Atelier de formation : Subventions et sous-octrois internationaux - - PowerPoint PPT Presentation

Atelier de formation : Subventions et sous-octrois internationaux

Les organismes subventionnaires fédéraux américains

 Céline Bouvet, PhD., Conseillère principale à la recherche, secteur santé, Bureau Recherche- Développement-Valorisation, Université de Montréal  Maureen Donato, Conseillère à la recherche, secteur santé, Bureau de la recherche, Université McGill  Marlene Boutet, M.A., Directrice administrative & gestion des subventions, Bureau de la recherche, Université McGill

Conférencières

 Les enregistrements obligatoires (Céline)  Les interfaces web (Céline)  NIH : pré-octroi (Maureen)  Autres organismes : pré-octroi (Marlene)  NIH : post-octroi et sous-octroi (Marlene)  FCOI (Céline) pas présenté le 10 avril  Questions

Plan de la présentation

Les enregistrements

• bligatoires

 National Institutes of Health (NIH)  Department of Defense (DoD)  Department of Energy (DoE)  National Science Foundation (NSF)

 Sous-octroi seulement

 Environmental Protection Agency (EPA)

 Sous-octroi seulement

De quels organismes allons-nous parler?

Les enregistrements

• bligatoires

1. Data Universal Number System (DUNS)

 9 chiffres identifiant une institution  http://fedgov.dnb.com/webform  24 heures par internet (10 minutes par téléphone) mais 24 heures avant de pouvoir l’utiliser sur SAM  Un numéro DUNS différent pour chaque division légale ou centre affilié

Les enregistrements

2. Employer Identification Number (EIN)

 9 chiffres (format: 12-3456789) identifiant les payeurs de taxes  Formulaire Form SS-4 www.irs.gov  Soumission par courriel ou par fax

3. NATO Commercial and Governmental Entity (NCAGE)

 Requis seulement pour les institutions étrangères  Nécessaire pour l’enregistrement dans SAM  5 chiffres  http://www.dlis.dla.mil/Forms/Form_AC135.asp  Soumission par internet

Les enregistrements

4. System for Award Management (SAM)

 Remplace CCR depuis juillet 2012  Renouvellement annuel

 Si le renouvellement n’est pas fait, il ne sera pas possible de soumettre une demande via grants.gov

 Confirmation du EIN avec IRS ce qui peut prendre quelques jours  E-Business POC : peut autoriser des individus dans une

• rganisation à soumettre des demandes (AOR Authorized

Organizational Representative)  Démarche pour un renouvellement 7-10 jours ouvrables

Les enregistrements

L’ensemble des démarches peut prendre de 6 à 8 semaines au début.

Les interfaces web

 NIH: http://grants.nih.gov

Les interfaces web

 NIH: http://grants.nih.gov

Les interfaces web

Grants.gov

• Portail unique du

gouvernement fédéral pour trouver des possibilités de financement et soumettre des demandes

• Utilisé par les 26 agences

fédérales offrant des subventions

 Agences participantes

http://www.grants.gov/web/grants/ grantors.html

 NIH: http://grants.nih.gov

Les interfaces web

Grants.gov

• Portail unique du

gouvernement fédéral pour trouver des possibilités de financement et soumettre des demandes

• Utilisé par les 26 agences

fédérales offrant des subventions

eRAcommons

• Système de gestion

administrative permettant l’accès, le partage et la transmission d’information liée aux demandes de subventions et aux projets subventionnés

• Utilisé par le NIH et

d’autres composantes du DHHS IMPORTANT : chaque système a ses propres exigences d’inscription et de soumission des demandes

 NIH

Les interfaces web

Grants.gov

• Accès réservé aux

universités, centres de recherche etc.

• Soumission d’une demande
• Pas besoin d’avoir un accès

pour trouver des

• pportunités de financement

eRAcommons

• Accès multiples SO, PD/PI,

FCOI, FO

• Le SO crée le compte pour le

PD/PI (obligatoire pour soumission)

• Après la soumission:
• Vérifier l’état de la demande
• Soumettre des informations en

pré-octroi (JIT)

• Préparer et soumettre des

informations en post-octroi (RPPR, FFR, NCE, FCOI etc.)

 DoD

 eReceipt System CDMRP  eBRAP (Electronic Biomedical Research Application Portal)

 permet de soumettre pré-application  Remplace eReceipt depuis février 2014

 Grants.gov permet de soumettre la demande complète

Les interfaces web

 FedConnect

 Portail regroupant les possibilités de contrats et de subventions avec le gouvernement fédéral américain.

 Agences participantes

 Department of Energy  Department of Homeland Security  Department of Housing and Urban Development  Department of the Interior  Environmental Protection Agency  Small Business Administration  Social Security Administration

 Pour avoir un compte :

 DUNS  Enregistrement SAM

Les interfaces web

NIH Pré-Octroi

 Largest granting agency in the United States  Like CIHR: its mission is to support medical research  Comprised of 27 Institutes & Centers (ICs)  Has a large Intramural Research Program: Supports

• ver 6000 basic & clinical researchers on NIH

campuses across the US  For external research: Office of Extramural Research

Brief overview of NIH

NIH Office of Extramural Research

Types of Funding Announcements

NIH Research Project Grant Program (R01)

 Supports a specified, circumscribed research project  NIH's most commonly used grant program  No specific dollar limit unless specified in Funding Opportunity Announcement (FOA)  Advance permission required for $500K or more (direct costs) in any year  Generally awarded for 3 -5 years  All ICs utilize  Parent FOA: PA-13-302

Types of Grants

NIH Small Grant Program (R03)  Provides limited funding for a short period of time to support a variety of types of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self- contained research projects, development of new research technology,  Limited to two years of funding  Direct costs generally up to $50,000 per year  Not renewable  Utilized by more than half of the NIH ICs  See parent FOA: PA-13-304

Types of Grants

NIH Exploratory/Developmental Research Grant Award (R21)  Encourages new, exploratory and developmental research projects by providing support for the early stages of project

• development. Sometimes used for pilot and feasibility studies.

 Limited to up to two years of funding  Combined budget for direct costs for the two year project period usually may not exceed $275,000.  No preliminary data is generally required  Most ICs utilize  See parent FOA: PA-13-303

Types of Grants

Research Project Cooperative Agreement (U01)  Supports discrete, specified, circumscribed projects to be performed by investigator(s) in an area representing their specific interests and competencies  Used when substantial programmatic involvement is anticipated between the awarding Institute and Center  One of many types of cooperative agreements  No specific dollar limit unless specified in FOA

Types of Grants

Type of Application-

 New = application submitted for the first time  Resubmission = revised or amended application to address reviewer feedback  Renewal = competing for additional years of funding to continue project  Continuation = annual progress report  Revision = additional funds to expand scope

Types of applications

 Find an opportunity  Confirm eligibility  Download the Application package and Instructions  Fill the application  Approve and submit the application  Fix any errors before the deadline date  Follow the progress of the application via eRA Commons

Steps when lead institution

 NIH Funding Opportunities & Notices http://grants.nih.gov/grants/guide/WeeklyIndex.cfm  http://grants.nih.gov/grants/guide/listserv.htm to sign up for weekly listserv  NIH Funding Opportunities now available in RSS (Really Simple News Syndication) format: http://grants.nih.gov/grants/guide/rss_info.htm

Finding Opportunities

 SF424 stands for Standard Form 424 – Research and Related  Is a combination of separate forms focusing on the many aspects of a proposed grant.  Used to apply for all Research and Research-related grants by 15 different Federal agencies

 Based on needs of all agencies, and not tailored to specific agencies, funding opportunities, or grant programs  Allows use of agency-specific forms and special instructions where appropriate

SF 424

 Complete application includes combination of (R&R) components & PHS 398 components  Must complete SF 424 (R&R) using package attached Funding Opportunity Announcement (Information is drawn from specific FOA and auto-completed for use in the forms)  Complete data entry in all necessary components and upload appropriate attachments  Instructions within the FOA supersede all other instructions

SF 424

 Grants.gov is a portal for receiving applications  Once validated, the grant moves from grants.gov to eRA Commons  Two validation processes  Error window: errors must be corrected before the deadline!  Commons is used to track application from submission to peer-review to award

Submission process

Foreign Justification

 Applications from Foreign Organizations. Reviewers will assess whether the project presents special

• pportunities for furthering research programs through

the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States

• r augment existing U.S. resources.

Important considerations

Budget

 Salary: an allowable expense on US grants  Equipment: per captialization institutional policy or $5K or more; excluded from indirects  Travel: Travel between Canada and the US is considered ‘domestic’, BUT we must comply with Fly America act: foreign (to/from South America and oversees) air travel funded by Federal funds may only be conducted on U.S flag air carriers and under applicable Open Skies Agreements

Important Considerations

Budget

 Indirect cost rate is 8% for all foreign entities  If subsites: indirects are assessed on all sub costs (DC & IDC); if US site, their negotiated indirect rate will apply  http://grants.nih.gov/grants/policy/nihgps_2013/nihgp s_ch7.htm#costs_activities_allowability

Important Considerations

Steps when subrecipient

 Many applications will be as sub sites to US institutions and will require the following:

 Detailed budget and budget justification  Scope of work  Bio-sketches for all Key Personnel  eRA Commons Account for all key personnel  Letter of Intent to enter into a consortium agreement and/or FCOI and other assurance forms from the US institution

Autres organismes: pré-octroi

Department of Defense (DOD)

 ARO (Army Research Office): soldier, ground force  AFOSR (Air Force Office of Scientific Research): pilot, aerospace  ONR (Office of Naval Research): sailor, marine, ship, ocean  DARPA (Defense Advanced Research Projects Administration): defense-wide technology innovation  DTRA (Defense Threat Reduction Agency): weapons of mass destruction  CBDP (Chemical Biological Defense Program): chem/bio warfare  CDMRP (Congressional Directed Medical Research Program): medical research  OSD (Office Secretary of Defense): overarching Defense issues

 Letter of Intent (LOI): mandatory via eBRAP  LOI: institutional signature not required but must identified authorized official  Full submission:

 depending on program: by invitation only; others, invitation not required  Via Grants.gov

DOD: CDMRP

 Broad Agency Announcement (BAA)  BAA = multi-year open program announcement  Multiple themes/area of research within each BAA  Agency-specific BAA (program/theme limitations, application process)  Army uses eBRAP for pre-application  Full proposal either via Grants.gov using SF424 or hard-copy paper application  SF424 application package for each agency and each research theme

DOD: Most other agencies

 Funding Opportunities via Office of Science  Application via Grants.gov using SF424  Application guidelines in each funding opportunity announcement  DOE-specific webportal: PRAMS  If LOI or pre-application required: submitted via PRAMS  Like eRA Commons, PRAMS serves as the communication portal between DOE, PI and you  17 National Labs

Department of Energy (DOE)

 National Science Foundation (NSF)  Environmental Protection Agency (EPA)  United-States Department of Agriculture (USDA)  National Endowment for the Humanities (NEH)  Foreign institutions = co-investigator/collaborator only

Other Federal Agencies

 Referred to as F & A rate  F = Facilities / A = Administrative  Negotiated with selected agencies on behalf of the government (DHHS, ONR)  Renegotiated every 3 or 4 years  In the US, also governs authorized fringe benefits  Assessed on direct costs base:  MTDC = modified total direct costs (all direct costs minus equipment)  Salaries & benefits only  Foreign institutions may negotiate a F&A rate or apply institutional rate  If applying institutional rate: may be requested to justify how rate was arrived at

Indirects on non NIH-grants

NIH: octroi & post-octroi

 Additional documentation requested if fundable score  Always includes Other Support; may include confirmation of human ethics (IRB) or animal approval  If lead: submitted via eRA Commons  Needed for 2nd level Council review  IC Director makes final decision  If selected for funding and significant budget cut applied: may also include revised budget, budget justification and scope of work  Foreign involvement = US State Dept (Ministère des Affaires Etrangères) clearance

Just-In-Time (JIT)

Other Support

 Not the same as research support in the Biosketch  Biosketch

 active research support & completed  used to evaluate investigator’s “capabilities”/overall research program  $ award, effort devoted should not be listed

 Other Support

 active & pending research support  used to assess over-commitment in effort & scientific scope  Includes $ (DC only) and effort  Effort cannot be blank or none  Cannot exceed more than 100% or 12 months

Effort

 % effort = # of person months  Used to qualify amount of time devoted by PI and other key personnel on project (directly charged or contributed (cost- shared effort))  Based on type of academic appointment, i.e. 9 AY months + 3 summer months or 12 CY months  Not measured in hours but on total professional activities (teaching, research, patient care, administration)  Cannot be more than 100%  At a minimum, annual effort certification required  Reduction by 25% or more in PI’s effort or any other investigator named on the NOA requires NIH prior approval

 Initial NOA issued anytime during FY  Released annually after submission of progress report  To distribute future noncompeting awards evenly throughout their FY: budget period 1 can be issued for less than 12 months but with full 12-month budget  Not unusual to have additional budget cuts upon issuance of yearly NOA: % cut per NIH Institute FY funding policy (annual appropriation of NIH budget by US Congress)  NIH/US Federal FY: October - September

Notice of Award

Notice of Award

Type: 1 = new award 2 = noncompeting award 3 = supplement 5 = competing renewal award Other: A1 = resubmission S1 = supplement

What does the award number mean: Type | Grant mechanism | Institute | award # | budget yr | other

2 | R01 | DK | 075302 | -06 | A1

Notice of Award

Review template NOA

 Code of Federal Regulations : 45 CFR 74 or 45 CFR 92  Office of Management & Budget (OMB) Circulars:

 OMB A-21: Cost Principals for Educational Institutions  Defines eligibility of expenses  Lays out effort reporting requirement  Delineates determination & application of indirect costs

Overarching Governing Terms

 Office of Management & Budget (OMB) Circulars:

 OMB A-110: Uniform Administrative Requirements for Grants & Agreements with Institutions of Higher Education, Hospitals & Non-Profit Organizations  Sets forth standards for obtaining consistency and uniformity among Federal agencies in the administration of grants to and agreements  Allocability of costs: reasonable , allocable, consistent

Overarching Governing Terms

 Office of Management & Budget (OMB) Circulars :

 OMB A-122: Cost Principals for Non-Profit Organizations

 Similar to A-21 but for non-profit organizations

 OMB A-133: Audits of States, Local Governments and Non-Profit Organizations  Required annually if receiving $500K or more per year in US federal grant funding (including foreign institutions)  Audits institution’s controls and compliance with OMB A-21/A-122, A-110 Think of the OMB Circulars as the Tri-Agency Administrative & Financial Guide; just more detailed!

Overarching Governing Terms

 The NIH Grant Policy Statement:  Bible  Summarizes in “lay” language the CFR regulations and the OMB circulars  Outlines US Public Policy Requirements:

 Animal welfare & human subjects protection  Civil Rights Act (N/A to foreign organizations)  Debarment & suspension  Drug-free workplace (N/A to foreign organizations)  Equal Employment Opportunity  Financial Conflict of Interest  Fly America Act  Human Stem Cell Research  Lobbying  Research Misconduct

Overarching Governing Terms

 The NIH Grant Policy Statement:

 Includes a very nice summary table of eligible type of expenses  Delineates authorities granted to institutions and prior approval requirements

Overarching Governing Terms

Overarching Governing Terms

Reporting Requirements

 Annual Progress Reports:

 If SNAP: 45 days prior to end of budget year

 Submitted via eRA Commons (eSNAP RPPR)

 Non SNAP: 60 days prior to end of budget year

 For now submitted hardcopy using PHS 2590

 Oct 2014: will mandate RPPR e-submission

 Key elements:

 Effort reporting all personnel devoting 1 month effort or more; whether paid or not from grant  Updated Other Support  Anticipated carryover greater than 25% must be explained (does not negate carryover authority)  RPPR: annual foreign involvement justification

Reporting Requirements

 Annual Financial Reports

 Submitted within 90 days after end of each budget year  Does not report on detailed cost categories

 total direct and indirect costs  unspent budget  NIH relies on audit mechanism to ensure compliance with all applicable requirements, including eligibility of expenses and appropriateness of rebudgeting

 Submitted via eRA Commons

 Cash payments now made upon request submission via Payment Management System

Reporting Requirements

 Closeout final reports:

 Final progress report  Final financial report  Final invention statement  All submitted via eRA Commons Significant difference with Canadian agencies: NIH interacts mostly with authorized business/signing

• fficial. All requests/documentation/reports must be

submitted by signing official. PI may communicate with NIH staff but concurrence will be sought from institution

• fficial

 Most NIH funding will come via subgrants  Same requirements apply but report to lead institution  US institutions will never submit an application involving another institution without acknowledgement from that institution’s research

• ffice (Consortium letter of intent)

 Accountable advances: not done in the US  Payment upon submission of detailed invoices

Subrecipient consideration

 Federal Demonstration Partnership (FDP) templates: standard subaward templates agreed upon by US institutions

 Template for subawards to foreign subrecipients but many institutions use the standard US-US template  Separate agency-specific terms & conditions attachments

 Some institutions may elect to use their own institutional template

Subrecipient considerations

 Things to consider when negotiating subagreement:

 A-133 requirements  Standard delay for submission of final invoice for US-US subs: 60 days  Civil rights act, drug-free workplace act and HIPAA does not apply to foreign institutions  PI’s effort: cost-shared for most of us. This is extremely unusual in the US so they may question.  If non-FDP template, refer to FDP template to argue revisions to audit requirements, indemnification, publication and IP

Subrecipient considerations

 Review template

FDP standard subaward template

 NIH Grant Policy Statement: http://grants.nih.gov/grants/policy/policy.htm  NIH tutorial on award and post-award management: http://grants.nih.gov/grants/policy/policy.htm  NIH tutorial for foreign organizations: http://grants.nih.gov/grants/foreign/index.htm  NIH Q&A on effort: http://grants.nih.gov/grants/policy/person_months_faqs.ht m (link to % effort to person months excel calculator)  FDP subaward templates: http://sites.nationalacademies.org/PGA/fdp/PGA_063626

Key/Useful Links

Financial conflict of interest

 Règles 42CFR Part 50 (subventions et ententes de coopération) et 45 CFR Part 94 (contrats)

 en vigueur depuis le 24 août 2012  s’applique au NOA à compter du 24 août 2012 (pas rétro- actif)  Appliquées par des organismes du PHS (US public Health Services) et des organismes non-PHS

Financial conflict of interest (FCOI)

Financial Conflict of Interest

PHS

 Office of Global Affairs (OG)  Office of the Assistant Secretary for Health (OASH)  Office of the Assistant Secretary for Preparedness and Response (ASPR)  Agency for Health Care Research & Quality (AHRQ)  Agency for Toxic Substances and Disease Registry (ATSDR)  Centers for Disease Control and Prevention (CDC)  Food and Drug Administration (FDA)  Health Resources and Services Administration (HRSA)  Indian Health Service (IHS)  National Institutes of Health (NIH)  Substance Abuse and Mental Health Services Administration (SAMHSA)

Non-PHS

 Alliance for Lupus Research (ALR)  American Asthma Foundation  American Cancer Society (ACS)  American Heart Association (AHA)  American Lung Association (ALA)  Arthritis Foundation (AF)  Juvenile Diabetes Research Foundation (JDRF)  Lupus Foundation of America (LFA)  Susan G. Komen for the Cure  CurePSP http://nrc59.nas.edu/pub/fcoi_home.html

 Obligation de déclaration des intérêts financiers significatifs pour tout investigateur qui planifie de participer ou qui participe à une recherche financée par les organismes mentionnés précédemment.

 Investigateur : pas seulement le chercheur principal  IFS : toute rémunération de l’investigateur ou de ses proches excédant 5 000$ liée aux responsabilités institutionnelles  Rémunération : salaire, paiement pour service, participation, droits de PI, remboursement de frais de voyage ou voyage sponsorisé

Financial Conflict of Interest

 Les obligations de l’institution

 Mettre à jour sa politique de conflits d’intérêts et la rendre publique  Informer les investigateurs de la politique  Exiger le suivi d’une formation spécifique (à renouveler au moins tous les 4 ans)  Exiger une déclaration d’IFS annuellement ou dans les 30 jours suivant l’apparition d’un nouvel IFS  Désigner un ou des représentants institutionnels qui solliciteront et réviseront les déclarations d’IFS  S’assurer qu’un sub-recipient se conforme à la réglementation

Financial Conflict of Interest

 Les obligations de l’institution

 Fournir un rapport initial et des rapports subséquents des conflits d’intérêts financiers (eRAcommons FCOI pour le NIH)  Conserver les déclarations d’IFS au moins 3 ans après la date de soumission du rapport financier final  Gérer les conflits d’intérêts en fonction du plan de gestion établi  Établir des mécanismes de renforcement, de sanction ou tout autre action administrative pour s’assurer de la conformité des investigateurs  Certifier pour chaque demande de subvention que l’institution se conforme aux exigences  Assurer un accès public à tout IFS soit sur un site internet soit par écrit dans les 5 jours ouvrables suivant une demande.

Financial Conflict of Interest

 À l’Université de Montréal

 Nouvelles directives d’application du règlement sur les conflits d’intérêts  Nouveaux formulaires (annexe spécifique FCOI)  Nouveau site web et formation de la communauté universitaire et capsules vidéo www.interets.umontreal.ca

Financial Conflict of Interest