Data Access

CRE Analysis

8. The term "published" leaves open to question exactly what data must be released under the new law.

Comment by Biotechnology Industry Association

CRE Response:

Most research organizations have taken the position that publication should mean only "publication in a scientific journal after formal peer review," CRE believes that this definition is too narrow. Under such a restrictive definition, award recipients would be able to avoid disclosure of data otherwise available to the public merely by failing to submit the data to a formal peer review publication. Studies and conclusions cited in support of a federal government action that are either unpublished or published in a non-peer reviewed journal should also be made available for public scrutiny. Indeed, it is precisely this type of study that most warrants thorough examination by the public.

CRE noted that every willful, pro-active release of results or conclusions by a scientist to the public domain could, in a real sense, be characterized as "publication". In many cases the need for access to data will arise well before research papers are officially accepted for publication in a peer reviewed scientific or technical journal. CRE cited, for example, posters displayed at scientific conferences. Such materials are often publically displayed, and the conclusions they present have been relied upon in some cases by government officials in developing policy.

Interestingly, the comments of the Biotechnology Industry Organization do not echo the sentiment of the research community. BIO suggested instead that "publication" should include "the first formal and complete presentation of research and its findings in whatever medium the researcher chooses to use." The basis for their recommendation is that a researcher who publishes findings on the Internet or in another non-peer-reviewed forum should not be permitted to avoid data access requirements on that basis. The BIO approach is thus more aligned with CRE's recommendations than with those of many research groups.

In its August 11, 1999 reproposal, OMB adopted the "peer reviewed journal" test favored by many researchers, but also stated that the "publication" element could be satisfied if a federal agency cited to the research findings in support of a regulation. This latter, alternative prong was consistent with comments submitted by CRE in April.