Summary of the requirements for compliance with the new public access plans from US federal agencies under the Office of Science and Technology Memo. This talk was presented to the Research Administration & Compliance group at VCU.
Many thanks to Rebecca Reznik-Zellen for the HHS slides that were developed for the eScience Symposium.
Thanks to Amanda Lea Whitmire for her one memo to rule them all slide.
3. NIH Public Access Policy
• SEC. 218. The Director of the National Institutes of Health shall require
that all investigators funded by the NIH submit or have submitted for them
to the National Library of Medicine’s PubMed Central an electronic version
of their final peer-reviewed manuscripts upon acceptance for publication,
to be made publicly available no later than 12 months after the official
date of publication: Provided, That the NIH shall implement the public
access policy in a manner consistent with copyright law.
https://publicaccess.nih.gov/
4. NIH Data Sharing Policy
The Final NIH Statement on Sharing Research Data was published
in the NIH Guide on February 26, 2003. This is an extension of
NIH policy on sharing research resources, and reaffirms NIH
support for the concept of data sharing. The new policy
becomes effective with the October 1, 2003 receipt date for
applications or proposals to NIH.
• Applications seeking $500K or more in direct costs in any
single year of the project period, or
• As a special requirement of a Funding Opportunity
Announcement (FOA)
• Applies to the sharing of Final Research Data for applications
submitted on or after October 1, 2003
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm
5. NIH Genomic Data Sharing Policy
“Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies (GWAS) (effective January 2015)
“The NIH is interested in advancing genome-wide association studies (GWAS) to
identify common genetic factors that influence health and disease. For the purposes
of this policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the presence
or absence of a disease or condition.”
• Applies to all NIH-funded research that generates large-scale human or non-
human genomic data, as well as the use of those data for subsequent research.
• Requires “Genomic Data Sharing Plan”.
• Allows for expenses in project budget.
• Requires public availability of data in a “timely manner.”
• Recommends NIH-funded or third-party repositories for deposition.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html
6. NSF Data Management Plan
NSF Data Sharing Policy
Investigators are expected to share with other researchers, at no more
than incremental cost and within a reasonable time, the primary data,
samples, physical collections and other supporting materials created
or gathered in the course of work under NSF grants. Grantees are
expected to encourage and facilitate such sharing. See Award & Administration
Guide (AAG) Chapter VI.D.4. http://www.nsf.gov/bfa/dias/policy/dmp.jsp
NSF Data Management Plan Requirements
Proposals submitted or due on or after January 18, 2011, must include
a supplementary document of no more than two pages labeled “Data
Management Plan”. This supplementary document should describe
how the proposal will conform to NSF policy on the dissemination and
sharing of research results. See Grant Proposal Guide (GPG) Chapter II.C.2.j for full policy
implementation. https://www.nsf.gov/eng/general/dmp.jsp
7.
8. OSTP Memorandum
Increasing Access to the Results of Federally Funded Scientific
Research -February 22, 2013
“ensuring that, … the direct results of federally funded scientific
research are made available to and useful for the public,
industry, and the scientific community. Such results include peer-
reviewed publications and digital data.”
“develop plans to make the results of federally-funded research
publically available free of charge within 12 months after
original publication.”
https://www.whitehouse.gov/blog/2013/02/22/expanding-public-access-results-federally-funded-research
9. FASTR
Fair Access to Science and Technology Research (FASTR) Act
FASTR calls for federal agencies with extramural research budgets in
excess of $100 million to establish consistent, permanent public
access policies for articles reporting on their funded research. This
means that articles reporting on the results of taxpayer-funded
research would be made available to the general public to freely
access and fully use. Embargo would be 6 months instead of 12.
FASTR would codify the February 22, 2013 White House Directive to
provide greater public access to taxpayer-funded research.
http://sparc.arl.org/news/2015-fastr-introduction
11. For all Grants: Check Author’s Rights
e.g. from DOD plan:
• Will be advised to work with the publisher
before any publication rights are transferred
to ensure that all conditions of the projected
DoD public access policy can be met.
• Will be advised not to sign any agreements
with publishers that do not allow the author
to comply with the projected DoD public
access initiative.
12. Department of Health and Human Services
Guiding Principles and Common Approach for Enhancing Public
Access to the Results of Research Funded by HHS Operating
Divisions (February 2015)
Provides continuity across Operating Divisions:
NIH, CDC, FDA, AHRQ, and ASPR (voluntary)
• PubMed Central will serve as the repository for
publications funded by HHS Operating Divisions
• HHS will enable stakeholders to petition to shorten the
12-month maximum embargo period for publications
• HHS will take a common, stepped approach to establishing
data policy and infrastructure: assessment, inventory,
DMPs, pilots, training
13. NIH – National Institutes of Health
Plan for Increasing Access to Scientific Publications and Digital
Scientific Data from NIH Funded Scientific Research
(February 2015)
• In effect for publications; policy changes to support data to be
implemented by December 2015
• Applies to research/researchers funded wholly or in part by
the NIH
14. NIH
Publications
• Peer-reviewed scientific articles
• Deposit of final peer-reviewed
manuscript into PMC
• Upon acceptance, with maximum
12-month embargo
• Include appropriate costs in
proposals
• Reporting through eRA Commons
and My NCBI
• Withholding of funds
Data
• Unclassified digital scientific
research data
• Submission of DMP; deposit of
data into appropriate, existing,
publicly accessible repositories,
including NIH data repositories
• Upon acceptance for publication
(will explore)
• Include appropriate costs in
proposals
• Utilize existing reporting
structures
• “enforcement actions” including
withholding of funds
15. CDC – Centers for Disease Control and Prevention
CDC Plan for Increasing Access to Scientific Publications and
Digital Scientific Data Generated with CDC Funding
(January 2015)
• In effect for publications; October 2015 (FY 2016 funding
cycle) for data
• Applies to research/researchers funded by the CDC (intra- and
extramural)
• CDC Stacks http://stacks.cdc.gov/ for public health
information
16. CDC
Publications
• Peer-reviewed research
publications
• Deposit of final peer-reviewed
manuscript into NIHMS (CDS
Stacks, PMC)
• Upon acceptance, with maximum
12-month embargo
• eClearance scientific clearance
system; existing reporting
structures (Office of Science
Quality)
Data
• Unclassified digital scientific
research data
• Submission of DMP (generic CDC
template); deposit of data into
suitable platform (tbd)
• Upon acceptance for publication
or within 30 months of collection
• Include appropriate costs in
proposals
• Utilize existing reporting
structures
• Reduction or restriction of funds,
award termination, negative
influence on future awards
17. FDA – Food and Drug Administration
Plan to Increase Access to Results of FDA-Funded
Scientific Research (February 2015)
• Effective October 2015
• Applies to research/researchers funded wholly or
in part by the FDA (intra- and extramural)
https://open.fda.gov/ open-source APIs (application
program interface)
18. FDA
Publications
• Peer-reviewed scientific
articles
• Deposit of final peer-reviewed
manuscript into PMC
• With maximum 12-month
embargo*
• Include appropriate costs in
proposals
• Utilize existing reporting
structures
• Termination of contract or
grant; withholding of funds
Data
• Digitally formatted scientific
data resulting from
unclassified research
• Submission of DMP; deposit of
data into discipline-specific
repositories
• Upon acceptance for
publication
• Include appropriate costs in
proposals
• Utilize existing reporting
structures
• Termination of contract or
grant; withholding of funds
19. AHRQ – Agency for Healthcare
Research and Quality
AHRQ Public Access to Federally Funded Research
(February 2015)
• Effective February 2015 for publications; October
2015 for data
• Applies to all research/researchers funded wholly or
in part by AHRQ (Intramural, extramural, or contract
researchers)
20. AHRQ
Publications
• Peer-reviewed scholarly
research articles
• Deposit of final peer-
reviewed manuscript into
PMC
• Maximum 12-month
embargo*
• Include appropriate costs in
proposals and applications
• Utilize existing reporting
structures (NIH)
• Withholding of funding
Data
• Unclassified research dataˡ
• Submission of DMP; deposit
of data to AHRQ▪ or other
repository
• Upon acceptance for
publication
• Include appropriate costs in
proposals and applications
• Utilize existing reporting
structures
• Negative influence on
future funding
21. ASPR – Assistant Secretary for
Preparedness and Response
Public Access to Federally Funded Research:
Publications and Data (February 2015)
• Effective October 2015
• Applies to Researchers funded wholly or in part by
ASPR
22. ASPR
Publications
• Peer-reviewed scholarly
research articles
• Deposit of final peer-reviewed
manuscript into PMC
• Maximum 12-month
embargo*
• Appropriate costs included in
proposals and applications
• Existing reporting structures
(NIH)
• Withholding of funding
Data
• Digital scientific dataˡ
• Submission of DMP; deposit of
data to recognized scientific
repository
• 30 months from creation of
data set, or upon publication
• Appropriate costs included in
proposals and applications
• Staff and peer review; existing
reporting structures
• Negative influence on future
funding
23. DOD
• Plan
• SPARC overview http://sparc.arl.org/blog/dod-releases-draft-public-
access-plan
• Starting FY 2015
• Completed 4th quarter FY 2106
• Allows for inclusion of costs in proposals
• Requirements: DMPs cover data sharing and data are available before
making subsequent awards
• Plan on compliance monitor and certification tokens
• Encourages authors to negotiate their copyright for papers
DTIC (Defense Technical Information Center): repository for full-text of peer-
reviewed author final manuscripts or publisher versions of research articles
and repository for metadata of digital scientific data sets.
24. DOD
Publications
• Peer-reviewed scholarly
publications arising from
unclassified, publicly releasable
research and programs.
• Deposit peer-reviewed scholarly
publications into DOD public
access archive system (DTIC)
• DOD will establish a system to
enable the submission of final,
peer-reviewed manuscripts.
• minimum 12 month embargo
Data
• Digitally formatted data arising
from unclassified, publicly
releasable research and
programs.
• Decentralized approach to data
storage.
• Require the submission of data
management plans.
• Allow for inclusion of costs for
data management and access.
• Will establish a system to enable
the identification, attribution,
(federated) storage, and access of
digital data.
25. DOE
• Public Access Plan
• Already started for Office of Science grants
• PAGES - a web-based portal that will provide free
public access to accepted peer-reviewed manuscripts
or published scientific journal articles within 12 months
of publication
• Data management plan requirements and guidance
• “unclassified and unrestricted”
• “Not all data need to be shared or preserved. The costs
and benefits of doing so should be considered in data
management planning.”
26. DOE
Publications
• Classified or protected data and
research will not be publicly
available.
• Public Access Gateway for Energy
and Science (PAGES) maintained
by Office of Scientific and
Technical Information (OSTI)
• Deposit abstract and metadata
and link to Version of Record
(publisher pdf, final MS in
repository, or DOE dark archive)
• within 12 months of publication
Data
• Office of Science started DMP
requirement in July 2014
(supports ⅔ of R&D)
• Other offices start Oct. 1, 2015
• DMP required and merits
evaluated.
• Covers unclassified and
unrestricted digital research data,
i.e. digital data required to
validate findings.
• Enterprise Data Inventory ->
Public Data Listing -> populates
data.gov
27. NSF
Plan – Starting January 2016
Public Access to Results of NSF-funded Research overview
SPARC Comments http://sparc.arl.org/blog/nsf-releases-incremental-plan-for-public-
access
“deposit final accepted manuscripts (or published articles) into the Department of
Energy’s “PAGES” repository – a dark archive – with public access to be provided via
links to publisher’s websites.”
“NSF plan will extend to papers published in “juried conference proceedings,” as well
as peer-reviewed journals, and the agency notes it intends to eventually include other
types of NSF-supported grey literature and educational materials under the final
policy”
“No indication of how the kinds of productive reuse (computation, text and data
mining etc.) set out by the White House Directive will be facilitated…”
28. NSF
Publications
• Working with DOE/OSTI to
create a version of PAGES for
NSF papers.(i.e. paper will
need to be available from
publisher or IR)
• Voluntary deposit will start
December 2015.
• Need persistent ID and
machine-readable metadata.
• No more than 12 month
embargo.
Data
• All proposals need 2 page
DMP that will be part of merit
review and be monitored.
• Data in appropriate repository,
metadata required.
• Funds available to prepare
data for sharing.
• Exploring data deposit at time
of paper publication.
• No time frame for
preservation
29. NASA
• Plan
• Started February 2015
• Completed by October 2015
• SPARC Overview http://sparc.arl.org/blog/nasa-public-access-plan-available-uses-
nihs-pmc-platform
“The analysis compared the merits of the NIH PubMed Central (PMC) database, the
DOE’s Public Access Gateway for Energy and Science (PAGES) system, and the
Clearinghouse for the Open Research of the United States (CHORUS) platform
proposed by the publishing industry. Ultimately, NASA opted to work with NIH’s PMC
database.” (SPARC emphasis!)
DMP FAQ ROSES (Research Opportunities in Space and Earth Science)
http://science.nasa.gov/researchers/sara/faqs/dmp-faq-roses/
“First of all, be reassured that we are not going to force you to reveal your precious
proprietary data prior to publication. No personal, proprietary or ITAR data is
included.”
30. NASA
Publications
• NIH PMC will provide a
NASA‐branded portal to the full
functionality of the PMC system.
• 12 month embargo. Publishers
can petition for longer.
• Publications cited in reports must
be in repository.
Data
• At a minimum required DMP for
ROSES must promise to release
the data needed to reproduce
figures, tables and other
representations in publications,
at time of publication or within
reasonable time period.
• Publication should provide link to
data.
• Only the data used to support,
validate, and corroborate
published research findings are
required to be shared, per this
plan. Preliminary data, trial data,
etc. are not included.
• NASA will develop a data catalog
31. Help is Available
Contact me for help with:
Data Management Plans for grants:
• DMPTool guide http://guides.library.vcu.edu/dmptool
• Consultation
• List of plans: http://guides.library.vcu.edu/data/USpubaccess
Training:
• Grant compliance for a faculty group
• Data management training for students
32. Thank you
Margaret Henderson, MLIS, AHIP
Associate Professor
Director, Research Data Management
VCU Libraries
Please contact me any time for help:
(804)628-2714
mehenderson@vcu.edu
I am available for consultations in your office or mine:
Room 146
Tompkins-McCaw Library for the Health Sciences
Virginia Commonwealth University
509 North 12th Street
Richmond, VA 23298
Editor's Notes
I have set up this slide deck so it provides you with an outline of what you need to know about the plans of the major US agencies, with links to the full regulations or plans if you need them.
I’m happy to answer any questions, or find an answer if I can’t. Please don’t hesitate to ask for help or refer people to me.
Recommended in 2004 by House Appropriations Committee, they recommended 6 month embargo, voluntary 2005 (per Peter Suber); mandatory requirement 2008; funding withheld 2013.
This policy took effect earlier than public access but it is limited to larger grants so it isn’t as well known. Policy requires Data Sharing Plan to describe how final research data will be shared, or explain why data sharing is not possible.
•Applies to any projects funded by NIH over 500K since 2003
As data sharing becomes the norm, there will be more an more policies to make sure privacy and other ethical concerns are taken into account.
Genomic Data Sharing Policy expands on previously implemented, long-standing policies to make data it funds publicly available in a timely manner.
Genome wide association studies (GWAS) had data sharing policies initially implemented in 2007.
No details on what should be in the genomic data sharing plan.
“... Whole genome information, when combined with clinical and other phenotype data, offers the potential for increased understanding of basic biological processes affecting human health, improvement in the prediction of disease and patient care, and ultimately the realization of the promise of personalized medicine. In addition, rapid advances in understanding the patterns of human genetic variation and maturing high-throughput, cost-effective methods for genotyping are providing powerful research tools for identifying genetic variants that contribute to health and disease.”
One Memo to Rule Them All
There is also a later Plan that requires agencies to make their scientific data collections open http://www.whitehouse.gov/blog/2014/06/02/ostp-s-own-open-government-plan
None of these are set in stone. Check the grant guides and award notifications for specifics.
For example, Anne Maglia, Program Director in the Biological Sciences Directorate of NSF, speaking at the NE eScience Symposium at the beginning of the month, told the group that the new NSF Awards and Administration Guide (NSF 16-1 – always the first publication of the year) will have specifics.
Also, check any rights when data is attached to a publication by the journal, or using journal recommended repository.
strategy for data policy development is “pragmatic” SPARC statement (March 2, 2015): assessment, inventory, DMPs, pilots, training; “setting a new default mode for research across the HHS”
HHS indicates it will provide the means for both the public and internal operating or staff divisions to petition for shorter embargo periods – particularly for articles resulting from funding initiatives that are considered to have important scientific, public health or societal value requiring rapid communication.
This is particularly important considering the variety of public health-related research conducted by the NIH, CDC, and FDA
“To the extent allowed by law, this Policy [NIH Public Access Policy] meets all the requirements of the OSTP Directive.” (p 4)
“NIH intends to make public access to digital scientific data the standard for all NIH-funded research.” -- “expanding its data sharing policy beyond current requirement…”
“This [policy] outlines current NIH policies, programs, and procedures that support the overall goals of the OSTP memorandum and identifies further steps that may be taken to fulfill these goals in a more comprehensive manner to ensure public access to digital scientific data.” (p 24)
“
data sharing plan and data management plan are different. Existing NIH policies establish expectations for data sharing (2007 FDA Amendment Act requiring applicable clinical trials to go to clinicaltrials.gov; 2003 NIH Data Sharing Policy; 2002 NIH Intramural Policy on large Database Sharing; 2014 NIH Genomic Data Sharing Policy; Grants Policy Statement requiring final progress reports to describe sharable data). DMP is modification to 2003 NIH Data Sharing Policy. Note that some funding mechanisms (training grants) may be exempted.
deposit to existing repositories “before considering other means of making data available.”
NIH will develop guidance for key elements to be included in a DMP; determining which data should be prioritized for preservation (6b); finding acceptable repositories not funded by NIH (8b);
NIH will expand its database of existing repositories for example NIH Data Science – The Commons http://datascience.nih.gov/commons (as per Philip Bourne)
In effect for publications per the Public Access to CDC Funded Publications Policy, which was issued in July 2013: http://www.cdc.gov/maso/Policy/policy596.pdf
Like the NIH, seeks to update and expand existing policies to comply with the objectives outlined in the OSTP memo.
funding for publications not mentioned in this policy; measures for failure to comply for publications not mentioned in this policy
Section C discusses the data covered, following the OMB-A110 definition and including microarray and aggregated data, quantitative measurements, survey and interview data, observational data, environmental data (p 18), and the data exempted;
CDC determines what is research or non-research data;
DMP will be assessed during proposal review and quality may affect scores -- DMP is aggregate of the Resource Sharing Plan and the Translation Plans sections of FOA/NOA;
CDC will develop an online data registry via DMP templates
FDA Transparency Initiative: Increasing Public Access to FDA's Compliance and Enforcement Data
currently focused on datasets in the following areas:
Adverse events. FDA’s publically available drug adverse event and medication error reports, and medical device adverse event reports.
Recalls. Enforcement report data, containing information gathered from public notices about certain recalls of FDA-regulated products.
Labeling. Structured Product Labeling (SPL) data for FDA-regulated human prescription drug, OTC drug and biological product labeling.
SPARC notes emphasis on roles and responsiblities in policy, as well as scope - which defines what they consider to be data.
SPARC notes emphasis on roles and responsiblities in policy, as well as scope - which defines what they consider to be data.
*embargo will be subject to the HHS petition process
ˡ OMB Circular A-110 definition of data; scope statement (§2) identifies field, lab, and other data as specifically in scope, making other kinds of data such as models and code conditionally appropriate upon context, and other kinds out of scope (PII, proprietary, critical infrastructure, public use data).
▪ AHRQ will contract to develop a commercial repository and develop a data discovery index.
IRs would not be sufficient for publications; IRs may be used as “publicly accessible database,” but not mentioned in policy document.
Overview from SPARC
Overview from Scholarly Kitchen