Research Compliance
April 21, 2008
NEW! NIH Publications Policy
The National Institutes of Health (NIH) is instituting a new publications policy. The following communication from The Council of Governmental Relations’ (COGR) Director for Research Compliance and Administration Carol Blum provides the following overview of the new policy, in a recent COGR communication:
“The National Institutes of Health released a Request for Information in the NIH Guide on March 28 seeking further comment on the NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (NIH Public Access Policy). The notice in the NIH Guide (NOT-OD-08-060) will be followed by a notice in the Federal Register (scheduled for released on March 31, 2008). NIH will consider comments received through May 31, 2008. Information on the NIH Public Access Policy
NIH issued a revised Public Access policy on January 11, 2008. The policy is in effect and requires submission of final, peer-reviewed manuscripts accepted for publication on/after April 7, 2008 resulting from NIH-supported research with current, active funding (grants funded since October 2007; contracts funded on/after April 7, 2008). This RFI (and forthcoming Federal Register notice) is a continuation of the discussion and consideration of how to implement the statutory requirement included in PL 110-161 (the Consolidated Appropriations Act of 2008). This RFI does not change the current requirement. Institutions should focus on informing investigators of the requirement and assisting them in reserving their right in copyright agreements to submit the manuscript to PubMed Central. Because of the limit to currently supported NIH projects, institutions should consider focusing on delivering information and assistance to investigators with on-going NIH support who are likely to have research results to report from prior year activities.
COGR will prepare a comment in response to the RFI. It will follow-on and add to the COGR comment made at the public meeting on March 20, 2008; a copy is available on the web site: www.cogr.edu. We welcome your thoughts and recommendations in response to the questions posed in the RFI seeking recommendations for: alternative implementation approaches; monitoring and oversight; additional training and informational resources from NIH. Send comments to cblum@cogr.edu
Dr. Jeff Thompson (CSU SB) and Dr. Tom Scott (SDSU) have provided helpful descriptions of the new compliance process. The following communication from Dr. Scott to the SDSU research community provides a step-by-step set of instructions:
Colleagues with NIH funding or the prospect of such funding:
On April 7, the National Institutes of Health will implement a policy that ensures that the public has access to the published results of NIH-funded research. It requires scientists to submit journal articles that result from NIH funding to the digital archive PubMed Central. The objective is to make NIH-supported research available to the public so as to advance scientific knowledge and improve human health. The new policy is mandatory and falls under the Consolidated Appropriations Act of 2008. It states:
The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit, or have submitted for them to the National Library of Medicine's 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.
Some Specifics
1. The NIH Public Access Policy applies to all peer-reviewed articles accepted for publication on or after April 7, 2008 that arise, in whole or in part, from direct costs provided by the NIH.
2. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles comply with this policy. That may involve withholding copyright transfer that would normally go to the publisher as it applies specifically to PubMed Central.
3. PubMed Central is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases.
4. The final, peer-reviewed manuscript should include all graphics and supplemental materials that are associated with the article.
5. Beginning May 25, 2008, NIH applications, proposals, and progress reports must include the PubMed Central reference number when citing an article that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator's NIH award. This policy includes applications submitted to NIH for the May 25, 2008 due date and subsequent due dates. The NIH has not defined the penalties it will exact if the reference number is not applied, but since they have the funds we are applying for, not complying would be unwise.
Submitting an Article:
Authors may submit an article to the journal of their choice for publication.
1. If you publish in most of the journals in the life sciences, you need do nothing further to comply with this policy. That is because some publishers have agreed to make their NIH-funded articles publicly available on PubMed Central within 12 months of publication. (For the list of the hundreds of journals that promise to comply--and so relieve you of that obligation). Some journals will submit the final manuscript (not the article), in which case you will have to verify and approve the manuscript. )
2. For journals not on this list, you must:
a. Inform the journal that the article is subject to the Public Access Policy when submitting it for publication.
b. Make sure that any copyright transfer or other publication agreement allows the article to be submitted to PubMed Central in accordance with the policy.
c. Submit the article to NIH, upon acceptance for publication.
Addditional information and FAQs
February 1, 2008
2008 Office for Human Research Protections (OHRP) Conference
The Office for Human Research Protections (OHRP) in conjunction with the University of California Davis will be sponsoring a National Research Community Forum entitled, “Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008,” on Friday, February 8, 2008, at the Doubletree Hotel Sacramento in Sacramento, California. Co-sponsors for this forum are the Northern California IRB Consortium Forum, the California State University Chancellor’s Office, California State University Long Beach, the San Jose State University, and the California State University San Marcos.
This forum will focus on specific applications and interpretations of the regulations entitled, “Protecting Human Subjects” for conducting biomedical and behavioral research that is funded by the Department of Health and Human Services. The program will showcase experts from academia and the federal and state governments who will address unique aspects for balancing the principles of The Belmont Report in conjunction with federal and state laws and ensuring that the protection of human subjects in clinical trials is maximized. Representatives from the OHRP, U.S. Food and Drug Administration, National Institutes of Health, Department of Education, and the Department of Defense will provide federal regulatory updates and clarification of key policy issues.
For more information visit UC Davis OHRP
