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Research Data Services: HHS/NIH Requirements

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NIH Data Management and Sharing

The National Institutes of Health, since 2003, has required recipients of grants totaling $500,000 per year or more to share the data produced by their research. All grant applications for this amount or more must include a data sharing plan, which should be "provided primarily in the form of a brief paragraph immediately following the Research Plan."

Research Data Services can assist you in creating a data sharing plan by determining what data can or will be shared as well as in what formats and where the data will be stored. Contact Research Data Services to schedule an appointment.


Here are some more resources to help you:

The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.  To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.

 Is My Research Part of This Mandate?

If you answer YES to any of the following criteria describing the funding for your peer-reviewed article, then you must deposit your article as outlined in this guide. The research upon which your article is based is:
 

  •     Supported in whole or in part by direct funds from NIH or;
  •     Directly funded in any part by NIH during Fiscal Year 2008 (October 1, 2007- September 30, 2008) or beyond, or;
  •     Directly funded in any part by NIH with a contract signed on or after April 7, 2008 or;
  •     Directly funded in any part by the NIH Intramural Program or;
  •     NIH pays your salary.

 NIH funded research at SU

This policy is NOT retrospective beyond April 7, 2008. Older articles do NOT need to be submitted to PubMed as outlined in this guide. For additional information, See To what types of papers does the NIH Public Access Policy apply?

 

CDC and AHRQ Public Access Policies

Two divisions of the Health and Human Services Administration, the Centers for Disease Control (CDC) and the Agency for Healthcare Research and Quality (AHRQ) will be implementing new policies regarding public access to publications and data generated from grants awarded by the two agencies. These policies were mandated for all federal agencies awarding grants by the White House Office of Science and Technology Policy in 2013 for the purpose of making research funded, ultimately, by the public available to the public.

Beginning in October 2015, both the CDC and the AHRQ will require all publications resulting from research funded by either agency to be deposited in PubMed Central (PMC). PMC is a repository of scholarly articles published in the biomedical and life sciences fields. Both agencies will require the articles to be submitted within one year of publication.

Additionally, both agencies will require that any data generated by the research will also need to be made public. Researchers must include a Data Management Plan (DMP) in their grant proposal which outlines how the data will be collected, processed, safeguarded and, ultimately, made publicly accessible. The CDC indicates that it will work to identify repositories for data with the possibility of using their existing archives administered by the National Center for Health Statistics. The AHRQ says that it will partner with a commercial archive to provide a place for data.

These requirements for making publications and data publicly available are not all that new. What is new, however, is the increased emphasis on compliance. Both agencies make it clear that the Data Management Plan will be reviewed with the rest of the proposal and could negatively impact the score assigned to the proposal. Until now, the DMP was reviewed separately from the rest of the proposal and was commented on, but did not affect the final funding decision. Additionally, new awards will not be made if the terms of previous awards, such as publishing the data or following the DMP as stated, had not been fulfilled.

The CDC’s plan is CDC Plan for Increasing Access to Scientific Publications and Digital Scientific Data Generated with CDC Funding, and the AHRQ plan is AHRQ Public Access to Federally Funded Research.