AURA Meeting. July 23, 2014

Transcription

1 AURA Meeting July 23, 2014

2 Welcome William Mitchell, MPSA Supervisor, Systems & Reporting Sponsored Projects Administration

3 Website Spotlight Cherrelle Duncan, MPSA Sponsored Projects Specialist Sponsored Projects Administration go.uth.edu\spa

4 Assigning a Delegate Sometimes, faculty members are unavailable. Delegates can be assigned to act in their stead. Delegates can see and edit proposals the faculty member can see or edit and will get the same notifications as the faculty member does, both and in the system. This includes the ability to route the application. Information on Assigning a Delegate can be found in three locations: Systems & Reporting -> Cayuses424 ->Helpful Information Table of Contents-> Assigning a Delegate Table of Contents-> Cayuse424-> Helpful Information

5 SPA Twitter Keith Comfort Financial Analyst, Post Award Finance Sponsored Projects Administration

6 SPA Twitter Home Page

7 Organizations on Twitter

8 Sample Lists of Health Tweeters

9 Sample NIH Tweets

10 Medical & Health Tweets

11 Tweets by Federal Health Agencies

12 OSP Name Change Karen Niemeier Contracts Director Sponsored Projects Administration

13 OSP Name Change

14 Research Conflicts of Interest Revised Certification and Disclosure Forms Loretta Davis, MPA Manager, Conflicts of Interest Program Office of Institutional Compliance (713) UCT 1510

15 Research COI Requirements - Overview Covered Individuals must complete the following requirements: 1. Complete the required RCOI education. (Employees fulfill this requirement through UTHealth s Mandatory Compliance Training. Others may take the RCOI training module available on the CITI site if they have not taken a comparable course at their own institution or company.) 2. Submit a "Research COI Certification Form" for each proposed research project: to SPA; to CPHS; upon request by the AWC; to the department for startup funds, gifts, endowments, etc. designated for their research; and to the program or official making the funding decision for internal awards. 2A. If there is a related Significant Financial Interest for a research project, submit a "Research COI Disclosure Form. 3. Submit an annual Financial Disclosure Statement.

16 Research Conflict of Interest Certification Form Effective July, 2014, a revised Research COI Certification Form is available. As always, the 1-page form is required of all Covered Individuals on proposed research grants, contracts, and protocols. The form is located at: and is also embedded within the OSP Review & Approval Form, and within the iris submission form. New: Two questions have been added, for a total of seven Yes/No questions:

17 Research Conflict of Interest Certification Form 1. Do you or a family member participate in an outside activity with the research sponsor that would be defined as a Significant Financial Interest? 2. Do you or a family member own stock, stock options, business ownership, or rights to such interests in the research sponsor, that would be defined as a Significant Financial Interest? 3. Do you or a family member personally own rights to the technology that will be studied or validated in the proposed research? (Does not include intellectual property owned by UTHealth.) 4. Do you or a family member have a Significant Financial Interest in an entity that owns or licenses the technology that will be studied or validated in the proposed research? 5. Do you or a family member have any other personal relationship or financial interest that could appear to affect, or be affected by, the proposed research? 6. New: Do you have an existing UTHealth Research Conflict of Interest Management Plan for this sponsor, or for the technology that will be studied or validated in the proposed research? 7. New: Are you aware of any Significant Financial Interest held by your supervisor (including a department chair, or a graduate or postdoctoral advisor) with the sponsor, or in the technology that will be studied or validated in the proposed research?

18 Research Conflict of Interest Disclosure Form Effective July, 2014, a revised Research COI Disclosure Form will be available. As always, the 3-page form is required only when a Covered Individual has certified a Significant Financial Interest with a proposed research project (as reported on his/her RCOI Certification Form). The Form is located at: New: The form is no longer required to be submitted with the proposal. New: Once the Research COI Office initiates a research conflict of interest review, the researcher will be contacted and the form will be requested at that time. New: Forms will be submitted electronically to Research_COI@uth.tmc.edu. (They may also be mailed to the RCOI Program Office, UCT 1510; however, incomplete forms will not be accepted.)

19 Research Conflict of Interest Disclosure Form The RCOI Disclosure Form obtains information about the investigator s related Significant Financial Interests, and the research, so that the RCOI Committee may conduct its review and make its recommendations to the EVPARA. 1. Financial interests and relationships; 2. Other financial interests (of supervisors, UTHealth, etc.); 3. Intellectual property; 4. Manufacture or commercialization of research-related items; 5. Use of experimental animals; 6. Human subjects research; 7. Research performance sites; 8. Description of the research; 9. Role(s) in the research; and 10. Whether an existing Management Plan (if one has been implemented) provides sufficient management strategies.

20 Financial Conflicts of Interest in Research From the Research Conflicts of Interest Policy (HOOP 94), Section III F: Research may be allowed in the face of a conflict depending upon: 1) the nature of the science; 2) the specific financial interest; 3) the magnitude of the interest and the degree to which it is related to the research; and 4) the extent to which the interest is amenable to effective oversight and management. Neither the institution nor a Covered Individual may expend research funds unless the EVPARA has determined that no financial conflict of interest exists or that any financial conflict of interest is manageable in accordance with the terms of a management plan that has been adopted and implemented.

21 SPA Training Program Amaris Ogu, MBA Clinical Research Financial Analyst Sponsored Projects Administration

22 SPA Training Program SPA Training Program is a series of training resources developed by Sponsored Projects Administration (SPA) to cover basic and advanced topics in research administration relevant to UTHealth policies and procedures.

23 Training Resources SPA Training Course o 3 day training course o Basic to intermediate topics o SPA and guest presenters o Hands on experience o First Sessions October 2014 & April 2015 Online Modules o Advanced Topics o Available September 2014 Website o Internal Training Opportunities o External Training Opportunities o Tips and Tools o go.uth.edu/ SPATraining

24 01 SPA Overview Purpose SPA Breakdown o Grants, Contracts, PAF, Systems & Reporting, Clinical Research Finance o Contact/Specialist List Signature Authority Hoop 124 o Delegation of Authority o SPA signature matrix Institutional Information o Institutional Data Sheet o Tax Status o UT Foundation Website Resources (News Feed, Training section: checklist & index) AURA Internal Routing/Review Process o Life Cycle of a Sponsored Project o Internal review process o Internal Deadlines Finding Funding/PI Initiates Proposal o SciVal o Other Mechanism to Find Funding Proposal Development A&F Packet Investigator/Department Responsibility R&A Forms (includes filling out) o R&A Form o Non monetary R&A o R&A Addendum o Additional Personnel Addendum o Signature Page Addendum RCOI o Conflict of Interest Disclosure Form o Annual Financial Disclosure o Define Covered Individual Agency Instructions & Guidelines o Uniform Circular Subcontracts (In/Out o Scope of Work o Letter of Intent/Face Page o IDC rate agreement o PHS FCOI Regulation/ Sub recipient COI form/fdp Institutional Clearinghouse o Budget/Budget Justification Exception Letters o Indirect Cost Waiver o Cost Sharing o Appointment Letters o Limited Nomination Assurances o Types Grant Application o Components/Parts of Application o Personnel Types o Multi PI Plan Budget & Budget Justification o Agency Guidelines o Effort Minimum Effort (HOOP 93) o Modular vs. Non Modular o Allowable Cost/ OMB A 21 o Indirect Cost o Exclusions Clinical Trial Budgets o Research Cost/Standard of Care Cost 02 Contracts Definition of a contract ocontract vs. Grant Internal Review Process o Submit R&A: Non monetary vs Monetary o Assurances Needed Types o Authorized Officials Negotiation Process o Negotiation Points Confidential Disclosure Agreements o OTM s involvement Material Transfer Agreements o UBMTA o AUTM Clinical Trial /Sponsored Research Agreements Subcontracts In/Out o FDP o A 133 Compliance Validation o Sub recipient vs. Vendor Data Use Agreements In/Out Salary Reimbursement Agreements Collaboration Agreements Proposal Submission/Tracking Tracking for Federal Proposal After the Fact Proposals Withdrawing a Proposal JIT o What is a JIT? o Internal review process o Timeline for submission o Required documents Post Submission Materials Award Receipt/NoA Notice of Award o Restrictions Project Set Up Process Guarantee Accounts Split Account Request X TRAIN appointment Award Management Transfer In/Out Budget Modifications No Cost Extensions Account Deficits Buy Cards Cost Transfers Personnel Actions o Retro PA s Prior Approval Request o Change in Scope o Change in Personnel o Change in Effort Account Reconciliation Financial & Progress Reporting Progress Report/RPPR/Continuations Financial Status Reports 03 o Carry Forward Request Award Close out Relinquishing Letters Final Progress Report PAF Project Account Close Out Process FSR & FIS Effort Effort/Effort Certification at UTHEALTH o What is/not Effort? o What is ecrt o Why is Effort Certification Important? o Effort Reporting Lifecycle & Calendar o Reporting Roles & Responsibilities o What is cost sharing? o Salary Cap Calculations o Clinical Trials o Forms o Certifying Effort Frequently asked questions Effort Guidelines & Policies o Federal Requirements o Minimum & Maximum Levels o Risk of Noncompliance o Reporting Schedule o Travel Restrictions Procedure Frequently asked questions with Effort Systems & Reporting Cayuse o Creating an account o Administrator Access o Login Instructions o How to create a new proposal o Routing chain creations o Non federal proposal upload o Subcontract upload o Transform and existing proposal o Permissions era Commons & Other Systems o ID Requests o Help Desk Issues SAM Registration

25 SPA Training Contact Information For more information please us at

26 CRF Policies/Training Heather Cody, MHA Supervisor, Clinical Research Finance Sponsored Projects Administration

27 CRF Policies/Training Effective 9/1 Clinical Research Finance will launch 2 new procedures designed to ensure the accuracy of clinical research billing. Needed to meet new regulation Ensures accurate billing of research costs

28 CRF Policies/Training Coverage Analysis Evaluates whether clinical services/items in a research study should be billed to the sponsor or as standard of care to a 3 rd party payor Justifies procedures that are deemed standard of care Registration/Scheduling Outlines a procedure to identify study patients in GE Centricity Designates how the study patient will be scheduled Allows for markers to identify claims that should receive evaluation prior to submission to 3 rd party payors

29 CRF Policies/Training Training for new policies Overview trainings for Coverage Analysis and Registration/Scheduling (3 available times) Trainings will cover a completed coverage analysis example and a high overview of the clinical research billing process. Advanced Training (2 available times) You should attend the overview 1 st A coverage analysis will be completed during training

30 CRF Team Heather Cody, MHA - Supervisor Heather.cody@uth.tmc.edu Amaris Ogu, MBA Financial Analyst Amaris.e.ogu@uth.tmc.edu Trae Rohan, BA, CHRC - Regulatory Specialist Trae.Rohan@uth.tmc.edu CRF Group - grp-crf@uthouston.edu

31 Effort Reporting William Mitchell, MPSA Supervisor, Systems & Reporting Sponsored Projects Administration

32 Effort Reporting Certification Period is now open July 21, 2014 through August 21, 2014 Travel restrictions effective August 25, 2014 Submit any retroactive PAs Place cards on hold if changes pending Contact the Effort Reporting Team or

33 Subaccount Transition Update Victoria Briscoe Assistant Director, Post Award Finance Sponsored Projects Administration

34 Subaccount Transition Update NIH Notice: NOT-OD

35 Facilities & Administrative Cost Rate Agreement Jodi S. Ogden, MBA, CRA Associate Vice President Sponsored Projects Administration

36 F&A Rate Agreement Institutional Information: go.uth.edu/instinfo

37 F&A Rate Agreement Off campus definition: For all activities performed in facilities not owned by the institution and to which rent is directly allocated to the project(s) the off-campus rate will apply. Grants or contracts will not be subject to more than one F&A cost rate. If more than 50% of a project is performed offcampus, the off-campus rate will apply to the entire project.

38 HOOP 69

39 HOOP 69 Changes B. Non-Federal Sponsored Projects Applications for non-federal sponsored projects shall include a minimum of 30 percent of total direct costs as indirect costs in the budget, unless: The funding agency has a written policy that it pays a different fixed indirect cost rate The request for proposal or funding opportunity announcement details a different indirect cost rate The agency provides a letter signed by a representative on official letterhead that it will pay a different rate on the specific award

40 Uniform Guidance Jodi S. Ogden, MBA, CRA Associate Vice President Sponsored Projects Administration

41 Uniform Guidance OMB is streamlining the Federal government's guidance on Administrative Requirements, Cost Principles, and Audit Requirements for Federal awards. These modifications are a key component of a larger Federal effort to more effectively focus Federal resources on improving performance and outcomes while ensuring the financial integrity of taxpayer dollars in partnership with non-federal stakeholders.

42 Uniform Guidance or A-81 This final guidance supersedes and streamlines requirements from OMB Circulars: A-21 A-87 A-110 A-122 A-89 A-102 A-133 A-50

43 Uniform Guidance or A-81 SPA Leadership team is reviewing the following: Cost Accounting Standards & DS2 Internal Controls Procurement Standard Terms and Conditions Closeout Subawards & Subrecipient Monitoring Conflict of Interest Compensation & Effort Reporting Compensation & Fringe Benefits Performance Measurement Direct Costs Administrative Salaries Prior Approval Requirements for Pass-Through Entities Indirect Costs Travel Costs Exchange Rates Fixed Amount Awards Equipment Program Income

44 Uniform Guidance or A-81 Implementation date is December 27, 2014

45 Next Meeting: September 24, 2014 Presentations & Schedule Posted at: go.uth.edu/aura