Enhancing Access to Biomedical Research Data: NIH Experience

Dina N. PaltooAssistant Director for Policy DevelopmentNational Library of MedicineNational Institutes of Health

NSTC Conference on Building Bridges Across the S&T EnterpriseBethesda, MD | 13 June 2019

2

NIH’s Longstanding Commitment to Data & Resource Sharing

20042003 2007 20142008

NIH Model Organism

Policy

NIH Genome-wide Association

(GWAS) Policy

2012

NIH Public Access Policy

(Publications)

Big Data to Knowledge

(BD2K) Initiative NIH Genomic Data Sharing (GDS)

Policy

White House Initiative

(“OSTP Memo”) Increasing Access

Results Fed-Funded Sci Research

2015 2017

NIH Public Access Plan

NIH Data Sharing Policy

Modernization of NIH Clinical Trials

Request for Information (RFI) on Data

Sharing

NIH Data Commons

Pilot

2016

Cancer Moonshot

2013

NLM Strategic Plan

NIH Data Science Strategic

Plan

2018

RFI on Policy Provisions for Data Management

and Sharing

HHS Rule and NIH Policy on Clinical Trial Results

Dissemination NIH New Models for Data Stewardship and

STRIDES Initiative

21st Century Cures Act

NIH All of Us Research Program

Precision Medicine Initiative

Adapted from NIH Office of Science Policy

NIH Genomic Data Sharing Policy Sets forth expectations and responsibilities to

ensure the timely, broad, and responsible sharing and use of genomic data from NIH funded research Study descriptions publicly available via dbGaP Access to human data (de-identified) is based on

informed consent of study participants Controlled-access: individual-level genomic and

phenotypic data (requires an application and approval by a Data Access Committee)

Unrestricted-access: Genomic summary results (for most studies) under a new data management update

Users agree to terms of use and security practices 1,145 studies available; 48,587 Data Access

Requests approved (cumulative) 2,000+ publications resulting from re-use of

dbGaP data

Clinical Trial Data Sharing Enhance transparency into NIH-funded

and other clinical trials Registration of study objectives,

design, etc. at ClinicalTrials.gov Summary results of clinical trial and

participant characteristics No participant level data Link to related information – possibly

participant level data Full study protocol 300,000+ registered studies; 37,000

summary results; 116,000 users/day

NIH Data Management and Sharing PolicyNIH Seeks Public Comment on Proposed Provisions for a Future Draft Data Management and Sharing Policy

Lessons Learned and Take-away Messages1. Considerable value from enhancing access to (biomedical) data

• Accelerates and improves science• Builds trust in the research enterprise

2. Sharing not binary (yes/no) – Effective models exist for sharing data while providing necessary protections, e.g., • Summary statistics from clinical trials, genomics research• Controlled access to deidentified participant level data

3. Consistency with informed consent of great importance4. Technology and policy go hand-in-hand

6