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Data Access

NIH Takes Lead in Implementing Data Access Rule Through Issuance of Guidance to Grantees and Applicants

The National Institutes of Health (NIH) has issued guidance on its Website to its grantees and applicants regarding steps to be taken to implement the Data Access provisions contained in revised OMB Circular A-110. NIH is among the first agencies to issue such guidance, and it can be expected to serve as a model for other federal agencies. The guidance lays out an overview of the process, including initial steps on cost reimbursement. Although the NIH process is not yet final, this guidance is an excellent first step in implementing meaningful Data Access across the federal government.

For easy reference, we have included the Overview of Process section of the NIH Guidance, which follows below (posted 3-21-00). However, we recommend that one also review the materials on the NIH Website itself, as these materials are likely to evolve over time.

  • Click to view the NIH Guidance for Data Access

  • Overview of NIH Process

  • The requestor prepares a FOIA request. The request must include:

  • The specific regulation or administrative order citing the data being requested;

  • The publication cited in the regulation or administrative order;

  • The grant number under which the data were produced; (Information on grants, including grants numbers, is available on the NIH web site in CRISP)

  • A specific description of the data being sought;

  • A statement that the data are being requested under the amendment to Circular A-110 (45 CFR 74.36).
  • NIH asks the requestor to send the request to the FOIA coordinator for the NIH Institute or Center (IC) funding the grant. A list of IC FOIA coordinators is provided on the NIH FOIA web page. (See http://www.nih.gov/od/foia/index.htm)

  • The FOIA coordinator for the funding IC processes the request.

  • The FOIA coordinator notifies the funding IC's grants management office and sends a letter to the Office of Sponsored Research at the grantee institution with a copy to the Principal Investigator notifying them about the request. Included with that letter will be guidance provided by the NIH FOIA office on how to respond to this request.

  • If the data are already available to the public through an archive or other source, the A-110 amendment allows the FOIA coordinator to direct the requestor to the public source. And the process stops here.

  • However, if the data are not publicly available, the process continues as follows.

  • The amendment to A-110 provides for a reasonable fee to cover the costs incurred in responding to the request. The fee will include both the costs to the NIH and the costs incurred by the grantee institution, which will be accounted for separately. To accomplish this, the FOIA coordinator:

  • Asks the grantee institution to estimate cost of providing the data; and

  • Tells the requestor the estimated cost of producing the data.

  • If the requester [sic] has a history of not paying for costs related to either FOIA or A-110 or if the estimated cost is greater than $250, then prepayment will be requested.
  • Under the A-110 amendment, the grantee institution and the investigator are required to provide data that are consistent with the definition of research data (see definitions above [on NIH site]) and deemed responsive to the request.

  • Prior to sending the data to the appropriate NIH FOIA coordinator, the grantee institution and the investigator redact the data to remove personal identifiers and other information in accordance with amended A-110 definitions (see above [on NIH site]) and FOIA procedures.

  • The grantee institution transmits the data to the FOIA coordinator of the funding IC along with an accounting of all associated costs. NIH will develop guidance on how to estimate associated costs.

  • The FOIA coordinator and a knowledgeable program official from the funding IC review the submitted data.

  • The FOIA coordinator responds to the requestor, issues a final invoice for the fees, and transmits the data.