NIH R01 Guide – Forms D This checklist is meant to be used as a tool and does not replace the detailed requirements for submission information, which are found in the SF424 (R&R)

Application Packages – Research Instructions for NIH and Other Agencies

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/research-forms-d.pdf

PI Name: ___________________________________

Title: ______________________________________ A “new’ application must have a different title from any other PHS project submitted for the same application due date with the same PD/PI. A “resubmission” or “renewal” application should normally have the same title as the previous grant or application. If the specific aims of the project have significantly changed, choose a new title. A “revision” application must have the same title as the currently funded grant. NIH and other PHS agencies limit title character length to 200 characters, including the spaces between words and punctuation.

Project Dates: ______________________________ Standard Due Dates for Competing Applications: http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/standard-due-dates.htm

Solicitation: _________________________________ Parent Announcements (For Unsolicited or Investigator-Initiated Applications): http://grants.nih.gov/grants/guide/parent_announcements.htm

Format Attachments Requirements• must be in PDF format• font size must be 11 points or larger (smaller text in figures, graphs, diagrams and

charts is acceptable as long as it is legible)• text color recommended black with the following recommended fonts: arial,

garamond, georgia, helvetica, palatino linotype, times new roman, verdana• do not include headers or footers in attachments• use paper size no larger than standard letter paper size (8.5’’ x 11’’)• provide at least one-half inch margins (top, bottom, left, right) for all pages

additional formatting information can be found here: http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm

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SF424 (R&R) Forms

□ Cover Letter Attachment (no page limit but generally 1 – 2 pages)Attach the cover letter, addressed to the Division of Receipt and Referral, in accordance with the announcement and/or the agency specific instructions. Applicants are encouraged to include a cover letter with the competing application. The cover letter should no longer be used for assignment requests. The new PHS assignment form is used for that purpose. Instead the cover letter should be used to relay information such as:

• Reason for late application• Explanation of why a Subaward isn’t active in all periods of the proposed project• Statements regarding agency approval documents (e.g., requests over

$500,000)• Intent to submit a video as part of the application (NOT-OD-12-141)• Indication that the proposed study will generate large-scale human or non-

human genomic data (NOT-OD-14-111 and NOT-OD-15-027)

Full instructions pages R-28-29

□ Project Summary/Abstract (30 lines of text maximum)State the application’s broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Full instructions pages R-39-40

□ Project Narrative (2 or 3 sentence maximum)Using no more than two or three sentences, describe the relevance of this research to public health. Full instructions page R-40

□ Bibliography & References Cited (no page limit)Each reference must 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. 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 or the PubMed Central (PMC) reference number for each article. Full instructions page R-40-41

□ Facilities & Other Resources (no page limit)Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). 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 will employ useful collaborative arrangements. If there are multiple performance sites, describe the resources available

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at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances. Full instructions page R-41

□ EquipmentList major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities. Full instructions page R-41-42

□ Other AttachmentsNot generally used for R01. Attach a file only to provide other project information in accordance with the announcement and/or agency-specific instructions.

R&R Senior/Key Person ProfileUnless otherwise specified in an agency announcement, senior/key personnel are defined as all individuals who contribute in a substantive, meaningful way to the scientific development or execution of the project, whether or not salaries are requested.

Also use this section to list any Other Significant Contributors (OSCs), who are those individuals who commit to contribute to the scientific development or execution of the project, but do not commit any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at effort of “zero person months” or “as needed.” Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs). Consultants should be included if they meet the OSC definition. OSCs should be listed after all senior/key persons. A biosketch is required for all senior/key persons and Other Significant Contributors.

□ Biographical Sketch (5 page limit)*see Appendix B for biographical sketch reference sheet*

R&R Budget Form R01 Applications will include either a R&R Detailed Budget or a PHS 398 Modular Budget form depending on the amount of Direct Costs requested per year. Modular budgets are applicable to R01 applications requesting $250,000 or less per year for direct costs. Detailed Budgets are applicable to applications that request more than $250,000 in Direct Costs per year.

Modular Budgets are simplified, therefore detailed categorical information is not required in the budget or justification. At a minimum, modular budget justifications require a personnel justification including project personnel names, roles, responsibilities and person months devoted to the project. A consortium justification

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.300-r&r-budget-form.htmhttps://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.320-phs-398-modular-budget-form.htmhttps://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.320-phs-398-modular-budget-form.htm

must be included if there is a subcontract. If there is a variation in the number of modules requested this must be explained in the additional narrative justification.

R&R Detailed Budgets require a detailed justification for each line item. A detailed justification includes descriptions of all costs requested, such as: personnel, fringe benefits, equipment, travel, materials and supplies, publication costs and consultant services. Applications requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must obtain approval from NIH IC programmatic staff at least six weeks before submitting the application.

□ Budget Justification*see Appendix C for Budget Justification Best Practices*

PHS 398 Research Plan Form

□ Introduction to Application (for resubmission or revision only, 1 page limit)NIH allows a thirty-seven month window for resubmission (only one resubmission is allowed for each new, unfunded application). Include an introduction for all resubmissions that summarizes substantial additions, deletions, and changes to the application and responds to the issues and criticism raised in the summary statement. Full instructions page R-80 and http://grants.nih.gov/grants/policy/amendedapps.htm

□ Specific Aims (1 page limit)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. Full instructions page R-80

□ Research Strategy (12 page limit)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 & References Cited section. Full instructions pages R-81-83. *note additions in Scientific Premise and Rigor Progress Report Publication List (renewal applications only)List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively. Full instructions page R-83

http://grants.nih.gov/grants/policy/amendedapps.htm

□ Protection of Human SubjectsComplete this section is you answered “yes” to the question “Are human subjects involved?”. If the answer is “no” to the question but your proposed research involves human specimens and/or data from subjects you must provide a justification in this section for your claim that no human subjects are involved. Full instructions page R-84 and Supplemental Instructions, Part II Section 4.1, https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental-instructions-forms-d.pdf

□ Data Safety Monitoring PlanComplete this section if you answered “yes” to Item 1, Clinical Trial. Refer to Supplemental Instructions, Part II Section 4.1.5, https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental-instructions-forms-d.pdf

□ Inclusion of Women and MinoritiesThis section is required for applicants answering “yes” to the question “Are human subjects involved?” and the research does not fall under Exemption 4. Refer to Supplemental Instructions, Part II (Section 4.2, 4.3, 5.6),http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental-instructions-forms-d.pdf

□ Inclusion of ChildrenThis section is required for applicants answering “yes” to the question “Are human subjects involved?” and the research does not fall under Exemption 4. Refer to Supplemental Instructions, Part II (Section 4.4, 5.8), http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental-instructions-forms-d.pdf

□ Vertebrate AnimalsComplete this section is you answered “yes” to the question “Are Vertebrate Animals Used?” If Vertebrate Animals are involved in the project, address each of the following criteria listed below:

1. Description of Procedures: Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Research Strategy section. Identify the species, stains, ages, sex, and total numbers of animals by species, to be used in the proposed work.

2. Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

Full instructions page R-86 additional information http://grants.nih.gov/grants/olaw/VASchecklist.pdf

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□ Select Agent ResearchIf any of the activities proposed in your application involve the use of select agents at any time during the proposed project period (list of agents:http://www.selectagents.gov/), either at the applicant organization or at any other performance site, address the following three points for each site at which select agent research will take place:

1. Identify the select agent(s) to be used in the proposed research.2. Provide the registration status of all entities where select agent(s) will be used.3. Provide a description of all facilities where the select agent(s) will be used.

□ Multiple PD/PI Leadership PlanFor applications designated multiple PD/PIs, a leadership plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedure for resolving conflicts. Full instructions page R-87-88

□ Consortium/Contractual ArrangementsExplain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s) The Letter of Intent from the Consortium site is uploaded here. Full instructions page R-88

□ Letters of SupportAttach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per year anticipated. Full instructions page R-88-89

□ Resource Sharing PlanWhen resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. See Supplemental Instructions, Part III 1.5, http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental-instructions-forms-d.pdf

□ Authentication of Key Biological and/or Chemical Resources (limit 1 page)If applicable to the proposed science, briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed

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research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Full instructions page R-90

□ AppendixA maximum of 10 PDF attachments is allowed in the appendix. Very few items are allowed in the appendix. Full instructions pages R-90-92See also New Policy Eliminates Most Appendix Material for NIH Applications NOT-OD-16-129

PHS Inclusion Enrollment Report The PHS Inclusion Enrollment Report form is used for all applications involving NIH-defined clinical research. This form is used to report both planned and cumulative (or actual) enrollment, and describes the sex/gender, race, and ethnicity of the study participants. Full instructions page R-93, additional information Supplemental Instructions, Part II Section 4.3, https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental-instructions-forms-d.pdf

PHS Assignment Request Form The optional Assignment Request Form may be used to communicate specific application assignment and review requests to the Division of Receipt and Referral (DRR) and to Scientific Review Officers (SROs). This information was previously collected in the Cover Letter Attachment, but now this optional information must be provided on the Assignment Request Form and not in the Cover Letter Attachment. Full instructions pages R-97-98

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NIH R01 Checklist – Forms D

□ Cover Letter (generally 1 – 2 pages)□ Project Summary/Abstract (30 lines of text maximum)□ Project Narrative (2 or 3 sentences maximum)□ Bibliography & References Cites□ Facilities & Other Resources□ Equipment□ Biographical Sketch (5 page limit)□ Budget Justification□ Introduction to Application (for resubmission or renewal only, 1 page limit)□ Specific Aims (1 page limit)□ Research Strategy (12 page limit)□ Progress Report Publication List (renewal application only)□ Protection of Human Subjects (if human subjects involved)□ Data Safety Monitoring Plan (if clinical trial)□ Inclusion of Women and Minorities (if human subjects involved)□ Inclusion of Children (if human subjects involved)□ Vertebrate Animals (if vertebrate animals used)□ Select Agent Research (if application involves the use of select agents)□ Multiple PD/PI Leadership Plan (if designated multiple PD/PI application)□ Consortium/Contractual Arrangements□ Letters of Support□ Resource Sharing Plan□ Authentication of Key Biological and/or Chemical Resources (1 page limit)□ Appendix□ Inclusion Enrollment Report□ Assignment Request Form

Appendix A – Additional Items Required For Subcontractors

□ Official organization name, DUNS number, address□ Administrative contact information for Institution□ Contact information from PI□ NIH biographical sketch for Subaward PI□ Letter of Intent to collaborate/consortium letter from Authorized (OSP) Official□ Letter of Support from collaborating Senior/Key Personnel□ COI Disclosure from PI (or evidence that their Institution is in compliance) IF not part of FDP

Pilot (See UMN FDP Pilot)

□ Information about Facilities/Equipment/Resources to add to UMN application□ Budget on R&R Budget Pages and budget justification□ Scope of Work (describes the actual work being completed by the Collaborator)

http://www.ospa.umn.edu/documents/FDPpilot.html

Appendix B – NIH General Biographical Sketch Reference Sheet

NIH General Biographical Sketch Reference Sheet

The biographical sketch may not exceed five pages and follows the format below:

A. Personal Statement• Briefly describe why you are well-suited for your role in the project described in

this application• Identify up to four peer-reviewed publications that specifically highlight your

experience and qualifications for this project• May explain impediments to your past productivity and include a description of

factors such as family care responsibilities, illness, disability, and active militaryservice

B. Positions and Honors• List in chronological order previous positions, concluding with the present

position. List any honors. Include present membership on any FederalGovernment public advisory committee.

C. Contribution to Science• Briefly describe up to five of your most significant contributions to science• For each contribution, reference up to four-peer reviewed publications or other

non-publication research products (can include audio or video products; patents;data and research materials; databases; educational aids or curricula;instruments or equipment; models; protocols; and software or netware) *note:applicants may use ‘et al’ in lieu of listing all authors in a citation

• The description of each contribution should be no longer than one half pageincluding figures and citations

• May provide a URL to a full list of published work – this URL must be to aFederal Government website (a .gov suffix). NIH recommends using MyBibliography. Providing a URL to a list of published work is not required, andreviewers are not required to look at the list.

D. Research Support• List both selected ongoing and completed research projects for the past three

years (Federal or non-Federally supported)• Begin with the projects that are most relevant to the research proposed in the

application• Do not include number of person months or direct costs

Appendix B- NIH General Biographical Reference Sheet – SAMPLE BIOSKETCH

BIOGRAPHICAL SKETCH DO NOT EXCEED FIVE 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. Add/delete rows as necessary.)

INSTITUTION AND LOCATION

DEGREE (if

applicable)

Completion Date

MM/YYYY

FIELD OF STUDY

University of California, Berkeley B.S 05/1990 Psychology

University of Vermont Ph.D. 05/1996 Experimental Psychology

University of California, Berkeley Postdoctoral 08/1998 Public Health and Epidemiology

A. Personal Statement I have the expertise, leadership, training, expertise and motivation necessary to successfully carry out the proposed research project. I have a broad background in psychology, with specific training and expertise in ethnographic and survey research and secondary data analysis on psychological aspects of drug addiction. My research includes 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 as documented in the following publications. 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. During 2005-2006 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. 1. Merryle, R.J. & Hunt, M.C. (2004). Independent living, physical disability and substance abuse among the

elderly. Psychology and Aging, 23(4), 10-22. 2. Hunt, M.C., Jensen, J.L. & Crenshaw, W. (2007). Substance abuse and mental health among community-

dwelling elderly. International Journal of Geriatric Psychiatry, 24(9), 1124-1135. 3. 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), 236-245. PMCID: PMC9162292 Hunt, M.C., Newlin, D.B. & Fishbein, D. (2009). Brain imaging in methamphetamine abusers across the life-span. Gerontology, 46(3), 122-145.

B. Positions and Honors

Positions and Employment 1998-2000 Fellow, Division of Intramural Research, National Institute of Drug Abuse, Bethesda, MD

Appendix B- NIH General Biographical Reference Sheet – SAMPLE BIOSKETCH 2000-2002 Lecturer, Department of Psychology, Middlebury College, Middlebury, VT 2001- Consultant, Coastal Psychological Services, San Francisco, CA 2002-2005 Assistant Professor, Department of Psychology, Washington University, St. Louis, MO 2007- Associate Professor, Department of Psychology, Washington University, St. Louis, MO

Other Experience and Professional Memberships 1995- Member, American Psychological Association 1998- Member, Gerontological Society of America 1998- Member, American Geriatrics Society 2000- Associate Editor, Psychology and Aging 2003- Board of Advisors, Senior Services of Eastern Missouri 2003-05 NIH Peer Review Committee: Psychobiology of Aging, ad hoc reviewer 2007-11 NIH Risk, Adult Addictions Study Section, members

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. Contribution to Science 1. My early publications directly addressed the fact that substance abuse is often overlooked in older adults.

However, because many older adults were raised during an era of increased drug and alcohol use, there are reasons to believe that this will become an increasing issue as the population ages. These publications found that older adults appear in a variety of primary care settings or seek mental health providers to deal with emerging addiction problems. These publications document this emerging problem but guide primary care providers and geriatric mental health providers to recognize symptoms, assess the nature of the problem and apply the necessary interventions. By providing evidence and simple clinical approaches, this body of work has changed the standards of care for addicted older adults and will continue to provide assistance in relevant medical settings well into the future. I served as the primary investigator or co-investigator in all of these studies.

a. 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), 222-238.

b. 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), 46-58.

c. 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),26-37.

d. 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), 1436-1606. PMCID: PMC9000292

2. In addition to the contributions described above, with a team of collaborators, I directly documented the effectiveness of various intervention models for older substance abusers and demonstrated the importance of social support networks. These studies emphasized contextual factors in the etiology and maintenance of addictive disorders and the disruptive potential of networks in substance abuse treatment. This body of work also discusses the prevalence of alcohol, amphetamine, and opioid abuse in older adults and how networking approaches can be used to mitigate the effects of these disorders.

a. 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), 15-23.

b. 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), 134-149.

c. Merryle, R. & Hunt, M.C. (2007). Randomized clinical trial of cotinine in older nicotine addicts. Age and Ageing, 38(2), 9-23. PMCID: PMC9002364

Appendix B- NIH General Biographical Reference Sheet – SAMPLE BIOSKETCH 3. Methadone maintenance has been used to treat narcotics addicts for many years but I led research that

has shown that over the long-term, those in methadone treatment view themselves negatively and they gradually begin to view treatment as an intrusion into normal life. Elderly narcotics users were shown in carefully constructed ethnographic studies to be especially responsive to tailored social support networks that allow them to eventually reduce their maintenance doses and move into other forms of therapy. These studies also demonstrate the policy and commercial implications associated with these findings.

a. Hunt, M.C. & Jensen, J.L. (2003). Morbidity among elderly substance abusers. Journal of the

Geriatrics, 60(4), 45-61. b. Hunt, M.C. & Pour, B. (2004). Methadone treatment and personal assessment. Journal Drug

Abuse, 45(5), 15-26. c. Merryle, R. & Hunt, M.C. (2005). The use of various nicotine delivery systems by older nicotine

addicts. Journal of Ageing, 54(1), 24-41. PMCID: PMC9112304 d. 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.

Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/collections/public/1PgT7IEFIAJBtGMRDdWFmjWAO/?sort=date&direction=ascending

D. Additional Information: Research Support and/or Scholastic Performance

Ongoing Research Support R01 DA942367 Hunt (PI) 09/01/08-08/31/16 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 MH922731 Merryle (PI) 12/15/07-11/30/15 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 08/15/09-08/14/15 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. Role: PI

Completed Research Support R21 AA998075 Hunt (PI) 01/01/11-12/31/13 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

http://www.ncbi.nlm.nih.gov/sites/myncbi/collections/public/1PgT7IEFIAJBtGMRDdWFmjWAO/?sort=date&direction=ascendinghttp://www.ncbi.nlm.nih.gov/sites/myncbi/collections/public/1PgT7IEFIAJBtGMRDdWFmjWAO/?sort=date&direction=ascending

Appendix C- Budget Justification Best Practices

Budget Justification Best Practices

Budget justifications are critical to explain the necessity and importance of project costs. Explanations should focus on how each budget item is required to achieve the aims of the project. The budget justification should:

• Follow funding agency guidelines • Explain why each item is required to accomplish the specific aims of the proposed project • Be organized • Clearly identify that all budget requests are reasonable and consistent with sponsor and University of Minnesota

guidelines Generally budget justifications are broken into the main categories listed below. Funding agency guidelines may list different categories or criteria allowable in a budget. Always follow funding agency guidelines.

Personnel This category can be split into two categories: Senior/Key Personnel and Other Personnel depending on agency guidelines. Senior/Key Personnel List any personnel who is a PI, Co-PI, Co-I or Project Director. Provide their name, title, and effort to be given to the project in calendar, academic and/or summer months. Describe what the individual’s role will be on the project.

Example: Key Personnel Jane Smith, MD (Effort: 2.64 calendar in Y1, 3.6 calendar in Yrs 2-5) Principal Investigator. Dr. Smith is currently an Associate Professor in Physical Medicine and Rehabilitation. She will coordinate and lead the exercise intervention study with acquisition of biopsies and will be the Site PI of the study. Dr. Smith will oversee the investigative team and will perform the biopsies. She will work with the MoTrPAC program to implement the proposed studies. John Doe, MD (Effort: .36 calendar in Y1, .96 calendar in Yrs 2-5) Co-Investigator. Dr. Doe is currently a Professor in biostatistics with experience with large scale clinical trials. He will work with Dr. Smith on implementing the proposed protocol by providing guidance on clinical trial management, recruitment, compliance, ongoing quality control and statistical analysis. See letter from Dr. Doe. John Jones, PhD (Effort: 1.2 calendar in Yrs 1-5) Co-Investigator. Dr. Jones is currently a Professor in the School of Kinesiology with experience with training-based studies including muscle biopsy based analysis and use of SphygmoCor CP system. Dr. Jones will work with the study’s exercise physiologist to ensure the quality and implementation of the training program as well as providing trainers through the Intervention Research Course. Other Personnel List all other individuals that contribute effort to the proposed project. Include their name (when known), title, amount of effort to be given to the project in calendar, academic and/or summer months and a description of the individual’s role.

Appendix C- Budget Justification Best Practices Example Other Personnel Jane Doe, Postdoctoral fellow, (12.0 Calendar Months): Dr. Doe obtained her PhD in kinesiology in 2015, and since then has worked in the Department of Neurology. She is an expert in equipment and data processing workflows which will be used in the present proposal. Dr. Doe will assist Dr. Smith in collecting, processing, analyzing and reporting data. Dr. Doe will assist with data analysis, maintain the equipment and make sure there are adequate supplies. She will also contribute to the writing of project reports, abstracts and papers. John Smith, Biostatistics Fellow, (6.0 Calendar Months): Under the direction of Dr. John Doe, this person will perform all analysis aspects of the project for Aim 2. His responsibility will include: distortion correction, segmentation of and volume rendering, all needed for the creation of a patient-specific model. Finally, the person will compute the volume of tissue activated (VTAs) and the overlap volume of the parcellated regions for each individual patient and correlate it with the stimulation setting under the clinical parameters being tested in the project. TBN, Study Coordinator, (6.0 Calendar Months): The study coordinator will be responsible for, study binders, adverse event reporting and other regulatory requirements, as well as recruitment, retention, and scheduling of participants, and will assist the postdoctoral fellow with collating and managing data.

Other Significant Contributors List individuals who will contribute to the scientific development or execution of the proposed project, but are not committing any specified effort.

Consultants Provide the consultants name, institution and expertise. Justify the area of expertise the consultant will provide to the proposed project. If the consultant is a paid consultant, justify the calculation of the rate. Provide a letter from each consultant with terms and willingness to consult.

Fringe Benefits List the benefit rate used for each University of Minnesota employee group. Current University of Minnesota fringe rates can be found here: U of MN Fringe Benefit Rates

Travel Justify domestic and foreign travel separately. Explain who is going, when, where and why and follow with estimated costs.

Example: Domestic Travel: Funds are requested for travel to one scientific meeting/year for the principal investigator and research fellow to present and discuss experimental findings. The primary scientific forums that will be targeted include Society for Neuroscience annual meetings as well as certain clinical venues (e.g. Movement Disorders Society). This request is for $1,800/meeting/person for an annual cost of approximately $3,600 Foreign Travel: Funds are requested in Year 3 for the Principal Investigator to travel to Costa Rica to collect data from the Center for Neuroscience and Clinical Research Unit where a concurrent arm of the trial is taking place. The estimate

http://www.ospa.umn.edu/forms/FringeBenefitRates.html

Appendix C- Budget Justification Best Practices is based on $1,500 airfare, $110 hotel per night for 10 nights, and standard government per diem rates for an estimated cost of $3600.

Equipment Equipment is defined as an item that has a useful life of more than one year and a cost of at least $5,000. Describe the type of equipment, model and vendor name and how the equipment will be used in the proposed project. Explain why the equipment is necessary for this specific project rather than a shared resource. Example Equipment 96-channel TDT electrophysiological workstation: Funds are requested to purchase for a neurophysiology workstation in year 2. This is a multichannel, real-time data acquisition system for simultaneous recording and analysis of neural activity from the cortical and subcortical arrays. The system will be purchased and set up during year 2 in preparation for implantation of arrays in the first set of Aim 2 in the second half of that year. The cost of the system is $75,250.

Supplies and Materials Describe in detail the supplies/materials that make up the costs proposed. Explain how the project will benefit from the purchase of the supplies and materials proposed. Categorize supplies if necessary (i.e. lab supplies, surgical supplies, computer software and supplies, etc.) then itemize and justify the expenses within the categories.

Example General Lab Supplies: General lab supplies include counting vials, pipettes, anesthetics, syringes, catheters and needles, solution sets, saline, alcohol and gauze pads, bandages, disposable pads, 3-way stopcocks, gloves, booties and tourniquets. We estimate general supplies will total roughly $5,275. Imaging Software: Dedicated software to integrate PET and MRI will be required to generate accurate and reproducible data. We currently use the Pixelwise Modeling Software package, since we have established that this package works with our existing instruments to output quantitative data. One PMOD license with the required modules is $12,000/yr. Computer Supplies: Server maintenance and data archival also require costs such as back-up media and accessories costs, back-up media and accessories will be dedicated to this maintaining the integrity of this project and archiving the data for reproducibility $3,238/yr.

Other Expenses Costs that are essential to the project’s research and which will be used solely for the project may be budgeted with proper justification. Always explain why purchases are essential to the project’s aims and dedicated only to research on this project, and explain how the costs were calculated. Though different grant mechanisms allow or disallow various other direct costs, typical allowable other direct costs include the following:

• Publication costs • Animal purchase and care costs • Fees-for-service (i.e. processing, surgical, imaging, and lab services expenses) • Human subject payments • Equipment maintenance for equipment dedicated to the project

Appendix C- Budget Justification Best Practices Example Other Expenses Research Animal Resources, housing costs for mice: per diem is $0.70/cage; can house up to 4 female mice/cage. Aggressive male mice require single housing. On average, cages hold 2.4 mice. All pups produced by a responder x activator mating will be housed for up to 60 days, until genotyping is completed, experimental animals identified, and litters are culled. We estimate 2400 mice (960 cages) dedicated to this project each year for the duration of the work. Genotyping for Mice: In addition to in-house genotyping, with supplies listed above, we anticipate using Transnetyx automated genotyping as possible, at a cost of $7 - $9 per sample, to classify mice for this project. Machine shop charges: Fabrication of superfusion chambers for electrophysiological recordings, adjustable mount for gene-gun; 15 hours

Subawards Indicate the reasons why a portion of the technical or programmatic effort must be subcontracted and provide an explanation of the method used to select the subrecipient, as well as the reasons why the subrecipient was selected.

NIH Grants

Modular Grants Justify the personnel only.

Non-Modular Grants Use a detailed justification that uses the following format:

A) Senior/Key Personnel B) Other Personnel C) Equipment D) Travel E) Trainee Costs (leave this blank unless otherwise stated in the FOA) F) Other Direct Costs (Do not use categories you aren’t spending in and only use the headers, not the letters)

a. Materials and Supplies b. Animal Costs c. Publication Costs d. Consultant Services e. ADP/Computer Services f. Alterations and Renovations g. Research Patient Care Costs h. Tuition i. Other Expenses

G) Consortium/Subawards For more information: Develop your Budget (NIH) Need more help on a budget justification? Reach out to an established investigator or your grant administrator.

https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget.htm#personnel

Appendix C – Budget Justification Best Practices

Budget Justification Checklist

□ Does the budget justification follow the same order as the budget?

□ Does the budget justification give additional details to explain the costs included inthe budget?

□ Does the budget justification include only items allowable, reasonable & allocable?

□ Is the budget justification easy to read (short paragraphs, headings for differentbudget categories, etc.)?

□ Is the budget justification concise? (No more than 3 pages for NSF)

□ Do the numbers in the budget justification match those in the budget?

biosketch-sample-Forms-D.pdfBIOGRAPHICAL SKETCHA. Personal StatementB. Positions and HonorsPositions and EmploymentOther Experience and Professional MembershipsHonors

C. Contribution to ScienceComplete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/collections/public/1PgT7IEFIAJBtGMRDdWFmjWAO/?sort=date&direction=ascending

D. Additional Information: Research Support and/or Scholastic PerformanceOngoing Research SupportCompleted Research Support

Budget Justification Best Practices.pdfPersonnelExample:Example

Other Significant ContributorsConsultantsFringe BenefitsTravelExample:

EquipmentSupplies and MaterialsExample

Other ExpensesExample Other Expenses

SubawardsNIH GrantsModular GrantsNon-Modular Grants

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