EXECUTIVE SUMMARY
Part One of these comments presents the argument that the new federal policy on data access, including the proposed revisions to section ___.36 of Circular A-110, is basically sound and is well supported by statutory authority, public policy considerations, and broad precedent.
With respect to statutory authority, the Fiscal Year 1999 Omnibus Appropriations Act requires OMB to amend its Circular A-110 so that all data produced under a federal award will be made available to the public through procedures established under the Freedom of Information Act, 5 U.S.C. § 552, et seq. ("FOIA"). This mandate follows on and clarifies earlier congressional directives set forth in the Paperwork Reduction Act of 1995.
Strong policy arguments favor public access to federally funded research data. These arguments include traditional public right to know principles inherent in open government. The government itself benefits from guaranteed public access to research data, because this access allows public policy to be based on more thoroughly analyzed research findings. The scientific enterprise is advanced through more rigorous scrutiny of conclusions, an increased confidence in scientific determinations, more efficient data collection and data management practices, and an improved perception of federal research among the public.
There is a growing consensus for the release of federally sponsored research data. This consensus is evidenced by a host of precedents allowing and encouraging the liberal sharing of research data. The comments below discuss a number of these precedents. Several federal government agency policies are examined, including policies of the FDA, the National Science Foundation, the National Center for Health Statistics, NIH and others. The comments set forth data access policies adopted by major scientific organizations and journals, including the National Research Council, the Institute of Medicine, The British Medical Journal, Cancer Research, The Journal of the American Medical Association, Nature, and several others. Professional Commentary supportive of data access is included. Examples of policy statements on data access from several distinguished research universities are also given, including Duke, MIT, Mount Sinai, the University of Minnesota, and others. This section of the comments concludes with a discussion of some state legislation that also provides public access to certain research data.
Part Two of the Comments addresses specific issues that arise in connection with the proposed revisions to Circular A-110 and attempts to allay some of the most frequently voiced concerns relating to data access.
The new law provides that data will be made available though FOIA procedures, and the comments therefore discuss how the FOIA procedures will protect against harmful disclosures of research data. In particular, this section discusses key exemptions under FOIA for non-disclosure of confidential medical, personnel and other data affecting privacy rights. Protections for intellectual property rights and the FOIA exemption for national security are then discussed. The section concludes with a discussion of various procedural and logistical concerns relating to FOIA and agencies' FOIA regulations.
The FOIA exemptions for non-disclosure of private personal data actually duplicate and are consistent with other privacy protections familiar to researchers. Existing ethical standards and research practices for screening and coding already assure confidentiality to human subjects participating in medical research. The comments therefore discuss some of these practices.
A brief section addressing procedural aspects of the revised OMB circular follows the privacy discussion. One crucial point that should be understood about the current administrative process is that the awarding agencies will be required to issue conforming regulations, and those regulations can be tailored to address specific problems. The public will be allowed an opportunity to participate in this subsequent data access rulemaking.
The comments next set forth a proposed notice to researchers and other awardees that we recommend accompany all federal awards. The notice fulfills a number of important functions, including informing the awardee and any private research partners of the possibility that some or all of the researchers' data relating to the award may be requested and publically disclosed through FOIA.
Because many of the issues that have arisen in connection with the data access debate center around a few key words in the statute and OMB's proposed revisions, we have included a comment section discussing definitions directly. This section addresses six important words or phrases, including "data", "published" and "used in developing policy or rules." We offer proposed language for defining some of the most important terms.
We next address the issue of cost reimbursement. As a general proposition, we believe that researchers, as a condition of receiving federal funds, should be required to maintain their data in a manner sufficient to allow retrieval of the data by the government. We nevertheless also believe that both Congress and OMB intend that many, if not all, of the additional costs that researchers incur in responding to public requests for study data should be borne by those making the requests. CRE notes that the issues relating to cost reimbursement are susceptible of resolution by OMB prior to the end of the current fiscal year.
The final section of comments presents a series of anticipated criticisms of the new federal data access policy and the revisions that OMB has proposed to Circular A-110. Similar to a Q and A format, this discussion is organized around individual issues that have appeared in the press and elsewhere, and the discussion attempts to answer the questions pragmatically, often by reference to mechanisms proposed elsewhere in these comments.
