently working, or has worked, with the applicant Please note: Recommendation letters are separate from the Sponsor and/or Department Head Statement required as part of the Research Plan (please review Section 10, Part VIII). An application must have a total of 4 letters (3 recommendations and 1 Sponsor/ Department head statement). Letters of Recommendation are to be completed and signed on institutional letterhead and UPLOADED to the applicant s application in proposalcentral by the Referee. Electronic signature is permitted. Steps for the Applicant to Contact the Referee: 1. Enter the address of the referee in the text box provided and click ADD. 2. A small window will open; enter the Last Name and First Name of the referee. If the referee is already registered in proposalcentral, the name will automatically display in the window. 1. Click the red SEND button and CLOSE WINDOW. An will be sent to the referee from proposalcentral requesting a Letter of Recommendation. The will include instructions and a link for the referee to upload the completed Letter of Recommendation, directly to your grant application. You will see that once the has been sent, referee information is displayed in the table (i.e., name, address, date/time was sent, etc.). You can refer to this table to check on the status of the letters that have been uploaded to your application. When each of the letters is uploaded, the status will display as SUBMITTED. You may want to check periodically on the status of the referee letters. The referee will not have access to any portion of your grant application in the upload process. For your information: The REFEREE is provided with the following instructions: The person who sent you this is an applicant requesting an online reference from you for a grant application to the American Lung Association. Letters of Recommendation must be completed and signed on institutional letterhead. Letters of Recommendation that need to be scanned must be at 100%, and at least 150 dots per inch resolution. Providing an electronic signature is permitted and mentor recommendation letters must be labeled. The resulting file should be converted to PDF format. Your letter will then need to be uploaded to the applicant s grant application in proposalcentral. Once your Letter of Recommendation is ready to upload, access the link provided in the from the applicant. Login to proposalcentral with the details provided in your . Please include your name in the ATTACHMENT LABEL DESCRIPTION. Click the BROWSE button to peruse your workstation and locate your Letter of Recommendation file. SELECT/OPEN the file. You will see the (long) PATH of your file displayed in the window adjacent to Page 4 of 16

5 the Browse window. Now click SAVE to upload your Letter of Recommendation to the applicant s grant application. Please make certain that you submit your Letter of Recommendation one week prior to the application deadline date/time. If you find it necessary to upload a revised Letter of Recommendation, you may do so. The revised Letter of Recommendation will overwrite the previously uploaded file. After the applicant submits the application, letters of recommendation cannot be changed. For assistance, please contact proposalcentral Customer Support at: (800) ; by at: pcsupport@altum.com. Requestor Name: Name of applicant displayed Grantor: American Lung Association Grant Program: Name of program displayed Deadline: Deadline date/time displayed Project Title: Project title displayed To provide the requested information, click the link provided below. LINK PROVIDED HERE Use the following information to login: User ID: User ID is displayed Password: Password is displayed Proposal Identifier Value: Proposal Identifier Value displayed 8) PROJECT SUMMARY General Audience Summary Please provide a summary of the research project in non-scientific terms that would be understood by a general audience. Do not include any proprietary or confidential information. Please observe the following limitations for the general audience summary: Limit the summary to 1,000 characters or less, including spaces. Information entered in this field must be text only: scientific notations, special characters, special fonts, and other rich-text formatting (e.g., bold, italics, underline) cannot be saved or displayed. Please type continuously - do NOT click ENTER at the end of each line. After cut and paste, check the text to make sure the lines are continuous. Click ENTER to begin a new paragraph(s). Technical Audience Summary Please provide an abstract of the research project in technical terms that would be appropriate for experts in the field. Do not include any proprietary or confidential information. Please observe the following limitations for the technical abstract: Limit the abstract to 3,000 characters or less, including spaces. Information entered in this field must be text only: scientific notations, special characters, special fonts, and other rich-text formatting (e.g., bold, italics, underline) cannot be saved or displayed. Please type continuously - do NOT click ENTER at the end of each line. After cut and paste, check the text to make sure the lines are continuous. Click ENTER to begin a new paragraph(s). Scientific Categories Please select the most appropriate categories for your proposed project in order of relevance. Select choices with care as they will partially be used to facilitate selection of scientific peer reviewers. Page 5 of 16

6 9) ORGANIZATION ASSURANCES All research funded by the American Lung Association must comply with federal requirements regarding the use of human subjects, animals or biohazards in research. It is recommended that applicants submit projects to the appropriate Review Board at the time of application or before. Human Subjects and Stem Cells All research conducted on human subjects and/or human stem cells must comply with the provisions of the United States Department of Health and Human Services 45 C.F.R. pt. 46 to the same extent as each would were the research funded by the National Institutes of Health. If the proposed research project involves human subjects, the population sampled shall be inclusive of the general population, of relevance to the scientific question posed, without restriction in regard to gender, race, age, and socioeconomic status. Proposals that intentionally restrict the population sampled must include a compelling scientific rationale for such design. Indicate on the electronic application the institutional OHRP Assurance Number, as well as, the individual proposal IRB status approved or pending. If approved, please provide the corresponding date of approval on the electronic application. If exempt from IRB approval within your institution, place exempt and the date the exemption was approved. A hard copy of the IRB approval/ exemption, as well as, all approved patient consent forms must be provided to the American Lung Association prior to the start of an award. If these materials are not received by the American Lung Association by the start of an award, it will be withdrawn. Animal Use The American Lung Association allows animal use in biomedical research only when no other means of obtaining scientifically sound, valid and useful results are available. Applicants/ awardees must comply with the Public Health Service Policy on Human Care and Use of Laboratory Animals and the National Research Council Guide for the Care and Use of Laboratory Animals to the same extent as each would were the research funded by the National Institutes of Health. Indicate on the electronic application the institutional Animal Welfare Assurance Number as well as the Institutional Animal Care and Use of Committee (IACUC) status approved or pending. If approved, please provide the corresponding date of approval on the electronic application. In addition, please indicate whether or not the institution has been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Applicants from institutions that do not have an IACUC or accreditation from the AAALAC are not eligible to apply. A hard copy of the IACUC or AAALAC accreditation approval must be provided to the American Lung Association prior to the start of an award. If these materials are not received by the American Lung Association by the start of an award, it will be withdrawn. Biohazards Biohazards are broadly defined to be recombinant and/or infectious and tumor materials that may be deleterious to normal organisms upon controlled exposure. Indicate on the electronic application the Institutional Biosafety Committee (IBC) status. If approved, please provide the corresponding date of approval on the electronic application. If exempt from IBC approval within your institution, place exempt and the date the exemption was approved. A hard copy of the IBC approval/ exemption must be provided to the American Lung Association prior to the start of an award. If these materials are not received by the American Lung Association by the start of an award, it will be withdrawn. Page 6 of 16

7 Please note: Paper documentation of approval/exemption in each relevant assurance category is required. If these assurances are available at time of application, it is strongly encouraged that applicants submit documentation with the original paper copy of the application (not electronically). All required documents are due at the national office prior to the start of an award or the award will be administratively withdrawn. 10) RESEARCH PLAN AND OTHER SUPPORTING DOCUMENTS Part I. Preparation of Templates and Uploading Completed files (attachments): If you have not already done so, click the DOWNLOAD link for each template file, and SAVE to your local workstation to complete. Using the Provided Templates Some of the files you download will be required" attachments. All the required attachments are listed in the section directly above the templates section. This display is merely a tool to help you keep track of your completed required files. Once you upload a completed required template, the template name will display in the "Current List of Uploaded Attachments. The VALIDATE link in the Navigation Menu of the online application serves as a tool to check that all required attachment files are included in your application. The Validate link will also check for any missing required online entries. Language and Format Requirements All applications must adhere to the following language and format requirements. Not adhering to these requirements may result in an application being administratively withdrawn. 1. The applicant s name should always be in the top HEADER portion. The header information should carry forward to subsequent pages in the template. 2. Use English only and avoid jargon and any unusual abbreviations. 3. Use Arial 11 point font size, the NIH-suggested font, unless otherwise specified in the instructions for a specific template. 4. Be consistent with the use of font styles and indentation. 5. Type density, including characters and spaces, must be no more than 15 characters per inch (cpi). For proportional spacing, the average for any representative section of text must not exceed 15 cpi. 6. No more than 6 lines of type within a vertical inch. 7. Margins, in all directions, must be at least ½ inch. 8. Figures, charts, tables, figure legends, and footnotes may be smaller in size but they must be clear and legible. 9. Applicants are responsible for correcting any changes to templates resulting from input of data. Data should be completed in the space provided. Each template page must respect the original margins on all sides. 10. Attached files should be no larger than 3-5 MB to facilitate review of the application. Very large files can make a full and comprehensive review of the application difficult. The objective is to find a balance between the content of your application and file size. 11. For some templates, e.g., Biosketch, a single biosketch template is provided for you to complete. For projects with multiple key personnel, you can create a single document with a biosketch of all the key personnel, including the mentor and/or sponsor, by copying the template provided and pasting copies one after the other for as many people as required. 12. Do not use 3 rd party programs for references. Use the available reference tools built into Word. Page 7 of 16

8 Suggested Tips and Techniques for Images in Documents Ensure the file size of pictures or images are reduced to the lowest effective size before including in a document. If your document has many images, use the SAVE AS option to save a new version of the document before attaching it. Reduce the file size of documents with images by inserting the image (as opposed to cutting and pasting ). Save graphical images as a.jpg or.gif file. Insert the image into the document by selecting Insert Picture From File from the MS Word menu. Insert only.gif or.jpg graphic files as images in your Word document (other graphical file formats are either very large or difficult to manipulate in the document). Do not insert Quick Time or TIFF objects into your document. Anchor the images that you embed in your document. Once you have anchored the inserted image, you can format text to wrap around the image. Do not edit your images in Word. Use a graphics program. Do not embed your images in tables, text boxes, and other form elements. Do not add annotations over the images in Word but to the images itself in a graphics program. Uploading to Online Application Attachment files must be submitted and uploaded to electronic application as PDF files. Steps to attach your completed template to your online application 1. Make certain that the converted PDF file is closed on your computer. 2. Open your application and go to the page from which you downloaded the template. 3. Enter your own description of the file in the DESCRIBE ATTACHMENT field. 4. Choose from the drop-down list of attachment types, e.g., Biosketch, Other Support, etc. 5. Click on the Browse button. A Choose File dialog box opens for you to search for the template file on your computer s hard disk/network. 6. Select the file and click OPEN. The file location and name will display in the window adjacent to the Browse button. 7. Click on the UPLOAD ATTACHMENT button. You will get a confirmation message on your screen that the file was uploaded successfully. You will also see that your file is now listed in the Uploaded Attachment section of the screen. Two links are available in each row of an uploaded attachment: DEL and SHOW. Del allows you to delete the file, if necessary, and Show opens the uploaded file. It is strongly recommended that you open and review your uploaded file. If, for any reason, you wish to modify the file, make the revisions in the original document (offline), convert the file to PDF and once again, attach the newly revised file. ***Remember to delete any previously submitted versions of the file. Part II. Biographical Sketch Biographical Sketches are required for the applicant and all listed key personnel, including the applicant s sponsor and/or mentor, in Section 6. You must use the template provided. The Biographical Sketch must not exceed four (4) pages for each person listed as key personnel. Each Biographical Sketch should provide the following information about each key person, starting with the applicant: A. Personal Statement. Briefly describe why your experience and qualifications make you particularly well-suited for your role in the project that is the subject of the application. Also, briefly describe any changes in primary field of interest and/or career gaps due to personal or professional circumstances that may have affected your scientific advancement or productivity. Page 8 of 16

9 B. Positions and Honors. List in chronological order previous positions, concluding with your present position. List any honors. C. Selected peer-reviewed publications (in chronological order and no more than 15). Do not include manuscripts submitted or in preparation; abstracts or posters. Please choose selected publications based on recency, importance to the field, and/or relevance to the proposed research. D. Research Support. List selected ongoing or completed (during the last three years) research projects (federal and non-federal support). Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs. *** Remember to delete any previously submitted versions of the file. Part III. Budget and Justification Awards are given in one year increments. All awardees will be given the opportunity to renew their project for a second year of funding. Funding is contingent on the availability of funds and individual progress during the award year. Applicants are encouraged to request an appropriate amount not to exceed the total funds available for a specific award. Applicants are also encouraged to request the maximum number of years for each award. Refer to the individual Program Descriptions for specific award allocations. Budget Spreadsheet: The first page asks the applicant to estimate direct costs for the first year of the proposal only. The second page asks the applicant to estimate direct costs for the entire period of the award. Indirect costs are not allowed for any American Lung Association award. Where applicable, only indicate dollars (no cents). Personnel: For junior-level Investigator Awards there is an institutional base salary limitation of $199,000. Fringe benefits (these may be requested provided such are treated consistently by the applicant s organization as a direct cost to all sponsors). FOR LUNG HEALTH DISSERTATION (LH): No more than 75% of funds may go towards a stipend. FOR RESEARCH TRAINING FELLOWSHIP AWARDS (RT): 100% of funds must be used for the awardee s salary and fringe benefits. FOR ALL OTHER AWARDS AND GRANTS: No more than 25% of funds may be used for an awardee s salary and/or fringe benefits. There are no salary caps for other personnel. Equipment: FOR RESEARCH TRAINING FELLOWSHIP AWARDS (RT): Not available for this award. FOR ALL OTHER RESEARCH AWARDS AND GRANTS: Itemize equipment with costs. Equipment is defined as an item that costs $500 or more, has a primary function related to the research project, and ordinarily has a usable life expectancy of one year or greater. No more than 30% of the total award budget may go to fund the purchase of permanent equipment. Supplies: FOR RESEARCH TRAINING FELLOWSHIP AWARDS (RT): Not available for this award. FOR ALL OTHER RESEARCH AWARDS AND GRANTS: Itemize supplies with costs. For example, indicate the number of experimental animals to be used, unit cost per animal, and cost for daily use. Page 9 of 16

10 Travel: FOR RESEARCH TRAINING FELLOWSHIP AWARDS (RT): Not available for this award. FOR ALL OTHER RESEARCH AWARDS AND GRANTS: May not exceed $1,000 annually. Travel monies must directly relate to this project Publications: FOR RESEARCH TRAINING FELLOWSHIP AWARDS (RT): Not available for this award. FOR ALL OTHER RESESARCH AWARDS AND GRANTS: Purchase of reprints and expenditures in connection with publishing research results (e.g., publication page costs and photographs). May not exceed $1,000 annually. Other Project Support Expenses: FOR RESEARCH TRAINING FELLOWSHIP AWARDS (RT): Not available for this award. FOR ALL OTHER AWARDS AND GRANTS: No award shall be used for the purchase of furniture, computers, the construction or renovation of facilities, payment of honoraria, membership dues or tuition, purchase of textbooks or periodicals or payment for secretarial support. Total Costs may not exceed allowable award amounts. Correct arithmetic is the applicant s responsibility. Budget Justification: Please provide a justification for the proposed budget for the first year only. The budget justification must not exceed three (3) pages. *** Remember to delete any previously submitted versions of the file. Part IV. Resources Describe the institutional resources and facilities that are available or will be provided for the project. The Resource template must not exceed two (2) pages. FACILITIES: Specify the facilities to be used for the conduct of the proposed research. Indicate the performance sites and describe capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Under Other, identify support services such as machine shop, electronics shop, and specify the extent to which they will be available to the project. Use continuation pages if necessary. EQUIPMENT: List the most important equipment items already available for this project, noting the location and pertinent capabilities of each. *** Remember to delete any previously submitted versions of the file. Part V. Other Support Provide active and pending support for all key personnel. Information should be provided in the format shown in the Other Support template. No page limit applies to the Other Support information. Other Support includes all financial resources, whether Federal, non-federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Please specify who the Primary Investigator is for all other support listed. Prizes or gifts do not need to be included. Providing a list of current or pending training awards is only necessary for Research Training Fellowship applications. The American Lung Association will not award funds to duplicate any work that is being supported by other funding agencies. Budgetary overlap is not permitted; however, scientific overlap will be evaluated on an Page 10 of 16

11 individual basis. In cases of significant scientific overlap a successful applicant will have the option to choose between the American Lung Association award and that of the other organization. *** Remember to delete any previously submitted versions of the file. *** Remember to specify the Primary Investigator on Other Support listed. Part VI. Resubmission Statement A resubmission is considered an application previously reviewed and not funded in the prior application cycle. An applicant who is unsuccessful in a competition may resubmit the same or similar application up to two times. If major changes are made to the application or if this is an entirely different/new project, it should not be checked as a resubmission. Use the Resubmission Template to explain how the application has been strengthened or modified (additions, deletions, revisions) from the original. This statement must also include responses to criticisms and issues raised in the review critiques for the previous application. When an application is checked as a resubmission, it will be assigned to at least one of the previously assigned peer reviewers, whenever possible. Include sufficient information to permit an effective review without reviewers having to refer to any previous application. The Resubmission Statement must not exceed 2 pages. *** Remember to delete any previously submitted versions of the file. Part VII. Research Plan Please note: Page limits, language and format requirements (listed on page 7) must be adhered to in preparing your research plan. Not adhering to format and page limitations may result in an application being administratively withdrawn. Specific Aims State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. The Specific Aims section must not exceed 1 page in length. List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. Aims must not be too general, such as To define the determinants of maximal expiratory flow, but rather To study the influence of static lung recoil on maximal flows. Your statement should be limited to what can be accomplished during the award period. Research Strategy Organize the Research Strategy in the specified order using the instructions provided below. Start each section with the appropriate section heading Significance, Innovation and Approach. Cite published experimental details in the Research Strategy and provide the full reference in the References section. FOR TRAINING AWARDS (LH, RT): Applicants are limited to 5 pages. FOR ALL OTHER AWARDS: Applicants are limited to 6 pages. (a) Significance Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Page 11 of 16

12 Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. Explain how this research will impact your future goals or directions, as long as a clear distinction is made between your immediate and long-range plans. (b) Innovation Not Applicable for TRAINING AWARDS (LH, RT) Explain how the application challenges and seeks to shift current research or clinical practice paradigms. This provides an opportunity to demonstrate your knowledge and ability in this area, and to synthesize large volumes of information into a succinct and cohesive statement. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. Clearly synthesize your own contributions to the field, and demonstrate your relative stature in the area. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions. (c) Approach Explain why you have chosen to address a particular portion of the overall problem and why you have chosen a particular approach. Discuss your preliminary studies, data and/or experience pertinent to this application and specify all novel data. Describe the overall strategy, methodology, and analyses to be used to accomplish each of the specific aims of the project. For each aim, include how the data will be collected, analyzed, and interpreted (e.g., number of experiments, types of measurements to be made). Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. This should include discussion of what you will do if conflicting and contradictory data are obtained. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. d) Human Subjects When human subjects or material obtained from such subjects are used in the proposed project, the application must state how the rights and welfare of the individual subjects are protected and assured. Include copies of consent forms and questionnaires in appendix, if applicable. e) Animal Use and Justification When animals are used in the project, the application must include a succinct and complete description of the following five points: 1. Provide a detailed description of the proposed use of the animals in the work outlined in the Research Strategy section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work. 2. Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers. 3. Provide information on the veterinary care of the animals involved. 4. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury. 5. Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the American Veterinary Medical Page 12 of 16

13 Association (AVMA) Guidelines on Euthanasia. If not, include a scientific justification for not following the recommendations. f) Biohazard Materials When biohazard materials, defined as recombinant, infectious and tumor selected agents (i.e. radioisotopes) that may be detrimental to normal organisms upon controlled exposure are used: Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites. References: References must not exceed 5 pages. Appendix: May contain additional and relevant material such as letters of support, questionnaires and/or consent forms. No other material, such as preliminary data, photographs/images or publications, is allowed in the appendix. The appendix is limited to 5 pages. *** Remember to delete any previously submitted versions of the file. Part VIII. Sponsor/Department Head Statement Letter FOR TRAINING AWARDS (LH, RT): Sponsor Statement is required on Institutional Letterhead The applicant is required to upload the letter to their electronic application on proposalcentral, as well as, provide the American Lung Association with the original plus two copies as part of the hard copy submission. The Sponsor should complete as comprehensively as possible so that a meaningful evaluation of the training environment can be made by the reviewers. Content of Sponsor Statement: 1. Research Support Available List all current and pending research and research training support specifically available to the applicant for this particular training experience. Include funding source, complete identifying number, title of the research or training program, and name of the principal investigator, dates, and amount of the award. State your department s financial and space commitment to the applicant s career, and to the American Lung Association s project being submitted. The sponsor must specifically identify the availability of sufficient funds to complete the proposed research project. 2. Sponsor's/Co-Sponsor s Previous Fellows/Trainees Provide the total number of predoctoral and postdoctoral individuals previously sponsored. Select five that are representative and provide their present employing organizations and position titles or occupations. 3. Training Plan, Environment, Research Facilities Describe the research training plan that you have developed specifically for the Fellowship applicant including the approximate percentage of time allotted for teaching, research, clinical training, or opportunities for interaction with other groups and scientists. Describe the research environment and available research facilities and equipment. Indicate the relationship of the proposed research training to the applicant's career goals. Describe the skills and techniques that the applicant will learn. Relate these to the applicant's career goals. Clearly state your assurance that the rights and welfare of individual subjects or laboratory animals in any research will be reviewed and approved by the appropriate institutional board or committee. 4. Number of Fellows/Trainees to be Supervised During the Fellowship Page 13 of 16

14 Indicate whether pre- or postdoctoral. Include this information for any co-sponsor as well. 5. Applicant's Qualifications and Potential for a Research Career Describe how the Fellowship applicant is suited for this research training opportunity based on his/her academic record and research experience level, including how the research training plan, and your own expertise as the sponsor will assist in producing an independent researcher. FOR ALL INDEPENDENT INVESTIGATOR AWARDS (AI, RG, DA, CG, SB, LCD): Department Head Letter is required on Institutional Letterhead The applicant is required to upload the letter to proposalcentral, as well as, provide the American Lung Association with the original plus two copies as part of the hard copy submission. Content of Department Head Statement: 1. State the applicant s current and projected status during the initial term of the award. 2. State the applicant s faculty title and from what academic institution does the applicant currently hold his/her faculty appointment. The Department Head Statement must be explicit as to whether or not the applicant currently holds a faculty appointment, and/or if the applicant will be promoted to faculty between the time of application and award commencement. Without the confirmation of faculty status, the applicant will be disqualified. 3. State the applicant s future path at your institution and plan for academic development. 4. State your department s financial and space commitment to the applicant s career, and to the American Lung Association s project being submitted. 5. Describe the intellectual environment and your involvement in the applicant s award. 6. Guarantee that the budget does not overlap with any existing or pending support of the application s collaborations (including NIH-type other support information, from all collaborating scientists). 7. State minimum percent of overall effort and guaranteed time to be protected for research. 8. State whether you also function as the applicant s mentor. Please note: The Sponsor and/or Department Head Statements are separate from the 3 Letters of Recommendations required (Section 7). Applications should have four letters (3 recommendations and 1 sponsor or department head statement). Part IX. Significance to the American Lung Association Mission Provide a one page narrative as to how your proposed research project would help support the American Lung Association s mission To Save Lives by Improving Lung Health and Preventing Lung Disease and our mission-related Strategic Planning Goals of: > Eliminating tobacco use and tobacco-related lung diseases > Improving the air we breathe so it will not cause or worsen lung disease > Reducing the burden lung disease on patients and their families *** Remember to delete any previously submitted versions of the file. Part X. Certification Form Applicants must sign (electronic signature is allowed) form certifying their compliance with American Lung Association Policies and requirements including the following Conflict of Interest Clauses: Tobacco Use The American Lung Association will not provide research or other funding to investigators who have received direct funding or funding from agencies of the tobacco industry. Page 14 of 16

15 Financial Disclosure American Lung Association applicants/awardees must comply with the provisions of the United States Department of Health and Human Services regulations on financial conflicts of interest 42 C.F.R. pt. 50, Subpt. F to the same extent as each would were the research funded by the National Institutes of Health. In general, the purpose of the Conflict of Interest policy is to ensure that there is no possibility that an applicant or their family will receive financial gain as a result of American Lung Association supported research. 11) REQUIRED CITIZENSHIP & OPTIONAL DEMOGRAPHICS At the time of application, candidates must be United States citizens or foreign nationals holding one of the following visa immigration statuses: permanent resident (Green Card), exchange visitor (J-1), temporary worker in a specialty occupation (H-1B), Canadian or Mexican citizen engaging in professional activities (TN), Australians in Specialty Occupation (E-3 visa) or temporary worker with extraordinary abilities in the sciences (O-1). Non-citizens must submit a notarized copy of proof of possession of one of these visa types. Lung Health Dissertation applicants may hold a student (F-1) visa. At the time of application and throughout the award, an applicant/awardee must be employed by a U.S. institution. Please note that foreign nationals are required to provide a notarized copy of their valid visas as a part of their printed hard-copy application sent to the American Lung Association. Without proof of possession of a visa or permanent resident status, the application will be withdrawn. Do not upload copies of valid visas onto proposalcentral. Please note that the information under Optional Demographic Information will be used only for statistical purposes and will not be provided to the reviewers. 12) VALIDATE Click the 'VALIDATE' link (from any page of the online application). Validate checks for missing required information or files. Any missing required information will be listed on the screen. All required information must be supplied before you can Submit your grant application. 13) PRINT SIGNATURE PAGES Once you have completed and validated your online application (no missing required entries), and completed and uploaded all the required TEMPLATE attachments associated with the Research Plan and Other Supporting Documents, you will need to print your application and assemble for submitting an original plus two paper copies to the American Lung Association. Please collate the paper copies in the same order as that of the electronic application on proposalcentral. Click on the SIGNATURE PAGES section of the application, located in the gray navigation menu (appears just below the Validate link and above the Submit link in the gray navigation menu left side of your screen). NOTE: You will see two Print options, once you click this link. Click the PRINT button on the RIGHT side of the page. This print option will print the two Signature Pages AND all uploaded PDF files. Use this option to assist you in the hard copy requirement. (Clicking the print button on the left side of the page prints the Signature pages only with no attached PDF files.) The PRINT button will open the Signature Pages in PDF format. Data that you entered in the other sections of the proposal are automatically included in the Signature Pages. If information is missing in the Signature Pages, it could be because you have not entered the information in one of the proposal sections OR the information is not required for this grant program. ROUTE THESE PAGES FOR APPROPRIATE SIGNATURES (Electronic signatures are acceptable): Page 15 of 16

16 All Applications require: 1. Applicant Signature: The person submitting the proposal. The applicant s signature serves as certification of compliance with all American Lung Association policies including the Conflict of Interest statement. 2. Signing Official Signature: The person financially responsible for the application. This could be the Finance Officer or Sponsored Research Program Officer. 3. Depending on Award Mechanism - FOR TRAINING AWARDS (LH, RT): Additional Signature: Applicant s Sponsor. FOR ALL OTHER RESEARCH AWARDS AND GRANTS: Additional Signature: Applicant s Mentor OR Department Head. 14) SUBMIT (LAST STEPS) Part I. Online Submission of Applications is REQUIRED The American Lung Association requires all applications to be submitted electronically through proposalcentral. Once you have completed, validated and printed your application, you can then SUBMIT electronically to proposalcentral. The deadline for online submission is: November 12, :59 p.m. Eastern Time. Part 2. Paper (Hard Copy) Submission of your Application is REQUIRED The American Lung Association also requires one original and two copies of the application. Paper applications must be postmarked by November 12, Be sure to print out and send the final version of your application and not a working copy. Applications MUST be assembled in the following order: Signature Pages (Contact Information, Key Personnel, Project Summaries) Biographical Sketches Budget and Justification Facilities & Resources Other Support Resubmission Statement Research Plan Significance to ALA Mission Statement Certification Form Sponsor or Department Head Statement Letters of Recommendation Mail the completed and signed original application, (be certain all forms, letters, etc., are correctly and sequentially assembled) and 2 clear, single-sided photocopies in one package to: American Lung Association ATTN: Research Department 21 W. 38 th Street New York, NY Page 16 of 16