Vanderbilt Institute for Clinical and Translational Research (VICTR)

"Upcoming Changes to the NIH Public Access Policy: Be

informed, Be prepared"Melissa Stamm, PhDInformation Scientist

Knowledge Management

Clint Brown, MBA, CRADirector

Office of Sponsored Programs

Tara Helmer, MPH, PA-CResearch Services Consultant II

Research Support ServicesPresentation sponsored by: Knowledge Management,

Eskind Biomedical LibraryOffice of Sponsored Programs, and Research Support

Services

M E L I S S A S TA M M , P H . D.I N F O R M AT I O N S C I E N T I S T

K N O W L E D G E M A N A G E M E N TE S K I N D B I O M E D I C A L L I B R A R Y

A P R I L 2 0 1 3

NIH PUBLIC ACCESS POLICY TIPS FOR COMPLIANCE

NIH PUBLIC ACCESS POLICY

• Who is affected? • What is the policy? What to submit?• When to submit? When to make public?• Where to submit publications?• Why does this policy exist?• How to submit (or ensure submission)

BACKGROUND

• Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008):

“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”

Who

What

Where

When

WHY DOES THIS POLICY EXIST?

• ARCHIVE• To create a central collection of NIH-funded research publications to

preserve vital published research findings

• ADVANCE• To provide an information resource for scientists to research publications

and for NIH to manage better its entire research investment

• ACCESS• To make research publications resulting from NIH-funded research

available to the public

PUBLIC EXPECTATION

• Meets the public’s expectation that articles based on NIH-funded research are publicly available1.

“In an online survey of 2,501 U.S. adults, more than 80% of Americans say they agree strongly or somewhat that research should be available for free via the Internet because the research is paid for with U.S. tax dollars.

1. Harris Poll (2006) Most Americans back online access to federally funded research. Wall Street J Online Retrieved on July 20, 2006, from http://online.wsj.com/article_email/SB114893698047965609-IMyQjAxMDE2NDM4MTkzMzE2Wj.html.

PUBLIC ACCESS POLICIES

• NIH policy – currently in effect

• Other agencies may be following: • Fair Access to Science and Technology Research (FASTR) bill

• Introduced on Feb. 13, 2013 in U.S. House and Senate• Mandates actions similar to the NIH Public Access Policy for other agencies:

• Dept of Defense• Dept of Agriculture• Dept of Energy• National Science Foundation

WHY NOW?

• Policy was effective April 7, 2008

• Non-compliance could result in loss of or delay of funding• For non-competing continuation grant awards with a start

date of July 1, 2013 or beyond:

• NIH will delay processing of an award if publications arising from it are not in compliance

• Investigators will need to use My NCBI to enter papers onto progress reports. Papers can be associated electronically using the RPPR, or included in the PHS 2590 using the My NCBI generated PDF report

WHO IS RESPONSIBLE?

• Each principal investigator and institution is responsible for ensuring that the terms and conditions of their award are met

• Compliance is mandatory!

BUT MY ARTICLE IS ALREADY IN PUBMED…RIGHT?

• PubMed and PubMed Central (PMC) are different entities

• PubMed: bibliographic database containing journal citations, abstracts, links to publisher sites• Unique identifier: PMID• Use to access MyNCBI account

• PMC: free archive of biomedical literature, containing full-text, peer-reviewed journal articles• Unique identifier: PMCID• THIS is where your publication should be deposited

OVERVIEW: STEPS TO COMPLIANCE

1. Determine applicability2. Address copyright3. Submit (or ensure submission) to PMC

• 4 different methods4. Provide evidence of compliance (PMCID) when

citing the work in any proposals or reports

1. DETERMINE APPLICABILITY

• Any manuscript that is: +Peer-reviewed+Accepted for publication in a journal on or after April 7,

2008+Arises from

• Any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008 or beyond, or;

• Any direct funding from an NIH contract signed on or after April 7, 2008, or;

• Any direct funding from the NIH Intramural Program, or; • An NIH employee.

2. ADDRESS COPYRIGHT

• Check journal/publisher’s “For Authors” section Example: From Science’s “General Information for Authors” section:

Access policies … For research papers created under grants for which the authors are required by their funding agencies to make their research results publicly available, Science allows* posting of the accepted version of the paper to the funding body's archive or designated repository (such as PubMed Central) six months after publication, provided that a link to the final version published in Science is included. (Details on this can be found in the license agreement for authors.) …

*Just because their policy allows posting, does not mean the journal will automatically do it for you

• Vanderbilt researchers can use form with standard language:• NIH Public Access Policy Amendment

to Publication Agreement• https://www.mc.vanderbilt.edu/km/

nih/docs/NIH_Amendment_to_publication_agreement.pdf

• Submit this form at time of manuscript submission

2. ADDRESS COPYRIGHT

SUBMISSION METHODS OVERVIEW

• Method A: Journal deposits all NIH-funded final published articles in PMC without author involvement.• Example: PNAS

• Method B: Publisher will deposit (for a fee) a specific final published article in PMC.• Example: Springer OpenChoice (US$ 3000/EUR 2200; excl. VAT).

• Method C: Author/delegate deposits final peer-reviewed manuscript in PMC via the NIHMS. • Example: JAMA – 6 month embargo

• Method D: Publisher deposits final peer-reviewed manuscript via NIHMS, but author completes the submission process • Example: New England Journal of Medicine.

SUBMISSION METHODSMethod A Method B Method C Method D

Version of paper submitted

Final Published Article

Final Published Article

Final Peer-Reviewed Manuscript

Final Peer-Reviewed Manuscript

Who starts the deposit process?

Publisher Publisher Author or designee, via NIHMS

Publisher

Who approves paper for processing?

Publisher Publisher Author, via NIHMS Author, via NIHMS

Who approves paper for PMC display?

Publisher Publisher Author, via NIHMS Author, via NIHMS

Who is responsible?

NIH Awardee NIH Awardee NIH Awardee NIH Awardee

To cite, from acceptance to 3 months after publication

PMCID or “PMC Journal- In Process”

PMCID or “PMC Journal- In Process”

PMCID or NIHMSID PMCID or NIHMSID

3. HOW TO SUBMIT TO NIHMS

• Determine the method of submission• Use NIH journal tool at http://publicaccess.nih.gov/ to find your

journal/publisher

• If not found:• Check the link on the NIH Public Access page for journals using other

submission methods: http://publicaccess.nih.gov/select_deposit_publishers.htm

• Check journal/publisher website in “For Authors” section

http://publicaccess.nih.gov/select_deposit_publishers.htm#d

Publishers that Will Deposit a Specific Paper in PubMed Central on Request

• Example: Springer Publishing/Springer OpenChoice

…If you choose to publish your article as open access within the Springer Open Choice program, Springer deposits the final published version of your article into PubMed Central and it is made publicly accessible. The copyright will remain with you and the article will be published under the Creative Commons Attribution License. The cost of Springer Open Choice (USD 3000/ EUR 2200) is – as stated on the NIH web site – a permissible cost in your grant.

If you choose to publish your article with the traditional subscription based model (without open access), you can notify Springer to deposit the author’s accepted version of your article into the NIH Manuscript Submission System, from where it will be sent to PubMed Central and made publicly available 12 months after publication…

***"Authors may self-archive the author’s accepted manuscript of their articles on their own websites. Authors may also deposit this version of the article in any repository, provided it is only made publicly available 12 months after official publication or later. He/ she may not use the publisher's version (the final article), which is posted on SpringerLink and other Springer websites, for the purpose of self-archiving or deposit…

Method B

Method D

Method C

WHEN TO SUBMIT

• Submit upon acceptance for publication

• NOT the same as the delay/embargo period of 12 months• Manuscripts “must be accessible in PubMed Central no later than 12

months after publication”• Check journal info for delay period

WHAT TO SUBMIT- ‘METHOD C’

• Final Peer-Reviewed Manuscript• Author’s final manuscript accepted for publication• Includes all revisions from peer review process• TIP: create a file labeled “FINAL PEER-REVIEWED MANUSCRIPT” or

similar so you can easily identify the appropriate file to upload

• Files/information to have ready:• Manuscript body (Word document/pdf)• Figure/image files (if separate)• NIH grant numbers funding the work

• NOT the “final published article” • Version that appears in journal after copyediting, formatting, etc

NIHMS system • http://www.nihms.nih.gov/

• Each Login route has its own NIHMS account• Submitters must continue to use the same login method for

subsequent visits to NIHMS.

HOW TO SUBMIT- ‘METHOD C’

1. Deposit Manuscript Files and Link to NIH Funding• Can be done by author or delegate• NIHMSID created and sent to the submitter

2. Authors give permission to NIH to Process the Manuscript • Authors confirm copyright or permission, and specify delay period (from

journal/publisher’s website)• The NIHMS will contact the author if necessary.

3. Authors approve the PMC-formatted Manuscript for Public Display• Can only be done by an author.

Once submission is complete, the NIHMS emails the author and all PIs the citation with the PMCID

HOW TO SUBMIT – ‘METHOD D’

1. Publishers start the deposit process• Publishers pick the files, designate the delay period, and identify the

corresponding author.

2. The NIHMS contacts the corresponding author • Author receives the NIHMSID, identifies NIH awards.

3. Authors approve the PMC-formatted Manuscript for Public Display

Once submission is complete, the NIHMS emails the author and all PIs the citation with the PMCID

CHECK YOUR EMAIL!

MANUSCRIPT SUBMISSION ASSISTANCE

• User-friendly NIH tutorials are available to guide researchers in the manuscript submission process

• Submitting an Article to PubMedCentral• Approving Submission of an Article to PubMed Central

• Eskind Biomedical Library also provides a service to provide guidance on article submission procedures or train research assistants and investigators to deposit articles

4. EVIDENCE OF COMPLIANCE

• When citing your articles in NIH applications, proposals, and progress reports, include the PMCID at the end of the full citation. • This requirement only applies to articles that fall under the policy and

are authored or co-authored by you or arose from your NIH award.

ExampleVarmus H, Klausner R, Zerhouni E, Acharya T, Daar A, Singer P. 2003. PUBLIC

HEALTH: Grand Challenges in Global Health. Science 302(5644): 398–399. PMCID: PMC243493

• If a PMCID is not yet available, include the NIH Manuscript Submission system reference number (NIHMS ID) instead.

SUMMARY

• Compliance is MANDATORY!• July 1, 2013: Funding could be delayed or lost • Who is responsible? You/your institution

• Determining applicability• Ensuring copyright• Submitting (or ensuring submission)• Proper citation with PMCID• Monitoring compliance (next)

HELPFUL NIH LINKS

• NIH Public Access website• Main: http://publicaccess.nih.gov• Tutorials/help: http://publicaccess.nih.gov/communications.htm• FAQs: : http://publicaccess.nih.gov/FAQ.htm

• NIH Manuscript Submission (NIHMS) System• Main: http://www.nihms.nih.gov/• Tutorials/help: http://www.nihms.nih.gov/web-help/

• PubMed Central • Main: http://www.pubmedcentral.nih.gov

• My Bibliography feature of My NCBI • Main: http://www.ncbi.nlm.nih.gov/sites/myncbi/

• Contact NIH: PublicAccess@nih.gov

FOR FURTHER ASSISTANCE

Eskind Biomedical Library: http://www.mc.vanderbilt.edu/diglib/

VICTR: https://starbrite.vanderbilt.edu/research/manuscriptwriting.html

NEXT: MONITORING COMPLIANCE

• Monitoring Compliance: Internal and External Resources• Tara Helmer, MPH, PA-C, Research Support Services

• How Vanderbilt can help • Clint Brown, MBA, CRA, Office of Sponsored Programs

VICTR Resources to assist with NIH Public Access Compliance (NIH PAC)

• Regularly scheduled NIH PAC ‘clinics’ (starting May 2013)

• Voluntary registration for Triggers/Notifications

(Details for both will be posted on StarBRITE as they become available)

• Research Support Services hotline: 615-322-7343

• Ask a question through StarBRITE

VICTR Resources to assist with NIH Public Access Compliance (NIH PAC)

Monitoring Compliance

Do a quick PubMed search.

Free PMC Article = PMCID =

No Free PMC Article + 3 months post publication =

2. Search PubMed then SAVE the search with My NCBI - a tool integrated with PubMed to track literature searches and public access compliance.

Monitoring Compliance

• To Save Search you must sign into NCBI• Sign in with an eRA Commons username

and password, if available (green circle) • Create/Sign in with an NCBI username

and password (red circle)

1. Give your search a name

2. Click Save

3. Choose whether you want e-mail updates of new search results

4. Click Save

Once you sign into NCBI

Send your search results to My Bibliography

Monitoring Compliance

Click My Bibliography →Display Settings → Award → See visual clues

Monitoring Compliance

3. Voluntarily register for triggers/notifications through VICTR– Register your grant number and receive triggers as soon as

a publication becomes noncompliant (No PMCID 3 months post publication)

– A proxy can register a grant on behalf of a PI (but final registration must be approved by PI)

– Details will be posted on StarBRITE

Monitoring Compliance

Notification System Registration Frequency of Trigger

Compliance Monitoring

My NCBI (new pubs related to a saved search)

Voluntary One time notification

Proactive (Publication still compliant)

VICTR (noncompliant pubs that cited a registered grant)

Voluntary Variable but continuous until publication is compliant

Reactive (Publication noncompliant when you receive 1st notification)

Office of Sponsored Programs (noncompliant pubs that cited a registered grant)

Automatic* Up to two times † Safety Net (Publication noncompliant & notification related to APR)

*if you have noncompliant publications

† 120 days prior to budget period end date and after submission of annual progress report (APR) 45-60 days prior to budget period end date

Comparison of Notification Systems

Compliance should be ongoing!!!

APR Due Date

The Public Access Compliance Monitor (limited to Administrators with PACR role in eRA Commons); a web-based tool that institutions can use to track compliance of publications that fall under the NIH Public Access Policy.

Public Access Compliance Monitor Login Website: http://www.pubmedcentral.nih.gov/utils/pacm/

Compliance Monitor User Guide: http://www.pubmedcentral.nih.gov/utils/pacm/static/pacm-user-guide.pdf

Monitoring Compliance

Institution Summary

• The Institution Summary gives a snapshot of overall compliance during a selected date range

• Click on the Compliant, Non-Compliant, or In Process number to view details about the articles that are in each of these three states

• Results can be downloaded as a CSV file to allow for easy sorting by PI or grant number

• Office of Sponsored Programs (OSP) “non-compliant” email notifications to Faculty and Administrators:– 120 days prior to budget period end date– After submission of annual progress report (APR) 45-60

days prior to budget period end date

Monitoring Compliance

Take-Home Points

• Think about Public Access Compliance before you submit a manuscript for publication

• Determine which submission method applies (meaning who will submit the manuscript – you or the journal)– If you are submitting do so as soon as it is accepted for

publication

• If a publication is non-compliant it is never too late to make it compliant

• Utilize the resources available

• Ask for help if you are unsure