LEGAL AND POLICY REQUIREMENTS FOR ACCESS TO DATA

The Data Access Act and the Information Quality Act

Various government laws, regulations, and policies influence the accessibility of research data. Among these are the Data Access Act (DAA) of 1999 and the Information Quality Act (IQA) of 2001, also known as the Data Quality Act.48

The DAA is also known as the “Shelby Amendment,” after its sponsor, Senator Richard Shelby of Alabama. It was passed as a rider to an appropriations bill in 1999. The DAA requires that data from federally funded research be made available to requesting parties under Freedom of Information Act procedures if the research is: (1) used to support an agency action, and (2) performed by a university or other nonprofit institution.49 In response, OMB modified its Circular A-110 to read as follows:

[I]n response to a FOIA [Freedom of Information Act] request for research data relating to published research findings under an award that were used by the federal government in developing an agency action that has the force and effect of law, the federal awarding agency shall request, and the recipient will provide within a reasonable amount of time, the research data so that they can be made available to the public under FOIA.


The provision established which types of research data are subject to disclosure and the procedures, standards, and exemptions that apply in requesting and disclosing those data. Before the provision was published, persons could only obtain raw data that were in possession of a federal agency, whereas the revised provision provided access to data that are in possession of a grantee institution. If even a small amount of public money was used to produce data, those data may be subject to DAA requests. However, studies conducted by industry or by others without the use of public funds are not covered by the data-sharing requirements, even if the studies are employed in the formulation of public policy or regulations. Also, as interpreted by OMB, the provision applies only to data supporting regulations with a “major” impact on the economy and is prospective, covering studies launched after the OMB guidelines were put into effect.

The DAA was controversial at the time the legislation passed and when OMB was developing the specific changes to Circular A-110. Participants in a 2001 National Research Council workshop pointed out future problems that

48

National Research Council. 2002. Access to Research Data in the 21st Century: An Ongoing Dialogue Among Interested Parties: Report of a Workshop. Washington, DC: The National Academies Press.

49

Wendy Wagner and David Michaels. 2004. “Equal treatment for regulatory science: Extending the controls governing the quality of public research to private research.” American Journal of Law & Medicine 30:119–154.



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