Draft of Policy on Submission of Letters/Articles with Alternative Viewpoints

POLICY AND PROCEDURES ON SUBMISSION OF LETTERS/ARTICLES WITH ALTERNATIVE VIEWPOINTS

Effective date: April 16, 2004

Revised February 28, 2005

Summary:

The purpose of this policy is to provide an opportunity for the ALLHAT Steering Committee to be apprised of potential publications by Steering Committee members in which conclusions and recommendations diverge from those in previously approved ALLHAT publications, including those from ancillary studies. It is not the intention to limit the free exchange of ideas or individual interpretations of the results of ALLHAT. Rather, this process will enable Steering Committee members to be aware of and comment on such differences.

All articles with alternative views must include a disclaimer as described in the policy.

Policy:

Published ALLHATresults papers and the recommendations therein reflect a consensus position taken by the ALLHAT leadership.

As a matter of scientific probity, the Officers and Coordinators of ALLHAT must communicate to the scientific community and the general public any new development that might alter the conclusions or the recommendation published in official ALLHAT papers, including those from ancillary studies. If a member or members of this group wish to make such modifications or changes to the conclusions in a written communication, then they should seek consensus from the rest of the ALLHAT Steering Committee. In such an instance the Steering Committee will be afforded the opportunity to comment on the proposed modifications or changes and can sign on to the suggested changes following a positive majority vote of the Steering Committee.

Should the Steering Committee not reach a positive majority vote on the proposal, the proposing member(s) should consider not going forward. However, if the proposing member(s) still wish to publish the modification or changes, they should inform the Steering Committee accordingly. The written communications may not include previously unpublished data without the consent of the Steering Committee. The member(s)should advise the Steering Committee of the journal where these modifications or changes are to be submitted or published. In addition, the proposing member(s) may not serve on writing committees wherein the alternative views are in conflict. Members of the Steering Committee who are not in agreement with the alternative view may write an accompanying piece and submit to the same journal.

Neither the ALLHAT Steering Committee nor the sponsors of ALLHAT intend to limit free exchange of ideas or individual interpretation of the results of the ALLHAT. However, it is important that a disclaimer is included in the letter or article to clearly indicate that their opinion or position represents an alternative view to that of the ALLHAT Steering Committee.

Possible consequences for failure to submit such an article for ALLHAT review could include (1) barring the author(s) from participation in some or all papers for a period of time, or (2) other consequences as determined by the Steering Committee.

Procedures:

If an ALLHAT Officer or Coordinator wishes to submit a letter or article with an alternative view, they should notify Dr. Barry Davis at the ClinicalTrialsCenter. Once that is done, the CTC Publications Manager will request a formal submission package. The document must clearly state that the views presented represent those of the authors and not those of the ALLHAT Steering Committee. The submission package should point out specific sections of the letter or article that might be considered as alternative views. The Publications Manager will forward the package to the other members of the ALLHAT Steering Committee for comments within 2 weeks. All of the Steering Committee members’ responses will be returned directly to the Publications Manager. Within one week, the comments will be organized into a summary document which will then be forwarded to the ALLHAT Executive Committee for review and action. After reviewing all comments, the Executive Committee will respond within one week to the author(s) including all points of disagreement and suggestions for resolution. If the author(s) drafting the document is a member of the Executive Committee, they will be asked to excuse themselves from the Committee’s discussion of the comments. The authors are not obligated to make the suggested changes. However, they should respond to the Executive Committee regarding the changes prior to submitting the article or letter.