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Trans-Atlantic grants management

Presentation at the EARMA Conference in Dublin, July 11th, 2012
by

Olaf Svenningsen

on 20 November 2012

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Transcript of Trans-Atlantic grants management

Setting up your "foreign" (European) institution to
receive and manage NIH and other US research grants Trans-Atlantic grants management Olaf Svenningsen NIH's Notice of Grant Award "This award is pursuant to the authority of 42 USC 241 42 CFR 52 and is subject to the requirements of this statute and regulation and of other referenced, incorporated or attached terms and conditions.

Acceptance of this award including the “Terms and Conditions” is acknowledged by the grantee when funds are drawn down or otherwise obtained from the grant payment system." Managing NIH grants in Europe An emotional rollercoaster for research support Huh...? US laws and rules govern the management of this grant and your institution accepts that by drawing money on the grant, NOT by signing contracts or other documents. Common errors by European institutions when applying for their first NIH (or any US Federal) grant: Misunderstand requirements;
"Misunderestimate" requirements and conditions*;
Underestimate administrative burden*;
Fail to understand granting agency's expectations. Every PI/applicant is assigned AOR/SO role for the institution;
Christmas greeting from Program Officer is interpreted as permission to carryover substantial unobligated funds;
Unfortunate communication leading to entire institution being barred from receiving NIH/Federal funds;
NIH grant compliance issue prompts change in national legislation. Examples of interesting and/or difficult situations: First of all, make sure to read and understand the RFA/RFP* Are foreign institutions eligible?
What are the reasons that this particular project can NOT be done in the US?
Make sure that the PI has communicated with the relevant Program Officer! ...and as a general rule, do not submit proposals in response to the RFA in this example, Parent R01 (unsolicited proposals, not in program). Program staff
(Program Officer) Grants Management
Staff
(GMO, GMS) University admin
(You!) Researcher/-s
(PI) Normal communication channels with NIH
outside eRA Commons Your institution Grant proposal Grants.gov is essentially an electronic mailbox.
It checks your proposal for errors and sends it to
eRA Commons, NIH's e-admin portal. eRA Commons receives the proposal, checks it for errors and sends it to the appropriate institute or center within the NIH. * All requests for applications/proposals can be found at Grants.gov Notification of grant, or rejection, through eRA Commons. eRA Commons is used for reporting and various other purposes
post-award. Grants.gov and eRA Commons use different log-ins. Registering for one does not automatically give access
to the other! Registering for 1. Watch the tutorial and download instructions from Grants.gov

2. Check if your organization has a DUNS number (Data Universal Numbering System) in CCR.
2.a. If yes, secure control over it (it may be an individual researcher who did the registration).
2.b. If not, acquire one at Dun & Bradstreet (http://www.dnb.com).

3. Check if your organization is registered with CCR (Central Contractor Registry).
3.a. If yes, check that information is correct and updated, including E-Biz POC etc.
3.b. If no, designate an E-Biz Point-Of-Contact* and register your organization.
3.c. Oh by the way, you also need a NATO Commercial and Governmental Entity (NCAGE) Code,
which you can apply for from http://www.dlis.dla.mil/Forms/Form_AC135.asp

4. Your organization's AOR** (Authorized Organization Representative/-s) may now register (apply for)
for an account with Grants.gov.

5. Your organization's E-Biz POC approves the AOR's registration (the E-Biz POC may be the same
individual as the AOR).



* The E-biz POC is appointed by the institution, is responsible for updating CCR and managing
your institution's AOR privileges. This individual need to have legal authority to act on behalf
of the organization
** An AOR is a representative of your organization who has the right to submit proposals on behalf
of the organization.

A note about Taxpayer/Employer Identification Number (TIN/EIN): Many foreign organizations cannot acquire such numbers, so NIH assigns its own EIN to these foreign organizations. So, now you are good to go for Grants.gov!
However, you still need to register for eRA Commons... Registering for 1. Check if your organization is registered in eRA Commons
(http://era.nih.gov/commons/quick_queries/)
1.a. If yes, you may be in for a challenge...
1.b. If no, begin the registration process.

2. Designate your organization's Signing Official (SO); this will typically be
the same individual that is AOR for Grants.gov. It is VERY IMPORTANT
that the SO/AOR really has legal authority to sign for the organization!

3. Find the "Register Grantee Organization" link on eRA Commons portal
page and follow the on-line instructions. It is relatively uncomplicated
(and you get to use your fax machine!).

4. Assign other eRA Commons roles, at least one PI, and you are ready to
submit proposals.

5. However, your organization needs to understand the compliance
requirements, and register your ethics review system for human subjects
and animals in research, understand audit requirements, financial
conflicts of interest and many others... Fun with compliance The SO/AOR needs to become familiar with requirements for applying for and managing NIH and US Federal research grants.

This is NOT a trivial task.

Rules, requirements and conditions are described in the NIH Grants Policy Statement (NIH-GPS), available at:

http://grants.nih.gov/grants/policy/nihgps_2011/index.htm

and a substantial number of legal documents referred to in the NIH-GPS.

Pay special attention to sections on "Grants to foreign institutions..." (16) and "Terms and conditions..." (II), in particular the "Public Policy Requirements" (4). The Foreign Organization System (FOS) Review What is it?

A 4-day visit that performs a very thorough review of all of your institution's administrative systems to check compliance with a.o. the NIH-GPS.

The questionnaire is 26 pages long... Rules and regulations are constantly changing. Subscribe to NIH announcements, for example:

NIH Guide
http://grants.nih.gov/grants/guide/listserv.htm
NIH Extramural Nexus
https://list.nih.gov/cgi-bin/wa.exe?SUBED1=extramuralnexus&A=1
eRA Commons News
http://era.nih.gov/about_era/get_connected.cfm Help yourself Table of Contents
A. GENERAL INFORMATION
B. APPLICATION AND PROPOSAL PREPARATION
C. POLICIES AND PROCEDURES
D. AWARD MONITORING
E. FISCAL AND SCIENTIFIC OVERLAP
F. STANDARDS OF CONDUCT
G. CONSORTIUM ARRANGEMENTS
H. INDIRECT COSTS
I. RECORD MANAGEMENT
J. FINANCIAL BANKING ARRANGEMENTS
K. BUDGETARY CONTROLS
L. ACCOUNTING SYSTEM
M. INTERNAL CONTROLS AND AUDITS
N. PERSONNEL
O. PAYROLL
P. PROCUREMENT
R. TRAVEL
S. CONSULTANTS FOS Review questionnaire Human subjects and animals in research
Ethics review requirements Requirements are described in the NIH-GPS and e.g. in CFR 45 Part 46.
Local review boards need to be registered, and the institution needs a certification called Federalwide Assurance (FWA) for human subjects.
In US rules/legislation, ethics review boards are referred to as Institutional Review Boards (IRB).

Problems arise for example in the Scandinavian countries, where ethics review boards are external to the institutions. One example of potential problems Read about FOS Review and download documents at:
http://www.niaid.nih.gov/researchfunding/int/pages/fos.aspx Are we there yet? Sorry, but no. This is just a brief primer.

However, the NIH's Office of Extramural Research maintains an excellent website for foreign grantees:

http://grants.nih.gov/grants/foreign/

Here you will find all the information you need, although without the stories... Thank you for your attention! Olaf Svenningsen
E-mail: osvenningsen@health.sdu.dk This presentation is available at EARMA's web pages and: NIH Acronym Soup CCR R&R ORI RFA DEAS CFR 45 Part 46 GMO OPERA AOR CSR A&R OER OLAW OMB NIH-GPS NCAGE DUNS A-21 A-133 eSNAP NEARC FCOI HHS FSR FWA IACUC F&A FOS Review SO AOR PI AA SRG NIAID NCI NIDA NIMS OMG! http://prezi.com/aznfm5puie2e/trans-atlantic-grants-management/ To sum up... Applying for NIH grants entails
substantial administrative burden;

The applicant institution NEED to commit itself at the senior management level – that level is responsible, whether it likes/realizes it or not;

Adequate administrative resources need to be dedicated to the NIH business, one staff member who is at, or has access to, senior management levels (= is taken seriously by that level);

Periodically – depending on the number of NIH grants and applications – NIH matters will fill the better (and sometimes the worst) part of this individual's workday.

Everything should be documented and saved in a secure and retrievable place – procedure is important. * "It's just one grant; how hard can it be?" Other potential problem areas include:
Research misconduct
Audits
Financial conflicts of interest
Use of overhead (F&A)
Data management
.... and many more... Standard phrasing: Key questions to ask yourself and PI: IMPORTANT!
By end of July 2012, CCR will migrate to/be substituted by System for Award Management (SAM). Information at http://www.sam.gov
Full transcript