# Presentation: 358204

## NIH Public Access Policy

- Council of Science Editors Meeting
- May 24, 2005

- Sheldon Kotzin
- Chief, Bibliographic Services And Executive Editor, MEDLINE
-  National Library of Medicine
- National Institutes of Health/DHHS

## Background

- NIH-supported research is essential to improving human health
- Public Access to information resulting from this research is vital
- Engage public in biomedical research
- Demonstrate productivity resulting from doubling NIH budget
- Enable information integration of biomedical literature and databases

## NIH Leading the Way

- Establish digital archive of publicly funded research
- Create venue for NIH funded authors to make work available independent of particular publication
- Provide high quality medical information for Internet-savvy public
- Enable end-to-end electronic management of NIH grant process & better portfolio analysis

## House Appropriations Language

- “The Committee is very concerned that there is insufficient public access to reports and data resulting from NIH-funded research. This situation, which has been exacerbated by the dramatic rise in scientific journal subscription prices, is contrary to the best interests of the U.S. taxpayers who paid for this research.”  **(July 8, 2003)**

**Notes:**
Over the last several years Congress has indicated its interest in ensuring that the results of NIH supported research is made available to the public.

This language appeared in the FY2005 appropriations report for NIH, highlighting Congress’ concerns and encouraging NIH to move forward with the policy it was developing for depositing  manuscripts resulting from NIH funded work in PubMed Central.

## House Appropriations Language (cont.)

- “The Committee is aware of a proposal to make the complete text of articles and supplemental materials generated by NIH-funded research available on PubMed Central (PMC)... The Committee supports this proposal and recommends that NIH develop a policy, to apply from FY 2005 forward, requiring that a complete electronic copy of any manuscript reporting work supported by NIH grants or contracts be provided to PMC upon acceptance of the manuscript for publication in any scientific journal listed in the NLM's PubMed directory.” **(Sept. 7,2004)**

## Policy Goals

- ACCESS Provide electronic access to NIH-funded research publications for patients, families, health professionals, teachers, and students.
-  ARCHIVE Keep a central archive of NIH-funded research publications—for now and in the future, preserving vital medical research results and information for years to come.
- ADVANCE SCIENCE Advance science by creating an information resource that will make it easier for scientists to mine medical research publications, and for NIH to better manage its entire research investment.

**Notes:**
The NIH policy has three basic goals.  

Improving access via the Internet to NIH funded research results for health professionals, researchers, and the public.
Creating a permanent archive of these publications to  ensure that they will be available in the future.
Enabling scientists to more effectively mine both the literature and related data sets to make new discoveries and to strength NIH’s ability to manage its research portfolio.

## Proposed Policy

- In September 2004, NIH proposed a policy to enhance public access to archived publications resulting from NIH-funded research.
- The draft policy requested, but did not require, that NIH-supported investigators submit electronically to the NIH the final, peer-reviewed author's copy of manuscripts upon acceptance for publication.
- The manuscripts would be archived in PubMed Central (PMC)
- The author’s copy would be made available freely to the public through PMC six months after the publisher’s date of final publication (or sooner if the publisher agrees).

**Notes:**
NIH issues a proposed policy in September 2004 for public comment.  The proposal had 3 major elements.

It REQUESTED that NIH supported investigators submit their manuscripts to PMC upon acceptance for publication.  The policy is focused strictly on the peer-reviewed literature.  [note: the NIH policy was always a “request”; not a requirement]
The manuscripts are to be archived in PMC/
The manuscripts would be made publicly available 6 months after final publication.

## Public Comments on Proposed Policy

- Public meetings
- Publishers and Associations (July 2004)
- Investigators (August 2004)
- Disease advocacy groups (August 2004)
- Notice in *NIH Guide for Grants and Contracts*
- September 3, 2004
- Notice in *Federal Register*
- September 17, 2004
- 6,249 comments received
- Talks, visits, interviews, letters

**Notes:**
The proposal built upon comments received from meetings with major stakeholders over the summer.

NIH issued the proposal for 60 day public comment in the Federal Register.

Over 6000 comments received (shows significant interest—although not close to #s received for stem cells!)

The NIH Director and senior staff held numerous meetings with interested parties, spoke at public meetings, etc.

---------LOTS of opportunity for public input and substantial amount of comments received.

## Final Policy 

- NIH-funded investigators are requested to submit an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part, with direct costs from NIH.
- Beginning May 2, Electronic submission will be made directly to the NLM’s Pub Med Central (PMC) digital repository of full-text, peer-reviewed, biomedical, behavioral, and clinical research journals.
- At the time of submission, author will specify the timing of the posting for public accessibility.
- NIH strongly encourages authors to post for public accessibility as soon as possible (and within twelve months of the publisher’s official date of final publication.) NIH expects that only in limited cases will authors deem it necessary to select the longest delay period.

**Notes:**
These are the major elements of the final policy.

Note that NIH is strongly encouraging posting as soon as possible and expects that only in limited cases will the authors choose 12 months.

## Final Policy Revisions

- In response to feedback, NIH revised the proposed policy in  February 2005 to:
- Emphasize the voluntary nature of authors’ submissions.
- Clarify “NIH-funded investigators” to mean those supported with “direct costs” from NIH.
- Provide authors with flexibility to specify the timing of the posting of their final manuscript for public accessibility through PMC.
- Strongly encourage posting for public accessibility through PMC as soon as possible and within 12 months of the publisher’s official date of final publication.

**Notes:**
The final policy was released in early February and contained the elements identified here.

The major change was to allow for authors to specify the timing of the public posting of their final manuscripts from “as soon as possible” after it is made available by the publisher through 12 months after final publication.

This responds to the call for flexibility in the policy—rather than a single date when manuscripts would become public.  It also enables the authors to make the determination rather than NIH mandating a specific time. 

## Final Policy – Coverage & Timing

*The policy applies to:*
- Peer-reviewed publications resulting from research supported in whole or in part with direct costs from NIH
- All research and career development award mechanisms, cooperative agreements, contracts, NRSA grants, and NIH intramural research studies
*The policy does *_*not*_* apply to:*
- Book chapters, editorials, reviews, conference proceedings
*Authors should submit publications resulting from:*
- Currently funded NIH research projects or
- Previously supported NIH research projects that are accepted for publication on or after May 2, 2005
- Author’s final manuscript* = final version accepted for journal publication and includes all modifications from the peer review process*

**Notes:**
Again, the focus of the policy is on the peer reviewed literature.

It covers all individuals receiving direct NIH support.

## NIH is Not a Publisher

- NIH supports the current publishing process by providing direct costs to its funded investigators for publication costs.
- The Policy creates a stable archive of peer-reviewed, research publications financed with NIH funds.
- The Policy is compatible with any publishing model that authors and journals choose to employ.

**Notes:**
NIH is creating an archived of published material; it is not acting as a publisher.  We believe this is an important distinction.

Because the goal is to create an archive and the policy allows flexibility on the timing of public access, any publishing model that authors choose is compatible with the policy.  NIH is not dictating that authors must choose open-access publishing approaches.

## Copyright Issues

- The NIH policy explicitly recognizes and upholds the principles of copyright.
- Authors/journals can continue to assert copyright in NIH-funded scientific publications, in accordance with current practice.
- While individual arrangements can take many forms, NIH encourages authors and institutions to sign agreements that specifically allow the manuscripts to be deposited with NIH for public posting on PMC as soon as possible after journal publication

**Notes:**
One of the main legal concerns was that NIH was taking away authors and/or publishers’ copyright.   The policy explicitly states that existing copyright agreements will be upheld.

NIH expects that authors will inform publishers of their intentions to deposit their manuscripts and make them pubic at a specific time.  NIH will not get involved in negotiating copyrights, but here is some sample language that could be used by authors. 

## Linking Vs. Archiving

**Notes:**
It’s been suggested that linking to various sites where full text might reside would satisfy NIH’s objectives.  However, we disagree with that for the simple reason that linking to disparate resources doesn’t create an archive, especially an archive where we have confidence that it will persist in the future and will continue to be accessible.  

We believe it is not only reasonable for NIH to maintain its own archive of the results of its supported research, but it is imperative if we hope to ensure the optimal use of the results of that research.

We also want to emphasize, however, that we don’t believe that this should be the only archive and NIH welcomes the existence of multiple archives that will contribute to a robust digital preservation effort.

## Advantages of Depositing in PMC

- Fulfills a grant progress reporting requirement by substituting deposit for submission of paper copies of articles
- Cross-links to a variety of research related databases, such as: DNA, protein sequences, protein structures, chemical structures
- Provides linkage to a broad collection of other health-related information resources including MedlinePlus and ClinicalTrials.gov
- Heightens the visibility of the research and enhances the likelihood of early and increased citation
- Ensures permanence of the record of science
- PubMed Central as NIH’s institutional repository
- NLM has statutory mandate to archive the biomedical literature and over 150 years experience

**Notes:**
As I will demonstrate, once a manuscript is in the system we are able to link it to multiple resources.

Sheldon: you may want to describe some of the capabilities of linking between Medline, PMC, and other resources---the demo is from David and is based on the gene databases.

## PMC in March 2005

**178** journals
**373,000** items (> 50% from digitized back issues)
- includes some pieces (e.g., book reviews) not in PubMed
- Users: **1,073,000** unique IP addresses. Actual users estimated to be **2.5 times** this number.
- Retrieval: 3** million** full-text (HTML or PDF) articles. Abstracts, TOCs, full-text, etc.: 6 million.

**Notes:**
I thought it would be useful to give you a picture of what is currently in PMC.

Our back issue scanning project is vastly increasing the material in PMC and making this critical information available electronically for the first time.

You may find it amusing to note the title of the most accessed article in the last month.

## Slide 17

**Notes:**

What I’d like to demonstrate are some of the benefits of having this archive at NLM and the capabilities for researchers to compute against both the text and the data.   You’ll see how PubMed and PMC can be portals into navigating a broad range of information resources, from disease and gene descriptions, to sequences, and back to the supporting scientific literature.

So I’m going to start with a general search on huntington disease in PMC.  I find a paper that looks interesting to me and click on that.

## Slide 18

**Notes:**
I retrieve the full text of the article that’s displayed here.  Let me highlight a few things of particular interest.

First, you’ll see that we make a concerted effort to represent the banner of the journal that publishes the article.

Second, we have a copyright notice prominently displayed at the beginning with a link to NLM’s copyright statement that explains the responsibility of users to adhere to copyright law.

Third, we have links to other articles that have been cited in PMC—I’ll demonstrate a bit more of this in a minute.
Finally, we have links to other related NLM resources.  In this case, I’m interested in finding more scientific information about huntington disease so I click on OMIM, the Online Mendelian Inheritance in Man. 

## Slide 19

**Notes:**
OMIM is a catalog of over 10,000 human genetic disorders authored and edited by Dr. Victor A. McKusick and his colleagues at Johns Hopkins and elsewhere, and developed for the Web by NCBI. The database contains textual information and references, along with many links to MEDLINE and sequence records in the Entrez system, and links to additional related resources at NCBI and elsewhere. 

In OMIM I get a lot of information about a particular disease gene that is implicated in Huntingtons.  This peaks my interest and I want to know more about this particular disease gene so I click on the available links and connect to the Gene database, which is basically a directory of gene descriptions.

## Slide 20

**Notes:**
Here I can get lots of descriptive information on the Huntington disease gene, including its sequence, where it’s been mapped on the human genome, and links to all the NCBI resources referring to this gene.

One of the things that I’d like to do at this point is to find out what other literature is available about this particular disease gene.  So I scroll down this screen.....

## Slide 21

**Notes:**
...and I find a bibliography of the key references to the disease gene that have been indexed in PubMed.  I click on the PubMed links..

## Slide 22

**Notes:**
...and get a list of citations and choose one that looks of particular interest to me.

## Slide 23

**Notes:**
Here is the PubMed full item which shows the link to the full text in PMC. 

So now I have come full circle---starting with the full text literature in PMC, linking to a variety of genetic databases and then returning to the literature to further explore what work has been done related to the new insights I’ve gleaned from the factual databases.

It is this ability to  “compute across the literature and the factual data” that is one of the enormous benefits of building this repository of full text literature that results from NIH funded research.   We believe that these capabilities will be instrumental in advancing discoveries and improving the productivity of science.

## NIH Public Access Implementation

- Implementation of final Policy, published February 3, 2005 in the *NIH Guide *and* Federal Register.*
- Create Public Access Advisory Working Group of NLM Board of Regents composed of stakeholders to advise NIH and NLM on implementation and evaluation of policy.
- Develop information and training for NIH program staff and funded investigators.

## NLM Board of Regents Working Group on Public Access

-     Dr. Thomas Detre, Distinguished Service Professor of Health Sciences, University of Pittsburgh – Chairman
-    Deanna Marcum, Associate Librarian of Congress for Library Collections
-    Jim Williams, Dean of Libraries, University of Colorado, ex-officio

## NLM Board of Regents Working Group on Public Access (cont.)

- _Publishers/Editors_
- Brian Nairn, CEO, Health Sciences, Elsevier
- Annette Thomas, Managing Director, Nature Publishing Group
- Jeffrey Drazen, Editor, NEJM
- Marke Sobel, Executive Officer, American Society for Investigational Pathology
- _Public Interest/Patient Advocacy_
- Sharon Terry, The Genetic Alliance
- T.J. Koerner, The American Cancer Society
- Mike Stern, Fisher Center for Alzheimer’s Research Foundation

## NLM Board of Regents Working Group on Public Access (cont.)

- _Libraries/Universities_
- Pat Thibodeau, Library Director, Duke Medical Library
- Ann Wolpert, Director, MIT Libraries
- Mark Kamlet, Provost, Carnegie Mellon University
- _Scientists_
- Susan Buchanan, National Institute of Diabetes and Digestive and Kidney Diseases
- Harvey Fineberg, Institute of Medicine
- Gary Ward, University of Vermont

## Voluntary Submission Process

-  Electronic version of author’s final manuscript
-  Include al modifications from peer review
-  Submission system will be password protected

## Voluntary Submission Process (cont.)

-  Will accept most word processing formats or PDF
-  System generates email confirming submission
-  Author specifies public accessibility
-  Publisher’s final version may also be submitted

## Voluntary Submission Process (cont)

-    Sending electronic copies is Voluntary and will not be a factor in the review of scientific progress or in the review of new grant requests.

## NIH Manuscript Submission http://www.nihms.nih.gov/

## NIH Public Access

**www.nih.gov/about/publicaccess/index.htm**

**Notes:**
We have posted the final policy, along with useful Q&As on the NIH website.