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
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.
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.
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
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.