Open Access, Federal Public Access & Biosketch Policies, NIH Compliance Tools & You

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Facilitator: Mary Whitemw@unc.edu March 30, 2016

Take Home Point

• Importance of Journal Articles• Open Access vs. Public Access• Other Federal Public Access Policies• Whys, Hows & Goals of NIH Public Access Policy• NIH PAP How To Comply: The Steps• NIH Biosketch How To Comply: The Steps• How To Comply: The NIH Toolset• Finding More Information

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Overview

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Journals & Articles:Public Access vs. Open Access

What Do We Want?Journal Articles!

Journal Articles: Why?• Literature Review…

Making Sense of What Others Have Discovered…

• Publishing Articles…Sharing What They’ve Discovered…Publish or Perish

• Knowledge Building & Filling Gaps

Journal Articles: How?• Traditional Publishing Model

• Open Access: A Publishing Model that Makes Articles More Highly Available/Accessible

• NIH Public Access: A Federal Policy that Makes Articles More Highly Available

Open Access

Equitable Access to Research Author’s Rights

Promote Author Work & Show Impact

Wide DistributionOf Research

Publishing Model: Open Access

Open Access Overview• https://youtu.be/L5rVH1KGBCY • What is open access? Nick Shockey and

Jonathan Eisen take us through the world of open access publishing and explain just what it's all about.

Open Access Overview• https://

www.youtube.com/watch?v=o2HMouOV-Lg• Brief overview of Open Access from Wiley

(Publisher)

HSL Guides:http://guides.lib.unc.edu/measureimpact

http://guides.lib.unc.edu/open-access-and-scholarly-communications

NIH Public Access

National Institutes of Health

Policy: NIH Public Access• The National Institutes of Health (NIH) Public

Access Policy requires that all peer-reviewed publications arising from NIH-funded research must be submitted to the digital archive PubMed Central upon acceptance for publication. The Policy requires that these papers are accessible to the public in PubMed Central no later than 12 months after publication.

• The full policy can be found here:http://publicaccess.nih.gov/policy.htm

Why: NIH Public Access

• Who funds the NIH?

Relevance: No NIH $$$ ?

• Accessibility of Publications!

What is the Difference?The Public Access Policy ensures that the public has access to the peer-reviewed and published results of all NIH-funded research through PubMed Central (PMC). United States and/or foreign copyright laws protect most of the papers in PMC; PMC provides access to them at no cost, much like a library does, under the principles of Fair Use.

Generally, the Open Access Model involves the use of a copyrighted document under a Creative Commons or similar license-type agreement that allows more liberal use (including redistribution) than the traditional principles of Fair Use. Only a subset of the papers in PMC are available under such Open Access provisions. See the PMC Copyright page, http://www.ncbi.nlm.nih.gov/pmc/about/copyright.html, for more information.

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Federal Public Access Policy Compliance Issues & Steps

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Other Federal Public Access Policies• On February 22, 2013, the Director of the White House

Office of Science and Technology Policy (OSTP), Dr. John Holdren, issued a memorandum to all agency and department heads entitled, “Increasing Access to the Results of Federally Funded Scientific Research.” The memo directed federal agencies with more than $100 million in annual conduct of research and development to develop plans for increasing public access to peer-reviewed scientific publications and digital data resulting from federally funded research investments.

• More information at:http://www.whitehouse.gov/administration/eop/ostp/library/publicaccesspolicy

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Other Federal Public Access Policies• Be on the look out for:– Other Federal Agencies Public Access Policies for

publications and data: AHRQ, ASPR, CDC, DOD, DOE, FDA, NIST, NASA, NOAA, NSF, USDA, USGS, VA…

– Other Agencies releasing new or updated policies: USAID, NIH

– Clarification & Explanation of Policies and Implementation

• More Information:– White House Office of Science and Technology Policy

http://www.whitehouse.gov/administration/eop/ostp/library/publicaccesspolicy

– Dept of Health and Human Services Open Governmenthttp://www.hhs.gov/open/public-access/index.html 25

Why & How: NIH Public AccessTwo changes to compliance with the NIH Public Access Policy went into effect as of July 1, 2013:

• Why: The NIH will delay processing of an award if publications arising from it are not in compliance with the NIH public access policy.

• How/The Tool: Investigators must use My NCBI to enter publications into progress reports.

See NIH Notice NOT-OD-13-042 for more details: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-042.html

From: era-notify@mail.nih.gov [mailto:era-notify@mail.nih.gov] Sent: Thursday, February 11, 2016 3:13 PMTo: Cc: Cyr, Robin L; UNC SOM Sponsored Programs; mshea@niaid.nih.gov; TWeRANotifications@mail.nih.gov; barbara.sina@nih.govSubject: eRA Commons: RPPR for Grant 5R25XXXXX-12 Submitted to NIH with a Non-Compliance warning*** This is an automated notification - Please do not reply to this message. ***

Dear Grantee,

The progress report for the above-reference award includes citation(s) that are out of compliance with the NIH Public Access Policy. Compliance with the NIH Public

Access Policy is a legal requirement and a term and condition of all NIH awards. This award will be delayed until all publications arising from it are in compliance with the policy. The Authorized Organization Representative (AOR) or PD/PI with delegated Progress Report Submit Authority must provide verification that all publications are in compliance with the NIH Public Access Policy, to the Grants Management Specialist (GMS). The Public Access compliance verification may be submitted either using the new Progress Report Additional Material (PRAM) link on the eRA Commons Status page or via email.

Instructions for SO/AOR verification:• Verify that the PD/PI has used My NCBI to enter publications and/or update compliance status.• Include a My NCBI PDF report demonstrating all the formerly non-compliant public access citations are now compliant. To process your award, every citation in the report

should be either complete, in process or exempt N/A). Please see http://publicaccess.nih.gov/citation_methods.htm for more information about acceptable compliance statuses for public access papers. We have more information about My NCBI at http://publicaccess.nih.gov/communications.htm.

• If unable to provide verification, provide a justification for why the specific publication(s) cannot be brought into compliance.• NIH awardees are responsible for ensuring that evidence of compliance is included in all NIH applications, proposals and reports. If you have questions about the Policy,

please check the NIH Public Access Website or send an email to PublicAccess@nih.gov.• For any further questions about this email, call the eRA Help Desk at 1-866-504-9552 or refer to http://grants.nih.gov/support for additional methods of contact. Please

access Commons at http://public.era.nih.gov/commons/. For more information please visit http://era.nih.gov/

Source: UNC Office of Sponsored Research27

The Goal: Avoid This!Sample Non-Compliance Notification

The Goal: NIH Public Access – PubMed Central (PMC)

• Platform…Repository...Archive...Storage & Access

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Macon MB, Fenton SE. Endocrine disruptors and the breast: early life effects and later life disease. J Mammary Gland Biol Neoplasia. 2013 March 18; 18(1): 43-61; PubMed Central PMCID: PMC3682794.

The Goal: Proper Citation & Reporting

Steps: How to Comply & Timing

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More Details on these 3 Compliance Steps in Supplementary Materials

Determine submission method:A: publisher submits; monitorB: publisher submits for fee; monitor if select this methodC and D: author (C) or publisher(D) submits final peerreviewed manuscript to NIHMS; Author has 2 approval steps

Inform journal/publisherReview copyright agreementDetermine: Who will submit Which version to submit Embargo period________________________

Cite PMCID in NIH apps, progress reports, renewalsInclude for articles subject toPolicy AND authored by PI orarising from their award.

New “identification wizard” to identify method: http://publicaccess.nih.gov/submit_process.htm

Steps: Submission Method ASummary Version of

PaperWho Deposits?

(Task 1)Who Approves

Processing?(Task 2)

Who Approves

PMC Format?(Task 3)

Journal deposits all NIH-funded articles in

PMC

Final published

article

Journal, direct to

PMC

N/A N/A

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Author/Investigator Responsibilities:• Make sure journal knows to submit article• Watch for PMCID assignment in My NCBI• Make sure journal submits final published version

List of Method A Journals: http://publicaccess.nih.gov/submit_process_journals.htm

Steps: Submission Method B

Author/Investigator Responsibilities:• Request journal to submit article• Pay fee (if applicable)• Watch for PMCID assignment in My NCBI• Make sure journal submits final published version

List of Method B Publishers: http://publicaccess.nih.gov/select_deposit_publishers.htm

Summary Version of Paper

Who Deposits?(Task 1)

Who Approves Processing?

(Task 2)

Who Approves

PMC Format?(Task 3)

Author asks publisher to deposit

specific article in

PMC

Final published

article

Journal, direct to

PMC

N/A N/A

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Steps: Submission Method C

Author/Investigator Responsibilities:• Submit files (final, peer-reviewed manuscript, tables,

figures, etc.) Delegates can perform this step.• Approve PDF receipt of content for processing by NIHMS• Approve formatting of PMC manuscript • Watch for PMCID assignment in My NCBI

Summary Version of Paper

Who Deposits?(Task 1)

Who Approves Processing?

(Task 2)

Who Approves

PMC Format?(Task 3)

Author deposits article in PMC via NIHMS

Final peer-reviewed

manuscript

Author or delegate, via NIHMS

Author, via NIHMS

Author, via NIHMS

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Steps: Submission Method D

Author/Investigator Responsibilities:• Make sure journal submits manuscript files• Approve PDF receipt for processing• Approve formatting of PMC manuscript • Watch for PMCID assignment in My NCBI

List of Method D Publishers: https://publicaccess.nih.gov/Method%20D%20Publishers

Summary Version of Paper

Who Deposits?(Task 1)

Who Approves Processing?

(Task 2)

Who Approves

PMC Format?(Task 3)

Publisher deposits

via NIHMS, author

completes submission

Final peer-reviewed

manuscript

Publisher, via NIHMS

Author, via NIHMS

Author, via NIHMS

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Steps: How to Comply: Cite(When reporting to NIH)

In press or less than 3 months post-publication in journal

• PMCID, if available or• Methods A and B: ‘PMC

Journal-In Process’• Methods C and D: NIHMSID

3 months post-publication in journal – 12 mos and beyond

• All methods: PMCID

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Assignment of PMCIDs is estimated at 4 weeks once the submission is approved by the submitting author for processing.

The status of your submissions can be tracked on your manuscript list under the "status" column.

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New NIH Biosketch & Steps

New NIH Biosketch Format• All NIH and AHRQ applications submitted on or after

May 25, 2015 must use the new format. – Standard format – Fellowships-specific formats

NIH announced a change in the format for the Biosketch for NIH and AHRQ applications in late 2014.

– NOT-OD-15-024 (11/28/14) - announces new format and effective date of 1/25/2015

– NOT-OD-15-032 (12/5/2014) – update, changed effective date to 5/25/2015.

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Old Format New Format4 page limit 5 page limit

Personal Statement Personal Statement + up to 4 peer reviewed references5 "Contributions to Science" + up to 4 references for each contribution (variety of research products can be cited)

15 selected refs Up to 24 selected references

Link to online bibliography

Summary of Biosketch Changes

Adapted from: Best Foot Forward – Navigating the New NIH Biosketch, presentation by David Carroll, PhD, NC TraCS, January 8, 2015 38

Effective May 25, 2016• A URL for a publication list is optional and, if provided, must

link to a government website (.gov) like My Bibliography

• Publications (peer-reviewed and non-peer-reviewed) and research products may be cited in both the personal statement and the contributions to science sections

• Graphics, figures and tables are not allowed in the Biosketch

Biosketch Clarifications

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NIH Notice NOT-OD-16-004 (10/13/2015): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-004.html

C. Contribution to ScienceMy early publications directly addressed the fact that substance abuse is often overlooked in older adults. However, because many older adults were raised during an era of increased drug and alcohol use, there are reasons to believe that this will become an increasing issue as the population ages. These publications found that older adults appear in a variety of primary care settings or seek mental health providers to deal with emerging addiction problems. These publications document this emerging problem but guide primary care providers and geriatric mental health providers to recognize symptoms, assess the nature of the problem and apply the necessary interventions. By providing evidence and simple clinical approaches, this body of work has changed the standards of care for addicted older adults and will continue to provide assistance in relevant medical settings well into the future. I served as the primary investigator or co-investigator in all of these studies.

a. Gryczynski, J., Shaft, B.M., Merryle, R., & Hunt, M.C. (2002). Community based participatory research with late-life addicts. American Journal of Alcohol and Drug Abuse, 15(3), 222-238.

b. Shaft, B.M., Hunt, M.C., Merryle, R., & Venturi, R. (2003). Policy implications of genetic transmission of alcohol and drug abuse in female nonusers. International Journal of Drug Policy, 30(5), 46-58.

c. Hunt, M.C., Marks, A.E., Shaft, B.M., Merryle, R., & Jensen, J.L. (2004). Early-life family and community characteristics and late-life substance abuse. Journal of Applied Gerontology, 28(2),26-37.

d. Hunt, M.C., Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A. (2007). Community-based intervention strategies for reducing alcohol and drug abuse in the elderly. Addiction, 104(9), 1436-1606. PMCID: PMC9000292

“indicate the historical background that frames the scientific problem”

“the central finding(s)”

“the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology”

“your specific role in the described work”

40From: Best Foot Forward – Navigating the New NIH Biosketch, presentation by David Carroll, PhD, NC TraCS, January 8, 2015

Contributions to Science: SampleFrom NIH Biographical Sketch Sample – Forms Version C

• Can include references for a wide array of research products……“For each of these contributions, reference up to four peer-reviewed publications or other non-publication research products (can include audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware) that are relevant to the described contribution. The description of each contribution should be no longer than one half page including citations.”

• A URL for full publication list may be included (but not in the text)- No other URLs permitted- Must provide full URL (“http:// etc etc”) [My NCBI creates this for you]- NIH Biosketch FAQ section IV on Contributions to Science section

41Adapted from: Best Foot Forward – Navigating the New NIH Biosketch, presentation by David Carroll, PhD, NC TraCS, January 8, 2015

Contributions to Science: References

➢ Contributions to Science (C2S) address “Science”, rather than the specific application – will require only gradual updating (unlike Personal Statement)

➢ Keep it short and simple• You’re allowed ½ page per contribution – you don’t have to fill up the page• You’re allowed 5 items – you don’t have to include 5.• Bullet points• Be realistic about what is considered “significant”

➢ What is the early career investigator to do?• Doctoral work• Citation counts / journal impact factors / author h-index• See NIH Biosketch FAQ - advice for new scientists re: Contributions to Science

➢ Start now to be ready for upcoming applications – use My Bibliography and SciENcv to facilitate the process

42Adapted from: Best Foot Forward – Navigating the New NIH Biosketch, presentation by David Carroll, PhD, NC TraCS, January 8, 2015

Biosketch Take Aways

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NIH Compliance Toolset: MyNCBI, NIHMS, My Bibliography,

SciENcv

Tools: Managing NIH PAP Compliance with My NCBI

Personalized account integrated with National Center for Biotechnology Information (NCBI) databases• Used to save searches and citations• Manage NIH compliance with My Bibliography

Reminder: You MUST use My NCBI to enter publications into NIH reports! (effective July 1, 2013)

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Tools: My NCBI Tour(Overview)

• Login options (in general: eRA Commons login for investigators; NCBI login for delegates)

• Link My NCBI account to eRA Commons account (For investigators; a critical step for compliance management)

• Adding citations to My Bibliography ( author search + "chapel hill"[Affiliation] AND author manuscript[filter])

• Awards view (activated by linking eRA Commons account; enables compliance tracking and ability to attach grants to pubs)

• Assigning delegates (enables others to help manage your My Bibliography and Biosketch)

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Sign In to My NCBIhttps://www.ncbi.nlm.nih.gov/account/

or Google “My NCBI”

Login Options:My NCBI username and password

OR

Partner organization username and password

Managing Compliance: My NCBILogin Options

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Managing Compliance: My NCBILogin Guidance

I Am a... Existing My NCBI Account

Existing eRA Commons Account

Initial My NCBI Login Method

Investigator No Yes Use eRA Commons account information

Investigator Yes Yes Use My NCBI account information, then link to eRA

Commons account

Delegate No No Register for My NCBI account

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Managing Compliance: My NCBILink My NCBI and eRA Commons

• Link eRA Commons account to My NCBI account

– My Bibliography citations display in eRA Commons

– NIH grants in eRA Commons show in My NCBI

– Enables Award View

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Managing Compliance: My NCBIHow to Link Accounts

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1. Search for “NIH”(or scroll down)

2. Select “NIH & eRA Commons” to link your eRA Commons account to your My NCBI account

Managing Compliance: My NCBIHow to Link Accounts

Managing Compliance: My Bibliography• Add citations:– From PubMed– Manually

• Use Award View to:– Track NIH Public Access Policy compliance– Start the compliance process– Associate citation with funding– Create bibliography for progress reports

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HSL Guide: http://guides.lib.unc.edu/content.php?pid=456313&sid=3765274

Tools: Monitoring Compliance with MyNCBI

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Managing Compliance: My BibliographyAwards View

? : Cannot determine status

Green: Compliant

Yellow: In-process at NIHMS

Red: Non-compliant

N/A: PAP does not apply

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Managing Compliance: Award View in My Bibliography

Managing Compliance: Delegates• What is a delegate?

– Person granted access to an investigator’s My Bibliography (and/or SciENcv Biosketches)

• What can a delegate do?– Modify My Bibliography (and/or SciENcv Biosketches)– Monitor compliance– Connect publications to grants/awards– Submit article via NIHMS with MyNCBI login info (Method C, task 1)

• See HSL NIH compliance guide for details on assigning delegates: http://guides.lib.unc.edu/compliance

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New interface released January 28, 2015

Always use the same login

route!!

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How to Comply: NIHMS System

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How to Comply: NIHMS System

Tools: NIH BiosketchMy NCBI & SciENcv

https://www.ncbi.nlm.nih.gov/account/

• Generate URL to full bibliography for inclusion in NIH biosketch with My Bibliography (part of My NCBI)

• Create online biosketch(es) in SciENcv (recommended)• Pull in content from My Bibliography (citations), eRA Commons, ORCID• Copy and edit a previous SciENcv biosketch• Copy and paste from previous biosketch in Word document• Outputs biosketch in Word, PDF or XML formats

Option: NIH provides a Word template if you prefer to create your Biosketch in Word and convert to PDF on your own:http://grants.nih.gov/grants/funding/424/index.htm#biosketch

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ORCID & My NCBIShould you link your ORCID account to your My NCBI account, the following information would be made available in SciENcv: • You would be able to display your ORCID ID in the

personal information section.• Citations listed in your ORCID account would be

made available under the Personal Statement and Contributions to Science sections.

• Grant information in your ORCID account would be made available in the Research Support section.

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ORCID & My NCBI• If your accounts are linked, you can also create a

new Biosketch and choose ORCID as the data source. Should that information be available, doing so will automatically fill in fields in the:– Personal information section, – the Education/Training section, and – Positions and Honors section

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Recap / For More Info

• Importance of Journal Articles• Open Access vs. Public Access• Other Federal Public Access Policies• Whys, Hows & Goals of NIH Public Access Policy• NIH PAP How To Comply: The Steps• NIH Biosketch How To Comply: The Steps• How To Comply: The NIH Toolset• Finding More Information

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Recap

For More Info…http://guides.lib.unc.edu/compliance

Sources of HelpPublic Access Policies

• Guides from the Health Sciences Library– NIH Public Access Policy: http://

guides.lib.unc.edu/compliance – Federal Agency Public Access Plans for pubs and data (OSTP

responses): http://guides.lib.unc.edu/researchdatatoolkit

• Help Desks (see Help page links in HSL guide)– eRA Commons Help Desk: Help with eRA Commons accounts– NIHMS Help Desk: Help with manuscript submission or approval– NCBI Help Desk: Help with My NCBI accounts or delegate assignment– NIH Public Access Policy Help Desk: Help with general policy questions

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Sources of HelpNIH Biosketch

• Guides from the Health Sciences Library– http://guides.lib.unc.edu/nihbiosketch – http://guides.lib.unc.edu/measureimpact

• NIH Guidance (linked on HSL Biosketch guide)– Sample Biosketches: http://

grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample_VerC.docx– Biosketch Templates (SciENcv Tool and Word templates): http://

grants.nih.gov/grants/funding/424/index.htm#biosketch – Biosketch FAQ: http://grants.nih.gov/grants/policy/faq_biosketches.htm

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Your Questions

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