Introduction to Cayuse424. NIH Sample Proposal

Transcription

1 Introduction to Cayuse424 NIH Sample Proposal

2 APPLICATION FOR FEDERAL ASSISTANCE SF 424 (R&R) 1. * TYPE OF SUBMISSION Pre-application Application Changed/Corrected Application 2. DATE SUBMITTED Applicant Identifier 3. DATE RECEIVED BY STATE State Application Identifier 4. a. Federal Identifier b. Agency Routing Number 5. APPLICANT INFORMATION * Organizational DUNS: * Legal Name: The Ohio State University Department: Division: * Street1: 1960 Kenny Road Street2: * City: Columbus County/Parish: Franklin * State: OH: Ohio Province: * Country: USA: UNITED STATES * ZIP / Postal Code: Person to be contacted on matters involving this application Prefix: * First Name: Middle Name: * Last Name: Suffix: Aimee Nielsen-Link * Phone Number: Fax Number: nielsen-link.1@osu.edu 6. * EMPLOYER IDENTIFICATION NUMBER (EIN) or (TIN): A1 8. * TYPE OF APPLICATION: New Resubmission Renewal Continuation Revision If Revision, mark appropriate box(es). A. Increase Award B. Decrease Award C. Increase Duration D. Decrease Duration E. Other (specify): * Is this application being submitted to other agencies? Yes No What other Agencies? 11. * DESCRIPTIVE TITLE OF APPLICANT'S PROJECT: The psychology of proposal submission 12. PROPOSED PROJECT: * Start Date * Ending Date 12/01/ /30/ * TYPE OF APPLICANT H: Public/State Controlled Institution of Higher Education Other (Specify): Women Owned 9. * NAME OF FEDERAL AGENCY: National Institutes of Health Small Business Organization Type Socially and Economically Disadvantaged 10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: TITLE: 13. CONGRESSIONAL DISTRICT OF THE APPLICANT: OH PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION Prefix: * First Name: Middle Name: * Last Name: Suffix: Virginia Hunt Position/Title: Professor * Organization Name: The Ohio State University Department: Psychology Division: College of Arts and Sciences * Street1: 100 North Oval Mall Street2: * City: Columbus County/Parish: Franklin * State: OH: Ohio Province: * Country: USA: UNITED STATES * ZIP / Postal Code: * Phone Number: Fax Number: * vhunt@osu.edu

3 SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page ESTIMATED PROJECT FUNDING 16. * IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE ORDER PRO- CESS? a. YES a. * Total Federal Funds Requested $1,525, b. Total Non-Federal Funds $0.00 c. * Total Federal & Non-Federal Funds $1,525, d. * Estimated Program Income $0.00 DATE: b. NO THIS PREAPPLICATION/APPLICATION WAS MADE AVAILABLE TO THE STATE EXECUTIVE ORDER PROCESS FOR REVIEW ON: PROGRAM IS NOT COVERED BY E.O ; OR PROGRAM HAS NOT BEEN SELECTED BY STATE FOR REVIEW 17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with any resulting terms if I accept an award. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001) * I agree * The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions. 18. SFLLL or other Explanatory Documentation. : : 19. Authorized Representative Prefix: * First Name: Middle Name: * Last Name: Suffix: Aimee Nielsen-Link * Position/Title: Director * Organization Name: The Ohio State University Department: Division: Health Sciences Office * Street1: B030 Graves Hall Street2: 333 W. 10th Avenue * City: Columbus County/Parish: Franklin * State: OH: Ohio Province: * Country: USA: UNITED STATES * ZIP / Postal Code: * Phone Number: Fax Number: * nielsen-link.1@osu.edu * Signature of Authorized Representative * Date Signed 20. Pre-application : :

4 Project/Performance Site Location(s) Project/Performance Site Primary Location Organization Name: The Ohio State University * Street1: 100 North Oval Mall Street2: Department of Psychology * City: Columbus County: Franklin * State: OH: Ohio Province: DUNS Number: * Country: USA: UNITED STATES * Zip / Postal Code: * Project/Performance Site Congressional District: OH-016 Additional Location(s)

5 RESEARCH & RELATED Other Project Information 1. * Are Human Subjects Involved? Yes No 1.a. If YES to Human Subjects Is the Project Exempt from Federal regulations? Yes No If yes, check appropriate exemption number Exemption Number: If no, is the IRB review Pending? Yes No IRB Approval Date: Human Subject Assurance Number 2. * Are Vertebrate Animals Used? Yes No 2.a. If YES to Vertebrate Animals Is the IACUC review Pending? Yes No IACUC Approval Date: Animal Welfare Assurance Number A * Is proprietary/privileged information Yes included in the application? No 4.a. * Does this project have an actual or potential impact on the environment? Yes No 4.b. If yes, please explain: 4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or environmental impact statement (EIS) been performed? Yes No 4.d. If yes, please explain: 5.a. * Is the research performance site designated, or eligible to be designated, as a historic place? Yes No 5.b. If yes, please explain: 6.a. * Does this project involve activities outside the U.S. or partnership with International Collaborators? Yes No 6.b. If yes, identify countries: 6.c. Optional Explanation: 7. * Project Summary/Abstract Project_Abstract pdf : application/pdf 8. * Project Narrative Project_Narrative pdf : application/pdf 9. Bibliography & References Cited Attachment pdf : application/pdf 10. Facilities & Other Resources Facilities_and_Other_Resources pdf : application/pdf 11. Equipment Equipment pdf : application/pdf

6 Project Abstract The first and major component of the Project Summary/Abstract (i. e., Description ) is a Project Summary. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the application s broad, longterm objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe concisely the research design and methods for achieving the stated goals. This section should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate reader. Avoid describing past accomplishments and the use of the first person. Finally, please make every effort to be succinct. This section must be no longer than 30 lines of text, and follow the required font and margin specifications. An abstract which exceeds this allowable length may be flagged as an error by the agency upon submission. This would require a corrective action before the application will be accepted.

7 Project Narrative For NIH and other PHS agencies applications, this attachment will reflect the second component of the Project Summary. The second component of the Project Summary/Abstract (i.e., Description ) is Relevance. Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience.

8 Facilities and Other Resources This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. Provide any information describing the Other Resources available to the project (e.g., machine shop, electronic shop) and the extent to which they would be available to the project. No special form is required but this section must be completed and attached for submissions to NIH and other PHS agencies unless otherwise noted in an FOA. If there are multiple performance sites, then resources available at each site should be described. In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment, or subject populations or employ useful collaborative arrangements. If research involving Select Agent(s) will occur at any performance site(s), the biocontainment resources available at each site should be described.

9 Equipment List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities

10 RESEARCH & RELATED Senior/Key Person Profile (Expanded) PROFILE - Project Director/Principal Investigator Prefix * First Name Middle Name * Last Name Suffix Virginia Hunt Position/Title: Professor Organization Name: The Ohio State University Department: Psychology Division: College of Arts and Sciences * Street1: 100 North Oval Mall Street2: * City: Columbus County: Franklin * State: OH: Ohio Province: * Country: USA: UNITED STATES * Zip / Postal Code: *Phone Number Fax Number * vhunt@osu.edu Credential, e.g., agency login: VHUNTOSU * Project Role: PD/PI Other Project Role Category: Degree Type: PhD Degree Year: 1996 *Attach Biographical Sketch biosketchsample pdf application/pdf Attach Current & Pending Support Tracking Number:

11 RESEARCH & RELATED Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments When submitting senior/key persons in excess of 8 individuals, please attach additional senior/key person forms here. Each additional form attached here, will provide you with the ability to identify another 8 individuals, up to a maximum of 4 attachments (32 people). The means to obtain a supplementary form is provided here on this form, by the button below. In order to extract, fill, and attach each additional form, simply follow these steps: Select the "Select to Extract the R&R Additional Senior/Key Person Form" button, which appears below. Save the file using a descriptive name, that will help you remember the content of the supplemental form that you are creating. When assigning a name to the file, please remember to give it the extension ".xfd" (for example, "My_Senior_Key.xfd"). If you do not name your file with the ".xfd" extension you will be unable to open it later, using your PureEdge viewer software. Using the "Open Form" tool on your PureEdge viewer, open the new form that you have just saved. Enter your additional Senior/Key Person information in this supplemental form. It is essentially the same as the Senior/Key person form that you see in the main body of your application. When you have completed entering information in the supplemental form, save it and close it. Return to this "Additional Senior/Key Person Form Attachments" page. Attach the saved supplemental form, that you just filled in, to one of the blocks provided on this "attachments" form. Important: Please attach additional Senior/Key Person forms, using the blocks below. Please remember that the files you attach must be Senior/ Key Person Pure Edge forms, which were previously extracted using the process outlined above. Attaching any other type of file may result in the inability to submit your application to Grants.gov. 1) Please attach Attachment 1 2) Please attach Attachment 2 3) Please attach Attachment 3 4) Please attach Attachment 4 Filename ADDITIONAL SENIOR/KEY PERSON PROFILE(S) MimeType Additional Biographical Sketch(es) (Senior/Key Person) Filename MimeType Additional Current and Pending Support(s) Filename MimeType Tracking Number:

12 Program Director/Principal Investigator (Last, First, Middle): Hunt, Virginia, L. BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME Hunt, Virginia Lively era COMMONS USER NAME (credential, e.g., agency login) huntvl POSITION TITLE Associate Professor of Psychology EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) University of California, Berkeley B.S. 05/90 Psychology University of Vermont Ph.D. 05/96 Experimental Psychology University of California, Berkeley Postdoctoral 08/98 Public Health and Epidemiology A. Personal Statement The goal of the proposed research is to investigate the interaction between drug abuse and normal aging processes. Specifically, we plan to measure changes in cognitive ability and mental and physical health across a five-year period in a group of older drug users and matched controls. I have the expertise, leadership and motivation necessary to successfully carry out the proposed work. I have a broad background in psychology, with specific training and expertise in key research areas for this application. As a postdoctoral fellow at Berkeley, I carried out ethnographic and survey research and secondary data analysis on psychological aspects of drug addiction. At the Division of Intramural Research at the National Institute on Drug Abuse (NIDA), I expanded my research to include neuropsychological changes associated with addiction. As PI or co-investigator on several previous university- and NIH-funded grants, I laid the groundwork for the proposed research by developing effective measures of disability, depression, and other psychosocial factors relevant to the aging substance abuser, and by establishing strong ties with community providers that will make it possible to recruit and track participants over time. In addition, I successfully administered the projects (e.g. staffing, research protections, budget), collaborated with other researchers, and produced several peerreviewed publications from each project. As a result of these previous experiences, I am aware of the importance of frequent communication among project members and of constructing a realistic research plan, timeline, and budget. The current application builds logically on my prior work, and I have chosen coinvestigators (Drs. Gryczynski and Newlin) who provide additional expertise in cognition, gerontology and geriatrics. In summary, I have a demonstrated record of successful and productive research projects in an area of high relevance for our aging population, and my expertise and experience have prepared me to lead the proposed project. B. Positions and Honors Positions and Employment Fellow, Division of Intramural Research, National Institute of Drug Abuse, Bethesda, MD Lecturer, Department of Psychology, Middlebury College, Middlebury, VT Consultant, Coastal Psychological Services, San Francisco, CA Assistant Professor, Department of Psychology, Washington University, St. Louis, MO Associate Professor, Department of Psychology, Washington University, St. Louis, MO PHS 398/2590 (Rev. 06/09) Page 5 Biographical Sketch Format Page

13 Program Director/Principal Investigator (Last, First, Middle): Hunt, Virginia, L. Other Experience and Professional Memberships Member, American Psychological Association Member, Gerontological Society of America Member, American Geriatrics Society Associate Editor, Psychology and Aging Board of Advisors, Senior Services of Eastern Missouri NIH Peer Review Committee: Psychobiology of Aging, ad hoc reviewer NIH Risk, Adult Addictions Study Section, member Honors 2003 Outstanding Young Faculty Award, Washington University, St. Louis, MO 2005 Excellence in Teaching, Washington University, St. Louis, MO 2008 Award for Best in Interdisciplinary Ethnography, International Ethnographic Society C. Selected Peer-reviewed Publications (Selected from 42 peer-reviewed publications) Most relevant to the current application 1. Merryle, R.J. & Hunt, V.L. (2004). Independent living, physical disability and substance abuse among the elderly. Psychology and Aging, 23(4), Hunt, V.L, Jensen, J.L. & Crenshaw, W. (2007). Substance abuse and mental health among communitydwelling elderly. International Journal of Geriatric Psychiatry, 24(9), Hunt, V.L, Wiechelt, S.A. & Merryle, R. (2008). Predicting the substance-abuse treatment needs of an aging population. American Journal of Public Health, 45(2), PMCID: PMC Hunt, V.L., Newlin, D.B. & Fishbein, D. (2009). Brain imaging in methamphetamine abusers across the lifespan. Gerontology, 46(3), Hunt, V.L. & Sher, K.A. (2009). Successful intervention models for older drug-abusers: Research across the life-span. American Psychologist, in press. NIHMSID: NIHMS99135 Additional recent publications of importance to the field (in chronological order) 1. Gryczynski, J., Shaft, B.M., Merryle, R., & Hunt, V.L. (2002). Community based participatory research with late-life addicts. American Journal of Alcohol and Drug Abuse, 15(3), Shaft, B.M., Hunt, V.L., Merryle, R., & Venturi, R. (2003). Policy implications of genetic transmission of alcohol and drug abuse in female nonusers. International Journal of Drug Policy, 30(5), Hunt, V. L., Marks, A.E., Shaft, B.M., Merryle, R., & Jensen, J.L. (2004). Early-life family and community characteristics and late-life substance abuse. Journal of Applied Gerontology, 28(2), Hunt, V.L., Merryle, R. & Jensen, J.L. (2005). The effect of social support networks on morbidity among elderly substance abusers. Journal of the American Geriatrics Society, 57(4), Hunt, V.L., Pour, B., Marks, A.E., Merryle, R. & Jensen, J.L. (2005). Aging out of methadone treatment. American Journal of Alcohol and Drug Abuse, 15(6), Hunt, V.L, Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A. (2006). Community-based intervention strategies for reducing alcohol and drug abuse in the elderly. Addiction, 104(9), PMCID: PMC Merryle, R. & Hunt, V.L. (2006). Randomized clinical trial of cotinine in older nicotine addicts. Age and Ageing, 38(2), PMCID: PMC Hunt, V.L., Jensen, J.L. & Merryle, R. (2008). The aging addict: ethnographic profiles of the elderly drug user. NY, NY: W. W. Norton & Company. 9. Hunt, V.L. (2009). Contrasting ethnicity with race in the older alcoholic. TheJournals of Gerontology Series B: Psychological Sciences and Social Sciences, in press. PMCID: PMC Journal In Process. 10. Hunt, V.L. (2009). Intervening successfully with the older methadone patient. Journal of Applied Gerontology, 13(4), PHS 398/2590 (Rev. 06/09) Page 6 Continuation Format Page

14 Program Director/Principal Investigator (Last, First, Middle): Hunt, Virginia, L. D. Research Support Ongoing Research Support R01 DA Hunt (PI) 09/01/07-08/31/12 Health trajectories and behavioral interventions among older substance abusers The goal of this study is to compare the effects of two substance abuse interventions on health outcomes in an urban population of older opiate addicts. Role: PI R01 MH Merryle (PI) 07/15/05-06/30/10 Physical disability, depression and substance abuse in the elderly The goal of this study is to identify disability and depression trajectories and demographic factors associated with substance abuse in an independently-living elderly population. Role: Co-Investigator Faculty Resources Grant, Washington University 08/15/09-08/14/11 Opiate Addiction Database The goal of this project is to create an integrated database of demographic, social and biomedical information for homeless opiate abusers in two urban Missouri locations, using a number of state and local data sources. Completed Research Support K02 AG Hunt (PI) 09/01/06-08/31/09 Drug Abuse in the Elderly Independent Scientist Award: to develop a drug addiction research program with a focus on substance abuse among the elderly. Role: PI R21 AA Hunt (PI) 01/01/04-12/31/06 Community-based intervention for alcohol abuse The goal of this project was to assess a community-based strategy for reducing alcohol abuse among older individuals. Role: PI PHS 398/2590 (Rev. 06/09) Page 7 Continuation Format Page

15 PHS 398 Cover Page Supplement 1. Project Director / Principal Investigator (PD/PI) Prefix: Middle Name: * Last Name: Hunt Suffix: * First Name: Virginia 2. Human Subjects Clinical Trial? No Yes * Agency-Defined Phase III Clinical Trial? No Yes 3. Applicant Organization Contact Person to be contacted on matters involving this application Prefix: Middle Name: * Last Name: Nielsen-Link Suffix: * First Name: Aimee * Phone Number: Fax Number: nielsen-link.1@osu.edu * Title: Director * Street1: Street2: 1960 Kenny Road * City: County: * State: Province: Columbus Franklin OH: Ohio * Country: USA: * Zip / Postal Code:

16 PHS 398 Cover Page Supplement 4. Human Embryonic Stem Cells * Does the proposed project involve human embryonic stem cells? No Yes If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: Or, if a specific stem cell line cannot be referenced at this time, please check the box indicating that one from the registry will be used: Cell Line(s): Specific stem cell line cannot be referenced at this time. One from the registry will be used.

17 PHS 398 Modular Budget, Periods 1 and 2 OMB Number: Expiration Date: 9/30/2007 Budget Period: 1 A. Direct Costs Start Date: 12/01/2010 End Date: 11/30/2011 * Direct Cost less Consortium F&A Consortium F&A * Total Direct Costs Funds Requested ($) 250, , B. Indirect Costs 1. Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($) On Campus Organized Research , , Cognizant Agency (Agency Name, POC Name and Phone Number) DHHS, Henry Williams, Indirect Cost Rate Agreement Date 07/24/2009 Total Indirect Costs 131, C. Total Direct and Indirect Costs (A + B) Funds Requested ($) 381, Budget Period: 2 Start Date: 12/01/2011 End Date: 11/30/2012 A. Direct Costs * Direct Cost less Consortium F&A Consortium F&A * Total Direct Costs Funds Requested ($) 250, , B. Indirect Costs 1. Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($) On Campus Organized Research , , Cognizant Agency (Agency Name, POC Name and Phone Number) DHHS, Henry Williams, Indirect Cost Rate Agreement Date 07/24/2009 Total Indirect Costs 131, C. Total Direct and Indirect Costs (A + B) Funds Requested ($) 381, Tracking Number:

18 Budget Period: 3 A. Direct Costs PHS 398 Modular Budget, Periods 3 and 4 Start Date: 12/01/2012 End Date: 11/30/2013 * Direct Cost less Consortium F&A Consortium F&A * Total Direct Costs OMB Number: Expiration Date: 9/30/2007 Funds Requested ($) 250, , B. Indirect Costs 1. Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($) On Campus Organized Research , , Cognizant Agency (Agency Name, POC Name and Phone Number) DHHS, Henry Williams, Indirect Cost Rate Agreement Date 07/24/2009 Total Indirect Costs 131, C. Total Direct and Indirect Costs (A + B) Funds Requested ($) 381, Budget Period: 4 Start Date: 12/01/2013 End Date: 11/30/2014 A. Direct Costs * Direct Cost less Consortium F&A Consortium F&A * Total Direct Costs Funds Requested ($) 250, , B. Indirect Costs 1. Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($) On Campus Organized Research , , Cognizant Agency (Agency Name, POC Name and Phone Number) DHHS, Henry Williams, Indirect Cost Rate Agreement Date 07/24/2009 Total Indirect Costs 131, C. Total Direct and Indirect Costs (A + B) Funds Requested ($) 381, Tracking Number:

19 PHS 398 Modular Budget, Period 5 and Cumulative OMB Number: Expiration Date: 9/30/2007 Budget Period: 5 Start Date: End Date: A. Direct Costs * Direct Cost less Consortium F&A Consortium F&A * Total Direct Costs Funds Requested ($) B. Indirect Costs Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($) Cognizant Agency (Agency Name, POC Name and Phone Number) Indirect Cost Rate Agreement Date C. Total Direct and Indirect Costs (A + B) Total Indirect Costs Funds Requested ($) Cumulative Budget Information 1. Total Costs, Entire Project Period * Section A, Total Direct Cost less Consortium F&A for Entire Project Period $ 1,000, Section A, Total Consortium F&A for Entire Project Period $ * Section A, Total Direct Costs for Entire Project Period * Section B, Total Indirect Costs for Entire Project Period * Section C, Total Direct and Indirect Costs (A+B) for Entire Project Period $ $ $ 1,000, , ,525, Budget Justifications Personnel Justification Modbudget pdf Consortium Justification Additional Narrative Justification Tracking Number:

20 Attachments PersonnelJustification_attDataGroup0 Modbudget pdf ConsortiumJustification_attDataGroup0 application/pdf AdditionalNarrativeJustification_attDataGroup0 Tracking Number:

21 Virginia Hunt, Ph.D., Principal Investigator, (3 calendar months effort) will be responsible for morphological and immunohistochemical characterization of eye, brain, and other tumors arising in transgenic retinoblastomas and uveal melanomas as well as the study of cell death in the HPV E6 and E7 models. Alan Jones, Ph.D., Co-investigator, (1 academic month, 2 summer months effort) will develop the HPV E6 and E7 models of transgenic retinoblastoma mice and will determine the cellular genes responsible for the retinoblastoma in animal models. Steven Johnson, Ph.D., Statistician, (2.4 calendar months effort) will assist with experimental design by performing sample size calculations. He will analyze data on new models of transgenic mice as well as data from Vitamin D and virus treatment studies. Ms. Rachel Lato, M.S., Research Assistant, (12 calendar months effort) is responsible for the Lh-Tag mouse colony under the direction of the PI. She will maintain a breeding program to ensure adequate numbers of transgene-bearing animals. She will perform DNA extractions and PCR. Ms. Stephanie Wilson, Technician, (6 calendar months effort) is responsible for laboratory animal preparation and some of the biochemical analyses. To be Appointed Technician, (3 calendar months effort) is responsible for the repair and maintenance of the equipment and will run a variety of assays. Ms. Whitney Thomas, Graduate Student, (6 calendar months effort) in Dr. Smith's laboratory will participate in all aspects of the proposed experiments.

22 PHS 398 Research Plan 1. Application Type: From SF 424 (R&R) Cover Page and PHS398 Checklist. The responses provided on these pages, regarding the type of application being submitted, are repeated for your reference, as you attach the appropriate sections of the research plan. *Type of Application: New Resubmission Renewal Continuation Revision 2. Research Plan Attachments: Please attach applicable sections of the research plan, below. 1. Introduction to Application (for RESUBMISSION or REVISION only) 2. Specific Aims 3. Research Strategy Attachment pdf Attachment pdf 4. Inclusion Enrollment Report 5. Progress Report Publication List Human Subjects Sections 6. Protection of Human Subjects Attachment pdf 7. Inclusion of Women and Minorities 8. Targeted/Planned Enrollment Table 9. Inclusion of Children Other Research Plan Sections 10. Vertebrate Animals Attachment pdf 11. Select Agent Research 12. Multiple PD/PI Leadership Plan 13. Consortium/Contractual Arrangements 14. Letters of Support 15. Resource Sharing Plan(s) 16. Appendix

23 Attachments IntroductionToApplication_attDataGroup0 SpecificAims_attDataGroup0 Attachment pdf ResearchStrategy_attDataGroup0 Attachment pdf InclusionEnrollmentReport_attDataGroup0 ProgressReportPublicationList_attDataGroup0 ProtectionOfHumanSubjects_attDataGroup0 Attachment pdf InclusionOfWomenAndMinorities_attDataGroup0 TargetedPlannedEnrollmentTable_attDataGroup0 InclusionOfChildren_attDataGroup0 VertebrateAnimals_attDataGroup0 Attachment pdf SelectAgentResearch_attDataGroup0 MultiplePDPILeadershipPlan_attDataGroup0 ConsortiumContractualArrangements_attDataGroup0 LettersOfSupport_attDataGroup0 ResourceSharingPlans_attDataGroup0 Appendix Attachment pdf application/pdf application/pdf application/pdf application/pdf application/pdf

24 Specific Aims attached here limit one page

25 Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section (Part I Section 4.4.9). Follow the page limits for the Research Strategy in the table of page limits (Table 2.6-1), unless specified otherwise in the FOA. Note that the page limit for this attachment will be validated as a single file. (a) Significance Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. 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. (b) Innovation Explain how the application challenges and seeks to shift current research or clinical practice paradigms. 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. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions. (c) Approach Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 15 (Resource Sharing Plan), include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. 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. Point any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of Select Agents should appear in Item 11, below. As applicable, also include the following information as part of the Research Strategy, keeping within the three sections listed above: Significance, Innovation, and Approach. Preliminary Studies for New Applications: For new applications, include information on Preliminary Studies as part of the Approach section. Discuss the PD/PI s preliminary studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data (however, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in application

26 from Early Stage Investigators than on the preliminary data in applications from more established investigators). Progress Report for Renewal and Revision Applications. For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes to the specific aims and any new directions including changes resulting from significant budget reductions. A list of publications, patents, and other printed materials should be included in Item 5 (Progress Report Publication List); do not include that information here.

27 4.1 Protection of Human Subjects Risks to Human Subjects a. Human Subjects Involvement, Characteristics, and Design Describe the proposed involvement of human subjects in the work outlined in the Research Strategy section. Describe and justify the characteristics of the subject population, including their anticipated number, age range, and health status if relevant. Describe and justify the sampling plan, as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulation. Explain the rationale for the involvement of special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. Note that 'prisoners' includes all subjects involuntarily incarcerated (for example, in detention centers) as well as subjects who become incarcerated after the study begins. If relevant to the proposed research, describe procedures for assignment to a study group. As related to human subjects protection, describe and justify the selection of an intervention s dose, frequency, and administration. List any collaborating sites where human subjects research will be performed, and describe the role of those sites and collaborating investigators in performing the proposed research. Explain how data from the site(s) will be obtained, managed, and protected. b. Sources of Materials Describe the research material obtained from living individuals in the form of specimens, records, or data. Describe any data that will be collected from human subjects for the project(s) described in the application. Indicate who will have access to individually identifiable private information about human subjects. Provide information about how the specimens, records, and/or data are collected, managed, and protected as well as whether material or data that include individually identifiable private information will be collected specifically for the proposed research project. c. Potential Risks Describe the potential risks to subjects (physical, psychological, financial, legal, or other), and assess their likelihood and seriousness to the human subjects. Where appropriate, describe alternative treatments and procedures, including the risks and potential benefits of the alternative treatments and procedures, to participants in the proposed research Adequacy of Protection Against Risks a. Recruitment and Informed Consent

28 Describe plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. If a waiver of some or all of the elements of informed consent will be sought, provide justification for the waiver. Informed consent document(s) need not be submitted to the PHS agencies unless requested. b. Protections Against Risk Describe planned procedures for protecting against or minimizing potential risks, including risks to privacy of individuals or confidentiality of data, and assess their likely effectiveness. Research involving vulnerable populations, as described in the DHHS regulations, Subparts B-D must include additional protections. Refer to DHHS regulations, and OHRP guidance: Additional Protections for Pregnant Women, Human Fetuses and Neonates: Additional Protections for Prisoners: OHRP Subpart C Guidance: Additional Protections for Children: OHRP Subpart D Guidance: Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a general description of the plan for data and safety monitoring of clinical trials and adverse event reporting to the IRB, the NIH and others, as appropriate, to ensure the safety of subjects Potential Benefits of the Proposed Research to Human Subjects and Others Discuss the potential benefits of the research to research participants and others. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to research participants and others Importance of the Knowledge to be Gained Discuss the importance of the knowledge gained or to be gained as a result of the proposed research. Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result. NOTE: Test articles (investigational new drugs, devices, or biologics) including test articles that will be used for purposes or administered by routes that have not been approved for general use by the Food and Drug Administration (FDA) must be named. State whether the 30-day interval between submission of applicant certification to the FDA and its response has elapsed or has been waived and/or whether use of

29 the test article has been withheld or restricted by the FDA, and/or the status of requests for an Investigational New Drug (IND) or Investigational Device Exemption (IDE) covering the proposed use of the test article in the Research Plan.

30 If Vertebrate Animals are involved in the project, address each of the five points below. If all or part of the proposed research involving vertebrate animals will take place at alternate sites (such as project/performance or collaborating site(s)), identify those sites and describe the activities at those locations. Although no specific page limitation applies to this section of the application, be succinct. Failure to address the following five points will result in the application being designated as incomplete and will be ground for the PHS to defer the application from the peer review round. Alternatively, the application s impact/priority score may be negatively affected. The five points are as follows: 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 Association (AVMA) Guidelines on Euthanasia. If not, include a scientific justification for not following the recommendations. If the involvement of animals is indefinite, provide an explanation and indicate when it is anticipated that animals will be used. If an award is made, prior to the involvement of animals the grantee must submit to the NIH awarding office detailed information as required in points 1-5 above and verification of IACUC approval. If the grantee does not have an Animal Welfare Assurance then an appropriate Assurance will be required (See Part III, Section 2.2 Vertebrate Animals for more information). Do not use the vertebrate animal section to circumvent the page limits of the Research Strategy.

31 List references cited here

32 PHS 398 Checklist 1. Application Type: From SF 424 (R&R) Cover Page. The responses provided on the R&R cover page are repeated here for your reference, as you answer the questions that are specific to the PHS398. * Type of Application: New Resubmission Renewal Continuation Revision Federal Identifier: 2. Change of Investigator / Change of Institution Questions Change of principal investigator / program director Name of former principal investigator / program director: Prefix: * First Name: Middle Name: * Last Name: Suffix: Change of Grantee Institution * Name of former institution: 3. Inventions and Patents (For renewal applications only) * Inventions and Patents: Yes No If the answer is "Yes" then please answer the following: * Previously Reported: Yes No

33 4. * Program Income Is program income anticipated during the periods for which the grant support is requested? Yes No If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and source(s). Otherwise, leave this section blank. *Budget Period *Anticipated Amount ($) *Source(s) 5. * Disclosure Permission Statement If this application does not result in an award, is the Government permitted to disclose the title of your proposed project, and the name, address, telephone number and address of the official signing for the applicant organization, to organizations that may be interested in contacting you for further information (e.g., possible collaborations, investment)? Yes No

34 Only one copy of appendix material is necessary. Use the Add Attachments button to the right of this field to complete this entry. A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 appendix attachments are needed, combine the remaining information into attachment #10. Note that this is the total number of appendix items, not the total number of publications. When allowed there is a limit of 3 publications that are not publicly available (see below for further details and check the FOA for any specific instructions), though not all grant activity codes allow publications to be included in the appendix. Do not use the appendix to circumvent the page limits of the Research Strategy. Appendix material may not appear in the assembled application in the order attached, so it is important to use filenames for attachments that are descriptive of the content. A summary sheet listing all of the items included in the appendix is also encouraged but not required. When including a summary sheet, it should be included in the first appendix attachment. Applications that do not follow the appendix requirements may be delayed in the review process. New, resubmission, renewal, and revision applications may include the following materials in the Appendix (note, however, that some FOAs do not permit publications): Publications No longer allowed as appendix materials except in the circumstances noted below. Applicants may submit up to 3 of the following types of publications: o Manuscripts and/or abstracts accepted for publication but not yet published: The entire article should be submitted as a PDF attachment. o Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available: The entire article should be submitted as a PDF attachment. o Patents directly relevant to the project: The entire document should be submitted as a PDF attachment. (Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.) Surveys, questionnaires, and other data collection instruments; clinical protocols and informed consent documents may be submitted in the Appendix as necessary. For materials that cannot be submitted electronically or materials that cannot be converted to PDF format (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Officer for instructions following notification of assignment of the application to a SRG. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application. Items that must not be included in the appendix: Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Strategy PDF. However, images embedded in publications are allowed. Publications that are publicly accessible. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section.