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NIH: The View from 10,000 Feet

Sally J. Rockey, PhD

Deputy Director for Extramural Research

National Institutes of Health

AASCU Grants Resource Center Conference

August 2014

NIH: Steward of Biomedical & Behavioral Research for the Nation

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems…

…and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

U.S. Dept. of Health & Human Services

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)

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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

authority NIH

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

National Institutes of Health

Understanding the Dual Nature of NIH

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Data: Assoc of University Technology Managers (AUTM) Survey 2004

Alaska

NIH supports institutions & people (Extramural Research)

>4,000 institutions

>300,000 scientists & research personnel

~Approx. 80% of the NIH budget

NIH is an institution (Intramural Research)

~Approx. 6,000 scientists

~Approx. 10% of NIH

budget

OER Preserves Public Trust in Biomedical Research

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Scientific

Integrity

Public

Accountability Program

Stewardship

Services and Infrastructure

Development,

Implementation, and

Oversight

Systems & Data Communications Admin Support Education & Training

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Office of the Director

Office of Extramural Programs

(OEP)

Office of Policy for

Extramural Research

Administration

(OPERA)

Office of Research Information Systems

(ORIS)

Office of Laboratory Animal Welfare

(OLAW)

Office of Administrative

Operations (OAO)

Divisions of

Communications & Outreach AND

Planning & Evaluation

Electronic Research Administration

Division of Information Services

Division of Policy and Education

Division of Assurance

Division of Compliance Oversight

Division of Administrative Services

Division of Quality Assurance

Division of Extramural Activities Support

(*MEO ends FY12)

NRSA Payback Center

Division of Grants Policy

Division of Extramural Inventions and Technology

Resources

Division of Grants Compliance Oversight

Director Sally J. Rockey, PhD

Division of Research Training Programs Division

Division of Extramural Staff Training and Information

Dissemination

Division of Scientific Program Management and Policy

Division of Loan Repayment

Director: Sherry Mills, MD,MPH

Director: Michelle Bulls

Director: Rick Ikeda, PhD

Director: Patricia Brown, VMH

Director: Mitzi Diley

OER Deputy Director Office of Planning &

Communication Director, Della M. Hann, PhD

OER Organizational Structure

Challenging times!!!!!

Compound Annual Growth Rate of Biomedical R&D

Expenditures by Country, Adjusted for Inflation

2007–2012

Canada

United States

Europe

Taiwan

Japan

India

Australia

Singapore

South Korea

China 32.8

11.4

10.0

6.9

6.7

5.7

5.2

-0.4

-1.9

-2.6

-5 0 5 10 15 20 25 30 35

Source: N Engl J Med. 2014 Jan 2;370(1):3-6

Compound Annual Growth Rate of Biomedical R&D Expenditures (%)

Biomedical Research and Development

Price Index (BRDPI)

• Measures changes in the weighted-average of the prices

of all the inputs (e.g. personnel services, various

supplies, and equipment) purchased with the NIH

budget to support research.

• Weights within the price index reflect the actual pattern

or total NIH expenditures on each of the

types of inputs purchased every year.

• Annual change indicates how much

NIH expenditures would need to grow to

maintain NIH-funded research activities

at the previous year’s level.

Trends Over Time in Growth Rates of BRDPI

and GDP Price Index, 1959 to 2012

National Institutes of Health Funding

1990-2041

NIH Program Level in Nominal Dollars and

Constant 1998 Dollars, FY1998 – FY2014

$0

$5

$10

$15

$20

$25

$30

$35

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Appropriation Appropriation in 1998 Dollars

(In B

illio

ns)

Research Project Grants: Competing

Applications, Awards, and Success Rates

Policy & Program News

Learning the Language of the Brain

BRAIN Initiative

“The Next Great American Project”

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Brain Research through Advancing Innovative

Neurotechnologies (BRAIN) Initiative – NIH goals

Generate a Census of Cell Types

Create Structural Maps of the Brain

Develop New Large-Scale Network Recording Capabilities

Develop A Suite of Tools for Circuit Manipulation

Link Neuronal Activity to Behavior

Integrate Theory, Modeling, Statistics, and Computation with

Experimentation

Delineate Mechanisms Underlying Human Imaging Technologies

Create Mechanisms to Enable Collection of Human Data

Disseminate Knowledge and Training

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FY 2014 Investments

Government Agencies $ in Millions

National Institutes of Health $40 .7

• Blueprint for Neuroscience Research $10M

• NIMH $12.85M

• NINDS $12.85M

• NIDA $4M

• NIBIB $1M

Defense Advanced Research Projects Agency $50

National Science Foundation $20

Food and Drug Administration N/A

+ Private

Investments

Antimicrobial Resistance

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Antimicrobial Resistance:

Obama Administration Activities

President’s Council of Advisors on Science and Technology

(PCAST) is developing recommendations for presidential-

level actions

Interagency Policy Committee (IPC) on Combating Antibiotic

Resistant Bacteria (CARB) is a trans-U.S. government

initiative led by the White House to unite all departments and

agencies in developing a blueprint for tackling this public

health issue

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Antimicrobial Resistance:

NIH-FDA Joint Leadership Council (JLC)

The JLC ensures that regulatory considerations inform

biomedical research planning and the latest science is

integrated into the regulatory review process

Workshop July 30-31 on Antimicrobial Resistance

– Industry, federal agencies, academia, advocates

– Develop the template for a common clinical protocol

– Promote the use of common control groups

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Big Data and Biomedical Research

The promise – and the challenges

Big Data and NIH

Partnerships: national, and international

Myriad Data Types

Other ‘Omic

Imaging Phenotypic

Clinical

Genomic

Exposure

Growth of Biological Databases

0

200

400

600

800

1000

1200

1400

1600

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Source: Michael Bell, Newcastle University, U.K.

Num

ber

of D

ata

bases

Daily Data Processing at NCBI

Interactive

Web

Data

Downloads

365TB/day

126

Petabytes/year

3TB/day

35 TB/day

4 Terabytes (TB)/day

NIH Is Tackling the “Big Data” Problem:

The NIH Digital Enterprise

New leadership position: Associate Director for Data

Science (ADDS), Dr. Philip Bourne

Scientific Data Council and External Advisory Board

Big Data to Knowledge (BD2K)

Data Commons

Big Data to Knowledge (BD2K)

Initiative to develop innovative, transformative

approaches and tools – to make Big Data a more

prominent component of biomedical research

Will lead to:

– Appropriate access to shareable biomedical data

– Development of, and access to, appropriate algorithms,

methods, software, and tools

– Appropriate protections for privacy and intellectual property

– Development of a sufficient cadre of skilled researchers

BD2K: Activities

Data sharing

– Data Discovery Index

– Data/metadata standards

Software development

Training, including

– K01 Mentored Career Development awards; new training grants

Centers of Excellence

– Applications have been received; reviewed

– Awards FY 2014

Recent Lapses in Lab Safety at Federal

Laboratories

• March 12, 2014: CDC lab accidentally shipped

H5N1 avian flu virus rather than a fairly benign

animal strain to a USDA poultry research lab.

• June 6-13: CDC employees may have been

exposed to live anthrax bacteria after potentially

infectious samples were sent to labs

unequipped to handle them.

• July 1, 2014: Smallpox was found in FDA lab

located on the NIH Bethesda campus.

Federal Response to Recent Lapses in

Lab Safety at Federal Laboratories

• Performing comprehensive search of all

HHS laboratories

• Reminding grantee institutions of the

requirement to meet all applicable

Federal, State, and local health and safety

standards

• Engaging with Institutional Biosafety

Committees

Possible Causes for Difficulties

Reproducing Data

• Poor experimental design: e.g., no blinding, randomization,

insufficient power, variable experimental conditions, insufficient

documentation of methods

• Errors in analysis & interpretation: lack of replication, inappropriate

use of statistics, misinterpretation of findings

• Inadequate reporting of: detailed methods, failures to replicate,

exclusion of outliers, changes to endpoints

• Overemphasis on the “exciting” or “big picture” finding sometimes

results in publications leaving out necessary details of experiments

performed

• Difficulty in publication of “negative” findings

• Underlying issues of poor training in experimental design and

perverse reward incentives

Trans-NIH Actions

• Discussing reproducibility and transparency of research findings

with stakeholder communities, such as journal editors

• Creating a new training module on research integrity and

experimental design

• Implementing pilot studies to address key concerns, such as:

▫ Developing a checklist to ensure more systematic evaluation of

grant applications

▫ Determining approaches needed to reduce “perverse incentives,”

e.g., longer term support for investigators

▫ Supporting replication studies

• Considering approaches to encourage applicants to:

▫ Authenticate cell lines and other unique research resources

▫ Analyze and report sex differences in preclinical research

NIH to Balance Sex in cell and

Animal Studies

Over the course of FY

2015, NIH plans to roll

out policies that will

require applicants to

address inclusion of both

sexes in biomedical

research.

NIH Application Resubmission Policy

• NIH Guide Notice (NOT-OD-14-074)

NIH and AHRQ Announce Updated Policy for

Application Submission, April 17, 2014

• “Effective immediately, the NIH and AHRQ will accept a

new (A0) application following an unsuccessful

resubmission (A1) application. The subsequent new

application need not demonstrate substantial changes in

scientific direction compared to previously reviewed

submissions, and must not contain an introduction to

respond to the critiques from the previous review.”

New Approaches to Supporting Science

• NIH is piloting the concept of awarding longer

grants that provide more stable support for

investigators at all career stages.

• Each Institute and Center will decide the

appropriate size and duration of their awards.

• Applications will not require specific aims in the

R01 format; investigators will describe their

research plans and demonstrate how they will

translate their prior accomplishments into future

research approaches.

• PAR-14-267: National Cancer Institute Outstanding

Investigator Award (R35)

▫ will provide long-term support to investigators who

have extraordinary records of cancer research

productivity.

▫ up to $600,000 annually in direct costs, for up to

seven years.

• NOT-GM-14-122: National Institute of General Medical

Sciences request for community feedback on the

“Maximizing Investigators’ Research Award.”

▫ would support all NIGMS-funded research in an

investigator’s laboratory.

▫ funding would range from $150,000-$750,000

annually in direct costs, for five years.

New Approaches to Supporting Science

The Modified Biographical Sketch (Biosketch) in

NIH Applications

• NIH has been piloting changes to the Biosketch in grant

applications

• A second round of Biosketch pilots (announced May 16,

2014) will:

▫ Extend the page limit from four to five pages.

▫ Allow researchers to describe up to five of their most

significant contributions to science, their specific role

in those discoveries, and the influence of their

contributions on their scientific field.

• The new Biosketch is intended to emphasize

accomplishments rather than a list of publications.

Upcoming Changes: New HHS Closeout

Requirements • GAO audits on HHS closeout activities reported that billions of

dollars were unobligated in the Payment Management System.

• HHS has issued new policies for closeout of grant awards.

• No changes are expected to the current NIH Standard Terms of

Award provision allowing grantees to initiate a one-time, no-cost

extension in the last year of the award.

• Anticipated changes:

▫ Must initiate “unilateral” closeout—i.e., without cooperation of the

grantee—if reports are missing or unacceptable.

▫ Must consider possible enforcement actions when unilateral

closeout conducted.

▫ When there are discrepancies between grantee’s final federal

financial report and cash transaction report—must adjust award

to lower amount, which may result in a debt obligation to the

grantees.

Upcoming Changes: Subaccounts

• Most payments for NIH domestic awards are

currently made via pooled accounts in the Payment

Management System.

• Per HHS directive, NIH will transition payment for grant awards

from pooled payments to subaccounts where funds can be

expended and monitored by each individual grant.

• FY 2014 – transition all awards with new document numbers

(Types 1, 2, 4, 6, 7, & 9).

• FY 2015-2016 – transition continuing awards (Types 5 & 8).

• Administrative supplements will be awarded to the same type of

account (subaccount or pooled) as the parent award.

• Carryover authority will not change as a result of this transition.

Uniform Guidance (UG), 2 CFR 200

• Streamlines Federal Government’s guidance on

administrative requirements, cost principles, and

audit requirements for all types of non-Federal

entities

• Combines eight previously separate sets of

OMB guidance:

▫ Cost Principles: A-21, A-87, A-122,

▫ Administrative Requirements: A-110 & A-102

▫ Audit Requirements: A-133 & A-50

▫ CFDA: A-89

• Eliminates overlapping, duplicative, and

conflicting requirements for grantee institutions

UG Implementation Timeline

• December 26, 2013: UG released by OMB

• June 26, 2014: Agency implementation plans

due

• ~September: Estimated public comment period

• December 26, 2014: Full Agency

implementation expected

▫ As the implementing agency, the HHS strategy will

inform NIH implementation efforts

UG Implementation Plans

• Applies to new awards and additional funding applied to existing awards made after December 26, 2014.

• Existing Federal awards will continue to be governed by the current terms and conditions of the award. ▫ Will likely mean mixed requirements for FY2015 awards

• Changes in Subpart F, Audit is based on FY year date and will change with all FY 2015 awards.

UG to Strengthen Grants

Administration Oversight

• New definitions, terms, and acronyms

• Subpart C:

▫ Conflict of Interest now captured

▫ 15 mandatory data elements contained in the Notice of

Award

▫ Use of standard OMB-approved collections is a new and

consistent theme throughout 2 CFR 200

▫ Review of applicant risk prior to award

• Subpart D:

▫ OMB-approved standard government-wide information

collections (i.e., RPPR).

▫ Internal Controls – moved from OMB A-133 to the

administrative section

UG to Strengthen Grants Administration Oversight

• Subpart D continued – ▫ Procurement Standards – open competition required; however, single

source is allowed with appropriate justification.

▫ Financial Reporting – agencies will now use OMB-approved

government-wide data elements for collection of financial information

in lieu of forms—currently the FFR data elements. No changes in

frequency requirements.

▫ Closeout – must be closed one year after the end of the period of

performance.

• Subpart E: ▫ Compensation for personal services – charges for salaries and wages

must be based on records that accurately reflect the work performed.

• Subpart F: ▫ Audit threshold increased from $500,000 to $750,000 in Federal

award expenditures during a non-Federal entity’s fiscal year.

What’s Next?

• Stay tuned for NIH Guide Notices and other

announcements (e.g., Federal Register) about

agency implementation.

Webpage of Grants and Funding

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Finding Funded Research: http://RePORT.NIH.Gov

•Quick access to “Frequently Requested Reports” (e.g. Funding by State,

Funding by Award Mechanism, etc.)

•Efficient search tools for locating data and reports

•Links to funding estimates for certain research areas, conditions, & diseases.

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