Research Administration Demonstration Training Series

Transcription

1 Research Administration Demonstration Training Series UTSW Proposal Development & Submission Jamie F. Wilson Supervisor, Pre-Award Administration (Proposals)

2 Lifecycle of an Award Identify Funding Opportunity Award Closeout Develop a Proposal SPA Award Management Award Acceptance

3 Objective Eliminate variation and promote consistency throughout the proposal submission cycle Decrease the margin of error and return ratio of a proposal once submitted to SPA Promote awareness through in-depth comprehensive documentation of processes Answer the WHY behind the processes Foster more efficient working relationship between SPA and the Research Community

4 Process Map egrants Proposal (i.e. Funding Proposal, Continuation, Modification) creation and initiation begins with the PI and/or Department PI/Department initiates SPA review (Submit for Review and Departmental and Division Approvals) SPA reviews/audits proposal and reconciles with Department AOR approves proposal and carries out submission (some sponsors require submission by PI)

5 When & Why to utilize egrants Initiated & Routed in egrants Initiated & Routed Outside of egrants (Utilize existing FP for historical record) Not routed in egrants (Utilize existing FP for historical record) New proposals Just in Time Sponsor Correspondence Competitive Renewals Award Terminations/Closeouts Pre-Applications (any requested information before official invitation to apply) Proposal Resubmissions Award Revisions Continuations (noncompeting renewals) Award Transfers Award Terminations/Closeouts Post Submission Material Request(s) for award modifications requiring sponsor approval

6 Who can utilize egrants? All UTSW personnel can access egrants Read-only rights and Edit rights are available All users are required to complete and submit an eresearch Access Request Form in order to be granted access. Personnel who have not completed/submitted a form will not only be prohibited to access egrants, but will not be available in egrants to select/add to a FP. Individuals will have to be added as TBD until the form is submitted.

7 Improving Accuracy Common errors (top 5 sponsors) National Institutes of Health (NIH) Commons ID for all PD/PI s listed Change/Corrected Application (requires Grants Tracking Number) Federal Identifier renewals & resubmissions 2 Letter NIH institute + 6 digit serial number (ex. CA012345) Project Dates Cover Letter content Non-Grants.gov Submission Incoming Sub-Award Prime guidelines (i.e. submission details, project period, budget limitations, effort, etc) Statement of Work (SOW) Budget & Budget Justification Consortium Letter DHHS Agreement Budget Justification IACUC and IRB Protocol Approval Status new & renewals = Pending Point 5 of the Vertebrate Animal is method of euthanasia consistent with AVMA guidelines? Sponsor Information (1.5) NIH = Specific NIH Institute Flow Through = Prime Institution Fellowship/Training Grants mentor should be listed on page 3.0 Personnel Costs Modular Budgets $250k Direct Cost limit, $25k increments Personnel justification only

8 Improving Accuracy Common errors (top 5 sponsors) NIH Continued Other Significant Contributors Senior key personnel, per NIH definition Do not have measurable effort or salary Bio-sketch should be included UTSW faculty requirement Cannot be listed as consultant (exception = AHA) Minimum of 3% effort Cannot be overcommitted Cancer Prevention and Research Institute of Texas (CPRIT) State and Legislative Districts State Senate District 23 State House District 100 (South Campus) 103 (North Campus) Bio-sketches limited to 2 pages (exception MIRA projects = 5 pages) Indirect Cost rate = 5% of Total Costs (actual rate = 5.263% of DC) Salary Cap = $200,000 Effort should be reported in percentage

9 Improving Accuracy Common errors (top 5 sponsors) Department of Defense (DOD) Application Filing Name = CDMRP Log Number (e.g. PC13####, BC13####, etc.) Credential, e.g. Agency Login Field = PI s username provided from CDMRP

10 Improving Accuracy Common errors (top 5 sponsors) DOD Continued Pre-Application (section 20 of SF424) Do Not include unless specified in FOA Other Support (Previous/Current/Pending) Title Time Commitments Supporting Agency Name & Address of Funding Agency s Procuring Contracting/Grants Officer Performance Period Level of Funding Brief Description of Project Goals Specific Aims Clearly state if there is overlap Welch Foundation Formatting very specific Single spaced/5 lines per vertical inch 1 inch margins Bio-sketch 2 page limit Progress Reports and Budgets require original signatures American Heart Association (AHA) UTSW personnel can be consultants AAALAC effective/accreditation date 7/3/2014

11 Grantsmanship vs. Compliance Created to convey a clear distinction between what SPA recommends versus what is required and/or what will hinder a successful submission. 3 Different Entities involved: (1) Federal Government (2) University of Texas System (3) Sponsor

12 Grantsmanship Component GRANTSMANSHIP ITEMS Point 5 verbiage of the Vertebrate Animals Section (method of euthanasia consistent with AVMA) Inclusion of Additional Narrative (Modular Budgets) Inclusion of only Personnel Justification for Modular Budgets Clearing Modular Offset in egrants Inclusion of Resource Sharing Plans Other Significant Contributors reporting no effort or salary and being designated as Key Personnel Budget Discrepancies Budget Justification Discrepancies Attachment of additional documents throughout application (ex. Other Attachments, LOS, Appendix) Effort reporting - calendar months vs. percentage (NIH Specific)

13 Compliance Component COMPLIANCE ITEMS Federal Identifier must be accurate Faculty must devote a minimum of 3% effort PD/PI s must have a faculty appointment to apply Commons ID must be accurate for PD/PI(s) Page Limitation for Science Related documents (i.e. Bio-sketch, Specific Aims, Research Strategy, Introduction, Responsible Conduct of Research, Mentor Statements, Candidate Information, etc.) Application of the correct F&A rate Institutional Base Salary must be utilized (salary augmentation disallowable) Bio-sketches for all Key Personnel Proper F&A Exclusions (i.e. tuition, capital equipment - over $5k, subcontracts, patient care costs, renovation/rental fees) Individuals cannot be included on the budget without effort Project Dates must be consistent throughout application (Application vs. Budget) Correct Budget Template must be utilized based on Direct Costs limit (Modular vs. Detailed) If Human Subjects are included, whether exempt or not, all 3 attachments are required (Protection of Human Subjects, Inclusion of Women, Inclusion of Children) If Vertebrate Animals and/or Human Subjects are included, the Assurance number is required

14 Federal Requirement Federal Identifier (grant number = institute code + 6-digit serial number) Commons ID (must be affiliated with current institution) Pagination / Page Limitation Application of correct F&A rate Bio-sketches for key personnel Proper F&A Exclusions Individuals cannot be included on a budget without effort Consistent Project Dates Budget Template (Modular vs. Detailed) IACUC and IRB protocol approvals Vertebrate Animal and/or Human Subjects assurance number

15 UT System Requirement Institutional Base Salary (salary augmentation disallowed) Minimum Level of Committed Effort (3%) Maximum Level of Committed Effort (based on position level) Appointment Eligible PD/PI Faculty Professor Associate Professor Assistant Professor Instructor Faculty Associate Non Faculty must have a faculty sponsor or mentor to submit Assistant Instructors Postdocs Graduate Students Max % Effort Min % Effort Department Chairman / Division Director 85 3 Faculty w/administrative Responsibilities 90 3 Faculty w/o Administrative Responsibilities 95 3 Faculty Mentor 95 0 Other Significant Contributor 95 0 Instructor Post Doc 100 0

16 Effort Conversion Table UT Southwestern Percent Effort Conversion Table % Effort Calendar Months % Effort Calendar Months 100% % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % 6.1 UT Southwestern Percent Effort Conversion Table % Effort Calendar Months % Effort Calendar Months 50% % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % 4.1 9% % 4.0 8% % 3.8 7% % 3.7 6% % 3.6 5% % 3.5 4% % 3.4 3% % 3.2 2% % 3.1 1% 0.1

17 Sponsor Requirement Federal Identifier (grant number = institute code + 6-digit serial number) Pagination / Page Limitation Application of correct F&A rate Bio-sketches for key personnel Individuals cannot be included on a budget without effort Consistent Project Dates IACUC and IRB protocol approvals

18 Roles & Responsibilities PI/Department SPA Primary Entity for Joint Roles egrants Proposal Creation Initiation of Proposal Review Timeliness of Review and Submission Completeness Accuracy Attachment (Science) Upload Budget Entry Budget Accuracy Completion of Sponsor Required Forms PI Assurances/Final Attachments Proposal Submission Post Submission Material (Submission) PI/Department PI/Department PI/Department PI/Department SPA

19 Planning & Timing 14 Days Prior to Deadline 12 Days Prior to Deadline 10 Days Prior to Deadline 5 Days Prior to Deadline 4 Days Prior to Deadline 3 Days Prior to Deadline 2 Days Prior to Deadline Deadline PI/DA submits proposal for SPA review Department and/or Division Chair issues approval SPA performs preliminary review and returns to department for requested edits Submission review conducted by AOR notification reminding department of Final Science deadline approaching notification to department that Final Science and PI Assurances are due notification reminding department that Final Science deadline has passed and SPA review will be compressed 3 notifications reminding department that the deadline is quickly approaching and that proposals will be submitted as is to maintain the opportunity for funding

20 Defined Science Components The Science Components, defined by UTSW, are required to be finalized and submitted to SPA 3 days in advance of the deadline by the PI/Department. Senior Key Personnel Profile Biographical Sketch Other Project Information Project Summary/Abstract Project Narrative Bibliography/References Facilities & Resources Research Plan Introduction to Application (when applicable) Specific Aims Research Strategy Resource Sharing Plan Final Science

21 Additional Science components Fellowships (F series) Respective Contributions Selection of Sponsor and Institution Responsible Conduct of Research Goals for Fellowship Training and Career Activities Planned Under this Award Doctoral Dissertation and Other Research Experience Sponsor(s) and Co-Sponsor(s) Final Science Career Development Awards (K series) Candidate s Background Career Goals and Objectives Career Development/Training Activities During Award Period Research Strategy Training in the Responsible Conduct of Research Mentoring Plan Plans and Statements of Mentor and Co-Mentor(s) Description of Institutional Environment Institutional Commitment to Research Career Development Training Grants (T series) Background Program Plan Recruitment and Retention Plan to Enhance Diversity Plan for Instruction in the Responsible Conduct of Research

22 NIH Page Limits Fellowships (F) Section of Application Page Limits* (if different from FOA, FOA supersedes) Introduction to Application (when applicable) 1 Specific Aims 1 Research Strategy 6 Respective Contributions 1 Selection of Sponsor & Institution 1 Responsible Conduct of Research 1 Goals for Fellowship Training & Career 1 Activities Planned Under This Award 1 Doctoral Dissertation & Other Research Experience 2 Sponsor(s) & Co-Sponsor(s) 6 Bio-Sketch 5

23 NIH Page Limits Career Development Awards (K) Section of Application Page Limits* (if different from FOA, FOA supersedes) Introduction to Application 1 Specific Aims 1 Candidate s Background, Career Goals & Objectives, Candidate s Plan for Career Development/Training Activities During Award Period, and Research Strategy Background, Program Plan, and Recruitment & Retention Plan to Enhance Diversity (Institutional Career Development - K12, KM1, and KL2 only) 12 (all sections combined) 25 (all sections combined) Training in Responsible Conduct of Research 1 Plan for Instruction in the Responsible Conduct of Research (Institutional Career Development - K12, KM1, and KL2 only) Candidate s Plan to Provide Mentoring 6 Plans & Statements of Mentor and Co-Mentor(s) 6 Letters of Support 6 Description of Institutional Environment 1 3 Institutional Commitment to Candidate s Research Career Development 1 Bio-sketch 5

24 NIH Page Limits Training Grants (T) Section of Application Page Limits* (if different from FOA, FOA supersedes) Introduction to Application (Resubmission) 3 Introduction to Application (Revision) 1 Specific Aims 1 Background, Program Plan, and Recruitment & Retention Plan to Enhance Diversity (includes International Training D43, D71, and U2R) Plan for Instruction in the Responsible Conduct of Research (includes International Training D43, D71, and U2R) 25 (all sections combined) 3 Bio-Sketch 5

25 NIH Page Limits Research Grants (R) Section of Application Activity Code Page Limits* (if different from FOA, FOA supersedes) Introduction to Application All Codes 1 Specific Aims All Codes 1 Research Strategy R03, R13, R21, R36, R41, R43 R01, R15, R18, R21/R33, R24, R28, R33, R34, R44, RC2, RC4, RF Commercialization Plan R42 and R44 12 Research Education Program Plan R25 (Research Education) 25 Bio-Sketch All Codes 5

26 NIH Page Limits All Other Application Types Section of Application Activity Codes Page Limits* (if different from FOA, FOA supersedes) Introduction to Application All Codes 1 Specific Aims All Codes 1 Research Strategy DP1 U13, SC2, SC3, X01 DP2 U18, U24, U34, U42, U44, DP3, DP5, G08, G11, G13, SC1, SI2, U01, UH2, UH3, UG1, UC4, UH2/UH3, X01, X02, UC2, UF1, U2C Research Education Program Plan DP7 (Research Education) 25 Bio-Sketch DPI and DP2 2

27 Facilities and Administrative Costs (F&A) UTSW current rate = 61.5% (9/1/2014 8/31/2016) = 62% (9/1/2016 8/31/2018) # of months during budget period at 61.5% # of months during budget period at 62% Rate to apply (Grid: Inflation & Indirect Rates) % % % % % % % % % % %

28 Off-Campus Rate UTSW current rate = 26% Applied for all activities performed in facilities not owned by the institution and to which rent is directly allocated to the project(s). Example: PI is a full time employee of UTSW but is conducting research at the Dallas Veteran s Affairs Medical Center (VA). The PI, lab, materials, etc. are all located at the VA and utilized solely in the VA Hospital. UTSW PI THR Presby, Children s Medical, etc. Performing research at

29 F&A Exclusions Modified Total Direct Cost (MTDC) is the basis and is utilized more frequently. Consortium Costs Equipment over $5,000 (capital equipment) Tuition Patient Care Costs Alterations and Renovations NOTE: These costs should be subtracted from the direct costs before applying the indirect cost rate. ***If consortium costs are deducted, $25,000 must be added back for each sub-recipient before applying the indirect cost rate. If the total consortium costs (directs + indirects) for each subrecipient exceed $25,000 in the first budget year, the total $25,000 would be added back only for the first year. If the total consortium costs do not exceed $25,000 in the first year, the total amount for the first year would be added back and the remainder of the $25,000 would be added in the subsequent years.

30 Funding Proposal Review Checklists Top 5 Sponsors 1) American Heart Association (AHA) 2) Cancer Prevention Institute of Texas (CPRIT) 3) Grants.Gov National Institutes of Health (NIH) Department of Defense (DOD) 4) Non-Grants.gov Flow Throughs Proposal Central Submissions (i.e. ADA, ALS) Fastlane Submission (i.e. NSF) 5) Welch Foundation Based on what SPA/AOR reviews Tremendous reduction in margin of error and number of times returned

31 AMERICAN HEART ASSOCIATION (AHA) ü ITEM 18 Verify Professional Time Usage Details totals 100% Be sure to review the Funding Opportunity Announcement before proposal preparation and execution of the review. egrants FUNDING PROPOSAL 19 Verify Applicant s total effort devoted to this project reflects the effort indicated in egrants Verify title reflects the AHA application Verify start date entered in egrants reflects the start date in AHA 20 Verify Grants Officer (Cheryl Anderson) and Fiscal Officer (David Ewing) Verify proposal is denoted as Non-Grants.gov (2.2) Verify section 7.0 Sponsor Information includes AHA guidelines (Funding Announcement) Verify items in Compliance reflect what has been selected in the AHA application (Vertebrate Animals, Human Subjects, etc.) Verify all required application components are attached on page 19.0 or in Miscellaneous Attachments (preferably as one appended PDF) egrants BUDGET 21 Verify Budget Details reflect the budget entered into egrants 22 Verify Funds Available (Other Support) 23 Verify Research Subjects/Assurances reflect the Compliance section in egrants Verify Sponsor salary cap, if applicable Verify F&A rate(s) are in compliance with Sponsor guidelines 24 Verify the AAALAC date and Animal Welfare Assurance number (if applicable) If F&A is not allowed, verify a Sub-ledger number is provided (2.1.1) Verify whether or not there is cost sharing and indicate in egrants (2.2 and 2.2.1) 25 Verify all required attachments are uploaded in the designated section Verify effort for PI and other Faculty is at least 3% or 0.4 calendar months and is captured on page 3.0 Personnel Costs Verify stipends and research/institutional allowance is captured on page 9.0 General Costs Verify budget reflects the AHA budget 26 SUBMISSION PROCESS Verify proposal has been submitted to SPA on the AHA webiste; state = "SubmittedtoGO" Verify a copy of the AHA budget is attached on page Verify corresponding funding proposal has been approved in egrants Verify the budget justification reflects the budget Verify the budget complies with the FOA guidelines 27 Verify proposal has been successfully submitted by SPA via the AHA application portal; state = "Submitted"

32 CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS (CPRIT) CGMS 17 Verify the title reflects what is indicated in egrants NO. ü ITEM 18 Verify the DUNS and EIN numbers are correct 1 Be sure to review the Funding Opportunity Announcement before proposal preparation and execution of the review. 19 Verify Application Signing Official (Cheryl Anderson) 2 Verify title reflects the CPRIT application egrants FUNDING PROPOSAL 20 Verify the State Senate District (23) and State House District (100 - South Campus) 103 (North Campus) 3 Verify start date entered in egrants reflects the start date in the CPRIT application 4 Verify proposal is denoted as Non-Grants.gov (2.2) 21 Verify all Key Personnel have been listed as Collaborators 5 Verify section 7.0 Sponsor Information includes CPRIT guidelines (Funding Announcement) 6 Verify items in Compliance reflect what has been selected in the CPRIT application (Vertebrate Animals, Human Subjects, etc.) 22 Verify all required documents are attached in the designated section. NOTE: biosketches should not exceed 2 pages 7 Verify all required application components are attached on page 19.0 or in Miscellaneous Attachments (preferably as one appended PDF) 23 Verify all Other Support has been provided. NOTE: required for the PI, Co-PI, and any individual who's bio-sketch has been included 8 Verify Sponsor salary cap ($200,000) 9 egrants BUDGET Verify F&A rate is in compliance with Sponsor guidelines (5.263%) NOTE: egrants applies only 5.26%, therefore, the total amount may be slightly different from the total amount in the CPRIT application. However, the total direct costs should reflect one another. 10 Verify whether or not there is cost sharing and indicate in egrants (2.2 and 2.2.1) 24 Verify Budget Details reflect the budget entered into egrants 25 Verify effort is reported in percentage in the budget justification 26 Verify Veterbrate Animals, Biological/Anatomic Substances, and Human Subjects, reflect the Compliance section in egrants 11 Verify effort for PI and other Faculty is at least 3% or 0.4 calendar months and is captured on page 3.0 Personnel Costs SUBMISSION PROCESS 12 Verify budget reflects the CPRIT budget 13 Verify a copy of the entire CPRIT budget is attached on page Verify proposal has been submitted to SPA in the CGMS; state = "Pending ASO Approval" 14 Verify the budget justification reflects the budget 28 Verify corresponding funding proposal has been approved in egrants 15 Verify the budget complies with the FOA guidelines 16 Verify any sub-award budgets are itemized in the budget justification, and the sub-award IDC is not included in UT Southwestern s Direct Costs 29 Verify proposal has been successfully submitted by SPA via CGMS; state = "ASO Approved and Submitted"

33 GRANTS.GOV 21 If Human Subjects are involved, verify the following are attached: Inclusion of Women and Minorities and Inclusion of Children NO. ü ITEM 1 Be sure to review the Funding Opportunity Announcement before proposal preparation and execution of the review. egrants FUNDING PROPOSAL 2 Verify title is not truncated; General Information (P.1); and Proposal Information (P.2) 3 If Sponsor is NIH, verify specific NIH institute (i.e. NCI, NIAID, NIDDK, etc.) is entered in the Sponsor field (1.5) 4 Verify COI Statement is current 5 Verify egrants Start date coincides with the Sponsor start date If Human Subjects are involved, verify Planned Enrollment Table is selected under Optional Forms and completed If renewal with Human Subjects, verify a Cumulative Inclusion Enrollment Report has been selected under Optional Forms and completed Verify consortium documents and budget are attached if applicable (signed Face Page and/or signed Letter of Intent, Budget (R&R budget if prime is submitting detailed budget and PHS 398 budget pages if prime is submitting a modular budget, F&A Checklist, DHHS Rate Agreement) Verify Multiple PD/PI Leadership Plan is attached if there is more than one PD/PI role listed in key personnel 6 Verify items selected in Compliance reflect what is selected in the SF424 and have the correct attachments: (Vertebrate Animals, Human Subjects, Special Agents) egrants BUDGET 26 Verify Appendices are comply with Sponsor guidelines and are allowable 27 For DOD, verify CDMRP log number is entered as the "Application Filing Name/Submission Title 7 Verify F&A rate(s) 8 Verify effort for PI and other Faculty is at least 3% or 0.4 calendar months 9 Verify whether or not there is cost sharing and indicate in egrants (2.2 and 2.2.1) 10 Verify exclusions on the budget (tuition, equipment over $5K, subcontract, etc.) 11 For modular budgets, verify the Additional Narrative Justification is attached if there is a variation in the number of modules requested (including R21s) and/or there are exclusions applied to the F&A base calculation. 12 Verify Modular Offset = 0 across all years 13 Verify budget entered in egrants reflects the budget in the SF Verify Salary Cap is $181,500 for NIH and true base salary of personnel is carried over in all years of the budget 15 Verify the budget justification reflects the budget 16 Verify the budget complies with sponsor guidelines SF Verify grant number/federal identifier is correct on line 4a (only renewals and resubmissions) Verify all special requirements of the FOA are met (other attachments, budget limits, effort requirements, etc.) Verify Cover Letter is attached and the title matches the title listed on the SF424. If a Renewal or Resubmission, verify FOA and Grant Number are included and correct. Verify Credentials (Commons ID for NIH; CDMRP login for DOD; and AHRQ login for AHRQ) 28 For DOD, verify whether application includes a Partnering PI; and if yes, a separate application (SF424) has been submitted per sponsor guidelines 29 For DOD, verify attachment file names comply with guidelines 30 For DOD, verify Other Support includes all information required by sponsor 31 For Fellowships (F series) and Career Development grant (K series), verify career documents and mentor plans are attached 32 For Training grants (T series), verify required tables are attached 33 For Instrumentation grants (S10), verify other support and upload confirmation SUBMISSION PROCESS 34 Validate Submission in egrants to check for errors and warnings 35 Create Pre-Submission PDF in egrants. NOTE: If PDF is blank, one of the attachments is a word document and will need to be converted into a PDF 36 Once AOR has submitted proposal, verify a Grants.gov Tracking Number has been assigned 37 Verify proposal has been accepted by sponsor with no errors/warnings via era Commons 38 If application has errors and/or is pulled back for corrections, verify type of submission has been changed from "Application" to "Change/Corrected" (Field 1 of SF424) and the Previous Grants.gov Tracking ID (can be located in egrants or era Commons) has been entered on Line 4c of the SF424

34 NON-GRANTS.GOV SUBMISSION PROCESS ITEM Be sure to review the Funding Opportunity Announcement before proposal preparation and execution of the review. egrants FUNDING PROPOSAL Verify title reflects the Sponsor application Verify start date entered in egrants reflects the Sponsor/Prime Recipient's start date For Subcontracts, verify the Prime Recipient/Institution is entered in the Sponsor field (1.5) and the Prime Sponsor (i.e. NIH, AHA, CPRIT, etc.) is entered in the Flow Through/Prime Awardee field. Verify proposal is denoted as Non-Grants.gov (2.2) Verify section 7.0 Sponsor Information includes sponsor/prime guidelines (i.e. budget restrictions, effort, type of budget, required application components, etc.) Verify items in Compliance reflect the items selected in the Sponsor application (Vertebrate Animals, Human Subjects, etc.) Verify all required application components are attached on page 19.0 or in Miscellaneous Attachments (preferably as one appended PDF) 18 Verify type of submission (i.e. NSF, ProposalCentral, , etc.) 19 Verify all documents that require institutional endorsement have been signed, if applicable (i.e. Face Page, Consortium Letter, Cover Letter, Sub-recipient Commitment Form, etc.) 20 Verify which entity carries out submission, SPA or Department Verify proposal has been successfully submitted by SPA via Sponsor portal, if applicable If submitted by Department, verify department is aware the proposal has been approved for submission If submission by SPA, verify the PI and Department Support individual(s) are copied Verify a single PDF of the Final Proposal and Signed Documents are uploaded under Miscellaneous Attachments in egrants. egrants BUDGET Verify Sponsor salary cap, if applicable Verify F&A rate(s) are in compliance with Sponsor guidelines If Sponsor does not allow indirects or a minimum of 10%, verify a Sub-ledger number is provided (2.1.1) Verify effort for PI and other Faculty is at least 3% or 0.4 calendar months Verify whether or not there is cost sharing and indicate in egrants (2.2 and 2.2.1) Verify exclusions on the budget (tuition, equipment over $5K, subcontract, etc.) Verify budget reflects the Sponsor budget Verify the budget justification reflects the budget Verify the budget complies with sponsor guidelines

35 WELCH FOUNDATION WELCH APPLICATION ITEM Be sure to review the Funding Opportunity Announcement before proposal preparation and execution of the review. egrants FUNDING PROPOSAL Verify title reflects the Welch application Verify start date is June 1 Verify proposal is denoted as Non-Grants.gov (2.2) Verify section 7.0 Sponsor Information includes Welch guidelines (Funding Announcement) Verify question 8.1 should is yes for cap limits Verify grant period (3 years) Verify all required application components are attached on page 19.0 or in Miscellaneous Attachments (preferably as one appended PDF) egrant BUDGET Verify grant amount ($60,000/yr) Verify grant period (3 years) Verify no F&A has been applied in accordance with Sponsor guidelines and an unrestricted Sub-ledger has been provided on page 2.0 Budget Characteristics. Verify voluntary cost sharing has been indicated (2.2 and 2.2.1) Verify effort for PI and other Faculty is at least 3% or 0.4 calendar months and is captured on page 3.0 Personnel Costs Verify budget reflects the Welch budget Verify a copy of the entire Welch budget is attached on page 10.0 Verify the budget complies with the FOA guidelines Verify the title reflects what is indicated in egrants Verify font size is 11 pts or higher Verify line spacing is at least 1.5 inch but no more than 5 lines per vertical inch Verify all margins are at least 1 inch in all directions Verify biosketch does not exceed 2 pages Verify research proposal does not exceed 5 pages Verify Other Support (if applicable) Verify PI's status has been confirmed (full-time with tenure or on tenure track); Ira Abrego prepares all letters. Verify the most current foundation forms are being utilized (updated forms can be accessed via the sponsor website. SUBMISSION PROCESS Verify corresponding funding proposal has been approved in egrants and institutional endorsement has been obtained PI sends all application materials to The Welch Foundation Verify travel does not exceed $1,500 Verify any postdocs listed have not received foundation support for more than 3 years

36 Flow-Through Awards UTSW = Sub-recipient Awards (funds) come to UTSW and are treated the same as Direct 1:1 Awards Minimum Requirements for egrants FP: Prime information (institution name, Prime PI, address, Signing Official {SO} name, etc.) Prime guidelines (i.e. budget information, project period, effort limitations, etc.) Statement of Work (SOW) Budget Budget Justification Face Page Letter of Intent (LOI)

37 Sub-Awards UTSW = Sponsor (Prime Recipient) Requirements from Sub Signed Face Page and/or LOI*** Statement of Work (SOW)*** Key Personnel Bio-sketches Resources F&A Checklist*** DHHS Agreement*** Budget if UTSW submits R&R detailed budget sub must submit a detailed budget if UTSW submits a modular budget sub must submit PHS 398 budget pages Budget Justification Sub-recipient Profile Questionnaire (risk assessment) COI Sub-recipient Form Financial Disclosure Form (only required if sub-recipient does not have a COI policy) *** items that should be uploaded under Consortium/Contractual Arrangements Section of the SF424

38 NIH Approved PHS 398 Face Page (approved through 8/31/2015)

39 Detailed budgets (R&R) vs. Modular Budgets Detailed Budget (R&R) Direct Costs exceed $250,000 per year All budget categories are addressed Budget Justification addresses all budget categories Modular Budget Direct Costs are $250,000 or less per year Requested in increments of $25,000 Detail is omitted Consortium F&A is excluded from the TDC when determining if DC are $250,000 or less Budget Justification addresses only personnel Additional Narrative provides explanations for any variations in the number of modules requested annually (i.e. F&A Exclusions)

40 Compliance Fiscal Compliance Contractual Compliance Safety Compliance Reporting Compliance Export Controls Human & Animal Research Conflict of Interest

41 Compliance Fiscal Compliance Cost Sharing Effort Reporting Subcontracting Safety Compliance Radiation & Laser Biosafety Environmental Contractual Compliance Subcontracting Property Management Technical Reporting Reporting Compliance Closeouts Invention Statements Financial Reports Publications Human & Animal Research IRB IACUC Conflict of Interest Financial Commitment Outside Activities Intellectual Property (IP) Other Export Controls Material Transfer Agreements (MTA) Stem Cells Misconduct

42 IACUC Protocol Approval TOPAZ Protocols approvals = 3 years Must be renewed or closed before the end of the 3 rd year Protocol reviews = annually (at least once a year) Approval date does not re-set with the performance of the annual review or the addition of a new grant. Regulations require written notification; however, formal approval letters are only generated upon request. The protocol must indicate the grant number; otherwise, the IACUC office will need to be contacted to confirm approval.

43 IRB Protocol Approval eirb Required to be reviewed annually Expedited Review vs. Full Board Review is based on risk Expedited Review minimal risk reviewed by Chair Full Board Review higher risk Human Subjects Training protection of humans HIPAA acceptable clinical practices

44 Conflict of Interest Each Covered Individual must complete COI Training before engaging in research at UT Southwestern Medical Center and at least once every four years thereafter. Covered Individual Any person who is required to submit a Statement of Financial Interest and Outside Activities, including: faculty members; exempt UT Southwestern employees, study team members (including students and post-graduate trainees); individuals who may influence the negotiation or execution of research or technology licensing agreements; Institutional Review Board (IRB) members; Institutional Animal Care and Use Committee (IACUC) members; and Conflict of Interest Committee (COI Committee) members. a Covered Individual new to UT Southwestern must complete the training before engaging in research, or must provide evidence of having completed the training at another UT System institution within the last four years. COI training must be completed immediately if it is found that the Covered Individual is not in compliance with this policy or a management plan, or if the policy is revised in a manner that affects the Covered Individual s duties. The Public Health Service (PHS) COI policy requires all study team members to have a current Statement of Financial Interest (SFI) on file with the COI Office at application stage. The policy expands the definition of investigators beyond key personnel to include individuals who are responsible for the design, conduct, and/or reporting of research.

45 Questions SPA Outreach Nell Cryer, Supervisor (214) Alina Grays (214) Main Line (214) David Ngo Assistant Vice President (214) Cheryl Anderson Director (214) Jamie Wilson Proposal Supervisor (214) Arriel Stevens, Contracts Supervisor (214)