October 25, 2004 - ASM Comments on NIH Proposal to Facilitate Enhanced Public Access to Research Information

The American Society for Microbiology (ASM) is providing the following comments in response to the Notice of the National Institutes of Health (NIH) of its proposal to facilitate enhanced public access to NIH health related research information (Notice for Comment, 69 Fed. Reg. 56074 September 17, 2004). ASM expresses its appreciation for the opportunity to comment on the NIH Notice and for NIH’s invaluable role in the promotion of science in the public interest in the United States.

Interest of the American Society for Microbiology

ASM is the largest life science professional society in the United States with approximately 42,000 microbiologist members. ASM plays a major role in promoting progress in the microbiological sciences by publishing quality journals and books, convening meetings and workshops, developing educational, training, and public information programs, providing scientific advice to inform public policy, and promoting ethical conduct among practitioners of microbiology. ASM activities and programs serve not only its members and the advancement of science, but contribute to the public interest. ASM publishes 11 journals that print over 7,000 scientific articles yearly. ASM has well-established peer-review procedures for manuscripts published in its journals, and ASM’s publishing procedures and activities contribute to ensuring the quality and integrity of the scientific literature.

ASM has a long-standing record of commitment to facilitating full access to the articles published in its journals. ASM uses the Internet for timely dissemination of research articles and currently offers free access to all users after six months for basic research journals and one year for its two review journals. ASM posts full text and figures to both Highwire and PubMed Central (PMC), subject to the six-month restriction. ASM also provides free access to all archival issues of its journals that are hosted by PMC and Highwire. ASM articles are indexed by Google to allow searches for articles by key words.

ASM offers the followings comments and questions that need to be addressed by the NIH before implementing an enhanced public access policy. ASM also stresses the need for continuing dialogue with scholarly publishers on issues related to access policies.

Comments of the American Society for Microbiology

ASM supports broad and timely access to articles presenting research results. The current ASM practice appears generally compatible with the proposed policy of providing free online access to published NIH-supported research articles through PMC six months after publication. The Notice by NIH, however, does raise a number of critical issues and concerns for publishers, grantees and the scientific enterprise. This initiative deserves careful attention and further dialogue and cooperation with scholarly publishers before implementation, especially in view of its impact on NIH grantees, the rapid and free dissemination of scientific information, and NIH funding and resources.

Specific Comments

  • The Notice states that NIH intends to “request” that its grantees and supported Principal Investigators provide NIH with electronic copies of all final-version manuscripts upon acceptance for publication. The Notice further describes such submission as an “alternate” means to fulfill the requirement to provide one copy of each publication in the annual final progress reports. Thus, the Notice suggests that submission of manuscripts for archiving and eventual posting in accordance with the procedures set forth in the Notice will be voluntary, albeit requested by NIH. Is that correct or does NIH intend to make submission of a manuscript for archiving and posting pursuant to a public access program a condition of receiving an NIH grant or award? 
  • The Notice states that NIH will archive manuscripts submitted by authors and any appropriate supplementary information in PMC. Will manuscripts received by NIH pursuant to such procedure be subject to disclosure in response to a Freedom of Information Act request before six months after the date of publication? Are there other legal ramifications of such a submission to NIH, such as establishing a date of publication for purposes of patent law issues? 
  • The Notice states that the manuscript will be made available to the public six months after “publication.” The Notice does not define what constitutes “publication.” NIH should define clearly when NIH considers that a supported research study is “published” for purposes of public posting. When exactly does the “clock start ticking” for the obligatory six month deadline for making the manuscript available on PMC. ASM recommends that “publication” should be defined to mean the date a peer-reviewed journal containing the article is issued by a publisher. 
  • ASM strongly recommends that, if a publisher permits public posting of the publisher’s published article six months after publication, only the final published article be provided to NIH. ASM currently posts full text and figures to PMC of articles six months after issuance of the journal containing the article; ASM, therefore, is especially interested in the procedure for posting a published article on PMC six months after publication. The Notice states that “if the publisher requests” the manuscript will be replaced in the PMC archive by the final publisher’s copy with an appropriate link to the publisher’s electronic database. If a publisher permits posting of the publisher’s copy by PMC six months after publication, there does not appear to be any reason for an author to submit a copy of the manuscript prior to publication. In fact, because the manuscript is not to be publicly available for six months (as ASM understands the Notice), such submission merely duplicates costs and creates the possibility of a public posting of varying versions of the same article when the published article is provided. The resource requirements and their justification must be evaluated to make the optimal use of resources. When a publisher expresses a willingness to cooperate with the posting of a published article by PMC six months after publication, limiting the submission to final published papers at six months would accomplish the goal of supporting public access to results and accomplishments of NIH-supported studies without a preliminary submission of an unpublished manuscript and would eliminate the possibility of a later public posting of both a manuscript and a published article that might well vary from the original manuscript. 
  • Is it the responsibility of a publisher to provide PMC the final published version of the manuscript and how will publishers work with PMC to accomplish the replacement in the PMC archive of an individual paper when the paper is part of a journal? It is important that the PMC make available the final, published version of each manuscript, not the author’s originally accepted manuscript. Only one final version of a paper should be extant, and the version of record should be the one available to the public. There should be a link from PMC to a journal’s web site for a final posted article. 
  • How will the grantee submit electronic copies of final-version manuscripts upon acceptance for publication to PMC? This requirement deserves further consideration. Will NIH provide and enforce standards for the electronic format for this submission? This step could be expensive, time consuming and burdensome and consideration should be given to eliminating this requirement in view of the need and desirability to have one final published article in the database. As set forth above, when a publisher permits posting of an article, this appears to be a redundant and unnecessary requirement. If the PMC becomes the final arbiter of the technical guidelines for the transmission and posting of electronic manuscripts, will assurances be provided that such guidelines keep pace with developments in the field? 
  • The Notice does not address issues that sometimes arise after acceptance of a manuscript for publication, such as scientific misconduct issues and disputes among and between authors and the final screening for use of microbiology contrary to human welfare, including the use of microbes as biological weapons.

General Comments

  • ASM recommends that the NIH policy explicitly state that PMC will post all NIH-supported research papers published in the peer-reviewed literature. 
  • The issue of archiving is critical for science. Since NIH funding and resources for this PMC activity are subject to annual appropriations that may experience instability in the future, what reassurance does the scientific community have that NIH will be able to sustain over time a complete archive, not just a subset, of NIH supported research articles. This is a key issue for science and the public in view of the unknown effects that this initiative may have on library archives and print journals. ASM recommends that archives for research papers should be redundant to ensure long term availability and continuity. The ASM recommends that PMC clearly state that it is not a comprehensive archive of all biomedical research. Only a portion of the articles published in scientific journals result from NIH funded studies. 
  • NIH’s enhanced public access initiative is specific for NIH-supported biomedical research. ASM recommends that NIH consider the ramifications such a policy may have for other life science research supported by other agencies and for research that is not federally funded, including the potential effect of disparate treatment on non-NIH-supported research. For example, will publishers have to track and make available several separate and disparate streams of articles? 
  • The issue of resources and good stewardship of biomedical research funding is an important consideration. Does PMC have the resources to undertake this initiative in a timely and efficient manner? NIH should establish the scope of the initiative in terms of numbers of articles and estimate the resources needed. Again, what assurance does the NIH research community have that this initiative will be timely, accurate, complete and sustained in the long term? Will PMC be able to keep pace with new technical approaches and incorporate them into the contemplated program? The ASM recommends that the actual costs of this policy should be monitored over time especially in view of the need to respond to technical advances and possible legal complexities. We recommend the process be evaluated after three years, with a public disclosure of the effects, costs and problems that may have arisen. 
  • As NIH recognizes, peer-reviewed articles are now available to interested researchers and the public. To some extent, therefore, the enhanced public access initiative provides another mechanism for accessing information that is already being made available. ASM recommends that NIH evaluate whether this initiative takes funds and time away from the performance of science and directs them to a redundant activity.
  • ASM recommends that further consideration be given to issues arising from a federal government agency, which may be subject to political pressures, being the centralized repository for NIH-supported research articles. ASM suggests that science and the public interest would be served if NIH would allow other nongovernmental, publicly available databases to be used with a link to PMC.

The ASM would be pleased to meet with NIH and discuss these issues and concerns.

Sincerely,

James M. Tiedje, Ph.D., President, ASM
Samuel Kaplan, Ph.D., Chair, Publications Board, ASM

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