US National Institutes of Health (NIH)

administration and compliance…

Emma Sinha

EMBL-EBI Grants Office

Supervisor

www.ebi.ac.uk

…an introduction…

HANDS UP!

Introduction

• 1. Who are the National Institutes of Health (NIH)?

• 2. EMBL-EBI and the NIH

• 3. Administering the NIH grant life-cycle

• 4. Where to get more information

Who are the National Institutes of

Health (NIH)?

Who are the NIH?

• The National Institutes of Health is the US medical

research funder

• Funded through US tax money

• Obtained from Congress annually (US federal financial

year runs Oct-Sep)

• Funding is subject not just to terms and conditions but

actual US laws

• Pre-award laws (45 CFR Part 75 - Subpart C)

• Post-award laws (45 CFR Part 75 - Subpart D)

What is the Scientific role of the NIH ?

Intersection between

Biology and Public

Health

Medical

Advances/Improved

Public Health

Human Biology:

Biological, Social

and Behavioral

Processes

U.S. Dept. of Health & Human

Services

g

Administration for

Children and Families

(ACF)

Food and Drug

Administration

(FDA)

Health Resources

and Services

Administration

(HRSA)

Secretary of

Health and

Human Services

Administration on

Aging

(AoA)

Center for Medicare

& Medicaid

Services

(CMS)

Indian Health

Services

(IHS)

National Institutes

of Health

(NIH)

Agency for

Healthcare Research

and Quality

(AHRQ)

Centers for

Disease Control

and Prevention

(CDC)

Substance Abuse and

Mental Health Services

Administration

(SAMHSA)

Agency for Toxic

Substances and

Disease Registry

(ATSDR)

8

National Institutes of Health

National Institute

on Alcohol Abuse

and Alcoholism

National Institute

of Arthritis and

Musculoskeletal

and Skin Diseases

National Cancer

Institute

National Institute

on Aging

National Institute

of Child Health

and Human

Development

National Institute

of Allergy and

Infectious Diseases

National Institute

of Diabetes and

Digestive and

Kidney Diseases

National Institute

of Dental and

Craniofacial

Research

National Institute

on Drug Abuse

National Institute

of Environmental

Health Sciences

National Institute on

Deafness and Other

Communication

Disorders

National Eye

Institute

National Human

Genome Research

Institute

National Heart,

Lung, and Blood

Institute

National Institute

of Mental Health

National Institute

of Neurological

Disorders and

Stroke

National Institute

of General

Medical Sciences

National Institute

of Nursing Research

National Library

of Medicine

National Center

for Complementary

and Alternative

Medicine

Fogarty

International

Center

National Center

for Advancing

Translational

Sciences

National Institute

of Biomedical

Imaging and

Bioengineering

No funding

authorityNIH

Clinical Center

Center

for Information

Technology

Center

for Scientific

Review

National Center on

Minority Health

and Health

Disparities

Office of the Director Office of

Extramural Research

!!!

Why do the NIH fund international research?

• To fund research not available in the U.S. or that

augments existing U.S. resources:

• Unusual talents

• Resources

• Populations

• Environmental conditions

• Has the potential for significantly advancing the health

sciences in the U.S.

• Involvement of Foreign applicants or components needs

to be justified – why can’t this be done in the U.S.?

!!!

EMBL-EBI and the NIH

BIG data, BIG global impact

*2016 independent Charles Beagrie impact report

• EMBL-EBI data resources calculated* to generate

>£920m in future research impacts annually

• 45% of EMBL-EBI data resource users stated they

could neither recreate nor find this data anywhere else

• NIH funding justification for EMBL-EBI data resources:

• unusual talents in bioinformatics

• bioinformatics resources not available in the U.S.

• and that augment existing U.S. resources

• significantly advancing the health sciences in the U.S.

NIH is a strategic funder of EMBL-EBI

• NIH projects tend to be large, strategic funds

• <10% applications over past 5 years have been to NIH

• Represents ~35% of our external income

• Past 5 years

• 68 submitted NIH applications

• Success rate average ~40%

• 37 active NIH grants and 2 NIH contracts

• 10 as Lead and 4 as Sole recipient

Administering the NIH grant life-cycle

https://grants.nih.gov/grants/glossary.htm

!!!

Application

Just In Time (JIT)

Notice of Award

(NoA) Yr 1

Notice of Award

(NoA) Yr 2

Notice of Award

(NoA) Yr 3

Closeout

Progress

Report

(RPPR)

Financial

Report

(FFR)

Supplements

Carry-forward

requestProgress

Report

(RPPR)

Financial

Report

(FFR)

Final

Report

(FRPPR)

Financial

Report

(FFR)

Life cycle of NIH grant

Changes and

Prior

approvals

How to apply…

• Calls advertised on Grants.gov

• Weekly digest -http://grants.nih.gov/grants/guide/listserv.htm

• Two key guidance documents for preparing applications:

• 1. Funding Opportunity Announcements (FOA) – specific instructions on how to apply to the call

• 2. SF424 (R&R) Application Guide –general instructions about how to apply to the NIH

21+312 = 333 pages

!!!

How to apply…

• Although there are a few ways to apply to the NIH, at

EMBL we use “ASSIST”

• This is a “system-to-system” solution

• There is also a guidance manual for this

21+312+306 = 639

pages!!!

Foreign institution eligibility & registrations

• Section III. Eligibility Information of FOA

• Registration is a multistep process ~ 6 weeks!

• Grants.gov & eraCommons – Institution & Investigators

• Data Universal Number System (DUNS)

• System for Award Management (SAM) – renewed annually

• NATO Commercial and Government Entity (NCAGE)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

!!!

https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-

apply-and-register/registration/org-representative-registration.htm

Costing Considerations• Salary cap $ 192,300 pro-rated

https://grants.nih.gov/grants/policy/salcap_summary.htm

• Salary cap for graduate students $ 50,004 pro-rated https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-036.html

• No staff that are excluded from receiving US funding https://sam.gov/SAM/pages/public/searchRecords/search.jsf

• No inflation, problems with increments (depends on IC)

• Have to adhere to Fly America/Open Skies policy – travel

may be expensive https://www.gsa.gov/policy-regulations/policy/travel-

management-policy/fly-america-act

• Prior approval ~6 weeks prior to deadline if budget

>$500k direct costs (excluding consortium F&A) per year

Costing Considerations: F&A – not just

overhead

• 8 % of modified total direct costs (MTDC), exclusive of

tuition and related fees, equipment, and subawards

>$25,000

• F&A 8% only for compliance with federal

requirements E.g., protection of human subjects, animal

welfare, invention reporting, other post-award reporting

requirements, financial conflict of interest and research

misconduct.

• Can ask for things that would be part of F&A in US as

direct costs – e.g., computers

Application

Just In Time (JIT)

Notice of Award

(NoA) Yr 1

Notice of Award

(NoA) Yr 2

Notice of Award

(NoA) Yr 3

Closeout

Progress

Report

(RPPR)

Financial

Report

(FFR)

Supplements

Carry-forward

requestProgress

Report

(RPPR)

Financial

Report

(FFR)

Final

Report

(FRPPR

)

Financial

Report

(FFR)

Life cycle of NIH grant

Changes and

Prior

approvals

JIT (Just In Time) information

• NIH ask for this before an award is made – all applications that receive an impact score of <40 (less is more)

• JIT information submitted on eRA commons <60 days from request – can be anything they want clarification on / to be changed

• Other support – check for scientific, budgetary, or commitment overlap

• Ethics approvals

• IRB – Human Subjects/Human subjects education certification

• IACUC – Animals

• Genomic data sharing

https://nexus.od.nih.gov/all/2015/05/27/how-do-you-convert-

percent-effort-into-person-months/

Application

Just In Time (JIT)

Notice of Award

(NoA) Yr 1

Notice of Award

(NoA) Yr 2

Notice of Award

(NoA) Yr 3

Closeout

Progress

Report

(RPPR)

Financial

Report

(FFR)

Supplements

Carry-forward

requestProgress

Report

(RPPR)

Financial

Report

(FFR)

Final

Report

(FRPPR

)

Financial

Report

(FFR)

Life cycle of NIH grant

Costs from 90 days before

start date are eligible

Changes and

Prior

approvals

How to comply with an NIH grant

• Policy is split into two:

• Uniform guidance: Aim to “Create greater consistency in the administration of Federal research awards”

• guidance or procedure starting “SF-424”

• across all federal funding (NIH, NSF, DOE etc).

• NIH grants policy statement is policy above and beyond the Uniform guidance

• including topics N/A to all federal agencies (e.g., human stem cell research)

• guidance or procedure starting “PHS”

• This contains most of the useful info

21+312+306+103+405 = 1,147

pages!!!

AOR individually legally responsible

• 2.3.6 Legal Implications of Applications NIH GPS

• The AOR role is expected to have legal accountability for

compliance with the NIHGPS when submitting

applications to the NIH

• “This individual is responsible to NIH for ensuring that

the organization complies with applicable Federal laws

and regulations, including required certifications and

assurances”

Compliance requirements: NIH GPS• 4 PUBLIC POLICY REQUIREMENTS, OBJECTIVES

AND OTHER APPROPRIATION MANDATES

• 16 GRANTS TO FOREIGN ORGANIZATIONS,

INTERNATIONAL ORGANIZATIONS, AND DOMESTIC

GRANTS WITH FOREIGN COMPONENTS

• 16.4 PUBLIC POLICY REQUIREMENTS AND

OBJECTIVES for foreign institutes

• Research Misconduct

• Animal Welfare

• Human Subjects (including 45 CFR 46)

• Financial Conflict of Interest (FCOI; 42 CFR 50, Subpart

F)

• Inclusiveness in Research Design

Financial Conflict of Interest (FCOI)

• When submitting a grant application, the signature of the

AOR certifies the applicant Institution’s compliance with

the requirements of 42 CFR 50, Subpart F, including that:

• Institution has a written and enforced administrative process

to identify and manage Financial Conflicts of Interest (FCOI)

on NIH projects

• The Institution shall identify and manage FCOIs and provide

initial and ongoing FCOI reports to the NIH consistent with

this subpart

• FCOI clearing house http://thefdp.org/default/fcoi-

clearinghouse/compliant-entities/

• FCOI training - https://nexus.od.nih.gov/all/2018/12/03/new-

financial-conflict-of-interest-training-module-available/

Compliance requirements: Uniform Guidance

• 45 CFR Part 75 - Subpart D – Post Federal Award Requirements

- Standards for Financial and Program Management

- Property Standards

- Procurement Standards

- Performance and Financial Monitoring and Reporting

- Subrecipient Monitoring and Management

- Record Retention and Access

- Remedies and Noncompliance

- Closeout

- Post-Closeout Adjustments and Continuing Responsibilities

- Collection and Amounts Due

Federal

Demonstration

Partnership

http://thefdp.org/de

fault/subaward-

forms/

Compliance requirements: Uniform Guidance

• 45 CFR Part 75 - Subpart F – Audit Requirements

• All NIH grant recipients that expend $750,000 or more

within a year in Federal awards are required to have a

“Single Audit” and submit it to the National External Audit

Review Center

• Audits are due within the earlier of 30 days after receipt of

the auditor’s report or 9 months after the end of the

recipient’s audit period

• Recipients delinquent in submitting audits risk the

imposition of sanctions and potential loss of Federal

funds

• PTE (Lead) responsible for ensuring sub-recipients do

this too

Compliance Summary

• If you want to apply, make sure that you are aware of all

the compliance conditions under section 4 of the NIH

GPS that would apply

• If you are the lead – you are not just legally responsible

compliance for your institute, but those of your partners

• Due diligence procedures

Where to get more information

If you are interested in finding specific things

out in a more structured way

• NIH website to help foreign institutes navigate NIH

funding https://grants.nih.gov/grants/foreign/index.htm

• NIH Regional Seminars ~3 Yrs F&A !!!

https://grants.nih.gov/news/contact-in-

person/seminars.htm#upcoming

• Slides from event earlier this year

https://regionalseminars.od.nih.gov/baltimore2019/presen

tations/

Questions…?

Questions?