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

Alison Yeung and Jeff Warner

Grace Park

Nancy Lewis

Chris Abernethy and Beverly Esparza

Barbara Inderwiesche and Allison

Ramos

Nancy Lewis

Bruce Morgan

November 2011 QRAM

Sponsored Projects Administration Update Federal UpdateAlison YeungContract and Grant Officer, Sponsored Projects [email protected]

Jeff WarnerContract and Grant Officer,Sponsored Projects [email protected]

November 2011 QRAM

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.

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

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.

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

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.

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.


• 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.


• 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.


• 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_m

ajor_changes.doc.

• Section 4.1.11 – Fly America Act – Revised text to

reflect updated GSA guidance related to Open Skies.


• 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.


• 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.


• 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.

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

• 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

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)

Special Award Conditions & Enforcement Actions

Application Requirements

• Implements revised multiple PI/PD policy (previous slide)

• Also includes clarification of “new investigator status”, “multiple PI” and “Lead Researcher

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

ESI:10 yrs after

PhD or medicalResidency

New investigator:Not previously a PD/PI for *substantial NIH independentresearch award

Kirchstein National Research Service Awards (NRSA): F-32 eligibility

*See notice and text for detail

Section 11.2.2.5

NOT-OD-11-097

Grad student institutionPostdoctoral training *should be at site other than graduate institution

NRSA: Individual Fellowships Eligibility Criteria

Section 11.2.2.4

Unless in process of becoming permanent resident and expected to be admitted by the earliest possible award date.

• Grantees must enter into a formal written agreement with subawards that addresses arrangements for meeting scientific, administrative, financial and reporting requirements of the grant

Written Agreement with Consortium participants (subawards)

Section 15.2.1

Subrecipient Commitment Forms must be submitted at the proposal stage

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

Domestic Grants with Foreign Components

Section 16.2

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)

Department of Justice Update

New Conference Costs and Reporting Requirements

October 21, 2011 – US DOJ issued high priority

memorandum with new conference cost requirements

to all DOJ grant recipients

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

…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 the extent possible

to avoid food and/or beverages

expenditures

Regardless, only ONE refreshment break a day is allowable to be charged.

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

Regardless, only ONE refreshment break a day is allowable.

Grantees funded through cooperative agreements or contracts may not enter into any contract for services without prior approval from the Office of Justice.

…and for Existing Contracts and Agreements

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

Stay tuned…

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

Conflict of Interest Update Sneak Preview:

The Revised PHS Financial Conflict of Interest Regulations

Grace ParkConflict of Interest [email protected]

August 2011 QRAM

Sponsored Projects Update NIH Genomic Array

Policy- UCI’s Implementation

Nancy LewisDirector, Sponsored Projects [email protected]

November 2011 QRAM

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

November 2011 QRAM

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.

November 2011 QRAM

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.)

November 2011 QRAM

Year 1 Year 2

Direct F&A Direct F&A

Supplies $50,000 $26,500 $50,000 $26,500

Subcontract w/ F&A $25,000 $13,250 $25,000 $13,250

Subcontract w/ F&A excluded

65,000 0 65,000 0

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.

November 2011 QRAM

Human Research Protections/Sponsored Projects Administration Update Determination of

Human Subjects Research

Beverly Esparza,Assistant Director, Human Research [email protected](949) 824-5746

Chris Abernethy, Principal Contract and Grant OfficerChris.Abernethy.uci.edu(949) 824-1749

November 2011 QRAM

Sponsored Projects Administration Update Gift/Grant

DistinctionsBarbara InderwiescheSenior Contract and Grant Officer Sponsored Projects [email protected]

Allison RamosPrincipal Contract and Grant Officer Sponsored Projects [email protected]

November 2011 QRAM

Sponsored Projects Subaward Update Subaward RemindersNancy LewisDirector, Sponsored Projects [email protected]

November 2011 QRAM

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.

Sponsored Projects Subaward Update Patent

Acknowledgement Amendment

Bruce MorganAssistant Vice Chancellor for Research/Research [email protected]

November 2011 QRAM

QUESTIONS ??

November 2011 QRAM

Documents

Quality Research Administration Meeting