A busy month of action on the NIH open-access plan
SPARC Open Access Newsletter, issue #78
October 2, 2004
by Peter Suber
A lot has happened with the NIH open-access plan since the last issue of the newsletter.  Here are the major developments in chronological order.  I comment on their significance afterwards.

(1) On September 3, the NIH released its own draft policy of the plan for a 60 day period of public comment.  (Until September 3, all we had was a July 14 directive from the House Appropriations Committee for the NIH to produce a plan.)

(2) Rep. Ernest Istook (R-OK) and Rep. Ralph Regula (R-OH) engaged in a "colloquy" about the House Appropriations Committee report language proposing the NIH open-access plan (Congressional Record, September 8, p. H6833).  

(3) On September 9, the House of Representatives adopted the NIH recommendation in the House appropriations report by an overwhelming bipartisan vote of 388-13.  The recommendation then moved to the Senate.

(4) Sen. Arlen Specter (R-PA), Chairman of the House Appropriations Labor-HHS Subcommittee (the subcommittee with jurisdiction over the NIH) decided not to include any language on the NIH plan in the Senate subcommittee report. 

(5) On September 17, the NIH plan was published in the Federal Register, for another 60 day period of public comment ending on November 16.  This is the same text published in the NIH Guide on September 3 for a 60 day public comment period ending on November 2.

(6) On September 24, the NIH announced that the comment periods from the two postings of its plan (September 3 in the NIH Guide and September 17 in the Federal Register) had been merged.  Now all comments are due on November 16, 2004 (60 days from the Federal Register publication).

(7) Supporters have continued to sign on.  Among the most notable are the American Association of Universities, the National Academy of Sciences, and the U.S. Chamber of Commerce.  Together with the open letter from 25 American Nobel laureates in science, the AAU and NAS endorsements solidify the support from the American research community.  The Alliance for Taxpayer Access embodies a large number of important endorsements in its rapidly growing membership list.  ATA members now include an impressive range of patient and disease advocacy organizations, universities, laboratories, and libraries.

The AAU endorsement of the NIH plan, September 27, 2004

The NAS endorsement, September 16, 2004

The Chamber of Commerce endorsement, September 9, 2004

Alliance for Taxpayer Access membership list

An editorial in the New England Journal of Medicine endorsed the key elements of the plan:  the open access and the six month embargo.  In fact, it went further and endorsed OA for "all research articles, not just those funded by the NIH".  NEJM qualified its support, however, by suggesting that the journals publishing these OA-archived articles should hold the copyrights.  It argued that journals need copyrights in order to block the redistribution of mangled copies of the text, for example, one-sided extracts showing the advantages of a new drug without its disadvantages.  (PS:  I'm confident that the NIH funding contract will not take this right away from authors.  Hence, it will be up to authors and journals whether authors will transfer this right to journals, just as it is today.)

Even Elsevier, which doesn't support the plan overall, gave it a kind of backhanded endorsement.  Bradie Metheny wrote in the September 8 issue of Washington Fax (accessible only to subscribers):  "John Regazzi, managing director of marketing development for Elsevier, the world's largest publisher of journals, said no one can argue against giving the public access to NIH information; it is in the public interest.  'But how you do it is the key,' he said.  '[The NIH proposal] is moving too fast,' Regazzi argued."  (PS:  I'd love to see other publishers start from the same premise that open access to this literature is in the public interest.  We could then focus the debate on whether it is or isn't outweighed by other considerations.  But on the whole other publishers are unwilling to make this obvious concession.)

Here are few new questions and answers about the current state of play.

* Why are there two or even three plans? 

The House Appropriations Committee language of July 14 makes some policy recommendations and directs the NIH to come up with its own plan by December 1 to implement them.  The NIH issued a draft of its plan on September 3, for a 60 day period of public comment ending on November 2.  The September 3 text was also published in the Federal Register on September 17, for another 60 public comment period ending on November 16.  The NIH has since merged the two comment periods, with a single deadline of November 16.  The new deadline will give the agency about two weeks after the comment period expires to digest the comments and finalize the plan language before the December 1 deadline.   For the purpose of anticipating what the final plan will or will not provide, consult the NIH's  text (the September 3 and September 17 versions are identical), and eventually consult the revised version of the text that emerges from the public comment period.

* What does it mean that the NIH issued its plan so quickly?

It's not so quick when you realize that it needs to collect and digest public comments before producing a final plan by December 1.  However, it was able to produce the draft plan to fit this timetable because it had already been thinking about the issues for a long time.  For example, it presented a report to Congress on OA issues in May 2004, and had already gathered a wide range of views in three stakeholder meetings in July and August.  The time had come to open the process to public comment.  The prompt release of the plan means that the NIH already supports open access based on its prior deliberations.  Congress is not compelling NIH to act against its better judgment.  Despite the prescriptive language in the House appropriations report, this is less a Congressional mandate than a convergence of views.

Access to Biomedical Research Information (the NIH report to Congress, May 2004)

* What are differences between the July House report and the September NIH plan?

(1) The September plan drops the provision in the July report requiring immediate OA if the NIH paid any part of the article's publication costs.  The new plan simply says that the OA edition will appear six months after publication "or sooner if the publisher agrees". 

Comment:  The public interest would be better served by immediate OA than a six month embargo, but I can accept the embargo as a political necessity to get the plan adopted.  The new change gives publishers even more than the original House version, guaranteeing that the embargo will never be shorter than six months without their consent.  If this concession does not reduce publisher opposition, then it was not worth making and should be revoked.

(2) The September plan gives new detail on exactly what grantees must deposit in PMC: "electronic copies of all final version manuscripts" accepted at peer-reviewed journals, when "final manuscript" is defined as "the author's version resulting after all modifications due to the peer review process."  But then the September plan adds a new provision: "If the publisher requests, the author's final version of the publication will be replaced in the PMC archive by the final publisher's copy with an appropriate link to the publisher's electronic database." 

Comment:  This is welcome detail.  Giving publishers the option to replace the unofficial author version with the official journal version is a very good idea.  Because they needn't exercise the option, publishers can't complain.  Because exercising it would improve the archived OA literature, it can only help.  In its endorsement of the plan, the National Academy of Sciences strongly urged publishers to take advantage of this option.

(3) The September plan gives new detail on what kind of NIH funding triggers the OA plan. The plan applies to NIH "grantees and supported Principal Investigators" and covers "all research grants, cooperative agreements, contracts, as well as National Research Service Award (NRSA) fellowships." The OA policy will apply to all articles whose underlying research "was supported in whole or in part by NIH funding." 

Comment:  This is welcome detail.  The House report fudged the "all or part" question, and the NIH has clarified it in the right decision.

(4) The September plan drops the condition in the July report that the policy will only apply to articles accepted by a "scientific journal listed in the NLM's PubMed directory".  

Comment:  This is two-sided.  On the one hand, it closes a worrisome loophole.  Now the plan will cover NIH-funded research published in any peer-reviewed journal, not just the portion published in certain journals.  On the other hand, it opens the door to criticism that the quality of PMC will be diluted by poor publications.  Since this criticism is easily answered, NIH made the right call.  How do we answer this criticism?  All articles covered by this plan will be based on research proposals that made it through the tough NIH vetting process prior to funding; taxpayers should have open access to all articles based on NIH-funded research anyway, regardless of their quality; and even the inclusion of occasional weak articles in PMC does nothing to detract from the strong ones. 

(5) The House report language wanted the NIH to develop a policy "requiring" deposit in PMC, but the NIH plan will merely "request" that grantees deposit their articles in PMC. 

Comment:  It's not clear whether this word-change is significant.  For example, two members of the House committee that wrote the requirement-language said in public, for the record, on the House floor, that the NIH draft is "consistent" with their own language.  (See the Istook-Regula colloquy, below.)  If they intended a hard and fast requirement and saw the NIH propose an optional request, then they wouldn't have given this endorsement.   Moreover, the NIH will enforce its "request", which gives it at least some of the flavor of a requirement.  The NIH will monitor grantee compliance and use non-compliance as a factor when deciding whether to award subsequent or follow-up funds.  Since serious researchers don't expect to do just one fundable project, they won't risk future funding by disregarding the NIH OA condition (even if they oppose OA, which is unlikely).  For the same reason, publishers who encourage authors to disregard the OA policy, on the ground that it is a mere request, would be harming those authors by exposing them to NIH sanctions.

For both reasons --legislative intent and operation in practice-- it seems that there's no bright line between requests and requirements here.  If that's true, then the softening of the language may just be diplomatic cordiality.  However, if the softening of the language is significant, and compliance is more optional than the sanction makes it appear, then it's a major concession to publishers and a major departure from the public interest in open access.  If further developments make clear that this is the proper way to interpret the language, then publishers should drop their opposition.  If they don't, then the concession was not worth making and should be revoked.

I once drafted a model OA policy for funding agencies that included a requirement (or what I called a requirement), not just a request.  My chosen enforcement mechanism was to have non-compliant grantees repay their grants.  To this day, the only criticism I've received on the policy was directed to the enforcement mechanism.  Several scientists pointed out that denying subsequent funds would suffice.  If so, then the NIH's enforcement mechanism will also suffice, regardless whether we use request or requirement language.

Model open-access policy for foundation research grants

(6) Finally, while the July report contained some background principles and goals of the House Appropriations Committee, the September plan articulates some goals and intentions of the NIH. I count at least these eight: (a) the goal to improve the health of Americans; (b) the goal "to share and support public access to the results and accomplishments of the activities that [the NIH] funds"; (c) the goal to improve access to scientific information for "other scientists, health care providers, students, teachers, and the many millions of Americans searching the web to obtain credible health-related information"; (d) the intention to "balance this need with the ability of journals and publishers to preserve their critical role in the peer review, editing and scientific quality control process"; (d) the intention to monitor the "economic and business implications" of the plan in order to avoid "compromising the quality of the information being provided"; (f) the intention to "maintain a dialogue with publishers, investigators, and representatives from scientific associations and the public to ensure the success of this initiative"; (g) the intention to monitor compliance with the new policy and to use compliance as one factor in evaluating subsequent applications for NIH funds; and (h) the intention to "consider options to ensure that grantees' budgets are not unduly affected by this policy", for example, by journals that impose "unreasonable or disproportionate charges" on grantees.

* What was the "colloquy" on the floor of the House (September 8) and what does it mean?

A colloquy is a scripted dialogue for entering additional language into the Congressional Record.  It provides legislative history on a bill without amending the bill.  The colloquy on September 8 was between Representatives Ernest Istook (R-OK) and Ralph Regula (R-OH), who are both members of the House subcommittee that originally proposed the NIH open-access plan.  Here's roughly what their dialogue added to the legislative history:  concern about rising journal prices; concern about diminishing public access to federally funded research; support for the principle of free online access to publicly-funded research; support for Elias Zerhouni in seeking comments from three stakeholder meetings; support for the NIH's speed in preparing and releasing its September 3 draft plan; and confirmation that the NIH's September 3 draft is consistent with the language in the House appropriations report.  All of this is for the good.

Text of the Istook-Regula colloquy on the House appropriations report, September 8, 2004

* What does it mean that Sen. Arlen Specter has decided not to include a version of the House NIH recommendation in the Senate appropriations bill?

The bad news is that no Senate version of the House language will be adopted.  The good news is that no Senate version will be amended or defeated.  (Sen. Specter is the chairman of the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, the subcommittee determining the budget appropriation for the NIH.)

The fate of the House language will be worked out in a conference committee.  This is what happens whenever the House and Senate appropriations bills differ.  Because the Senate action, or non-action, is compatible with any resolution in the conference committee, and because Sen. Specter knows this perfectly well, we should infer nothing about his support or opposition to the House plan from this decision.  He's keeping his options open and shifting the resolution of the question from a larger chamber to a smaller one.

This step does not help supporters more than opponents or vice versa.  If the Senate had included the House language and voted it up, that would have been best for us and worst for our opponents, since it would have settled the question in our favor and removed it from the conference committee.  But if the Senate had included the language and then watered it down with amendments, or defeated it, that would have been worst for us and best for our opponents.   Both outcomes are now closed, for both sides. 

The members of the conference committee are yet to be named.  But at this stage the Senators most worth reaching with your views are Specter (R-PA), Harkin (D-IA), Stevens (R-AK), Byrd (D-WV), Frist (R-TN), and Daschle (D-SD).  If you have a relationship with any of these Senators or their offices, or if you reside in one of their states, then your phone call, fax, or email would be a big help.

Senator Specter first disclosed his decision on September 3, in an interview with Rick Weiss of the Washington Post.

The AAAS is the only stakeholder group I've seen to make a public comment on Specter's decision.  The association supports the Senate omission of the language but also supports the NIH procedure of gathering public opinion on its draft policy.  One reason may be that the omitted House language would have required immediate OA in some circumstances and the draft NIH policy would not.  (PS:  Other publishers should see that the NIH text is much more favorable to them than the original House language and work for its support.)
(Scroll down about half way.)

Senate Appropriations Committee

Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education (the subcommittee with jurisdiction over the NIH)

* What does it mean that the NIH draft appeared on the "NIH Guide" page, and not originally in the Federal Register?

The NIH plan is a proposed revision of in-house agency guidelines for awarding research grants.  The NIH already has the authority to revise its own guidelines.  It doesn't need new statutes or regulations to give it this authority.  (The fact that the plan eventually appeared in the Federal Register as well doesn't change this fact.)

Hence, if Congress does not act, then the NIH could act on its own.  However, the NIH benefits from Congressional support, and Congressional opposition would certainly cause it to rethink its draft policy.

The NIH Guide web page

* What will the NIH plan cost?

Critics of the NIH plan have projected absurdly high estimates of the plan's costs and then protested that the high costs would unduly diminish the NIH funds available for research grants.  NIH officials repeatedly knocked down these high estimates in public meetings but in late September their estimates finally appeared in print.

Quoting Janet Coleman in the Washington Fax for September 27, 2004 (online access limited to subscribers):  "Preliminary estimates of the cost of offering all NIH-funded research studies on the National Library of Medicine's PubMed Central digital library are around $2.5 million and not the $100 million some critics have suggested, NLM Director Donald Lindberg, MD, said. NLM National Center for Biotechnology Information Director David Lipman 'worked up a budget of actual estimated costs...multiplied by everything under the sun and came up with $2.5 million,' Lindberg told the NLM Board of Regents Sept. 21."

This puts the annual cost of the OA archiving at about 0.008 % of the NIH's annual budget.

* What are the current priorities for what supporters should do to help the cause?

Above all, send comments to the NIH about its draft policy during the 60 day public comment period.  Comments will be accepted until November 16, 2004, and may be submitted by email or web form.  Get your friends and colleagues to submit comments.  Get your departments and institutions to submit comments.

Submit comments by email

Submit comments by web form

If you belong to a U.S.-based organization (university, department, laboratory, library, journal, publisher, patient or disease advocacy organization, etc.) then persuade your group to join the Alliance for Taxpayer Access.  It costs nothing to join and gives the ATA clout when making the case for open access to taxpayer-funded research. 

If you are an individual, see the ATA recommendations for individual actions that could help the cause.  Among the most effective options are sending a letter, fax, or email to your Senators expressing support for the NIH plan.

Comments and letters from U.S. citizens and U.S.-based organizations will carry more weight with the NIH and the U.S. Senate than comments from others, but the process is not limited to Americans.

* For other questions and answers on the NIH plan, see my FAQ, which I've enlarged several times during the past month.

The NIH now has its own page on the evolving OA plan.

For news stories on the NIH plan since the last issue of the newsletter, see the section on major stories, below.


Read this issue online

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