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Quality Research Administration Meeting

Quality Research Administration Meeting. November 2011. Agenda. Federal Update PHS Conflict of Interest Policy Update NIH Genomic Array Policy- UCI’s Implementation Determination of Human Subjects Research Gift/Grant Distinctions Subaward Reminders Patent Acknowledgement Amendment.

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Quality Research Administration Meeting

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  1. Quality Research Administration Meeting November 2011

  2. Agenda • Federal Update • PHS Conflict of Interest Policy Update • NIH Genomic Array Policy- UCI’s Implementation • Determination of Human Subjects Research • Gift/Grant Distinctions • Subaward Reminders • Patent Acknowledgement Amendment Alison Yeung and Jeff Warner Grace Park Nancy Lewis Chris Abernethy and Beverly Esparza Barbara Inderwiesche and Allison Ramos Nancy Lewis Bruce Morgan

  3. Sponsored Projects Administration Update • Federal Update Alison Yeung Contract and Grant Officer, Sponsored Projects Administration Alison.Yeung@research.uci.edu 949.824.2644 Jeff Warner Contract and Grant Officer, Sponsored Projects Administration warnerj@uci.edu 949.824.4781

  4. Significant Changes and Clarifications to the NSF Agency Specific Requirements to the Research Terms and Conditions, dated 02/12 • Travel, Article 14, has been updated to incorporate revised circumstances under which use of a foreign-flag air carrier is permissible. The Article provides information on recent modifications to the “Open Skies” Agreement with the European Union. • Expenditure Reports, Article 9, has been modified to reflect that all Federal Financial Reports must now be submitted through Research.gov.

  5. Significant Changes and Clarifications to the NSF Agency Specific Requirements to the Research Terms and Conditions, dated 02/12 • Indirect Costs, Article 11, is a new Article reminding awardees subject to OMB Circular A-21 that they must use the indirect cost (F&A) rate(s) approved by the cognizant Federal negotiating agency that are in effect at the time of the initial award, throughout the life of the award, unless otherwise specified in the award notice. • Grantee Responsibilities and Federal Requirements, Article 12, has been supplemented with a weblink to a listing of the National Policy Requirements. http://www.nsf.gov/bfa/dias/policy/rtc/appc_june11.pdf

  6. NIH eRA Commons User Guides New and Updated • The eRA Commons User Guide provides extensive information on how to use the Commons and was updated on October 7th. The updated eRA Commons User Guide can be found at http://era.nih.gov/docs/COM_UGV2630.pdf and the updated User Guide FAQ can be found at http://era.nih.gov/commons/faq_commons.cfm. • The Account Management tool has replaced the eRA Commons Admin module. The Account Management (AMS) User Guide can be found at http://era.nih.gov/files/AMS_user_guide.pdf.

  7. DHHS ACF Submissions • The DHHS’ Administration of Children and Families announced in the Federal Register that effective January 2012 it will require electronic submissions through Grants.gov or GrantSolutions.gov for its discretionary programs. With the implementation of electronic submission of discretionary grant applications via Grants.gov, ACF will extend the timeframe for application receipt from 4:30 p.m., E.T., to 11:59 p.m., E.T. • See the notice at http://www.gpo.gov/fdsys/pkg/FR-2011-10-27/pdf/2011-27878.pdf

  8. NIH Update • New focus at all NIH Institutes on progress and final reports. Failure to submit complete and timely reports may affect future funding to the organization. • NOT-OD-12-004 - NIH is operating under a Continuing Resolution (CR) that was enacted on October 4, 2011. The CR continues NIH’s operations at the FY 2011 level minus 1.5%. Until FY 2012 appropriations are enacted, NIH will issue non-competing research grant awards at a level below (generally up to 90% of the previously committed level) that indicated on the Notice of Grant Award. NIH will consider providing upward adjustments to those awarded levels after the FY 2012 appropriation is enacted.

  9. Significant Changes to the NIH GPS for October 2011 Version • Section 1.2 – Definitions of Terms - In response to user input: This revision provides consistent terminology in referring to funding mechanisms and peer review, aligning definitions with other policy source documents as appropriate. • Section 2.3.4 – NOT-OD-10-140 - NIH will not accept a Resubmission that is submitted later than thirty-seven months after the date of receipt ("receipt date") of the initial New, Renewal, or Revision application.

  10. Significant Changes to the NIH GPS for October 2011 Version • Section 2.3.9.4 – New Section - Submissions of identical applications to one or more components of the PHS are not allowed, and the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. Reflects consistent policy with relevant section of the SF424 (R&R) Application Guide. • Section 2.3.11.2.2 – Confidentiality of Information – The Freedom of Information Act: Edited by NIH FOIA officer for clarity in response to user input.

  11. Significant Changes to the NIH GPS for October 2011 Version • Section 2.4.2 – NOT-OD-1106 – NOT-OD-11-101 – Revises NIH policy on Appeals of Initial Scientific Review. Appeals must be based on one of the following: evidence of bias on the part of one or more peer reviewers; conflict of interest, on the part of one or more non-Federal peer reviewers; lack of appropriate expertise within the SRG; factual error(s) made by one or more reviewers that could have altered the outcome of review substantially. • Section 4.1.3 (Not 4.1.6) – Clinical Trials.gov Requirement – Section edited by OGC in response to user input and current status of the rulemaking process. In particular, grantees should be aware that if an applicable clinical trial is funded in whole or in part by an NIH grant or cooperative agreement, any application or progress report shall include a certification that the Responsible Party has made all required submissions to ClinicalTrials.gov.

  12. Significant Changes to the NIH GPS for October 2011 Version • Section 4.1.10 – NOT-OD-11-109 – Implements new Financial Conflict of Interest policies. Summary of major changes can be found here: http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc. • Section 4.1.11 – Fly America Act – Revised text to reflect updated GSA guidance related to Open Skies.

  13. Significant Changes to the NIH GPS for October 2011 Version • Section 8.1.1.3 – NOT-OD-11-098 - Notifications may not be submitted via e-mail or fax. Upon receipt of the notification, the GMO will process and acknowledge the extension. If the no-cost extension notification is submitted late, the extension notification automatically becomes a request and requires the approval of the IC Chief GMO. • Section 8.1.2.4 – Carryover of Unobligated Balance - In general, carryover action requiring prior approval will be approved using the F&A rate that was in effect at the time the initial funds were awarded. However, actual expenditures will still be based on the rate applicable when the cost is incurred.

  14. Significant Changes to the NIH GPS for October 2011 Version • Section 8.1.2.6 – NOT-OD-11-118 - The grantee is required to submit a prior approval request to the GMO if: There is a change from a multiple PD/PI model to a single PD/PI model. There is a change from a single PD/PI model to a multiple PD/PI model. There is a change in the number or makeup of the PD/PIs on a multiple PD/PI award. • Section 8.1.2.7 – Change of Grantee Organization – The list of required documents for this request was edited for clarity in response to user input.

  15. Significant Changes to the NIH GPS for October 2011 Version • Section 8.4.2.1 – Streamlined Progress Reports Reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more. Once agency approval has been given for a significant change in the level of effort, then all subsequent reductions are measured against the approved adjusted level. • Section 8.4.1.3 - New Section - Progress Reports for Multiyear Funded Awards: A limited number of NIH grant awards are multi-year funded, i.e., not funded in budget years but funded in full at the start of the project period from a single fiscal year appropriation. The project period and the budget period are the same in a multi-year funded (MYF) award, and are longer than one year. Progress reports for MYF awards are due annually on or before the anniversary of the budget/project period start date of the award.

  16. Financial Expenditure Reports • Implements the use of the Federal Financial Report (FFR) system located in eRA Commons for reporting expenditure data • including new reporting dates for annual FFRs, and reporting of cumulative data only. • See the notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-017.html Section 8.4.1.5.2 & 8.4.1.4.3 NOT-OD-11-017

  17. Special Award Conditions & Enforcement Actions • Special Award Conditions & Enforcement Actions (Section 8.5) • If you do not comply with Terms & Conditions of the award: • NIH may place special conditions on awards; prevent you from obtaining future awards for a specified period, or more closely monitor the award • Modification of the Terms of Award (Section 8.5.1) • Grants management officer may include special conditions during the grant performance – which would result in a modification of the award

  18. Special Award Conditions & Enforcement Actions • Suspension, Termination, and Withholding of Support (8.5.2) • Other Enforcement Actions (8.5.3) • Recovery of funds (8.5.4)

  19. Application Requirements • Implements revised multiple PI/PD policy (previous slide) • Also includes clarification of “new investigator status”, “multiple PI” and “Lead Researcher New investigator: Not previously a PD/PI for *substantial NIH independent research award ESI:10 yrs after PhD or medical Residency • Sections 9.3 and 9.4 • Notice NOT-OD-11-118 • See the notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-118.html

  20. Kirchstein National Research Service Awards (NRSA): F-32 eligibility Postdoctoral training *should be at site other than graduate institution Grad student institution *See notice and text for detail Section 11.2.2.5 NOT-OD-11-097

  21. NRSA: Individual Fellowships Eligibility Criteria Unless in process of becoming permanent resident and expected to be admitted by the earliest possible award date. Section 11.2.2.4

  22. Written Agreement with Consortium participants (subawards) • Grantees must enter into a formal written agreement with subawards that addresses arrangements for meeting scientific, administrative, financial and reporting requirements of the grant Subrecipient Commitment Forms must be submitted at the proposal stage Section 15.2.1

  23. Consortium Agreements: Allowable and Unallowable Cost • Clarification of NIH policy on third party F&A in the absence of a rate agreement: Grantee must include in consortium agreements the applicable government-wide cost principles and NIH cost policies and requirements related to allowable/unallowable costs described in the Cost Considerations Chapter of NIH GPS. Section 15.2.3

  24. Domestic Grants with Foreign Components Foreign component: performance of a significant part of the project outside the US by the grantee or by another researcher at a foreign institution (regardless of whether $$ are expended) Section 16.2

  25. Department of Justice Update New Conference Costs and Reporting Requirements

  26. October 21, 2011 – US DOJ issued high priority memorandum with new conference cost requirements to all DOJ grant recipients

  27. Newly Enacted Conference Costs & Reporting Requirements for New Contracts and Agreements Effective immediately, NO OJP funding can be used for food and/or beverages at conference, meeting, training, any other event *Exceptions require prior approval from DOJ

  28. …and for Existing Contracts and Agreements For events for which you have entered into a contract prior to 10/21/2011, the contract should be renegotiatedto the extent possible to avoid food and/or beverages expenditures Regardless, only ONE refreshment break a day is allowable to be charged.

  29. …and for Existing Contracts and Agreements For events for which you have entered into a contract prior to 10/21/2011, the contract should be renegotiated to avoid food and/or beverages expenditures Grantees funded through cooperative agreements or contracts may not enter into any contract for services without prior approval from the Office of Justice. Regardless, only ONE refreshment break a day is allowable.

  30. Caveat: Conference Planning • DOJ has identified conference planning costs as an area for further review • Avoid situations where conference planning costs are not critical or exceed necessary levels

  31. Stay tuned…

  32. NSF Expiration Date Change • Effective 10/21/2011 • New grants will specify the award effective date and anticipated “final” expiration date • If an award includes additional incremental funding in the out-years, the time associated with the increment will be included in the final expiration date • No more “incremental time”; only incremental funds

  33. Conflict of Interest Update • Sneak Preview:The Revised PHS Financial Conflict of Interest Regulations Grace Park Conflict of Interest Administrator parkgj@uci.edu 949.824.7218

  34. Sponsored Projects Update Nancy Lewis Director, Sponsored Projects Administration nancy.lewis@research.uci.edu 949.824.2897 • NIH Genomic Array Policy- UCI’s Implementation November 2011 QRAM

  35. NIH Genomic Array Policy NOT-OD-10-097 : Budgeting for Genomic Arrays in NIH Grants, Cooperative, Agreements and Contracts • Places a cap on indirect cost assessment under NIH grants, cooperative agreements, and contracts. • Costing limitation is incorporated into UCI’s F&A

  36. NIH Genomic Array Policy (cont.) • Indirect Cost may be assessed on the first $75,000 of external genomic array purchases per budget year. • Funds in excess of the first $75,000 per budget year will be exempt from indirect cost assessment.

  37. Procedures for Budgeting Annual external genomic array costs that do not exceed $50,000 per year should be budgeted as supplies. Annual external genomic array costs in excess of $50,000 per year should be budgeted as follows: (Example: Purchase of $140k genomic arrays per year.)

  38. Procedures for Costing New Object Codes created for use when charging external genomic array purchases to NIH awards: • Object Code 7010: • Use on NIH awards only. Genomic Array expenditures in excess of $75,000 per year from external sources are exempt from F&A in the MTDC base. • Object Code 7011: • Use on NIH awards only. Genomic Array expenditures form external sources less than $75,000 per year to be charged to F&A in the MTDC base.

  39. Human Research Protections/Sponsored Projects Administration Update • Determination of Human Subjects Research Beverly Esparza, Assistant Director, Human Research Protections besparza@uci.edu (949) 824-5746 Chris Abernethy, Principal Contract and Grant Officer Chris.Abernethy.uci.edu (949) 824-1749

  40. Sponsored Projects Administration Update • Gift/Grant Distinctions Barbara Inderwiesche Senior Contract and Grant Officer Sponsored Projects Administration barbarai@uci.edu 949.824.7697 Allison Ramos Principal Contract and Grant Officer Sponsored Projects Administration acramos@uci.edu 949.824.3428

  41. Sponsored Projects Subaward Update Nancy Lewis Director, Sponsored Projects Administration nancy.lewis@research.uci.edu 949.824.2897 • Subaward Reminders November 2011 QRAM

  42. Subrecipient Commitment Form • Effective, October 1st, form is required for all proposals that include subawards and after-the-fact subawards proposal submissions. • Provides SPA with data and assurances that we need to meet federal reporting and compliance requirements (FFATA, ARRA etc.) • Must be submitted at the proposal stage as part of the proposal package submitted to the Sponsored Projects Officers for review. • SPA is seeking clarification from the NIH policy office regarding the need for a letter of commitment/intent the proposal. Clarification will be disseminated via the SPA list serve . • SPA staff may ask for that it be completed for proposals submitted prior to October 1st as a means to collect data or assurances needed for the prime proposal.

  43. Sponsored Projects Subaward Update Bruce Morgan Assistant Vice Chancellor for Research/Research Administration Bruce.Morgan@uci.edu 949.824.5677 • Patent Acknowledgement Amendment November 2011 QRAM

  44. QUESTIONS ??

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