The U.S. CURES Act would mandate OA
SPARC Open Access Newsletter, issue #93
January 2, 2006
by Peter Suber
Senator Joe Lieberman (D-CT) has introduced a bill into the U.S. Senate that would mandate OA to the bulk of federally-funded medical research.  Called the American Center for CURES Act of 2005 (S.2104), it's co-sponsored by Thad Cochran (R-MS), Kay Bailey Hutchison (R-TX), and Thomas Carper (D-DE).  The bipartisan bill was announced on December 7 and formally introduced on December 14.

The CURES Act would create a new agency within the NIH, the American Center for Cures, whose primary mission would be to translate fundamental research into therapies.  The bill is large and covers a lot of territory but for our purposes the critical part is Section 499H, which contains the OA mandate and related provisions.  The OA mandate covers research funded by the Department of Health and Human Services, which includes the NIH, and is not limited to the NIH or to the new American Center for Cures.  Over half of the non-classified research funded by the federal government is funded by the Department of Health and Human Services.
 
The bill goes beyond the NIH public-access policy in several important ways. 

(1) It requires free online access and does not merely request it. 

(2) It requires deposit at the time of acceptance by a journal.

(3) It shortens to six months the permissible delay or embargo between deposit and free online access.  When the bill was first announced, the maximum delay was only four months.  But the number drifted up to six in order to harmonize with other OA legislation in the pipeline.  (Watch this space!)

(4) It extends the OA policy beyond the NIH to the other agencies within the Department of Health and Human Services, including the Centers for Disease Control and Prevention and the Agency for Healthcare Research. 

(5) It explicitly says that non-compliance may be a ground for the funding agency to refuse future funding. 

(6) It explicitly relies on the existing government purpose license (45 CFR 74.36) instead of publisher consent as the legal basis for disseminating the research results.  The NIH acknowledges that the license exists but decided to rely instead on publisher consent, at least for now.  By shifting from publisher consent to the regulatory license, the CURES Act will not accommodate publisher resistance.  This key step is needed to insure that protecting publishers does not take priority over public health.

The only difference from the NIH policy that I consider a step backward rather than a step forward is that the CURES Act does not offer to let grantees use grant funds to pay the processing fees charged by some OA journals. 

There are several large similarities to the NIH policy.  Public access would be provided by PubMed Central, although the articles could be deposited in other repositories as well.  The CURES Act would apply only to the author's final peer-reviewed manuscript, not to the published version, although publishers would have the option to replace the former with the latter if they wished.  The Act applies to government employees as well as government grantees.  The Act applies to research supported in whole or in part by public money from the relevant agencies.

In addition to mandating OA for federally-funded medical research, the Act would mandate that NIH-funded clinical drug trials taking place in the U.S. register in an OA registry and deposit their data in an OA database.  Any organization submitting a clinical trial protocol to the Food and Drug Administration (FDA) would have to register the trial in the registry, even if the trial received no federal funding.  NIH grantees who do not comply risk loss of funding, while non-grantees who do not comply risk fines of up to $1 million.

The bill is excellent.  The public-access provisions fix everything that is wrong with the NIH policy and extend it beyond the NIH to the other major medical research agencies.  The only stronger OA policy put forward by a public funding agency is the draft policy released for comment last June by the Research Councils UK (RCUK).  The draft RCUK policy stronger because it applies to all government funded research, not just medical research; it relies on distributed institutional repositories, not a central repository; and it lets authors use grant funds to pay processing fees at journals that charge processing fees.  But we haven't seen the final form of the RCUK policy.  The CURES Act hasn't been adopted, merely proposed, but we do know its final form and, at least for now, it would make the U.S. Department of Health and Human Services the worldwide leader in providing public access to publicly-funded medical research.

The CURES Act has had remarkably little press coverage.  The reason is not that OA is insignificant to the press and public.  The bulk of the bill is devoted to its breakthrough healthcare provisions and they are getting equally little coverage.  (The OA provisions are such a small part of the whole package that they aren't even mentioned in Senator Lieberman's summary.)  Members of Congress, including the bill's sponsors, and the reporters who cover them, have been preoccupied by the more urgent business of renewing, blocking, or modifying the Patriot Act.

The THOMAS entry on the CURES Act, including the text of the bill and a log of Congressional actions.
http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.02104:
(the final colon is part of the URL)

CURES Act, summary, December 7, 2005
http://lieberman.senate.gov/documents/bills/051207curesbill.pdf

CURES Act, section by section breakdown, December 7, 2005
http://lieberman.senate.gov/documents/bills/051207curessectionbysection.pdf

Quotations in support of the CURES Act, December 7, 2005
http://lieberman.senate.gov/documents/bills/051207curesquotes.pdf

Senator Lieberman's press release announcing the bill, December 7, 2005
http://lieberman.senate.gov/newsroom/release.cfm?id=249566

Senator Lieberman's speech on the floor of the Senate introducing the bill, December 14, 2005
http://thomas.loc.gov/cgi-bin/query/F?r109:1:./temp/~r109FG9sqY:e55683:
PDF of the Congressional Record
http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2005_record&page=S13578&position=all

Government purpose license, 45 CFR 74.36
http://www.peo7.com/CFRFiles/PEOusCFR_45PUBLICWELFARE_119259.htm

Press release from the Alliance for Taxpayer Access, December 7, 2005
https://mx2.arl.org/Lists/SPARC-OAForum/Message/2600.html
http://www.earlham.edu/~peters/fos/2005_12_04_fosblogarchive.html#113413512422857244

Press release from five library groups, December 21, 2005.  The groups signing this statement are the American Association of Law Libraries (AALL), American Library Association (ALA), Association of Research Libraries (ARL), Medical Library Association (MLA), and the Special Libraries Association (SLA).
http://www.arl.org/info/publicaccess/cures_121605.pdf
http://www.earlham.edu/~peters/fos/2005_12_18_fosblogarchive.html#113517300873851380

Here's some news coverage of the CURES Act:

Anon., New NIH center would tackle common diseases, ResearchResearch, December 16, 2005.
http://www.researchresearch.com/news.cfm?pagename=newsStory&type=default&elementID=57940

Ana Radelat had two very brief stories on the CURES Act in Mississippi papers:  six sentences in the Hattiesburg American and two sentences in the Clarion Ledger, both on December 11.
http://www.hattiesburgamerican.com/apps/pbcs.dll/article?AID=/20051211/NEWS05/512110316/1002/NEWS01
http://www.clarionledger.com/apps/pbcs.dll/article?AID=/20051211/NEWS/512110357/1002/NEWS01
http://www.earlham.edu/~peters/fos/2005_12_11_fosblogarchive.html#113456559232769957

New NIH Translational Research Center Proposed By Sens. Lieberman, Cochran, Research Policy Alert, December 7, 2005.
http://www.researchpolicyalert.com/fdcreports/story/viewStory.do?targetGUID={F11FDCF2-9D45-40BB-948A-018E2B5CD4D1}

John Brummett, At the mercy of a dysfunctional Congress, Pahrump Valley Times, November 25, 2005.
http://www.pahrumpvalleytimes.com/2005/11/25/opinion/brummett.html

Long before Sen. Lieberman introduced the CURES Act, the US Mayors Conference adopted a resolution endorsing the launch of an American Center for Cures, June 29, 2004.  The resolution does not mention the public-access provisions,
http://www.usmayors.org/uscm/resolutions/72nd_conference/chhs_08.asp


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