Presented at APLIC's 2016 conference

1. Open Access, Federal Public Access
& Biosketch Policies, NIH
Compliance Tools & You
1
Facilitator: Mary White
mw@unc.edu
March 30, 2016

2. Take Home Point

3. • 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
3
Overview

4. 4
Journals & Articles:
Public Access vs. Open Access

5. What Do We Want?
Journal Articles!

6. 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

7. 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

8. Open
Access

10. Equitable Access
to Research
Author’s Rights
Promote Author
Work & Show
Impact
Wide Distribution
Of Research

11. Publishing Model: Open Access

12. 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.

13. Open Access Overview
• https://www.youtube.com/watch?v=o2HMou
OV-Lg
• Brief overview of Open Access from Wiley
(Publisher)

14. HSL Guides:
http://guides.lib.unc.edu/measureimpact
http://guides.lib.unc.edu/open-access-and-
scholarly-communications

15. NIH Public
Access

16. National Institutes of Health

17. 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

18. Why: NIH Public Access
• Who funds the NIH?

19. Relevance: No NIH $$$ ?
• Accessibility of Publications!

20. 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.

21. 21
Federal Public Access Policy
Compliance Issues & Steps

22. 22

23. 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/libr
ary/publicaccesspolicy
23

24. FederalAgencyPublicAccessPolicies
24
Source:Valen,Dan;Blanchat,Kelly(2015):OverviewofOSTPResponses.figshare.
http://dx.doi.org/10.6084/m9.figshare.1367165Retrieved15:17,Oct19,2015(GMT)

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

26. Why & How: NIH Public Access
Two 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

27. From: era-notify@mail.nih.gov [mailto:era-notify@mail.nih.gov]
Sent: Thursday, February 11, 2016 3:13 PM
To:
Cc: Cyr, Robin L; UNC SOM Sponsored Programs; mshea@niaid.nih.gov; TWeRANotifications@mail.nih.gov; barbara.sina@nih.gov
Subject: 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 Research
27
The Goal: Avoid This!
Sample Non-Compliance Notification

28. The Goal: NIH Public Access –
PubMed Central (PMC)
• Platform…Repository...Archive...Storage & Access

29. 29
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

30. Steps: How to Comply & Timing
30
More Details on these 3 Compliance Steps in Supplementary Materials
Determine submission method:
A: publisher submits; monitor
B: publisher submits for fee;
monitor if select this method
C and D: author (C) or publisher
(D) submits final peer
reviewed manuscript to NIHMS;
Author has 2 approval steps
Inform journal/publisher
Review copyright agreement
Determine:
Who will submit
Which version to submit
Embargo period________________________
Cite PMCID in NIH apps,
progress reports, renewals
Include for articles subject to
Policy AND authored by PI or
arising from their award.
New “identification wizard” to identify method: http://publicaccess.nih.gov/submit_process.htm

31. Steps: Submission Method A
Summary Version of
Paper
Who 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
31
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

32. 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
32

33. 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
33

34. 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
34

35. 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
35
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.

36. 36
New NIH Biosketch & Steps

37. 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.
37

38. Old Format New Format
4 page limit 5 page limit
Personal Statement Personal Statement + up to 4
peer reviewed references
5 "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

39. 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
39
NIH Notice NOT-OD-16-004 (10/13/2015): http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-16-004.html

40. C. Contribution to Science
My 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”
40
From: Best Foot Forward – Navigating the New NIH Biosketch, presentation by David Carroll, PhD, NC
TraCS, January 8, 2015
Contributions to Science: Sample
From NIH Biographical Sketch Sample – Forms Version C

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

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

43. 43
NIH Compliance Toolset:
MyNCBI, NIHMS, My Bibliography,
SciENcv

44. 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)
44

45. 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)
45

47. 47
Sign In to My NCBI
https://www.ncbi.nlm.nih.gov/account/
or Google “My NCBI”

48. Login Options:
My NCBI
username and
password
O
R
Partner organization
username and
password
Managing Compliance: My NCBI
Login Options
48

49. Managing Compliance: My NCBI
Login 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
49

50. Managing Compliance: My NCBI
Link 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
50

51. 51
Managing Compliance: My NCBI
How to Link Accounts

52. 52
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 NCBI
How to Link Accounts

53. 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
53
HSL Guide: http://guides.lib.unc.edu/content.php?pid=456313&sid=3765274

54. Tools: Monitoring Compliance
with MyNCBI

55. 55
Managing Compliance: My Bibliography
Awards View

56. ? : Cannot determine status
Green: Compliant
Yellow: In-process at NIHMS
Red: Non-compliant
N/A: PAP does not apply
56
Managing Compliance: Award View in
My Bibliography

57. 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
57

58. New interface released January 28, 2015
Always use the
same login
route!!
58
How to Comply: NIHMS System

59. 59
How to Comply: NIHMS System

60. Tools: NIH Biosketch
My 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
60

61. ORCID & My NCBI
Should 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.
61

62. 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
62

63. 63
Recap / For More Info

64. • 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
64
Recap

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

67. Sources of Help
Public 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 questions67

68. Sources of Help
NIH 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
68

69. Your Questions
69