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Federal Agency Public Access Compliance

A Research Guide summarizing the Federal public access policies resulting from the US Office of Science and Technology Policy memorandum of February 2013.

Development of Health and Human Services (HHS) Plans and Guiding Principles

  • OSTP has determined that the Research and Development (R&D) threshold of $100 million in annual research and development expenditures be applied on an Operating Division (OPDIV) by OPDIV basis, and not to all of HHS.
  • Four HHS OPDIVs meet the Research and Development threshold:
    • National Institutes of Health (NIH)
    • Centers for Disease Control and Prevention (CDC)
    • Agency for Healthcare Research and Quality (AHRQ)
    • Food and Drug Administration (FDA)
  • Each OPDIV was directed to draft their own implementation plan.
  • All HHS agencies were invited to draft their own implementation plan.

HHS Common Approach to Public Access to Scientific Publications

  • The common public accesses policy approach will utilize existing infrastructure developed by the National Library of Medicine (NLM), including key elements of the NLM infrastructure.
    • PubMed Central, a web-based repository of biomedical journal literature providing free, unrestricted access to full-text articles.
    • PubMed, a publicly available database of journal citations.
    • The NIH Manuscript Submission System (NIHMS) for the deposit of final peer-reviewed manuscripts or published articles.
  • Each OPDIV is developing its own agreement with NLM for use of these systems, as detailed in their plans.
  • OPDIVs will utilize a common embargo period of not more than 12 months.

HHS Common Approach for Public Access to Scientific Data in Digital Formats

  • The HHS does not have a common repository for research data holdings, nor common standards for data management and archiving, nor common requirements or enforcement practices for the sharing of data.
  • Priorities for the Development of Public Access Plans for Scientific Data
    • Develop a better understanding of the types of data and the location of those datasets for each OPDIV.
    • Develop an information system for managing an Enterprise Data Inventory (EDI) to catalog the various sets of data generated, acquired, managed or collected by the agency.
      • The HHS Enterprise Architecture Repository (HEAR) will support a “federalized” approach to populating the EDI. HEAR will:
        • Be linked to HHS’s platform.
        • Be enabled to import data inventory entries from other repositories by harvesting them from agencies.
        • Serve as the place where data asset metadata can originate.
    • Strengthen requirements for investigator-initiated data management plans and data sharing requirements.
      • Researchers will be required to make the data underlying their publications publicly available.
      • NIH will apply requirements for data management plans to all its researchers, not just those with research awards in excess of $500,000.
      • CDC will pilot a data management plan template, which is aimed at standardizing the types and format of information submitted by researchers in their research proposals.
      • As described in the FDA, AHRQ and ASPR plans, these agencies will, for the first time, require all investigators to submit data management plans.