NIH CHECKLIST INTERNAL DEADLINE ELEMENTS TO COMPLETE COMPONENTS OF PROPOSAL PERSON RESPONSIBLE NOTES

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1 NIH CHECKLIST PRINCIPAL INVESTIGATOR: RFA IN RESPONSE TO (RFA/PA): DUE DATES: TITLE OF PROJECT: CO-PRINCIPAL INVESTIGATOR(S): SENIOR PERSONNEL: INSTRUCTIONS LINKS: PROGRAM OFFICER CONTACT: General Formatting Guidelines Allowable fonts: Arial, Helvetica, Palatino, Georgia, 11 point or larger, black in color; smaller fonts may be used in equations, tables, figure legends Type density: No more than 6 lines of text per vertical inch; 15 characters per inch Pagination: No headers or footers. Grants.gov and era Commons will automatically paginate the application and supply necessary headers and footers. Margins: 0.5 inches margins Page formatting: Use only single columns Attachments: Except for Biosketch, no specific form page for any required attachment. Should be converted to.pdf prior to upload. File names should contain no spaces or special characters. COMPONENTS OF PROPOSAL ELEMENTS TO COMPLETE NOTES PERSON RESPONSIBLE INTERNAL DEADLINE Cover Letter For internal use; placed at the beginning of original not included in copies (optional but highly recommended) Application title. 81 character limit for all titles (this includes spaces). should capture the essence of goals and objectives and hook the reader Funding Opportunity Announcement (PA, RFA or Parent Announcement title). Request of an assignment (referral) to a particular IC or Scientific Review Group (SRG). List of individuals (e.g., competitors) who should not review the application and why. Disciplines involved, if multidisciplinary. 1 of 6

2 COMPONENTS OF PROPOSAL ELEMENTS TO COMPLETE NOTES PERSON RESPONSIBLE INTERNAL DEADLINE Project Summary/Abstract 30 lines Should briefly summarize the project with greatest focus on the expected outcomes and broader impacts of the project as they relate to the NIH mission. Project Narrative 2-3 lines Should state in layman s terms the importance of the project to public health. Research Plan Includes elements 1-16 below as applicable to your proposal 1. Introduction 1 page Include only for supplements and A1 (or A2) submissions. 2. Specific Aims 3. Research Strategy Limited to 1 pg. 12 pages for R01; 6 pages for R21 or R03 Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section 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. 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. Must contain the following 3 sections: 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. 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 2 of 6

3 COMPONENTS OF PROPOSAL ELEMENTS TO COMPLETE NOTES PERSON RESPONSIBLE INTERNAL DEADLINE interventions. Approach - Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in the 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 out 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 If an applicant has multiple Specific Aims, then the applicant may address Significance, Innovation and Approach for each Specific Aim individually, or may address Significance, Innovation and Approach for all of the Specific Aims collectively. 4. Inclusion Enrollment Report Applies only to clinical research 5. Bibliography & References cited Progress Report Publication List No page limit References must include the names of all authors in the same sequence in which they appear in print include the names of all authors (in the same sequence in which they appear in the publication),the article and journal title, book title, volume number, page numbers, and year of publication. Progress Report applies only to competitive renewal applications 6. Protection of Human Subjects Is your project Human Subjects research?if NO, you do not need this section. If YES, you will need the following: The Protection of Human Subjects section consists of four parts: 1. Protection of Human Subjects 2. Inclusion of Women and Minorities 3 of 6

4 COMPONENTS OF PROPOSAL ELEMENTS TO COMPLETE NOTES PERSON RESPONSIBLE INTERNAL DEADLINE 3. Planned Enrollment Report 4. Inclusion of Children 7. Inclusion of Women/minorities To determine if Inclusion of Women and Minorities applies to the application, see Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, Sections 4.2 and Planned Enrollment Report Only if application involves the Inclusion of Women and Minorities 9. Inclusion of Children To determine if Inclusion of Children applies to the application, see Part II Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, Sections 4.4 and Vertebrate Animals Applies only if using animals 11. Select Agent Research If using Select Agents (hazardous biological agents and toxins) 12. Multiple PI Leadership Plan Applies only to multi-pi proposals. Should describe governance of the overall project and roles of the various PIs. Contact the NSM Research Office for examples 13. Consortium/ Contractual Arrangements Applies only when sub-recipient organizations are involved. Describe needed arrangements between organizations. If subcontracts represent a large portion of the project, justify for the lead institution being the grantee instead of one of the subs. 14. Letters of Support Included letters should demonstrate true consortium or collaboration support. 4 of 6

5 COMPONENTS OF PROPOSAL ELEMENTS TO COMPLETE NOTES PERSON RESPONSIBLE INTERNAL DEADLINE 15. Resource Sharing Plan Please see SF424 Application Guide and/or specific RFA or PA to determine if this is required Biographical Sketches 4 page max. unless otherwise stated Include for each key person; Must use NIH format (Format & Example provided) include PMCIDs for all applicable papers NOTE: a personal statement is required as new section A and Publications now limited to 15 Budget Budget Justification Direct Costs <$250K/yr=Modular; >$250K/yr=Detailed For MODULAR budgets the budget justification will consist of personnel descriptions only. For NON-MODULAR budgets, the budget justification will be a fully detailed categorical description. Sub-Recipient Budget Include separate budget justification attached to sub-recipient budget file; if modular budget, include Consortium Justification Facilities Should contain information on applicable laboratory, animal, computer, office clinical and other facilities as well as information regarding general scientific (including intellectual) environment For ESIs, should contain information regarding institutional commitment to investigator; Should compile information for all subrecipients as well Equipment Describe all relevant available major equipment, either in PI lab or through department; Should compile information for all sub-recipients as well Appendix No more than 10 files, of which no more than 3 can be accepted manuscripts or published journal articles not publicly accessible online. NSF Checklist Completion of form 5 of 6

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7 Program Director/Principal Investigator (Last, First, Middle): 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 POSITION TITLE era COMMONS USER NAME (credential, e.g., agency login) 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) NOTE: The Biographical Sketch may not exceed four pages. Follow the formats and instructions below. A. Personal Statement Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application. Within this section you may, if you choose, briefly describe factors such as family care responsibilities, illness, disability, and active duty military service that may have affected your scientific advancement or productivity. B. Positions and Honors List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee. C. Selected Peer-reviewed Publications NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference (note that copies of publicly available publications are not accepted as appendix material.) D. Research Support List both selected ongoing and completed research projects for the past three years (Federal or non-federallysupported). Begin with the projects that are most relevant to the research proposed in the 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 /0002 (Rev. 08/12) Page Biographical Sketch Format Page

8 Program Director/Principal Investigator (Last, First, Middle): Hunt, Morgan C. 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, Morgan Casey era COMMONS USER NAME (credential, e.g., agency login) huntmc 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 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 peer-reviewed 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 co-investigators (Drs. Gryczynski and Newlin) who provide additional expertise in cognition, gerontology and geriatrics. During my career was disrupted due to family obligations. However, upon returning to the field I immediately resumed my research projects and collaborations and successfully competed for NIH support. In summary, I have a demonstrated record of accomplished 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 /0002 (Rev. 08/12) Page 5 Biographical Sketch Format Page

9 Program Director/Principal Investigator (Last, First, Middle): Hunt, Morgan C Associate Professor, Department of Psychology, Washington University, St. Louis, MO 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 2004 Excellence in Teaching, Washington University, St. Louis, MO 2009 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, M.C. (2004). Independent living, physical disability and substance abuse among the elderly. Psychology and Aging, 23(4), Hunt, M.C., Jensen, J.L. & Crenshaw, W. (2007). Substance abuse and mental health among communitydwelling elderly. International Journal of Geriatric Psychiatry, 24(9), Hunt, M.C., 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, M.C., Newlin, D.B. & Fishbein, D. (2009). Brain imaging in methamphetamine abusers across the life-span. Gerontology, 46(3), Hunt, M.C. & 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, M.C. (2002). Community based participatory research with late-life addicts. American Journal of Alcohol and Drug Abuse, 15(3), Shaft, B.M., Hunt, M.C., 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, M.C., 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, M.C., 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, M.C., 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, M.C., Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A. (2007). Community-based intervention strategies for reducing alcohol and drug abuse in the elderly. Addiction, 104(9), PMCID: PMC Merryle, R. & Hunt, M.C. (2007). Randomized clinical trial of cotinine in older nicotine addicts. Age and Ageing, 38(2), PMCID: PMC Hunt, M.C., Jensen, J.L. & Merryle, R. (2008). The aging addict: ethnographic profiles of the elderly drug user. NY, NY: W. W. Norton & Company. 9. Hunt, M.C. (2009). Contrasting ethnicity with race in the older alcoholic. The Journals of Gerontology Series B: Psychological Sciences and Social Sciences, in press. PMCID: PMC Journal In Process. 10. Hunt, M.C. (2009). Intervening successfully with the older methadone patient. Journal of Applied Gerontology, 13(4), /0002 (Rev. 08/12) Page 6 Biographical Sketch Format Page

10 Program Director/Principal Investigator (Last, First, Middle): Hunt, Morgan C. D. Research Support Ongoing Research Support R01 DA Hunt (PI) 09/01/08-08/31/13 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) 12/15/07-11/30/12 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) 02/01/02-01/31/05 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) 01/01/02-12/31/04 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 /0002 (Rev. 08/12) Page 7 Biographical Sketch Format Page

11 Program Director/Principal Investigator (Last, First, Middle): 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 POSITION TITLE era COMMONS USER NAME (credential, e.g., agency login) 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) Please refer to the application instructions in order to complete sections A, B, C, and D of the Biographical Sketch. OMB No /0002 (Rev. 08/12 Approved Through 8/31/2015) Page Biographical Sketch Format Page

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