What is it?
The FDA now requires that those receiving research grant funding from the FDA take steps to make their publications and research data publicly accessible. Here's link to the policy: http://www.fda.gov/downloads/ScienceResearch/AboutScienceResearchatFDA/UCM435418.pdf
When?
Publications: Effective October, 2015.
Data: Effective October, 2015.
How?
Publication manuscripts will be submitted to PubMed Central; the Data Management Plan (DMP) should include a repository where the data will be deposited. FDA is exploring the establishment of a "Research Data Commons".
Why?
This plan was developed in response to the White House's Office of Science and Technology Policy’s (OSTP) February 22, 2013 memorandum, “Increasing Access to the Results of Federally Funded Scientific Research."
DATA
- Include a Data Management Plan (DMP) in the grant proposal, which names an open access repository where the data will be deposited by the researcher.
PUBLICATIONS (Journal articles, conference proceedings articles)
- Submit the Author Manuscript version of any research publications which result from FDA funding to PubMed Central. This should be done as soon as the article is accepted for publication. (The author manuscript version is the author's own copy of the peer reviewed manuscript, unformatted by the publisher).
If you have any questions about your grant proposal, your award, your funding agency, or other logistical questions, please contact the Office of Sponsored Programs.
