Comments of The American Association of Immunologists In Response to the 
National Institutes of Health Request for Information: NIH Public Access Policy 
(NOT-OD-08-060 - March 28, 2008)

May 30, 2008

Transmitted via http://publicaccess.nih.gov/comments2/comments.htm

The American Association of Immunologists (AAI), a professional association of 
more than 6,500 research scientists and physicians dedicated to understanding 
the immune system, and the publisher of The Journal of Immunology (The JI), the 
worlds most cited immunology journal, respectfully submits the following 
comments in response to the National Institutes of Healths (NIH) March 28, 2008 
Request for Information: Public Access Policy (RFI) (Notice number NOT-OD-08-
060).

AAI has deep concerns about the NIH Public Access Policy (Policy) and plans 
for its implementation.  The Policy, as enacted by the Consolidated 
Appropriations Act of 2008 (P.L. 110-161), requires that all investigators 
funded by the NIH submit or have submitted for them to the National Library of 
Medicines 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.

While AAI strongly supports - and successfully implements - activities to 
enhance access to scientific information and publications, we continue to 
believe that the Policy will duplicate, at great cost to NIH and to taxpayers, 
publication services which are already provided cost-effectively and well by the 
private sector.  The private sector, including not-for-profit scientific 
societies, already publishes - and makes publicly available - thousands of 
scientific journals that report cutting-edge research funded by both NIH and 
other public and private entities.  Rather than creating a new government 
bureaucracy, a particular burden in this era of severe budget constraints, NIH 
should partner with these publishers to develop a plan that enhances public 
access while also addressing publishers key concerns, which include ensuring 
journals continued ability to provide high quality, independent peer review of 
NIH-supported research.

AAI is concerned that the information that NIH has provided to investigators and 
institutions is confusing and, in some cases, mischaracterizes the plain 
language of the federal law.  The Consolidated Appropriations Act of 2008 (P.L. 
110-161) requires (t)hat the NIH implement the public access policy in a manner 
consistent with copyright law.  And yet, in its Notice and Revised Policy 
Statement dated January 11, 2008 (NOT-OD-08-033), NIH shifts what is clearly its 
legislative responsibility to ensure (i.e., that the Policy respects publishers 
copyright rights) to institutions and investigators: Institutions and 
investigators are responsible for ensuring that any publishing or copyright 
agreements concerning submitted articles fully comply with this Policy. This is 
clearly creating concern and confusion among investigators and institutions and 
must be addressed in a way that eases compliance for authors while respecting 
publishers rights. As the NIH deflects this responsibility, it accepts whatever 
the authors send to PubMed Central (PMC) without confirming the existence of 
copyright agreements with the publishers.  This has resulted in NIH consistently 
posting material which violates copyright agreements with publishers, requiring 
publishers to seek out the violations and bring them to NIHs attention.  In 
addition, a recent NIH directive by Michael Gottesman, Deputy Director of 
Intramural Research (NIH Employee Procedures for Complying with NIH Public 
Access Policy, May 15, 2008), which requires intramural investigators to use 
NIH submission forms for all journals and to reject the use of publishers forms 
(irrespective of whether they comply with the Policy), has created confusion for 
NIH investigators and an administrative burden for publishers.  [Publishers 
submission forms often include - in addition to copyright transfer agreements - 
statements regarding Conflict of Interest and Author Responsibility (e.g., 
appropriate approval for human and animal use, prior publication history, the 
availability of unique materials, responsibility for scientific integrity, etc.) 
that authors are required to sign.]

AAI also has serious concerns about the legality of the Policy.  Many of these 
concerns were addressed in great detail in a legal analysis commissioned by AAI 
and the American Physiological Society (APS) in 2004, when NIH had proposed a 
mandatory program (NOT-OD-04-64, September 3, 2004).  This legal analysis, which 
was submitted to NIH on November 16, 2004, and resubmitted via an electronic 
link in our March 14, 2008 comments (responding to NOT-OD-08-057), addresses 
legal issues that NIH had dismissed as irrelevant when the NIH plan was 
initially implemented as a voluntary policy.  With the passage of the 
Consolidated Appropriations Act of 2008 (P.L. 110-161), which made the Policy 
mandatory, key legal issues raised in this analysis (see 
http://www.aai.org/News_Board/CommentsNIHPublicAccess.pdf), including the 
following, must now be addressed:
  
1. whether NIH has complied with the Freedom of Information Act (and has 
considered its impact on patent applications); 
2. whether NIH has complied with the provisions of the Administrative 
Procedures Act, including whether the notice provided to the public under this 
Act, and the opportunity for public comment, has been satisfied; 
3. whether NIH has complied with the provisions of OMB Circular A-76; 
4. whether NIH has complied with the Regulatory Flexibility Act; and 
5. whether NIH has complied with the Paperwork Reduction Act. 

Other legal/procedural concerns include the following: 

1. NIH moved forward with the implementation of this Policy even as it 
announced the imminent publication of this RFI.  In its March 7, 2008 notice 
[NOT-OD-08-057], NIH announced that it would issue an RFI later in March and 
respond to comments after a 60-day comment period.  Yet NIH went ahead to 
implement this Policy with an effective date of April 7, 2008.  In addition to 
the obvious legal flaws with this approach, it creates a sense that the NIH is 
neither interested in, nor willing to work with, the stakeholders who are 
deeply affected by this new Policy.  NIH should proceed with implementing this 
Policy only after formal Notice and Rulemaking.  

2. There are problems with the implementation guidance on the NIH website.  
While NIH appears to have corrected many of these errors in early May, there 
were serious problems for several months, including but not limited to the 
frequent incorrect use of the phrase journal article when it should have used 
final peer reviewed manuscript. 

3. NIH has created an appearance of favoritism by posting on its website a 
list of journals which submit authors articles directly to PMC 
(http://publicaccess.nih.gov/submit_process_journals.htm). Authors might 
perceive these publishers as preferred by NIH, their funding agency, dealing an 
unfair blow to other publishers who are not submitting authors articles but who 
comply fully with the Policy. 

In written (March 14, 2008) and oral (March 20, 2008) comments to NIH regarding 
the  implementation of the Policy, AAI identified and requested additional 
information that stakeholders needed in order to be able to submit thoughtful 
comments in response to this RFI.  This information has not been provided; 
therefore, AAI again respectfully requests that NIH respond to the following 
questions and provide stakeholders with an opportunity to comment before the 
Policy is implemented or enforced:

1. What are the total funds that were expended on implementing the 
voluntary NIH Public Access Policy (May 2, 2005  January 11, 2008)?
2. What is the cost anticipated for implementation of the mandatory Policy 
in FiscalYear (FY) 2009? 
3. How much of the cost anticipated for implementation in FY 2009 will be 
a one-time implementation cost, and how much will be an annual implementation 
cost? 
4. In responding to the above three questions, please report the cost 
incurred by the National Library of Medicine (NLM) as well as the various NIH 
Institutes, Centers, and Offices involved, including: 
a) the number of FTEs and contracted services used to accommodate 
this initiative; 
b) the cost of personnel and administrative services for this program 
(including associated space for infrastructure and personnel); 
c) time spent directly on the promotion, management, enforcement and 
assessment of this program to/by NIH grantees and the public; and 
d) all costs associated with network infrastructure improvements 
including but not limited to bandwidth capabilities, server capacity, and 
equipment.  
5. What steps is NIH taking to ensure that it posts only articles that 
comply with a particular publishers embargo period?
6. Who will be responsible if the publishers embargo period (and 
therefore the publishers copyright rights) is violated?
7. Who will ensure that NIH complies with a publishers copyright rights 
once a manuscript is submitted (i.e., who will make sure that NIH does not 
transfer a manuscript to any other entity/repository without permission 
from the publisher)? 
8. Who within NIH/the various Institutes will be responsible for determining 
whether a grantee is in compliance?  (Institute directors, Program officers, etc.?) 
9. What will be the penalties for non-compliance by a grantee?  Will it matter 
if the non-compliance is intentional or inadvertent?
10.Why wont NIH accept the Linking Proposal offered to NIH in 2005 by 
fifty-seven not-for-profit scientific publishers, which would provide seamless 
links on PMC to the journals websites, enable readers to access the full text 
of any article funded by NIH (and in many instances, the full text of all 
articles published in the journal, irrespective of funding source).  This 
proposal has the following advantages:
a) it provides the public with free access to all published articles 
funded by the NIH;    
b) it provides access to the final, copy-edited article of record 
(and any related materials, including corrections);
c) it is cost effective, since the NIH would not have to create a 
new repository, educate grantees about compliance and copyright, or 
monitor for compliance;   
d) it addresses publishers copyright concerns;
e) it satisfies the new law; and
f) it complies with copyright law by ensuring that an article cannot 
be posted before the journals embargo period is over. 
In subsequent conversations with NIH about this Linking Proposal, publishers 
offered to consider ways to satisfy NIHs need for a repository of all NIH-funded 
works, i.e. to help NIH populate a dark archive for internal NIH use only.

In addition to the above questions, AAI respectfully requests answers to the 
following questions:

1. How will NIH address allegations of/evidence regarding plagiarism, 
including issuing corrections and retractions? 
2. How will NIH ensure that manuscripts accepted for publication but not 
ultimately published (due to legal or other issues arising between the date of 
acceptance and the date of publication) are not posted?
3. How will NIH provide publishers with the data necessary to evaluate the 
effect of this Policy on their business model (including their subscription 
base)?  Will NIH provide publishers with PMC usage (and other relevant) 
statistics?
4. Since publishers invest millions of dollars in the publication process 
(including peer review, editing, design, printing, and posting online), will NIH 
compensate publishers for their loss of revenue when PMC posts articles within 
12 months after publication?
5. How will NIH ensure that it posts only manuscripts eligible for posting under 
this Policy,and how will NIH ensure the prompt removal of manuscripts which should 
not have been posted? To date, the burden of ensuring compliance has fallen to 
publishers who have been forced to expend time and resources monitoring the PMC 
site and contacting NIH to request removal of articles which have been posted in 
violation of journals copyright rights.   
6. How will NIH prevent the piracy, alteration, re-publication, or other 
illegal use of copyrighted material that is published on PMC?  Will NIH notify 
publishers and provide them with the information necessary to protect their 
copyright?
7. How will NIH prevent repurposing, i.e., modifications to the 
manuscript by authors or NIH that result in variations from the original 
manuscript?  This includes inadvertent repurposing (e.g., inserting links to 
databases or other articles).
8. How will NIH ensure the inclusion of - and protect - publisher and 
society trademarks and branding?  Absence of these proprietary marks may confuse 
or mislead readers as to the owner of the copyright (or the existence of 
copyright), and may result in inadvertent misuse.
9. How will NIH prevent the distribution of copyrighted material to sites 
outside the United States if publishers do not grant approval?  
10. Since the law applies to all investigators funded by the NIH, how will NIH 
address situations where investigators have minimal NIH funding and 
depend on another primary funder who objects to submitting to PMC? 
11. How will NIH educate Principal Investigators (PIs) and their institutions 
about their responsibilities to ensure that all authors submitting manuscripts 
based on funds from their grants are aware of, and comply with, the Policy?  What 
will be the penalties to PIs and their institutions for failure to comply?  Will it 
matter if there has been a good faith effort to comply?
12. What is NIH doing to ensure that authors, institutions, and publishers 
are aware of this Policy and have an avenue for prompt responses to questions 
arising under it? 
13. How will NIH ensure that the law is being followed, particularly 
the following provision: Provided, That the NIH shall implement the public 
access policy in a manner consistent with copyright law?