eunice kennedy shriver nichd grants management overview ted williams supervisory grants management...

Eunice Kennedy Shriver NICHD Grants Management Overview Ted Williams Supervisory Grants Management Specialist (Team Leader) Foreign Grant Training July 23, 2012

Topics to Cover Why and how the NIH Supports Foreign Awards Competing Applications Policy updates Progress reports Compliance and Prior Approvals Other important reminders

NIH Supports Foreign Grants when Application presents special opportunities for furthering research programs through the use of unusual talents, resources, populations, or environmental conditions in other countries not available in the U.S. Specific relevance to the mission and objectives of the awarding Institute or Center (IC) and has the potential for significantly advancing the health sciences in the U.S.

What Constitutes a Substantial Foreign Component? Significant scientific element or segment of a grant project which is to be performed outside the U.S. Any activity that may impact on U.S. foreign policy through the involvement of grantee project staff in the affairs or environment of the foreign country. Extensive foreign travel by grantee staff for the purpose of data collection, surveying, sample collection, etc. Foreign travel for consultation is not considered foreign involvement. Involvement of human or animal subjects whether or not grant funds are expended.

Foreign Funding Facts ALL competing applications from foreign institutions (with the exception of Fellowships) must be presented to Council as a special issue before funding Department of State Approval required for: All New or Competing grants to foreign institutions* Domestic grants with foreign component(s)* Foreign grants may NOT be awarded without Department of State approval *Regardless of funding level

POLICY UPDATES

FY2012 Policy updates Presidents FY2012 NIH budget is ~ $30.7 billion NIH FY 2012 Fiscal Policy NOT-OD-12-036: http://grants.nih.gov/grants/guide/notice-files/NOT- OD-12-036.html FY 2013 budget not set yet no idea when it will be FIC FY2012 Funding strategy is now posted: http://fic.nih.gov/About/FundingStrategy/Pages/2012.as px

Policy updates continued Central Contracting Registry (CCR) is being replaced by the System for Award Management (SAM) near the end of July 2012. SAM includes Federal Agency Registration (FedReg), Online Representations and Certifications Application (ORCA), and the Excluded Parties List System (EPLS). CCR/SAM needs to be updated at least annually CCR/SAM registration mandatory prior to application

PROGRESS REPORTS

Continuation Progress Reports Due 60 days before next budget period start date Budget for the next Budget Period and Budget Justification All Personnel Page Biographical Sketch only required for new key personnel Other Support

Continuation Progress Reports Progress Report Progress Report Summary Administrative challenges Long term program accomplishments Future plans Ensure that manuscripts/publications have PMICD #s Ensure that the CCR/SAM registration is active

Continuation Progress Report Research subjects HS education documentation is required for all personnel working with human subjects IRB approval confirmation for the domestic and foreign sites Federalwide Assurance (FWA) # for each U.S. or foreign site Animal subjects information if applicable In-country collaborating institutions and individuals

COMPLIANCE and PRIOR APPROVALS

Consortia The prime recipient is responsible for performance of the project, reporting requirements, etc. Requirements of prime generally apply to sub-awardees and administrative and cost principles flow down to consortium participants. The grantee is responsible for obtaining NIH approval for any actions to be undertaken by consortium participants that require such prior approval. Domestic grantees with foreign consortium sites are responsible for ensuring foreign institutional compliance.

Consortia Projects Involving Human Subjects The prime grantee is responsible for ensuring all sites engaged in research involving human subjects have: All sites need Office for Human Research Protections (OHRP)-approved assurances (FWA#) IRB approval for each protocol at each site Documentation of completed required human subjects protection education for key researchers working with humans

Consortia with Animals The prime grantee is responsible for ensuring all sites engaged in research involving animal subjects have: OLAW-approved assurance (Animal Welfare Assurance # (AWA) IACUC approval Domestic grantees with foreign consortium: The foreign site(s) must have: OLAW-approved AWA# IACUC approval This certifies that the activity, as conducted at the foreign performance site, is acceptable to the grantee. The grantee IACUC may accept, as its own, the approval of a foreign entity's IACUC; however, the grantee IACUC remains responsible for the review Direct foreign grantees: Need OLAW-approved AWA# and are encouraged to use the Guide for the Care and Use of Lab Animals (8 th edition, 1/1/12) More at: http://grants.nih.gov/grants/olaw/2011positionstatement.htm

Prior Approval Common actions requiring prior approval from NIH: Change in Scope always requires prior approval Significant changes in status of PD/PI and key personnel named in Terms of Award Deviation from Terms and Conditions Carryover of unobligated balances, if applicable Need for additional funds Change of institution New foreign component Second and subsequent no cost extensions

Prior Approval Requests Need to be submitted in writing to the Grants Management Specialist from the authorized institutional Signing Official no later than 30 days prior to the proposed change. Requests are acceptable via email, but there must be proof that an authorizing (Signing) Official concurs with the request.

Administrative Requirements Under Expanded Authorities Foreign grants often not included under the Streamlined Non-competing Application Procedures (SNAP) IC discretion Annual Federal Financial Reports Audit requirements as specified in 45 Code of Federal Regulations - CFR 74.26(d)

No Cost Extensions First No Cost Extension (NCE): eRA Commons required for submission of 1 st NCEs from 60 days prior to end of the project period end date: Additional NCEs: A prior approval request must be submitted and must include: Reasons why the project was delayed The amount of unobligated balance available An explanation of what work will be done during the extension An itemized budget and justification Updated IRB/IACUC assurances, if applicable The existence of a balance is NOT sufficient justification for a NCE The proposed use of funds during NCE MUST be within the originally approved scope of the project

Grant Closeout Final Federal Financial Report (FFR) Final Invention Statement (FIS) Final Progress Report (FPR) Grantee required to keep records minimum of three years after project period ends maybe more time if human subjects are involved

OTHER IMPORTANT REMINDERS

Travel: US carriers must be used to the maximum extent possible and should not be influenced by cost, convenience, or personal travel, only a few exceptions to this dictate Also follow your institutions policy for travel Link to Fly America Act: http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch4.htm#fl y_america_act OTHER IMPORTANT REMINDERS

Existing NIH Policy Reminders Institutional vs. NIH Policy Remember. Institutional policy can be more restrictive than NIH policy. If this is the case, then institutional policy trumps NIH policy. Institutional policies must be consistently applied regardless of the source of funding. Maintain communication with your Sponsored Research Office their Signing Officials need to provide all official communications with the NIH. If your institutional policy allows something that is not allowable under NIH policy, then you can not charge costs associated with those activities to the grant.

Allowable costs The NIH Grants Policy Statement is an excellent resource for determining allowability of certain costs Part II: Terms and Conditions of NIH Grant Awards, 7, Cost Considerations http://grants.nih.gov/grants/policy/nihgps_2011/nihgps _ch7.htm

Common Unallowable Items Major Alterations and Renovations >$500,000 for foreign grants and domestic with foreign subcomponents Consular fees, visa costs, custom surtaxes, value added taxes and other related charges are unallowable under foreign grants and domestic with foreign sub-components F&A costs for foreign institutions are provided for compliance purposes and regular F&A is unallowable Patient care costs provided in only exceptional circumstances at foreign institutions Honorariums for speakers Grants policy discusses a multitude of others, this list is not all-inclusive or exhaustive

Public Policies - Assurances REQUIRED Research Misconduct Research Misconduct Animal Welfare Animal Welfare Human Subjects Human Subjects Inclusiveness in Research Design Inclusiveness in Research Design Lobbying Lobbying Debt Debt Debarment Debarment Drug Free Workplace (may be exempt) Drug Free Workplace (may be exempt) NOT REQUIRED Civil Rights Civil Rights Disabled Disabled Sex Discrimination Sex Discrimination Age Discrimination Age Discrimination

Financial Conflict of Interest Revised Regulation on Financial Conflict of Interest (FCOI) http://www.gpo.gov/fdsys/pkg/FR-2011-08- 25/pdf/2011-21633.pdf New Notice Number: NOT-OD- 12-080 This Notice announces the availability of a web- based tutorial which addresses the main requirements of the 2011 revised regulation FCOI

New Payment Procedures Transitioning Payment of Foreign Grantees from a manual quarterly check to draw downs through Payment Management System (PMS) Will align payment and Federal Financial Report (FFR) reporting processes with those for domestic grantees Anticipated Date = October 2012 (FY2013 awards) Stay tuned for Guide Notice on details

Payment- Direct Foreign Grantees Payment Management System is not currently used Funds are issued using wire, transfer, US treasury check or electronic deposit Only paid in US dollars and not adjusted for currency exchange fluctuation after the award is given Money is received in advanced four quarterly payments and placed in an interest bearing account For assistance with a payment issue, contact Jennifer Rock ([email protected]) PH: 301-402-9171

Foreign Subcontractor Payment We cannot supersede the administrative polices of a grantee institution However, awardee should be aware that the foreign subcontractor might have unique needs which includes lack of funds to spend in advance Grantee institutions should develop their own policies to determine cash flow to international sites or sub- awardees, but the NIH recommends that U.S. grantees with foreign consortiums may consider providing quarterly advances of funds or arranging a reasonable payment schedule to accomplish the goals of the grant.

Five Takeaways Foreign applications should utilize special resources, populations or environmental conditions not available in the United States. Generally, everything relating to NIH grants can be handled electronically. Grantees must separately track and report on use of Federal funds and follow Federal policies on their use. By policy, the NIH does not pay for institutional overhead costs. The 8% for F&A pays for NIH reporting requirements and compliance with policies. Program Officers handle the science; Grant Managers handle the fiscal and administrative matters.

Summary of Helpful NIH Web Pages Office of Extramural Research (OER) Web Page http://grants.nih.gov/grants/oer.htm NIH Grants Policy Statement (Rev. 10/11) http://grants.nih.gov/grants/policy/nihgps_2011/index.htm Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm FIC Progress Reports: http://fic.nih.gov/Grants/Pages/progress-reports.aspx FIC Funding Strategy: http://fic.nih.gov/About/FundingStrategy/Pages/2012.aspx FIC Foreign Grant Info: http://fic.nih.gov/Grants/Pages/Foreign.aspx Applying Electronically http://grants.nih.gov/grants/ElectronicReceipt/index.htm Annotated SF424 (R&R) Application Forms (General and Small Business) http://grants.nih.gov/grants/ElectronicReceipt/communication.htm#forms Ten Checks to Help Avoid Common Application Errors http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm#10checks Do I have the right electronic forms for my NIH application? http://grants.nih.gov/grants/ElectronicReceipt/files/right_forms.pdf

Summary of Helpful NIH Web Pages 34 NIH Extramural Response to Natural Disasters http://grants.nih.gov/grants/natural_disasters.htm eRA Commons Web pages http://era.nih.gov/ Updated (8-6-2010) eSNAP User Guide http://era.nih.gov/docs/eSNAP_UG_v2.25.0.0_041210.pdf Updated (1-24-2012) Commons User Guide http://era.nih.gov/Docs/COM_UGV2630.pdf Self Help Resources page: http://era.nih.gov/help/self_help.cfm Intellectual Property Policy http://grants.nih.gov/grants/intell-property.htm Official publication for NIH Grant Policies, Guidelines & Funding Opportunities http://grants.nih.gov/grants/guide/listserv.htm Office for Human Research Protections (OHRP): Office for Human Research Protections (OHRP) Office of Laboratory Animal Welfare (OLAW): http://grants.nih.gov/grants/olaw/references/list.htm Separate listservs available for scientists and administrators http://era.nih.gov/ElectronicReceipt/listserv.htm NIH OER Nexus http://grants.nih.gov/grants/nexus.htm NIH Guide for Grants and Contracts http://grants.nih.gov/grants/get_connected.htm#listsers Foreign Grants Information http://grants.nih.gov/grants/foreign/

Who to Contact General Application Questions: E-Mail: [email protected] Phone: 301-435-0714 Grants.gov Customer Support: E-Mail: [email protected] Webpage: http://grants.gov/ Phone: 800-518-4726 eRA Commons Helpdesk: Webpage: http://ithelpdesk.nih.gov/era/ Phone: 301-402-7469 or 800-504-9552

Grants Management Overview Thank you! Any questions? Ted Williams [email protected] 301-435-6996 Tuesday, Wednesday, Thursday 301-326-4650 Monday, Friday

Washington D.C., USA, 22-27 July 2012www.aids2012.org Building Grants Management Capacity at IDI in Uganda Fred Wabwire-Mangen MBChB, Ph.D. Infectious Disease Institute, Uganda Glenn Wagner, Ph.D., RAND Corporation, USA Social and Behavioral HIV Research Capacity Building in Uganda

Washington D.C., USA, 22-27 July 2012www.aids2012.org Outline of Presentation Background Infectious Diseases Institute Project Summary Grant Application Process Pre-application considerations Preparing the application and budget Electronic application submission Grants Management at IDI Status of grants office in 2007 Strengthening of grants management at IDI Successes and Challenges

Washington D.C., USA, 22-27 July 2012www.aids2012.org Infectious Diseases Institute

Washington D.C., USA, 22-27 July 2012www.aids2012.org Infectious Diseases Institute History: Started in 2004 by Academic Alliance members Not-for-profit public private partnership owned by Makerere University and funded from public and private sources Activities A center of excellence in training, research as well as care and treatment of HIV and related IDs Other programmatic areas include HIV prevention, laboratory services and outreach programs

Washington D.C., USA, 22-27 July 2012www.aids2012.org Project Summary Title: Social and Behavioral HIV Research Capacity Building in Uganda Implementing Institution: Makerere University and RAND Corporation through a consortium of partners Duration of Grant: from Aug 1, 2007 to Jul 31, 2012 Funding Agency: NICHD of the US National Institutes of Health Funding Mechanism: Global Partnerships for Social Science (R24) Prime PI: Fred Wabwire-Mangen Sub-Contract PI: Glenn Wagner

Washington D.C., USA, 22-27 July 2012www.aids2012.org Project Components Component A: Capacity Building Provision of research tools and skills Strengthening research infrastructure and institutional capacity Component B: Research Studies Study 1: Impact of ART on Social, Economic, and Risk Behavior Outcomes Study 2: Formative Research to Explore the Potential for HIV Clients to be Agents for Prevention Study 3: Evaluating Strategies to Improve Clinic Efficiency, Quality of Care, and Cost-Effectiveness

Washington D.C., USA, 22-27 July 2012www.aids2012.org Pre-Application Considerations Registration at grants.gov Required for e-grant submission Multi-step, convoluted process that involves several complicated forms Steps 1) obtain a DUNS number and NCAGE code; 2) registration with CCR 3) designation of an AOR Registration at eRA Commons Done by a Signing Official or Account Admin; allows communication between NIH and grantee officials Register institution to get FWA and IRB numbers

Washington D.C., USA, 22-27 July 2012www.aids2012.org Preparing the Application Conceptualize/hypothesize the research idea Assemble the research consortium with the appropriate investigators and skills mix Identify the correct forms for the application Write the research plan Keeping within the pre-requisite word limits is a challenge for a novel applicant Describe the resources and environment Preparing the budget

Washington D.C., USA, 22-27 July 2012www.aids2012.org Tips on Preparing the Budget Salaries and benefits Use institutional rates and policies. However, challenges when base rates are not competitive FTEs: investigators time cannot be more than 100%. Adjust FTE if multiple projects Timesheets used to monitor effort on multiple projects Indirect Costs IDI does not have a NICRA but has an audited IR F&A costs set at 8% for NIH foreign grants. Can only be used for compliance costs

Washington D.C., USA, 22-27 July 2012www.aids2012.org Prepare to apply Find opportunity and download application package Submit application to Grants.gov (AOR submits) Know your role Register Obtain software: Compatible Adobe Reader; PDF generator Find specific opportunity in Grants.gov or NIH Guide and download application package Grants.gov performs basic checks eRA Commons checks application against guidelines Electronic SF424 (R&R) Application Process Through Grants.gov Processed successfully; no errors (may have warnings) Prepare application Check submission status in Commons Check assembled app. PD/PI registers through AOR/SO in Commons PD/PI & AOR/SO check app; AOR/SO has option to reject or app. moves forward after 2 business days AOR registers with Grants.gov, Commons Application assembled Submission complete If errors found, AOR must submit corrected application to Grants.gov Wait for NIH to retrieve application Select submission approach Forms-based; Org. system-to- system; Service Provider Errors found Abbreviation Key AOR: Authorized Organizational Representative SO: Signing Official PD/PI: Project Director/ Principal Investigator

Washington D.C., USA, 22-27 July 2012www.aids2012.org Status of Grants Office (2007) No understanding of online submission, management or reporting of NIH grants IDI was not registered to submit or receive NIH grants electronically There were a handful of accountants and research administrators at our disposal for the grant Prior to the R24, there was no grants and contracts office or officials at IDI

Washington D.C., USA, 22-27 July 2012www.aids2012.org Strengthening of Grants Management at IDI Creation of Grants and Contracts Office Staffing of Office 3 staff in 2007 12 staff in 2012 Training of staff NIAID Grants Policy and Management Training has been used to impart skills to grants office staff Hands on experiential training has been the best vehicle for building capacity in grants management

Washington D.C., USA, 22-27 July 2012www.aids2012.org Success of Approach Used IDI has 20 NIH grants totaling to $8,813,356 IDI a centre of excellence for grants management and research administration Application, submission, pre and post award administration of grants done online through the eRA Commons and grants.gov Timely reporting for annual Progress and Financial status reports means NOA and carryover funds now received on time

Washington D.C., USA, 22-27 July 2012www.aids2012.org NIH Grants to IDI Grant No.Title of Grant Start Date End Date Amount Grants to IDI as Prime Contractor 5R24HD056651- 05 Social and Behavioral HIV Research Capacity Building in Uganda Sept. 30 2007 Jul 31 2012 $2,122,075 1R01AI078934- 01A1 The immunopathogenesis of HIV-related Immune Reconstitution Inflammatory Syndrome June 1 2010 May 31 2014 $432,000 Grants to IDI as Sub-Contractor N001300201 Impact of HIV and HIV Therapy on the Etiology and Outcome of Meningitis in May 15 2011April 30 2012 $91,692 N001971101 Trial for Optimal Timing of HIV Therapy after Crytoccoccal Meningitis Jul 15 2010 June 30 2015 $2,540,830 5R01CA119903- 05 Antiretroviral Therapy of AIDS-related Kaposis Sarcoma in Sep 30 2005July 31 2012 $1,712,817 1R21MH083346 5-01 HIV Dementia and Sensory Neuropathy in Jun 1 2009 May 30 2012 $138,030

Washington D.C., USA, 22-27 July 2012www.aids2012.org Challenges Experienced Funds Transfer funds are transferred to IDI 3 months after start of the budget year leading to a funding gap Exchange rate fluctuations Gains or losses due to fluctuations; losses have to be borne by IDI Carryover Initially carryover of unobligated balances posed challenges

Washington D.C., USA, 22-27 July 2012www.aids2012.org Challenges Experienced Accounting Principles IDI accounts in accordance with International Financial Reporting Standards (IFRS) and with the requirements of the Uganda Companies Act. FFRs submitted to NIH report cumulative expenses whereas FFRs submitted to other donors eg. CDC report expenses for the current budget year only Sub-Contracting IDI sub-contracts to the RAND Corporation in the US Mechanism was a challenge to IDI at the beginning

Washington D.C., USA, 22-27 July 2012www.aids2012.org Challenges Experienced IT Infrastructure (more in 2007 than 2012) Bandwidth limitations make online grants submissions a challenge Current application package based on Adobe Acrobat Reader 9 is susceptible to unstable internet connections. Modifications to the computer network setup are required to enable successful online grant submissions

Washington D.C., USA, 22-27 July 2012www.aids2012.org Acknowledgements

Washington D.C., USA, 22-27 July 2012www.aids2012.org 55

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