# Presentation: 292829

## NIH Public Access Policy

- Department of Energy
- STI Advisory Board
- March 10, 2005

- Sheldon Kotzin
- Chief, Bibliographic Services, National Library of Medicine
- National Institutes of Health/DHHS

## 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)**
- “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)**

**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.

## A repository of freely accessible life sciences journal articles and supporting research data, including multimedia data
a permanent archive 
a platform for enriched linking, analysis, and use of research reports and data
one of many sources of full-text articles linked to PubMed/MEDLINE citations

- a permanent archive
- a platform for enriched linking, analysis, and use of research reports and data
- one of many sources of full-text articles linked to PubMed/MEDLINE citations

## 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.

## Examples of Public Comments - Pros

- Taxpayers should have access to research results in timely manner.
- Enhanced access to information strengthens and expands impact of research.
- Policy provides equal access to less wealthy individuals, institutions, and countries.
- Online access to information less expensive and easier to obtain.
- Taxpayers not responsible for business models of publishers.
- Without policy, government favoring publishers at taxpayers’ expense.
- Policy will improve the visibility of my work as a researcher.

**Notes:**
As you might expect, comments in favor of the policy came primarily from public advocacy groups, libraries, and some scientists.

The arguments they made are familiar to those who advocate greater access to government information.  See access as a right of taxpayers, but also something that increases the value of the information, gives researchers more visibility for their work, and fosters advances in research,

## Examples of Public Comments -- Cons

- Policy will harm financial stability of publishers.
- Policy will adversely impact peer review of research prior to publication.
- Overall implementation of this plan is too costly.
- Policy may lead to an increase in cost for publications or an increase in costs for researchers to submit work.
- Policy does not adequately address copyright issues.
- Policy will hurt learned societies and the efforts that they support financially.
- Regardless of enhanced access, general public does not understand research.

**Notes:**
Those opposing --primarily commercial publishers and professional societies that are publishers—made arguments about potential negative impact on scholarly communication.

Some also questioned the need for the public to have access to this type of material, but our experience demonstrates that the public is interested in research results, as well as consumer-focused material.

## Examples of Questions

- Will the quality of peer review be harmed?
- Will there be a negative impact on scientific publishing?
- Will authors and journals be able to copyright?
- Why archive in PubMed Central?
- What will this cost to implement?

**Notes:**
These are some of the key questions raised.  I’ll be addressing several of the specifically.  

NIH believes strongly that this will not have any impact on peer review and tha NIH is a strong contributor to the peer review process.

## 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 

- 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.
- 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 -- Coverage

*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
- 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.

## Legal Concerns and Issues

**Policy Infringes Copyright Interests of Grantees**
- NIH 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.
- Encourages authors and institutions to inform publishers, and if necessary specify in any copyright transfer agreement, that author or institution will provide their manuscripts to PMC.
- Sample language:  “Journal acknowledges that Author retains the right to provide a copy of the final manuscript to NIH upon acceptance for Journal publication or thereafter, for public archiving in PubMed Central as soon as possible after publication by Journal."

**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. 

## Benefits of Archiving & Access

- Maximizes utility of publication (genomics)
- Diversity & datamining
- Evolution of publishing models
- Maximizes usage & minimizes delay
- Once free online, PubMed usage increased 100 fold
- GeneTests usage increased several fold just eliminating registration (was already free)
- Empowering patients &  families with the most up-to-date & accurate information
- Also provides a new foundation for high school and undergraduate education

**Notes:**
We see lots of benefits to creating an archive.  In a minute I’ll show you a demo of how we are able to link multiple resources and mine the data contained in these files.

We also know that as publishing changes it will be important to maintain an archive that is used and dynamic.

Our experience with PubMed being made freely available demonstrates the impact these resources can make.  We experienced a 100 fold increase in use once we made Medline free to the public.

The availability of these resources will have major benefits for patients and families, as well as have great potential for education.

## Cost &  Permanence

- Cost
- Able to build on existing PubMed Central infrastructure
- Enables NIH to better manage research portfolio
- Ensures permanence of the record of science
- PubMed Central as NIH’s institutional repository
- Importance of creating archive vs. linking to other sites
- NLM has statutory mandate to archive the biomedical literature and over 150 years experience

**Notes:**
Because we already have an infrastructure in place with PMC we are able to build on that in a very cost-effective way.  We estimate the added annual costs at about $2.5 million.

It also will help NIH more effectively manage its grant funding—especially important as our budget is no longer growing.

We view PMC as NIH’s institutional repository. 

Some argued that it would accomplish the same objective if NIH linked to the full text on publishers’ sites, rather than depositing the manuscripts in PMC.  Our response is simply that linking doesn’t create an archive of material that has a common format, can be tagged to facilitate connections with other materials, and over which we have control.  HOWEVER, we don’t think that PMC should be the only archive and welcome others.

## Advantages of Depositing in PMC

- PMC manuscripts will be cross-linked to a variety of research related resources and databases, such as:
- DNA, protein sequences, and protein structures
- Clinical trials
- Small molecules (PubChem)
- Taxonomy
- By having these links, users can then obtain dynamically-updated information relevant to the article and exploit computational and retrieval tools that are tailored to this factual data.
- These databases also provide linkage to a broad collection of other biological and health-related information resources including MedlinePlus.
- Investigators applying for new and competing renewal support from the NIH can also utilize this resource by providing links in the applications to their PMC-archived information.

**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 February 2005

**178** journals
**373,000** items (> 50% from digitized back issues)
- includes some pieces (e.g., book reviews) not in PubMed
- Users: **844,000** unique IP addresses. Actual users estimated to be **2.5 times** this number.
- Retrieval: Over **3.48 million** full-text (HTML or PDF) articles
- Most accessed article in past 30 days 
- _[Online journals: impact on print journal usage](http://www.pubmedcentral.gov/articlerender.fcgi?artid=57966)_Sandra L. De Groote ...Bull Med Libr Assoc. Oct 2001;89(4):372-378

**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 19

## Taxonomy

## Slide 21

## Slide 22

## Slide 23

## Slide 24

## 2.  Lynch C. Medical libraries, bioinformatics, and networked information: a

- 2**.  Lynch C. Medical libraries, bioinformatics, and networked information: a**
**     ****coming convergence?  ***Bull Med Libr Assoc**.* 1999;87(4): 408-14 _[PubMed]_

## Table of Contents

## Full Text Summary View

## Page Browse, HiFi Image, PDF

## 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.** **

**Notes:**
We have been working on implementation and will have the author submission system in place in advance of the May 2 date for authors to begin to submit manuscripts. 

We are creating a working group of the NLM Board of Regents to include all stakeholder perspectives to advise on implementation and help in evauation.

We are actively publicizing the policy and providing training for NIH investigators and program staff.  This afternoon we are conducting a session for NIH intramural scientists and program managers. 

## 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.