1. Update from the National Institutes of Health (NIH)
Carrie D. Wolinetz, PhD
Acting Chief of Staff and
Associate Director for Science Policy
National Institutes of Health

2. National Institutes of Health
NIH seeks fundamental knowledge about the nature and behavior of living
systems and the application of that knowledge to enhance health, lengthen
life, and reduce the burdens of illness and disability.

3. 27 Institutes and Centers
NHLBI

6. NIH Supports 300,000 scientists and research staff at 2,500 Institutions
The largest portion of our $30 billion dollar budget supports support grants that fund over 300,000 scientists and research staff at about 2,5000 institutions, including 1,300 small businesses, across the country. U.S. taxpayer support for NIH has helped empower the US to make great advances in health science and extend and improve the lives of millions here and abroad. NIH has been the envy of the world.

7. NIH: The Highlights Edition…
A little science
BRAIN
PMI: All of Us research program
Opioids
A little policy
Clinical trials stewardship
Rigor & reproducibility
Data sharing policy
Some time for questions…

8. Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative®
Expand efforts to address fundamental neuroscience questions
Increase investment to support groundbreaking neuroscience research, neuroimaging, training
Explore collaborations with industry to develop/test devices for mapping/tuning brain circuitry

9. Participants will have opportunities to:
The All of Us Research Program Cornerstone of the Precision Medicine Initiative
A new model of research, based on collaboration among researchers, providers, and participants
Program core: one million or more volunteers, reflecting the broad diversity of the U.S.
Participants will have opportunities to:
Provide and receive their own data on an ongoing basis
Learn some of their own health indicators
Volunteer to take part in clinical trials
Will generate a rich data resource, including biospecimens
Shared freely and rapidly to inform a variety of research studies

10. All of Us Mission and Objectives

11. Established Program Infrastructure
Data and Research Center
Biobank
Participant Center
Participant Technology
Systems Center
Health Care Provider
Organizations
Communications and
Engagement Partners 11

12. The Crisis: Overdose Death Rates
1999
2015
Estimated Age-adjusted
Death Rate per 100,000:
Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System

13. NIH Opioid Research Initiative Using Research to End the Opioid Crisis
Pain Management
Safe, more effective strategies
Opioid Addiction
Treatment
New and innovative medications and technologies
Overdose Reversal
Interventions to reduce mortality and link to treatment

14. NIH Enhancing Stewardship of Clinical Trials

15. NIH Efforts to Increase Reproducibility of Research
2014: NIH clarified requirements to increase reproducibility through scientific rigor and transparency
Scientific remise
Rigorous experimental design
Consideration of relevant biological variables, such as sex
Authentication of key resources
Transparency in reporting methods, statistical approaches, and generalizability of research is a key component of the policy

16. Data sharing… one policy at a time

17. The Challenge… Data generators/data users What do we mean by data?
All data? Underlying publications?
Types of data? High value data?
What so we mean by sharing?
FAIR principles
Technical details
Complicating factors…
Clinical data: aggregate or IPD?
Avocados vs. fine wine
Is the juice worth the squeeze?
Balance point between burden and value

18. Full circle…

19. Stay in touch…. NIH Office of Science Policy
Website:
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