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March 15, 2005Client Alert

OMB Issues Final Guidance Identifying When Scientific Information Should be Subject to Peer Review

Recently, the White House Office of Management and Budget ("OMB") issued the final version of its Information Quality Bulletin for Peer Review ("Bulletin"). The Bulletin is important because it establishes uniform standards encouraging peer review of all important scientific information disseminated by federal agencies. The Bulletin provides that peer review is required if scientific information is "influential," which is generally described as information an agency can reasonably determine will have a clear and substantial impact on important public policies or private sector decisions. Stricter minimum requirements are imposed on certain types of scientific information categorized as "highly influential." Although some agencies already employ various methods of scientific peer review, the Bulletin represents the first time comprehensive guidelines have been issued to all federal agencies. Individual agencies, however, are left with significant discretion in determining what type of peer review is appropriate, and which peer reviewers to select. The Bulletin also exempts certain types of information from the peer review guidelines.

The Bulletin, which is less prescriptive than the earlier drafts, was issued after more than 15 months of consideration, two rounds of public comment, and an interagency workshop. The Bulleting was issued under OMB's general authority to oversee the quality of federal agency information and analyses. Essentially, the Bulletin functions as a "gloss" on the "Information Quality Act", where Congress directed OMB to issue guidelines that "provide policy and procedural guidance to federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information" disseminated by those agencies. Prior to this Bulletin, there were no uniform standards requiring, or even encouraging, peer review.

Scientific peer review is the practice of subjecting scientific findings to the scrutiny of independent analysis conducted by qualified individuals to verify that the research presented is of sufficient quality, importance, and interest to be published. It is an important form of deliberation used to judge both the appropriateness of the methods and the inferences made by those conducting the research. The evaluation or critique -- which often suggests ways to clarify assumptions, findings and conclusions -- can then be used by the authors of the draft to improve the final product. A peer review typically evaluates:

  1. the clarity of the hypothesis,
  2. the validity of the research design,
  3. the quality of the data collection procedures,
  4. the robustness of the methods employed,
  5. the appropriateness of the methods for the hypothesis being tested,
  6. the extent to which the conclusions follow from the analysis, and
  7. the strengths and limitations of the overall product.

The Bulletin is careful to make clear that peer review should not be confused with public comment and other stakeholder input. The Bulletin also makes clear that, while peer review may be an important aid in decision-making that involves the dissemination of information, it will rarely be an agency's sole consideration. The Bulletin explicitly provides that agencies are not expected to "cede their discretion with regard to dissemination of use of information to peer reviewers."
The scope of the Bulletin is limited to "review of scientific information disseminations that contains findings or conclusions that represent the official position of one or more agencies of the federal government." With some limited exceptions, the requirements of the Bulletin become effective either six months or one year after publication, based on the type of information to be disseminated.

For further information regarding this Bulletin or how this may impact your business or regulated operations, please contact David A. Crass at dacrass@michaelbest.com or 608.283.2267.

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