3 June 2010

Research Data and Information:

Recent Developments and Continuing NIH Interests

Jerry Sheehan Assistant Director for Policy Development National Library of Medicine National Institutes of Health

National Academies Board on Research Data and Information June 3, 2010, Washington, DC National Academies - BRDI 1

Recent Developments of Interest

• NIH Public Access Policy • NIH Data Sharing Policy • Genomic Sequence Sharing Policy • Clinical Trials Information • Genetic Testing Registry • NIH Biennial Report and Catalog • Implementation of Recovery Act and HITECH Act programs 3 June 2010 National Academies - BRDI 2

22 000 000 20 000 000 18 000 000 16 000 000 14 000 000 12 000 000 10 000 000 8 000 000 6 000 000 4 000 000 2 000 000 0 PubMed Central Continues to Grow articles available and retrieved, by month, 2008 - 2010

Articles retrieved Articles available The mandatory NIH Public Access Policy applies to peer reviewed articles that are accepted for publication on or after April 7, 2008.

2 000 000 1 800 000 1 600 000 1 400 000 1 200 000 1 000 000

Public Access Policy

• PubMed Central celebrates 10 th Anniversary – TOMORROW (JUNE 4) • Federal Research Public Access Act – S.373 introduced June 2009 – HR.5037 introduced April 152010 • America COMPETES Reauthorization – [HR.5325] House S&T Committee – Interagency Public Access Committee • OSTP Request for Information (Dec-Jan) 3 June 2010 National Academies - BRDI 4

NIH Data Sharing Policy

• Took effect in October 2003 (FY2004) • Applies to ALL awards of >$500K in direct costs in any single year • Requires – inclusion of data sharing plan in application – OR – indication of why data cannot be shared (e.g., privacy, national security) • Not included in determination of scientific merit or priority score • “Timely release and sharing" = no later than acceptance for publication of the main findings from the final data set 3 June 2010 National Academies - BRDI 5

Improved Guidance for NIH Data Sharing Plans

http://grants.nih.gov/grants/sharing_key_elements_data_sharing_plan.pdf

3 June 2010 National Academies - BRDI 6

Sequencing Data NIH Sequence Read Archive

• Fastest-growing genomic database; • Currently ~16 terabases + 1 terabase per month (

cf

, Genbank ~100 gigabases) • Raw sequencing data from next generation sequencing • Data exchange with European Read Archive and DDBJ’s Read Archive (Japan) 3 June 2010 National Academies - BRDI 7

Forthcoming Sequence Data Sharing Policy

http://grants.nih.gov/grants/guide/notice-files/NOT-HG-10-006.html

3 June 2010 National Academies - BRDI 8

Clinical Trials Data

• Rulemaking (FDA Amendments Act of 2007) Single, integrated rule (forthcoming): – Registration – Results reporting (including adverse events) – Expansion items, including. . . • Results of unapproved products?

• Narrative summaries in addition to data?

• ClinicalTrials.gov enhancements, operation – >90K registered trials (+ 17K per year) – >1800 trial results records – Improved data quality on first submission 3 June 2010 National Academies - BRDI 9

Genetic Testing Registry

• Repository of info ABOUT genetic tests – Validity and usefulness of tests – Assign unique identifier for tests – Voluntary submission of information by manufacturers, providers • Request for Information – May 28 NIH Guide; forthcoming in FedRegister – Types of tests to include/exclude – Types of info to collect – Responses DUE within 30 days of FedRegister http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-101.html

3 June 2010 National Academies - BRDI 10

Health IT for Economic and Clinical Health (HITECH) Act

• 4 Draft regulations issued – NPRM on “meaningful use” of electronic health records – Interim final rule on breach notification req’ts – Interim final rule on EHR certification criteria – NPRM on certification program • Funding opportunities & awards – Research and education programs – Health IT extension centers – Beacon community cooperative agreements • NIH interests – Electronic health records as source of data for research – Patient education materials linked to EHR – Standards and interoperability 3 June 2010 National Academies - BRDI 11

Health care reform: Some items of interest

• Cures Acceleration Network – flexible funding authorities & mechanisms to bridge gap between discovery and commercialization of therapies.

• Comparative Effectiveness Research – Patient Centered Outcomes Research Institute (PCORI) • Physicians Sunshine Act – database of disclosure of payments by manufacturers to physicians or teaching hospitals • Prevention & Wellness – Includes Federal website for use by the public in prevention planning. 3 June 2010 National Academies - BRDI 12

http://report.nih.gov/biennialreport/ http://report.nih.gov/UploadDocs/Biomed_Info_Resources_FY08_09.pdf

3 June 2010 National Academies - BRDI 13

http://report.nih.gov/UploadDocs/Biomed_Info_Resources_FY08_09.pdf

3 June 2010 National Academies - BRDI 14

Continuing NIH Interests in Research Data & Information

• Recognize and reward data sharing by researchers – Promotion and tenure decisions – Recognition by peers, funding agencies – Metrics • Embed data sharing in scientific training – Shift away from ad hoc model, based on apprenticeship – Include training in principles of data management, data curation, and sharing – Roles of institutional libraries and individual labs, departments • Research agenda for management of data &information – Take advantage of ongoing trends in information and communications technology – Research areas for agency investments • Identify and Promote good practice – Policies, practices, norms for agencies, institutions, scientific communities – Identification of necessary resources and infrastructure (e.g., centralized repositories, distributed databases, registries, standards) 3 June 2010 National Academies - BRDI 15

More information on data/ information sharing at NIH

NIH Data Sharing Policies http://sharing.nih.gov/ NIH Public Access Policy http://publicaccess.nih.gov/ NIH GWAS Policy http://grants.nih.gov/grants/gwas/ ClinicalTrials.gov

http://www.clinicaltrials.gov

National Library of Medicine http://www.nlm.nih.gov

3 June 2010 National Center for Research Resources http://www.ncrr.nih.gov

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