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

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.

27 Institutes and Centers NHLBI

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.

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…

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

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

All of Us Mission and Objectives

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

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

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

NIH Enhancing Stewardship of Clinical Trials

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

Data sharing… one policy at a time

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

Full circle…

Stay in touch…. NIH Office of Science Policy Website: http://osp.od.nih.gov/ Blog: http://osp.od.nih.gov/under-the-poliscope Twitter: https://twitter.com/cwolinetznih Subscribe to the OSP listserv by sending an email to LISTSERV@list.nih.gov with “Subscribe OSP_News” in the message body