Introduction
CRE and the regulated community have a strong interest in assuring the public's right to obtain and examine data that are produced with public funds and upon which federal regulatory policy is based. We believe, on the whole, that the new federal data access policy now being adopted represents a balanced approach between the need for protection of researcher and subject confidentiality and the public's right to open government. We are confident that, with the addition of some discrete provisions, the revised Circular will produce both a higher standard of scientific rigor in federally funded research and a more authoritative body of study to assist government decision makers in the creation of federal policy.
As an initial matter, we commend OMB for issuing the proposed revisions to section ____.36 of OMB Circular A-110, and issuing them in time for completion of the revision process by the end of the current fiscal year, October 1, 1999. We believe that the proposed revisions represent an important step forward in assuring fair access to government-sponsored research findings.
These comments are intended to serve two broad functions. First, they are offered as a statement of authorities and policy arguments in support of the broadened federal data access law and many of the proposed revisions to the OMB Circular. Part One of these comments discusses the statutory basis for the proposed revisions to Circular A-110, as well as the policy arguments that were the impetus for that legislation. An extensive cross section of current data access policies -- from government agencies, private and public research institutions, professional publishing organizations, and other sources -- are then examined.
Second, we address a number of discrete areas where we believe the proposed revisions need to be fleshed out. In Part Two of the comments, we discuss the concerns most frequently cited in opposing a broader data access policy, and we offer suggestions for implementation of the revised Circular by which these objections may be resolved. An extensive analysis of the Freedom of Information Act and the protections it affords against disclosure is presented in this part. Longstanding ethical and institutional protections against disclosure of human subject data are then considered. The discussion is then broken down, first, on an issue-by-issue basis, where we have set forth our analysis and recommended resolutions, and second, in a criticism-response format where we address specific arguments that opponents of certain aspects of the new federal data access policy have raised.
One overarching procedural aspect of the revised federal policy on data access warrants discussion at the outset. OMB's revisions to Circular A-110, including the public comment process, OMB's review of the comments submitted, and the subsequent reissuance of the revised Circular, represent the adoption of only an umbrella agency policy. Each separate awarding agency will apply the Circular to the research it funds in a manner consistent with the terms and conditions set forth by OMB. In doing so, the agency will take into account the unique circumstances of the universities, hospitals, and non-profits that receive awards from that agency, as well as the kinds of research these entities typically undertake. The individual awarding agencies thus will be able to tailor their own regulations, to a certain degree, to fit the special needs of their own awardees. During the course of this secondary agency rulemaking, the public will be provided another opportunity to comment on each agency's proposed regulations in accordance with the Administrative Procedure Act and Executive Order 12866.
The immediate task for OMB in revising Circular A-110, therefore, is not to resolve each conceivable data access issue for every federal agency. The focus instead should be on providing a workable framework for all federal agencies, within which particularized solutions may be designed. Guidance from OMB can serve the useful purpose of making those solutions as uniform and internally consistent as possible while implementing the new data access law.
