Eunice Kennedy Shriver NICHD Grants Management Overview Ted Williams Supervisory Grants Management Specialist (Team Leader) Foreign Grant Training July 23, 2012
Eunice Kennedy Shriver NICHD Grants Management Overview Ted Williams Supervisory Grants Management Specialist (Team Leader) Foreign Grant Training July
Eunice Kennedy Shriver NICHD Grants Management Overview Ted
Williams Supervisory Grants Management Specialist (Team Leader)
Foreign Grant Training July 23, 2012
Slide 2
Topics to Cover Why and how the NIH Supports Foreign Awards
Competing Applications Policy updates Progress reports Compliance
and Prior Approvals Other important reminders
Slide 3
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.
Slide 4
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.
Slide 5
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
Slide 6
POLICY UPDATES
Slide 7
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
Slide 8
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
Slide 9
PROGRESS REPORTS
Slide 10
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
Slide 11
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
Slide 12
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
Slide 13
COMPLIANCE and PRIOR APPROVALS
Slide 14
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.
Slide 15
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
Slide 16
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
Slide 17
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
Slide 18
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.
Slide 19
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)
Slide 20
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
Slide 21
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
Slide 22
OTHER IMPORTANT REMINDERS
Slide 23
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
Slide 24
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.
Slide 25
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
Slide 26
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
Slide 27
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
Slide 28
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
Slide 29
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
Slide 30
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
Slide 31
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.
Slide 32
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.
Slide 33
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
Slide 34
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/
Slide 35
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
Slide 36
Grants Management Overview Thank you! Any questions? Ted
Williams [email protected] 301-435-6996 Tuesday, Wednesday,
Thursday 301-326-4650 Monday, Friday
Slide 37
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
Slide 38
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
Slide 39
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Infectious Diseases Institute
Slide 40
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
Slide 41
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
Slide 42
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
Slide 43
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
Slide 44
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
Slide 45
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
Slide 46
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
Slide 47
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
Slide 48
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
Slide 49
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 carry- over funds now received on
time
Slide 50
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
Slide 51
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
Slide 52
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
Slide 53
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
Slide 54
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Acknowledgements
Slide 55
Washington D.C., USA, 22-27 July 2012www.aids2012.org 55