Navigating Research Administration at Washington University

2. Navigating Research Administration at Washington University SPONSORED BY: The Office of the Vice Chancellor for Research and Your Central Research Administration Partners: Grants & Contracts, Research Education, Research Office, and Sponsored Projects Accounting

3. Navigating Research Administration at Washington University PRESENTERS: Denise McCartney, Associate Vice Chancellor for Research Administration Cynthia White, Director, Research Office (Hilltop Campus) Joe Gindhart, Director, Sponsored Projects Accounting Jacqueline Judie, Research Education Coordinator John Michnowicz, Director, Grants & Contracts (Medical School Campus)

4. Agenda • Welcome and introduction of presenters • Course objectives - Why are we here? • Research Mission • Roles and responsibilities • Proposal preparation, award process, research project management and award closure • The WU way, research administration infrastructure and available resources (Research Support Services and Office) • Questions and answers • Evaluation and adjournment

5. Why Are We Here? • To clarify and discuss: • The investigators role in managing research programs • The University’s role in managing research programs • Key policies and regulations affecting your grants • Support available to you

6. Research Mission • A message from Ted Cicero, Vice Chancellor of Research • Research is one of Washington University’s core missions. • The Office of the Vice Chancellor for Research exists to promote and support WUSTL investigators. • Each individual conducting research shall uphold the highest standards of ethical and professional conduct. • We are committed to providing information, tools and services to help further that standard. • http://vcresearch.wustl.edu/

7. WU Supports Investigators by: • Providing investigators with opportunities to conduct research • Promoting the ethical conduct of research • Implementing policies, procedures and systems that support compliance with sponsors’ policies and University-wide research policies to maintain the integrity of the University

8. WU Supports Investigators by: • Providing multiple resources at the school, department and central levels to support investigators in the design, conduct and reporting phases of research • Providing resources, organizational support and oversight necessary to help ensure that protocols are submitted in accordance with sponsors’ regulations and University policies • Establishing guidelines for the publication of results

9. School and/or Department Supports Investigators by: • Providing investigators with established departmental procedures • Providing the appropriate resources and environment to enable research to be conducted according to the terms of the award agreement, regulations, policies and procedures • Allocating department space to faculty

10. School and/or Department Supports Investigators by: • Holding investigators responsible for the accurate and timely submission of all technical /progress reports • Establishing a culture of compliance and dedicating department resources to ensure research is conducted according to regulations, policies and procedures

11. Department Administrators Supports Investigators by: • Assisting investigators in ensuring proposals meet all applicable regulations and policies • Coordinating with central administration personnel for interpretation of agency guidelines, policies and procedures • Assisting in obtaining appropriate internal approvals • Assisting in reviewing award terms and conditions

12. Department Administrators Supports Investigators by: • Assisting investigators in complying with and implementing terms and conditions • Assisting investigators in coordinating financial, personnel and related non-scientific aspects of the research program in accordance with regulations, policies and procedures • Assisting investigators in monitoring funding and notifying investigators of possible cost overruns

13. Central Administration Office Supports Investigators by: • Providing systems and support for faculty to search for funding • Providing support services for proposal submission • Assisting investigators in the commercialization of research results for public benefit • Providing research compliance education, training and tools

14. Investigators Support WU by: Their commitment to: • Conduct research responsibly and ethically • Comply with federal laws and regulations • Follow University policies and procedures • Protect human and animal subjects • Act as stewards of public funds

15. Investigator Commitments Are described more completely in: • Code of Conduct http://codeofconduct.wustl.edu/ • Roles and Responsibility document http://roles.wustl.edu/

16. Investigator Commitments Cont. Are described more completely in: • WU Research polices and procedures http://research.wustl.edu/MainPoliciesProcedures.htm • Sponsoring agencies, federal regulations, state laws

17. Key Strategies to Meeting Commitments • Understand your responsibilities • Work with your school or department grant administrator • Work with the research support service organizations • Use available resources • ASK QUESTIONS

18. Research Administration Process Investigators have responsibilities in the following four areas of research administration at Washington University. Proposal Preparation Award Research Project Management Project Closeout Identify Potential Sponsor Prepare Proposal Prepare Protocols Receive and Review Award Terms and Conditions Provide Information to Facilitate, Negotiate and Accept Contracts and Subcontracts Conduct Research Manage Research Manage Project Funds Manage Personnel and Laboratory Operations Submit Timely Progress Reports Complete and Submit Final Reports Follow Closeout Procedures and Protocols Commercialize Research Other Research Administrative Support Activities: Education, website, communication, monitoring and auditing

19. Research Administration Process Investigators have responsibilities in the following four areas of research administration at Washington University. Proposal Preparation Award Research Project Management Project Closeout Identify Potential Sponsor Prepare Proposal Prepare Protocols Receive and Review Award Terms and Conditions Provide Information to Facilitate, Negotiate and Accept Contracts and Subcontracts Conduct Research Manage Research Manage Project Funds Manage Personnel and Laboratory Operations Submit Timely Progress Reports Complete and Submit Final Reports Follow Closeout Procedures and Protocols Commercialize Research Other Research Administrative Support Activities: Education, website, communication, monitoring and auditing

20. Proposal Preparation • Identify potential sources of funding • Review sponsor submission guidelines • Discuss proposal with your Research Administrator • Develop research plan • Craft the proposal

21. Proposal Preparation Cont. • Negotiate with collaborators • Prepare the budget • Submit protocols and compliance documents • Submit entire proposal package

22. RESEARCH PROPOSAL PREPARATION This is a suggested timeline with major milestones outlined. Key Partners Mentors, Collaborators Dept Chairs & Senior Faculty Continuous ongoing feedback Review concept and science and provide feedback to investigator Dept Chair’s approval is required Review draft budget and draft proposal application and provide feedback to investigator PI Develop research concept. Discuss and Circulate. Develop science based on feedback and discuss project with RA. Review guidelines and compliance requirements. Develop budget with RA. Complete proposal. Investigator Submits Final Proposal to Sponsor Submit proposal to G&C/RO. Complete all protocols and compliance requirements with the assistance of RA. Sponsor’s Funding Decision 4 Weeks 1 Week 2 Months 6 Months Help investigator develop budget and seek commitments, resources and required approvals. Complete admin. part of proposal. Help investigator complete all protocols and compliance requirements. Review funding alerts and announcements for possible support for investigator. Discuss upcoming research project with investigator - notify G&C/RO of intent to submit. RA Reviews proposal, certifies compliance requirements and provides institutional signature Review the budget Not Funded Consult with RA and investigator to develop timeline that addresses proposal development, resources, protocols, required approvals, and budget. Funded Investigator makes submission- No go decision NOTE: Planning and communication are key to working with Central Admin Offices Central Admin Staff G&C and RO Investigator reviews Summary Statement Investigator decides whether to resubmit Central Admin. Staff negotiates award Investigator manages research project Investigator decides whether to revise Revise proposal for resubmission /address reviewers’ concerns from Summary Statement PI = Investigator or Principal Investigator G&C = Grants & Contracts Office (Medical School Campus) RA = Department/Grants/Division/Research Administrators RO = Research Office (Hilltop Campus)

23. Identify Potential Funding Sources • Register in funding databases • http://www.cos.com • http://www.grants.gov • http://www.grantsnet.org • http://privatefundingsources.wustl.edu • Set up effective electronic funding alerts that target your specific interests

24. Identify Potential Funding Sources Cont. • Work with the Funding Resources Coordinator to explore all federal and private sources • Explore internal sources of funding • Explore young investigator funding sources and network with peers who have successfully applied for these grants • Consider becoming a subcontractor on someone else’s grant

25. Proposal PreparationDeveloping the Budget General Budgeting Guidelines • Average R01 budget of direct costs • 70% for personnel costs • 30% for non-personnel costs (e.g., supplies) • Be realistic about your project period • If it takes four years, propose four years • Research should dictate the budget, not the reverse

26. Proposal PreparationDeveloping the Budget Budgeting General Guidelines Cont. • Think through the complete research project and include ALL costs in the proposed budget • (e.g., radioactive waste) • Involve your RA early in the budget process • Identify responsibilities and assign ownership • Cover Facilities and Administrative Cost (F&A) and verify that it is calculated correctly

27. Committees that Review Compliance Issues and Protocols TopicCommittee Animal Protection Animal Studies Committee (ASC) Financial Conflict of Interest Disclosure Review Committee (DRC) Lab Safety Environmental Health and Safety (EH&S) Radiation Safety Committee Institutional Biological & Chemical Safety Committee (IBC) Patient Privacy Protection HIPAA Office

28. Committees that Review Compliance Issues and Protocols TopicCommittee Human Subject Protection Human Studies Committees (HSC) Material Transfer Agreements Office of Technology Management (OTM) Scientific Misconduct Research Integrity Committee

29. Key Strategies for Proposal Preparation • Partner With Department/School Administrator • Budget preparation • Submission of protocols and required approvals • Web tools (http://research.wustl.edu) • Link to writing resources, protocols and compliance • Link to agency guides and on-line forms • Link to Fastlane and other agency systems

30. Key Strategies for Proposal Preparation Cont. • Consult Central Grant Administration • For interpretation of sponsor policies and guidelines • To formalize agreements with co-investigators

31. Research Administration Process Investigators have responsibilities in the following four areas of research administration at Washington University. Proposal Preparation Award Research Project Management Project Closeout Identify Potential Sponsor Prepare Proposal Prepare Protocols Receive and Review Award Terms and Conditions Provide Information to Facilitate, Negotiate and Accept Contracts and Subcontracts Conduct Research Manage Research Manage Project Funds Manage Personnel and Laboratory Operations Submit Timely Progress Reports Complete and Submit Final Reports Follow Closeout Procedures and Protocols Commercialize Research Other Research Administrative Support Activities: Education, website, communication, monitoring and auditing

32. Sponsor’s Funding Decision • What happens to your grant proposal once it has been submitted? • Proposals are usually evaluated by a peer review process • Successful senior faculty act as reviewers • Review teams usually have someone with knowledge in your specific area on the team • You will receive a summary statement with reviewers comments, questions and concerns as well as your score

33. Sponsor’s Funding Decision • JIT-Just in Time process (used by many sponsors) • Sponsor may ask you questions about: • The science • Budget adjustments, budget justifications, cost analysis • Protocols information and approvals • RA and Central Administration Staff partners will help you respond • Positive situation—You are likely to receive the award if they ask for more information

34. Receive and Accept Awards • Washington University is the Official Awardee • Don’t sign anything! • Only authorized institutional officials designated by the Chancellor may sign agreements and award documents.

35. Federal, industry and clinical trial agreements are handled by specific Central Research Administration Offices (see above)

36. Key Strategies for Receiving an Award • Read your award document; each award is distinct! • Terms and conditions • Expectations and responsibilities • Compliance issues • Understand your responsibilities and the responsibilities of Central Research Staff • Know who will submit “which report when” over the life of the grant, e.g., finance report

37. Key Strategies for Receiving an Award Cont. • Funds are available only after compliance assurances have been approved and the project officially begins • Remember: Expenditures support the scope of one specific research project

38. Research Administration Process Investigators have responsibilities in the following four areas of research administration at Washington University. Proposal Preparation Award Research Project Management Project Closeout Identify Potential Sponsor Prepare Proposal Prepare Protocols Receive and Review Award Terms and Conditions Provide Information to Facilitate, Negotiate and Accept Contracts and Subcontracts Conduct Research Manage Research Manage Project Funds Manage Personnel and Laboratory Operations Submit Timely Progress Reports Complete and Submit Final Reports Follow Closeout Procedures and Protocols Commercialize Research Other Research Administrative Support Activities: Education, website, communication, monitoring and auditing

39. Research Project Management • The investigator is responsible for: • Directing all aspects of the research project • Conducting research in compliance with the terms and conditions of the award and all protocol approvals • Expending funds in accordance with sponsor and University policies and the approved budget • Monitoring the performance of all collaborators

40. Research Project Management Cont. • Hiring and managing personnel on the research team in compliance with award approval and WU Human Resources policies and according to the project schedule • Managing relationships to facilitate research project • Submitting Timely technical Reports

41. RESEARCH PROJECT MANAGEMENT • WURESEARCH ADMINISTRATOR (RA) • Provides departmental assistance to support investigators’ research activities • Assists in proposal preparation • Handles Investigator accounting: • Salary Authorization Reports • Quarterly Expenditure Reports • Payroll • Purchasing • PARS submission monitoring • WU INVESTIGATOR • Designs and conducts research projects • Makes scientific and budgetary decisions, and follows University guidelines • Writes and submits progress reports as scheduled • Approves expenditures in accordance with the approved budget or as allowed by agency and University guidelines • Completes personnel activity reports (PARS) as required by the federal government Discussion Feedback Revisions Review Decisions Approves • WU Research Administrative Offices Provides advice, counsel and oversight • Grants & Contract (G&C)-Medical School Campus • Research Office (RO)-Hilltop Campus • Sponsored Projects Accounting (SPA) • Office of Technology Management (OTM) • SPONSOR* • PROGRAM ADMINISTRATOR • Initiates/encourages interest in area of scientific • importance to the institute’s mission • Monitors the peer review process • Prepares funding recommendations • Reviews yearly progress of grants • Prepares program reports (e.g., budget justifications, • scientific achievements) • SPONSOR* • GRANTS MANAGEMENT SPECIALIST • Analyzes grant application budgets and other grant-related • information • Interprets federal regulations and policies • Assures compliance by grantee • Awards grant funds • Reviews and responds to grantee requests or identifies • need for other grant changes *This is the typical structure of a sponsoring organization. RA= Research/Department/Division/Grants Administrators

42. Expend Funds in Accordance with WU and Sponsor Policies Federal: • OMB Circular A-21 (costing) • OMB Circular A-110 (administrative) • NIH Grants Policy Statement • NSF Grants Policy Manual Institutional (WU): • WU Direct Charging Policies (general) • Specific policies and procedures (travel, NIH Cap…)

43. Expend Funds in Accordance with WU and Sponsor Policies Costs are required to be: • Reasonable - goods or services involved and the amount reflect the action of a prudent person • Allocable - incurred solely for the benefit of the project • Allowable - allowable under the terms of the agreement and sponsor’s guidelines

44. Direct Costs Definition: Costs that can be specifically identified to a particular project or program • Salaries and fringe benefits • Travel • Equipment • Supplies • Sub-agreements • Patient care

45. Unallowable Costs • Costs that are not reasonable and not directly allocable to the project • Costs specifically deemed unallowable by the sponsor - Examples include: • Fines and Penalties • Deficits • Personal use of goods • or services • Office supplies • Advertising • Alcohol & Food • Charitable Contributions • Entertainment • Paper • Printer toner

46. Facilities & Administrative Costs(a.k.a., Indirect or Overhead) • Definition: Costs that are incurred for common or joint objectives which cannot be specifically identified with a particular project • Applied as a percentage of direct costs (53% mtdc = on-campus research)

47. Facilities Heat, light & A/C Building maintenance Building depreciation Interest on building loans/bonds Equipment depreciation Library Administrative Chancellor’s, VP’s and Dean’s Offices Human Resources Payroll, A/P & Purch. Research Office & SPA Department Admin. What do F&A dollars pay for?

48. What is Effort Reporting? • An individual certifies that salaries charged to sponsored projects are reasonable in relation to the work performed

49. Faculty Effort • Total activity for which a faculty member is compensated by WU • Regardless of the number of hours actually worked (100% institutional effort) • No standard hours or work week • Effort varies from individual to individual

50. Effort Categories • Annual compensation paid by WU for a faculty member’s appointment, whether that individual's time is spent on: • Organized Research • Instruction • Department Research • Patient Care (Clinical Care/Trials) • Graduate Medical Education • Department Administration • Management of Hospital Services