Research Roundtable 11/18/08

1. Research Roundtable11/18/08 R. Darren McCants Director Office of Research and Sponsored Programs (ORSP) 843-792-3832

2. Topics To Be Covered NIH POLICY NOTICES RESEARCH UPDATES/REMINDERS ORSP TRAINING/OUTREACH INITIATIVES

3. NIH Notices • NIH Opens xTrain to All Federal Demonstration Partnership Members - NOT-OD-08-081 (6/18/2008) • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-081.html • For T32 & T34 Research Training Grants • Appointment Forms & Termination Notices • NIH staff will review/approve • If YOUR area has a T32 or T34, xTrain will alleviate paper forms • Contact ORSP and/or visit http://research.musc.edu/orsp/Home.htm

4. NIH Notices • NIH Policy on Submission of Additional Grant Application Materials NOT-OD-08-082 (6/25/2008) • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-082.html • Before Peer Review i.e. revised budget pages, biographical sketches, letters of support and/or collaboration • Discretion of the Scientific Review Officer (SRO) • PDF attachment to an e-mail preferred • Sent separately to reviewers • Consent of Authorized Organization Representative (ARO)….ORSP (WITHOUT ARO, will not be accepted) • DEADLINE is 30 days before Peer Review

5. NIH Notices Clarification of NIH Policy on Late Submission of Grant Applications - NOT-OD-08-111 (9/2/2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-111.html Change emphasizes late consideration applies only to those with PD/PI role who have RECENT service, NOT PAST service. Keep bookmarked for reference or call ORSP

6. NIH Notices Reminder Concerning Grantee Compliance with Public Access Policy and Related NIH Monitoring Activities - NOT-OD-08-119 (9/23/2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html Describes NIH Compliance Monitoring Demonstrating Compliance Location of Literature Citations (see chart in handout) Varies by Application Type: Competing, Noncompeting, & Final Progress Reports

7. NIH Notices Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Indentify Early Stage Investigators - NOT-OD-08-121 (9/26/2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html To Begin with Traditional R01 Applications for the February 2009 Receipt Dates -New Investigator, Early Stage Investigator (ESI) & Extension of ESI Eligibility DEFINES BOTH NEW INVESTIGATOR and ESIs SEE NOTICE for PLANNED FEATURES of the IMPLEMENTATION PROVIDES NEW INVESTIGATOR WEBSITE LINK

8. NIH Notices • Revised New and Early Stage Investigator (ESI) Policies NOT-OD-09-013 (10/31/2009) • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-013.html • Indicates NEW INVESTIGATOR POLICIES limited to R01 support • Encourages New Investigators and ESIs to apply for R01s • Plan is to CLUSTER New Investigators and ESI applications…”more effectively evaluated” • ESIs will be identified using information available for applications to be reviewed during FY 2009

9. NIH Notices NIH Announces a New Business Process for Reporting an Identified Financial Conflict of Interest for Grants and/or Cooperative Agreements beginning October 10, 2008 - NOT-OD-09-001 (10/01/2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-001.html FCOI Module Part of eRA Commons Expanded to all FDP Members Initiate and prepare FCOI report, electronically submit reports and supporting documentation, search and view FCOI reports previously submitted, edit or rescind submitted reports, access history of actions

10. NIH Notices Non-Competing Grant Awards under the Continuing Resolution NOT-OD-09-002 (10/02/2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-002.html Applies Terms of the FY 2008 Appropriations Act to FY 2009 NIH will fund non-competing grant awards generally up to 90% of previously committed levels Once FINAL appropriations are enacted, NIH will CONSIDER upward adjustments to these levels INSTITUTIONS are EXPECTED to monitor expenditures closely during this period (IN OTHER WORDS NO PROMISES MADE)

11. NIH Notices New NIH Policy on Resubmission (Amended) Applications - NOT-OD-09-003 (10/08/2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html January 25, 2009 due dates and beyond ALLOWS for Original Submission and ONE Amendment Failure after the TWO attempts requires substantially re-designing the project Should lead to funding HIGH quality applications earlier THOSE SUBMITTED PRIOR TO 1/25/2009 WILL BE PERMITTED TWO AMENDMENTS (A1 & A2) HOWEVER NIH expects that any A2 should be submitted NO LATER than 1/07/2011 and A2’s will NOT be accepted after that date http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-016.htmlNOT-OD-09-016 (CLARIFIES ABOVE HAS NO IMPACT ON SUBMISSION DATES AND SPECIFIES LAST DEADLINES ALLOWING A2s)

12. Research Updates/Reminders Corporate Sponsored Research Negotiate for Non-Refundable Study Start-up Fees IRB FEES ($2,500.00 initial review/$500.00 continuing review) Payment Terms MUST BE Acceptable to Department If Payments are not received per agreement, PLEASE CALL ORSP immediately REMEMBER route ePDS once budget negotiations are final…DO NOT WAIT until contracts are received for execution Provides trainees on institutional training grants (T32,T34,T35 and T90) and fellows on individual research training fellowships (F30,F31,F32, and F33) UP TO 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or birth of a child. Either parent is eligible for parental leave. MUST BE APPROVED BY THE TRAINING PROGRAM DIRECTOR

13. Research Updates/Reminders Sub-agreements or Sub-awards PI responsible for ensuring reasonableness and accuracy of the invoices from OUTSIDE entities….Who knows better? ANY changes from original written terms, CONTACT ORSP PLEASE DO NOT RESORT to UNOFFICIAL Communications with “sub” sites. IF NOT IN WRITING BETWEEN AUTHORIZED INSTITUTIONAL OFFICIALS IT MEANS NOTHING DON’T GET LEFT HOLDING THE BAG

14. Research Updates/Reminders No Cost Extensions Remember During the No-Cost period ALL AWARD terms are still in effect Effort of KEY personnel must be maintained within approved range unless prior approval is obtained for a reduction of effort (>25%) IF ANY Cost Share obligations remain , must be maintained or met during extension period

15. Research Updates/Reminders Cost Sharing Remember to avoid Voluntary Cost Share If one is providing consistent measurable effort without funding, then Voluntary Cost Share is certainly in-play Let’s be really careful with unpaid “consultants” or “collaborator” language Is it really non-measurable effort?

16. Research Updates/Reminders • REMINDER: Facilities & Administrative (F&A) Costs Proposed as DIRECTS are Typically NOT Allowable • Administrative Personnel/Salaries • Desktop computers for general use • “GENERAL” office supplies • EXCEPTIONS (they do exist) must be clarified with ORSP at Proposal Stage (not post award).

17. Research Updates/Reminders • HHS Office of Inspector General FY 2009 List of Some Targeted Areas • Clinical and Translational Science Award (CTSA) Oversight • Financial Conflicts of Interest • Compliance with Cost Principles (specifically A-21) • Data Safety Monitoring Boards • Select Agents

18. ORSP Outreach/Training Initiatives • Electronic Research Administration • Cayuse Training • December 4th, 2008 10:00 – Noon • Register at the ORSP web site • Horizon Business Insight (HBI Training) • Reporting Tool for Proposals and Awards • December 9th, 2008 10:00 to 11:00 • ePDS Training • In Planning Stage

19. ORSP Outreach/Training Initiatives • General Research Administration • Grants Administration 101 • Knock off of Accounting 101 • Geared toward those new to the grants process at MUSC (Pre-Award) • Presented by ORSP Grant Administrators • THE PEOPLE WHO REALLY KNOW IT • Roundtables • Dates for next year to be determined • Personalized Sessions – Contact ORSP

20. ORSP Outreach/Training Initiatives • Faculty Research Orientation • First One (August 2008) • Next One (roughly February 2009) • Many Research Support Units Involved • Office of Research Development, Office of Research Integrity, ORSP, Department of Lab Animal Resources, SUCCESS Center, etc. • Plan to Hold Twice Per Year • Good for Faculty New to Research at MUSC

21. ERA Updates Robbie Lee ORSP November 18, 2008

22. Grants.gov • Grants.gov experienced significant delays for the November 5th NIH deadline • Processing times took up to 36 hours depending on time of submission • NIH extended the error-correction window to accommodate the delay in processing • Purpose of 2-day window • Correct any issues/problems caused by the submission process • Any late submission puts your proposal at risk

23. Grants.gov • All submissions made after the deadline must contain a cover letter (or addendum to existing cover letter) with the following info: • Why the application is late • Any changes made to the application since the deadline • Before rejecting a proposal, consider the following: • Is the reason for rejection a system issue? • Are you willing to accept the responsibility if NIH deems that the reason is inadequate?

24. Cayuse Updates Subawards.com

25. Subawards.com • Enables non-Cayuse customers to create sub-grants that can be uploaded to your prime proposal. • Contains many of the same features • Calculate and escalate budgets • Create a pdf version for proofing and routing • Store subawards and professional information for future use

26. Subawards.com • Benefits for MUSC • Subcontractor can create and maintain professional and institutional profiles. • IDC rates • Institutional Addresses • Professional Profiles • Upload subcontractor into prime proposal with one click • No more retyping data • No outside institutional profiles to maintain within the MUSC system

27. Subawards.com • MUSC users do not need a subawards.com account. • Once a user is registered, the account may be used for all Cayuse subcontracts (not just MUSC) • Send your subcontractors to http://www.subawards.com

28. Electronic Proposal Data Sheet Routing

29. ePDS Routing • New routing structure for the Proposal Data Sheet is in development • Designed with input from a university-wide working group • Includes representatives from all Colleges and both large and small departments • Goal • Provide flexibility to manage simple and complex routing • Provide some automation to assign routing order

30. ePDS Routing • New routing method will consist of approval groups instead of the current method of routing to individuals. • Three group levels will be available for each department or unit. • Chair Level • Business or Administrative Level • Division Level • Only the chair level is required by ORSP • Groups may be set up according to departmental needs

31. ePDS Routing • Routing to groups instead of individuals allows the designation of back-up reviewers • All individuals in a group have the ability to review, enter comments and approve/reject a proposal • Only one approval/rejection per group is allowed • Once approved, other individuals within a group will no longer have access to the proposal

32. ePDS Routing • Each department can set it’s own routing structure and rules. • Routing can be assigned automatically with one click of a button • Investigators and administrators no longer have to know other departmental routing rules • Additional reviewers may also be added to the routing to allow additional flexibility • Routing should be expedited through the use of backup reviewers and multiple access to proposals

33. ePDS Routing • Routing is accomplished in levels • Level corresponds to the number of groups used by each department/unit. • All reviewers at a given level are granted access to the proposal • Once all approvals are accomplished at a level, it is closed and individuals at the next level are notified. • If a proposal is rejected, all access is closed and the proposal is returned to the PI.

34. EpdS routing

35. ePDS Routing • Projected roll-out is January 2009 • Routing instructions and examples will be available in December with forms for group authorization levels • New system may require some departmental planning and discussion for work flow

36. Quarterly Research Roundtable Presented by:Office of Grants & Contracts Accounting November 18, 2008

37. Grants & Contracts Accounting Updates • Process Automation • Audit Update • Direct Cost / Other • Impact of Budget Cuts on Grant Activities • Activity Reporting

38. Process Automation • Grant Termination Notices • Affiliate Salary Worksheets

39. Audit Update • Audits in Process • COEE • A-133 • DHHS OIG • Cost Transfers • Administrative & Clerical • Gray Areas

40. Direct Cost / Other • Trainee Travel • Domestic Travel (51501) vs. Foreign Travel (51502) • Study Participant Travel (50236) • IRB Fees • Grant Closeout • Fringe Benefits Adjustment

41. Impact of Budget Cuts on Grant Activities • GCA Hiring Freeze • Furlough of Grant Employees • F&A Type Items

42. Activity Reporting • Certification & recertification of reports • Due Date/ Delinquent Date • Non-MUSC employees on grants • Training • System Improvements • Automation of effort coordinator email • Incremental time category system check

44. Questions? • Thank-you for coming, please do not forget to turn in your evaluation sheets.