This document discusses requirements for publicly available data from a presentation on data management. It outlines the US government's open data policy which instructs agencies to release data to the public whenever possible. It also discusses NIH requirements and plans for open data, including developing data management plans, peer reviewing plans, making data discoverable and citable, and archiving data in public repositories by the end of 2015. Helpful library resources for data management and plans are also provided.

1. REQUIREMENTS FOR
PUBLICLY AVAILABLE DATA
Data Management Webinar
Presented by:
Clara Fowler
Research Services & Assessment Manager
Research Medical Library, MD Anderson Cancer Center

2. "Open Science - Prinzipien" by Andreas E. Neuhold - Own work. Licensed under CC BY 3.0 via Commons -
https://commons.wikimedia.org/wiki/File:Open_Science_-_Prinzipien.png#/media/File:Open_Science_-_Prinzipien.png

3. PROJECT OPEN DATA
Open government data
means whatever data is
released is done so in a
specific way to allow the
public access without having
to pay fees or be unfairly
restricted in its use.
U.S. Government Open Data
Policy instructs agencies to
manage their data, and
information more generally, as
an asset from the start and,
wherever possible, release it to
the public in a way that
makes it open, discoverable,
and usable.http://opensource.com/government/10/12/what-%22open-data%22-means-
%E2%80%93-and-what-it-doesn%E2%80%99t
https://project-open-data.cio.gov/

4. OPEN FEDERAL HEALTH DATA

5. OPEN DATA POLICY AND SCIENTIFIC
RESEARCH GRANTS
 “It is likely that some agencies will begin providing additional
guidance with respect to managing digital scientific data
created under investigator-initiated grants as part of their
response to the Office of Science and
Technology’s Memorandum on Increasing Public Access to the
Results of Federally Funded Research.”

6. FEDERAL FUNDS AT MD ANDERSON
Based on August 2015 search of grants.gov to identify allocated funds in 2015.

7. FEBRUARY 2013
White House Office of Science and
Technology Policy (OSTP) releases a
memo
Subject: Increasing Access to the
Results of Federally Funded Scientific
Research
Requires all federal agencies create
plans to ensure that peer-reviewed
publications and digital scientific
data resulting from federally-funded
scientific research are accessible to
the public, the scientific community,
and to industry.

8. FEBRUARY 2015
NIH Responds with:
Plan for Increasing Access to
Scientific Publication and
Digital Scientific Data from NIH
Funded Scientific Research

9. CURRENT NIH REQUIREMENTS,
EXPECTATIONS, AND RECOMMENDATIONS
FOR DATA SHARING
1. Required to register clinical trials at clinicaltrials.gov and submit summary
results (only applies to certain clinical trials of drugs and medical devices)
2. Recommend that all clinical trials register at clinicaltrials.gov
3. Expects applicants receiving more than $500K in direct costs to submit a
data sharing plan or explain why data sharing is not possible
4. Required that research data must be retained for 3 years (OMB Circular A-
110)
5. Expects researchers receiving NIH funding for genomic research to develop
a data sharing plan and to submit data to a central depository to facilitate
sharing

10. NIH PLANS FOR DATA SHARING
CLINICAL DATA
“Clinical trials registration information and results informs future research and
improves study design, prevents duplication of unsafe trials, and enhances
transparency for increased public trust in clinical research.”
1. Promote registration and submission of results of all NIH-funded clinical trials
2. Develop policies to make the data underlying the conclusions of peer-
reviewed scientific research publications will be made freely available and
searchable in public repositories

11. Key:
ICMJE: Indicates when the
International Committee of
Medical Journal Editors
began requiring trial
registration as a condition of
publication (September
2005)
FDAAA: Indicates when the
expanded registration
requirements of FDAAA
began and were
implemented on
ClinicalTrials.gov (December
2007)

13. NIH PLANS FOR DATA SHARING
DATA MANAGEMENT PLANS
All NIH-funded researcher will develop data
management plans including:
1. A commitment to share data, at a minimum
the data underlying any publications
2. Description of the data to be produced and
the metadata standards used to describe the
data
3. Description of how data will be shared,
provisions for the reuse of data, and timelines
for public access of data
4. Provisions for protecting privacy,
confidentiality, data security, and intellectual
property
http://www.dlib.indiana.edu/~jenlrile/metadatamap/

14. NIH PLANS FOR DATA SHARING
PEER REVIEW OF DATA MANAGEMENT
PLANS
 NIH will ensure that the merits of digital
data management plans are
considered during the peer review
process for extramural research grants
and contracts.
 NIH will review progress reports for
data management plan adherence
http://blogs.warwick.ac.uk/rex23phd11/entry/thing_14_the/

15. NIH PLANS FOR DATA SHARING
DATA DISCOVERABILITY, CITING, AND
ARCHIVING
 Discoverability enhanced by creating a citable unique identifier (much like the
PMCID for articles)
 NIH will expect researchers to deposit data in a publicly-accessible NIH repository
before considering other means of making data available.
 Enhancements will be made to existing repositories to minimize submission burden,
accommodate additional data, and support interoperability
 Additional repositories will be created

16. http://blogs.nature.com/scientificdata/2013/07/23/scientific-data-to-complement-and-promote-public-data-repositories/
Publicly available scientific data is located in many different repositories

17. NIH PLANS FOR DATA SHARING
TIMELINE FOR CHANGES
Deadline for changes is by the end of 2015.

18. https://dmptool.org/video

19. HELPFUL RESOURCES FROM THE LIBRARY
 Consultations with librarians regarding metadata, data
management plans, or data repositories
 Data Management Guide:
http://mdanderson.libguides.com/datamanagement

20. QUESTIONS?
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Text: 281-369-4872
Twitter: @MDAndersonLib
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Email: rml-help@mdanderson.org