1. 1 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Sponsored Programs at Penn Module 2 Proposal Preparation, Budgeting and Submission

2. 2 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Agenda Budget preparation and construction Cost-sharing considerations Intellectual property Regulatory affairs –IACUC –IRB Proposal routing and review Export Controls Questions?

3. 3 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Where Do You Start? Gather the Facts –Talk to the Principal Investigator (PI) What is the Scope of Work? Who is the Sponsor? Where will the work be performed? Collaborators? Consultants?

4. 4 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Sponsor Guidelines Instructions and Contractual Terms Requests for Proposal/Quote (RFP/RFQ) Requests for Application (RFA) Funding Opportunity Announcements (FOAs) “Unsolicited” Applications Send sponsor guidelines, instructions, contractual terms, etc., to Research Services

5. 5 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Cover Page PI Name Title Name of Grantee –Trustees of the University of Pennsylvania Period of Performance Amount Requested Required Signatures

6. 6 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget Costs requested in proposal budget must: –Be Allowable (Factors used in determining) Allocable Reasonable Consistently Estimated –Directly benefit the proposed project Costs must be necessary for the performance of the award (OMB Circular A-21); SPP #2108, #2110, #2138OMB Circular A-21SPP #2108 #2110#2138

7. 7 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Regulatory guidance CAS 501 (appendix OMB A21)OMB A21 –“The purpose of this standard is to ensure that each educational institution's practices used in estimating costs for a proposal are consistent with cost accounting practices used by the educational institution in accumulating and reporting costs.”

8. 8 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Other considerations Sponsor guidelines and limitations –Salary caps –F&A limitations –Direct cost or total cost limits –Expense category exclusions Recover F&A as direct costs from non- governmental sponsors –SPP #2138 Direct Cost Expenditures for Non- Governmental AgenciesSPP #2138 Direct Cost Expenditures for Non- Governmental Agencies May be School-specific rules

9. 9 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Salary) Salary requests are expressed as % effort or person months Plan realistically –Determine the percent of effort for all personnel needed to conduct the project –Downward adjustments of effort may need sponsor approval Percent of effort=Percent of salary requested –Cost sharing is discouraged –Avoid hourly rates Cannot usually charge clerical salaries or administrative costs directly

10. 10 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Allowability of clerical and/or administrative staff expense Generally part of F&A costs. Possible exceptions (see OMB A21, Exhibit C):OMB A21 –Large, complex programs (e.g., Center grants). –Epidemiological studies, clinical trials. –Scheduling seminars/conferences attended by large numbers of participants. –Individual projects requiring project-specific tasks such as database management, human and animal protocols, etc.

11. 11 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Benefits) Fringe Benefits are charged as a % of Salary As of 6/23/10, rates on federally sponsored projects: –Full-time employees – 30.9% –Part-time employees - 9.7% For non-Federal sponsors, add Spouse and Dependent Tuition Benefit (2.2% ) for full- time employees Current F&A and benefits rates

12. 12 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Equipment) Definition –“Equipment” costs $5,000 or more per item, and has a useful life of more than 1 year –Includes computer software that meets this definition (capitalized computer software). Accounting Policy #1106.0 Justification –Why is this item necessary to support the science? –When is it necessary? Availability –Is the equipment available elsewhere in the University? Competitive Bid Requirement

13. 13 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Office Supplies) Generally not treated as direct costs. Can be allowable if specifically related to the project. For example: –Specific aim of the project is to create a manual or other instructional media. –Extensive human subjects data accumulation, questionnaires, etc., is required. Must be necessary for conduct of project –OMB Circular A-21, Exhibit COMB Circular A-21, Exhibit C

14. 14 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Travel) Usually restricted to employees Domestic Foreign –Fly America Act if Federal $$Fly America Act –May require prior approval even if in budget

15. 15 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Patient Care) Defined in rate agreement: “…hospitalization and other fees associated with patient care whether the services are obtained from an owned, related, or third- party hospital or other medical facility…” Excluded from MTDC base and F&A calculations.

16. 16 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 What is not included in patient care? Subject reimbursement and travel. Costs of ancillary tests performed outside the hospital on a fee-for-service basis. Costs accumulated in service centers at Penn, such as in Radiology for research patient care. Consulting physician fees. All of the above are “other” or “consultant” expense.

17. 17 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Subcontracts) Budget, including F&A costs Copy of F&A rate agreement Statement of Work (SOW) Cover page/Letter of Intent with Authorized Signature Reps/Certs required by sponsor

18. 18 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Consultants) Penn staff usually cannot be included in this category –If applicable, must coordinate payment through Penn Payroll Office. Consultant’s letter of intent and cost (not on “university” letterhead) –All costs related to the consultant are usually accumulated in this category. Statement of Work –Consortium agreements typically used if consultants are identified as Key Personnel.

19. 19 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (Other Direct Costs) Service Center charges Tuition and Fees Post Doctoral Health Insurance Publication Costs Protocol Review fees, when appropriate Rent, when appropriate, but excluded from MTDC. Animal per diem. Subject compensation and travel SPP #2110 Federal Direct Cost ExpendituresSPP #2110 Federal Direct Cost Expenditures; SPP #2138 Direct Costs Expenditures for Non-Government Organizations

20. 20 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (F&A Costs) F&A = Overhead = Indirect Costs –Pays for many costs that cannot be allocated to a specific project, i.e. utilities, payroll and other support services, etc. The “Colleges and Universities Rate Agreement” contains the federally negotiated F&A rates F&A usually expressed as a % of a baseColleges and Universities Rate Agreement Modified Total Direct Cost Base (MTDC) –Excludes equipment, patient care costs, student tuition, and fees, alterations and renovations, rental of off-site facilities and the portion of each sub-award in excess of $25,000 Check sponsor guidelines for appropriate base

21. 21 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Preparing the Budget (F&A Costs) Which rate to use? –Research rates (on- and off-campus) [59% & 26%] –Certain DOD Contracts [61%] –Instruction [57%] –Other Sponsored Activities (on- and off-campus) [36% & 26%] Examples: health or community service projects, seminars, conferences, exhibitions, lecture programs –Clinical Trials [26% Total Direct Costs (TDC)] –Corporate Contracts [61%] Current agreement

22. 22 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 When is the offsite rate applicable? Use this rate whenever activity will occur for 3 months (or 25%) or more at a facility not owned by the University. –Consider preparing a split-rate budget when appropriate. Remember that rent can be a direct charge when using the off-site rate. –Rent is excluded from MTDC and F&A calculations.

23. 23 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Don’t overlook Are there humans involved? –Subject compensation and travel? –Related patient care costs? –Equate costs proposed to research plan, especially with the consents. Are there animals involved? –Prepare detail cost estimate: included shipping and box charges. –Animal per diem? –Equate costs proposed to research plan.

24. 24 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 …and more Are there large pieces of equipment? –Installation and set-up included? –Maintenance contracts? –Space available or renovation costs included? Provide a quote. Are there pre- and or post-docs? –Tuition included? Excluded from MTDC and F&A. –Health insurance costs listed? Not excluded from MTDC.

25. 25 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Reasons for carefully preparing the budget Reduces the possibility of significant budget cuts by the sponsor. Aids post-award management. Aids the department in budget planning. Significant budget changes are interpreted by sponsors as a change in scope!

26. 26 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Budget Justification Each line item usually requires specific justification. Unusual or extraordinary expenses such as equipment, clerical salaries and administrative expenses, may require additional justification. Check sponsor guidelines for requirements.

27. 27 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Other Considerations Cost Sharing Specific Agency Requirements (NIH) Penn Participation Agreement Electronic Proposal Submission Terms and Conditions Regulatory Issues (Animals & Humans)

28. 28 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Cost Sharing Specific portion of the project cost not funded by the sponsor Types –Mandatory Required by sponsor –Voluntary committed Not required by sponsor but Penn PI promises to provide cost-sharing –Matching or In-Kind Some sponsors require University to match funds (i.e., 50/50) or provide “in-kind” funds.

29. 29 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Cost Sharing Cont’d Record-keeping obligations What is allowable –Can’t use federal $ without prior approval –Can’t use the same $ for two different projects –Time period requirements –Cost Sharing $ subject to the same allowability rules as award Department needs to provide funding ORS needs to account for separately and report cost sharing SPP #2119 Cost Sharing/Matching

30. 30 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Cost Sharing Cont’d Cost Sharing that is proposed or required must be indicated on the Transmittal Form ORS Cost Share form must be attached detailing proposed cost share –ORS cost-share formORS cost-share form List source of funding for the cost share Complete form, submit with proposal

31. 31 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Specific Agency Requirements (NIH) Modular proposals –Funding increments of $25K for max. of $250K in direct costs Proposals over $500,000 in any one year –Calculated on direct costs only –Must have prior approval in writing 6 weeks before submission –Data sharing plan requirement Salary cap Type size requirement & page limitations NIH WILL RETURN NONCOMPLIANT APPLICATIONS WITHOUT REVIEW

32. 32 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Specific Agency Requirements (NIH) Key Personnel –Individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested –Human Subjects training certification –Conflict of Interest declaration for all Key Personnel Other Significant Contributors –Individuals who have committed to contribute to the scientific development or execution of the project, but are not committing specified measurable effort

33. 33 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Penn Participation Agreement Intellectual Property Participation Agreement –Required of ALL salaried participants, adjunct & emeriti faculty, and students (Bayh-Dole Act & University Patent Policy) University Patent Policy –University will not process proposals for PIs who have not signed –Departmental responsibility –Found at Research Services website http://www.upenn.edu/researchservices/pdfs/par ticipation.pdfhttp://www.upenn.edu/researchservices/pdfs/par ticipation.pdf

34. 34 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Electronic Proposal Submission –All Electronic Submissions are not created equal –Read the Instructions –Does the PI or Institution need to be registered users? –Is the required technology available at the Department? At ORS? –All electronic applications must be approved by ORS before submitting to sponsor even if a paper copy with signatures is required after electronic submission. SPP #2102 Approval of Proposals

35. 35 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Terms & Conditions Terms and Conditions –Must be consistent with University mission of research, education and service –No bars on publication –University owns and controls intellectual property –Federal regulations appropriate to educational institutions are used

36. 36 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Regulatory Issues IACUC IRB PI Submits Protocol electronically for Human Subject research using the HS-ERA system (Animals will be transitioned to electronic submission in January, 2010

37. 37 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Office of Regulatory Affairs Administers –Institutional Review Board (IRB) –Institutional Animal Care and Use Committee (IACUC) Provides Research Services with approval status for all protocols

38. 38 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Institutional Review Board Protects the rights and welfare of human research subjects Authorized to approve, require modifications in, or disapprove all research activities involving human subjects

39. 39 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Human Subjects Approval Requirements & Timelines Approval of a human subject protocol for a new application is not required at time of submission –Unless mandated by sponsor –Approval can be “Just-in-Time” for NIH Human subject protocol approval and appropriate education certification –Required to be in place prior to the awarding of a new project

40. 40 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Human Subjects Approval Requirements & Timelines (cont.) For non-competing continuations the approval date must not be earlier than one year before the start date for which the progress report is submitted –If the protocol approval date does not meet this criteria the non-competing application will be delayed

41. 41 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Institutional Animal Care and Use Committee (IACUC) Reviews and approves the care and use of animals in research

42. 42 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Use of Animals Approval Requirements & Timelines Approval of an animal subject protocol for a new application is not required at time of submission –Unless mandated by sponsor –Approval can be granted “Just-in-Time” for NIH Non-competing continuation applications must have a valid approval date at the time of submission

43. 43 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Routing & Submission

44. 44 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 PI and BA Submit Proposal PI and Business Administrator (BA) have completed components of application in PennERA to be routed Participation Agreement signed and filed in department Proposal is certified by PI in PennERA and electronically submitted to BA BA completes e-transmittal form Appropriate departmental & School approvals secured in PennERA

45. 45 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Research Services Review Regulatory Issues Determine Type of Award F&A Cost Review Conflict of Interest Review e-Transmittal Form & PI certification for Accuracy & Completeness Cost Sharing Terms & Conditions if applicable

46. 46 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Purpose of e-Transmittal The Transmittal Form –Internal Form Does not get submitted to sponsor –Uses Departments, make commitments & determine thatproject is within total program and academic objectives of department Deans, make commitments project consistent with the total program objectives of the school and commitments for project (including any cost sharing/matching funds are acceptable Research Services uses it to create funds; accuracy matters

47. 47 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Proposal Routing and Submission Approvals –If project includes faculty from multiple schools/departments Plan for additional time to secure appropriate approvals –If project includes participation from another institution Information from the other institution must also be obtained and presented in the application on the Finalize Tab of PennERA Plan for delays –Electronic proposal submission issues –Administrative support assisting with multiple grant applications from multiple PI’s –Broken copiers

48. 48 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Proposal Routing and Submission Applications requiring additional information (financial reports) require more time Responses to RFP’s –Contractual terms sent to Research Services as soon as possible –Policy requires 5 days PI’s transferring from another institution should begin the transfer process as soon as they have accepted a position at Penn Observe individual School deadlines

49. 49 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Export Controls – What They Are and What You Should Know U.S. laws and regulations that restrict, limit, curtail, or prevent the distribution of strategically important products, services, and information to foreign nationals and foreign countries for reason of foreign policy and national security. –Export Administration Regulations (EAR) Department of Commerce, Bureau of Industry and Security (BIS) –International Traffic in Arms Regulations (ITAR) Department of State, Directorate of Defense Trade Control (DDTC) –Other Departments and Agencies – Treasury, NRC, DEA, EPA, FDA, etc.

50. 50 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Export Controls – So What? Foreign researchers and students in the U.S. (including at Penn!) or anyone outside the U.S. who participates in such research The sharing of research results with persons who are not U.S. citizens or permanent residents “Export” is defined very broadly as any oral, written, electronic or visual disclosure, shipment, transfer or transmission of a commodity, technology or software/codes. Note: Server access could be an export! How do these laws impact research at Penn? Export Control Laws are laws which prohibit the unlicensed “export” of certain controlled technologies for reasons related to national security, treaty compliance, and trade agreement. If Penn research involves these controlled technologies, Penn may be required to get U.S. government approvals before allowing:

51. 51 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Export Control Laws and Research at Penn General Rule: Penn, its faculty, and employees may not export to some foreign entities certain materials and information without a license from the U.S. Government, unless an exception applies ORS and OGC will determine whether an exception applies. Researchers are the first line of defense and need to make ORS aware of any potential Export Control issues with a particular study or agreement. So, what do you need to look out for?

52. 52 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Export Control Laws and Research at Penn What to look for in your study/agreement : 1)International Component Are there foreign entities, researchers, or students involved? Will information be shared with persons who are not U.S. citizens or permanent residents? 2)Items that may have a military application Includes obvious items like munitions, technology designed to kill, defend, or observe in a military situation, and technical data related to defense services Includes non-obvious items like outer space related technology and items designed for commercial purpose but which could have military applications (“dual use” items like computers, pathogens, chemical compounds) Items that may have a military application must also have an international component to subject to Export Control Laws. Any study/agreement that has an international component may be subject to Export Control Laws and should be reviewed by ORS to ensure compliance.

53. 53 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Export Control Laws and Research at Penn Important: Most research studies will pass Export Control review without any further action (90%+) because of the Fundamental Research Exception. Fundamental Research: basic and applied research in science and engineering, the results of which are ordinarily published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons. Consequences of Non-Compliance: 1)Loss of exporting privileges of the University 2)Place Federal funding at risk for both University and individual PIs 3)Criminal and Civil penalties for both the University and individuals Any questions? Please contact ORS at anytime.

54. 54 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Reminders Meet the specifications of the announcement Make it easy for the reviewers to see that you have done so Awards are made to the Institution Only Research Services is authorized to sign on behalf of the University

55. 55 The Office of Research Services The Office of Research Support Services REVISED August 3, 2009 Questions???