RESEARCH ADMINISTRATION A-Z

1. RESEARCH ADMINISTRATION A-Z Session VI: Conflict of Interest & Pre-award Functions Budget

2. Conflict of Interest & Pre-award Functions Budget • Valarie Dixon, Director, Conflict of Interest • Elise Jameson, Associate Director, Faculty Compensation • Erika Wilson, Department Business Officer, Pathology • Rachel Cook, Pre-award Analyst, HS SPPO • Andrea Rollins, Director, HS SPPO

3. Conflict of Interest Valarie Dixon, Director

4. Overview • Definition of Conflict of Interest • Conflict of Interest Office Mission • UC Conflict of Interest Code • Conflict of Interest Laws and Policies • Financial Disclosure Requirements • Role of the Independent Review Committee on Conflict of Interest in Managing Conflict of Interest • Conflict of Interest Management Strategies • Additional Conflict of Interest Resources

5. Definition of Conflict of Interest • The term “conflict of interest” refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising an employee’s professional judgment in administration, management, teaching, research and other professional activities.

6. Conflict of Interest Mission • Ensure that conflicts of interest are avoided or managed and that the best interests of the public and the University are served. • Assist employees in assessing circumstances under which their outside activities or interests may inappropriately conflict with their responsibilities to the University.

7. UC Conflict of Interest Code • Financial conflicts • Conflicts of time or commitment • Purchasing of goods and services • Use of University property and facilities • Personnel related • Codes of conduct • Inventions patents and licensing • Research

8. When is Financial Disclosure Required? A Principal Investigator (PI) and/or any individual responsible for the design, conduct or reporting of sponsored research must disclose a financial interest when applying for or receiving funds for: • University Research Contracts, Grants, and Material Transfers • Gifts • Clinical Trial Agreements • Lab Service Agreements • NIH/NSF federal grants

9. Disclosure of Financial Interests in Non-Federal Sponsors of Research and Donors of Gifts • Within the last 12 months the PI must disclose: • Service as a director, officer, partner, trustee, employee of or any management position in the sponsoring entity • Investments of $2,000 or more in the sponsoring entity • Income (including any payment, such as salary or consulting fees) of $500 or more from the sponsoring entity • Personal gifts of $50 or more from the sponsoring entity • Loans from the sponsoring entity exceeding $500

10. Disclosure of Financial Interests Related to Federal Sponsored Research • Principal Investigators, researchers and any individual responsible for the design, conduct or reporting of sponsored research must disclose their financial interest in any company that could reasonably benefit from the research results. Financial interest includes: • Equity (in excess of 5%) • Income (in excess of $10,000) • Any management position • Intellectual property licensed to a company

11. Disclosure of Financial Interests in Research Involving Human Subjects • In addition to the referenced disclosure requirements for federal and non-federal sponsored research, individuals who are responsible for the design, analysis, conduct, or reporting of the results of research to be performed under a human subjects protocol must disclose whether or not they have a financial interest in or association with the sponsor or the company supplying the materials, drugs, or devices for the project.

12. How are Conflicts of Interest Managed? The Independent Review Committee (IRC) on Conflict of Interest • The IRC functions as the principal advisory committee to the Chancellor for the review and management of conflict of interest in research • The IRC reviews financial disclosures for both privately and federally sponsored projects and makes recommendations on how to manage conflicts of interest

13. Commonly Disclosed Financial Interests • Income for consulting with sponsor and/or company or consults as a member of an advisory board • Management position/Board of Directors • Equity, stock, stock options or other ownership • Company holds the patent to the researcher’s invention • University researcher has a financial interest in a company and is directing the work of graduate students

14. Management Strategies for Conflict of Interest • Limit consulting activities • Resign from management position • Timetable for reduction of equity • Intellectual property review • Co-advisor for graduate students

15. Management Strategies for Conflict of Interest (cont.) • Acknowledgment of the researcher’s relationship with the company in publications of research results • Conflict of Interest (COI) Management Subcommittee assigned to monitor the researcher’s relationship with company

16. Management Strategies for Conflict of Interest in Research Involving Human Subjects • The IRC recommends that individuals who have independent roles in research to be performed under a human subjects protocol not concurrently receive any compensation from the sponsor or other entity supplying materials, drugs or devices for the project, including honoraria and consulting fees, during the course of the study.

17. Special Considerations for Research Involving Human Subjects In managing conflict of interest, the IRC will consider: • The investigator's role in the project. • Whether the investigator is involved in subject selection, including prescreening for inclusion/exclusion criteria. • Participation of the investigator in the consent process. • Investigator participation in clinical treatment of subjects, separate from the research interventions or procedures. • The design of the clinical study; whether it is a single-site, investigator-initiated study or a multicenter study with oversight provided by a sponsor or other third party.

18. Additional Conflict of Interest Resources • COI FAQs http://www.coi.ucsd.edu • Q&A on Employee Conduct, Relations with Industry and Conflict of Interest http://www.ucop.edu/services/conflictofintans.html • Conflict of Interest Policy and Compendium of Specialized University Policies Guidelines, and Regulations related to Conflict of Interest http://www.ucop.edu/ucophome/policies/bfb/g39.pdf • UC Business & Finance Bulletin (BUS-43 Materiel Management) http://www.ucop.edu/ucophome/policies/bfb/bus43.html

19. UC/VA Split Faculty Salaries & Effort Reporting Elise Jameson, Associate Director

20. Pre-Award Budget Functions Erika Wilson, Department Business Officer Rachel Cook, Pre-award Analyst Andrea Rollins, Director

21. Proposal Budget • Budget Guidelines available at: http://ocga3.ucsd.edu/Proposal_Preparation/Budgets/Budget_Preparation_Components.htm#Overview • Budget Tool available at: http://ocga3.ucsd.edu/Forms/UCSD_Proposal_Budget_Form_Instructions.pdf

22. Proposal Budget Salary & Benefits

23. Salary: Review Salaries are reviewed to ensure the Health Sciences policy regarding commensurate salary for effort is budgeted as appropriate, correct institutional base pay rates are used, budgeted increases are appropriate, and the correct NIH salary cap is used when applicable.

24. Salary: For PIs For the PI, there is no minimum percent of time which can be “donated” to a project without budgeted salary. Salary for effort is mandatory, unless • The agency does not allow salary • The PI holds an HHMI appointment • The agency limits the annual award amount to $50,000 • A salary waiver has been requested and approved

25. Salary: For Co-Investigators • For co-I’s, Health Sciences allows up to 5% effort without salary, with the approval of the home department. Greater than 5% donated effort of a faculty co-I requires approval of a salary waiver requested from the home department. • Donated effort which is greater than 5% is formal cost sharing, and must be reflected in the cost sharing section of the RES. If the proposal is funded, the value of this donated effort will need to be tracked and reported as cost sharing.

26. Salary: Salary Waiver Salary Waiver Requests are memos written by the chair of the individual’s home department, addressed to Gene Hasegawa, Assistant Dean for Administration, and consists of an explanation of why salary has not been budgeted and what fund source(s) the department will use to cover that salary. Salary Waiver Requests are not automatically approved. http://somlweb-dev.ucsd.edu/twiki/bin/view/HSSPPO/TemplatesBoilerplate

27. Salary: Use of NIH Salary Cap • Use of the NIH salary cap in proposals to agencies which do not have salary caps is not allowed. • Instead, the correct institutional base should be used, and a lower percentage of salary budgeted than the proposed effort, provided a salary waiver request has been approved.

28. Salary Projections Salary and wages are monetary compensation paid to UCSD employees working on a project. Personnel may include faculty, researchers, visiting scholars, staff, and graduate students.

29. Salary Projections • When preparing a salary projection for a budget the first things you will need to determine with the Principal Investigator are: • Who will be funded on this project. • What percentage of effort will they we working.

30. Salary Projections • EFFORT Evaluation and Planning • Principal Investigator effort should be evaluated with current awards. • The average percentage of effort submitted on a proposal is from 5% to 25%. • The SOMFISCAL website has updated Current & Pending support data.

31. Salary Projections • Some applications require a set percentage of effort ie. K Awards usually 75% depending on the agency you can check this at the NIH OER website • http://grants.nih.gov/training/careerdevelopmentawards.htm

32. Salary Projections

33. Salary Projections

34. Salary Projections • You will need the following information for the employees you are doing a salary projection on. Who are eligible for merit increases, what type of increases (Academic, Merit Base, Step Base) • Current base salary. This information you can get from PPS or the Home Department if the individual is paid from another Department. Home Department should provide salary projection.

35. Salary Projections

36. Fringe benefits The composite benefit rates are posted on the OCGA website: http://ocga3.ucsd.edu/ If your department is using actual benefit rates they can be calculated using the DOPES Benefit charge /Gross Salary = % Benefit Rate

37. Fringe benefits

38. Salary Projection • After you have gathered all the information you can begin the salary projection. • Using excel spreadsheet (sample) enter the data regarding each employee to be proposed on the budget.

39. Salary Projection

40. Graduate Students Researchers • Tuition Remission • allows Graduate Student Researchers or GSRs, who are employed at 25% time or more during any one academic quarter to be compensated for their tuition and various UCSD student-related fees. • Tuition Remission Rates Information: • http://ocga3.ucsd.edu/Budget_Preparation/Tuition_Remission_Rates_Budget_Preparation.htm

41. Graduate Students Researchers • There are four separate groups of rates for UCSD. Health Sciences falls under the “General Rates” group. • As of 10/01/08, the tuition remission rate is $1,251 per quarter, with a 7% escalation rate every academic year. • GSRs allowable effort: • Academic Year – is 20 hours/week (50% effort) • Summer – is 40 hours/week (100% effort)

42. Graduate Students Researchers • For more information: • The Office of Graduate Studies or OGS is responsible for the development of policy, rates, and implementation of tuition remission for UCSD. • http://ogs.ucsd.edu/Pages/default.aspx

43. Proposal Budget Consultants

44. Consultants • Consultants are individuals who do not provide a percentage of effort to the project or program, but rather provide expert advisory or other services for brief or limited periods of time during the period of performance. • UCSD Employees may be listed as consultants but cannot receive pay.

45. Proposal Budget Equipment

46. Equipment Equipment is identified as an item of non expendable, tangible personal property, meaning it can be appraised for value, has an acquisition cost of $5,000 or more, is free-standing or can stand alone, and has a normal useful life expectancy of one year or more.

47. Proposal Budget Supplies & Materials

48. Supplies & Materials Supplies and materials can include some of the following items; • Chemicals • Glassware • Animal purchases • Equipment items that have an acquisition cost of less than 5,000 dollars • Repair parts or replacement components for equipment items • Computer software. Each item in the supplies and materials category of the budget should be listed separately and include sufficient detail.

49. Proposal Budget Travel

50. Travel Travel are costs associated with the required travel for each UCSD employee working on the project or program.