data management federal requirements 9 2015

REQUIREMENTS FOR PUBLICLY AVAILABLE DATAData Management Webinar

Presented by: Clara FowlerResearch Services & Assessment ManagerResearch Medical Library, MD Anderson Cancer Center

"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

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/

OPEN FEDERAL HEALTH DATA

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.”

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

FEBRUARY 2013White House Office of Science and Technology Policy (OSTP) releases a memoSubject: 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.

FEBRUARY 2015NIH Responds with:

Plan for Increasing Access to Scientific Publication and Digital Scientific Data from NIH Funded Scientific Research

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.gov3. Expects applicants receiving more than $500K in direct costs to submit a

data sharing plan or explain why data sharing is not possible4. 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

NIH PLANS FOR DATA SHARINGCLINICAL 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

trials2. 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

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)

NIH PLANS FOR DATA SHARINGDATA MANAGEMENT PLANSAll NIH-funded researcher will develop data management plans including:1. A commitment to share data, at a minimum

the data underlying any publications2. 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/

NIH PLANS FOR DATA SHARINGPEER 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/

NIH PLANS FOR DATA SHARINGDATA 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

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

NIH PLANS FOR DATA SHARINGTIMELINE FOR CHANGES

Deadline for changes is by the end of 2015.

https://dmptool.org/video

HELPFUL RESOURCES FROM THE LIBRARY

Consultations with librarians regarding metadata, data management plans, or data repositories

Data Management Guide: http://mdanderson.libguides.com/datamanagement

QUESTIONS?Use the chat box to ask questions now.

To ask questions later:Call: 713-792-2282Text: 281-369-4872Twitter: @MDAndersonLibVisit: Pickens Floor21Email: rml-help@mdanderson.org