Manual of operations

s for presentation to scientific meetings and manuscripts of DASH results should be sent directly to members of the PASC for approval prior to submission. Abstracts must be in the hands of Publications and Ancillary Studies Committee members at least 5 working days prior to submission. Members of the Publications and Ancillary Studies Committee must respond within 4 working days. Three copies of each manuscript should be sent to the NHLBI Project Officer and one copy to each member of the PASC. The members of the PASC must respond in writing to the PASC chair within 30 working days unless they are unavailable and have so notified the Chair. A cover sheet will accompany each abstract and manuscript (Manuscript and Abstract Review Form, Form #57 in DASH Forms Manual) and should be returned to the Chair of the PASC, who will relay comments to the chairperson of the writing group. Nonresponse by a Publications and Ancillary Studies Committee member will be assumed to be an approval. Hard copies of data slides and handouts to be presented to national meetings should be circulated to the PASC for distribution to other DASH investigators. The Publications and Ancillary Studies Committee may, by majority vote, withdraw any abstract or manuscript after it has been submitted and before it is published. It is the responsibility of the senior (first) author of any manuscript, abstract, or presentation to notify the Publications and Ancillary Studies Committee of the acceptance of this paper, abstract, or presentation and the citation of an abstract or publication and to send a preprint along with the citation of any accepted manuscript to the Publications and Ancillary Studies Committee and to the Coordinating Center. Authorship This section applies to the main studies and papers, but not ancillary studies carried out at only one or two sites. Authors who participate in the writing of a manuscript from the DASH project do so in accordance with the International Committee of Medical Journal Editors guidelines (N Engl J Med 1991;324:424-8)(see attached). First authors are expected to delete names from the final list of authors if those individuals have not participated in the writing and/or analysis of the paper in accordance with those guidelines. All papers, excluding ancillary studies, should include the word "DASH" or "Dietary Approaches to Stop Hypertension Research Group" in the authorship line. All papers should also include an "Acknowledgments" section that lists the DASH investigators and key staff at the Clinical and Coordinating Centers unless journal policy prohibits publication of such a list. In general, at least one investigator from the Coordinating Center should be included as an author on papers using study-wide DASH data. DASH Manual of Procedures Version 4.2 06-Dec-1996 Page 2-9 First authors will usually be DASH investigators. Fellows and other scientists may serve as first authors if: 1. the opportunity of first authorship on a project has been offered to all DASH investigators and none requested to serve as first author, 2. at least one other DASH investigator serves as a co-author and "sponsor" of the project, and 3. the fellow or scientist has played a major role in the data analysis and writing for the paper. First authorship will be decided by the writing group that is convened by the individual who first submitted an Analysis Proposal Form. The first author will generally serve as chair of the writing group. Conflicts about first authorship should be resolved, if at all possible, by members of the writing group. In case the writing group is unable to resolve a conflict, the Publications and Ancillary Studies Committee will adjudicate and may assign first authorship. Disputes about first authorship, if not settled by the writing group, will be referred to the Publications and Ancillary Studies Committee and thence to the Steering Committee. If progress on a given writing project is unduly slow, the Publications and Ancillary Studies Committee may request an explanation from the chair of the writing group. If timely progress is not likely to occur in the near future, the Publications and Ancillary Studies Committee may, at its discretion, assign a new Chair to the writing group. Such an assignment may be appealed to the Steering Committee. The order of co-authorship on a paper should be determined by the first author. In general, authors will appear in order of contribution to the writing and analysis of the paper. When contributions to writing and analysis have been similar, priority should be given to: 1. DASH investigators from Clinical Centers, 2. more junior authors, and 3. those who have contributed to a greater degree to management and data collection for the study, and to DASH investigators who have had fewer opportunities to author DASH papers. If conflicts regarding the order of authorship cannot be resolved by the writing group, the Publications and Ancillary Studies Committee will adjudicate and may assign order. Ancillary Studies All studies of subjects enrolled in the DASH project that are not part of the main protocol must be approved by the Publications and Ancillary Studies Committee prior to enrolling subjects. In order to obtain approval, complete and submit the Ancillary Study Request DASH Manual of Procedures Version 4.2 06-Dec-1996 Page 2-10 Form (Form #59-see DASH Forms Manual) to the Publications and Ancillary Studies Committee. If a proposal is subsequently submitted to your IRB, you must send a copy of the final approved proposal to the PASC. The Publications and Ancillary Studies Committee will review the proposal within 2 weeks and, if necessary, make suggestions for modification in order to assure that inclusion of subjects from the DASH study for ancillary protocols will not impede the basic data collection essential for the primary end points. The Publications and Ancillary Studies Committee may refuse to approve ancillary projects that appear to interfere with conduct of the main trial. For papers resulting from ancillary studies, the following language should be inserted in the Methods section of the paper. "This was a study ancillary to the Dietary Approaches to Stop Hypertension (DASH) study, and as such was designed, conducted, and analyzed only by the co-authors." All ancillary studies must be approved by the Steering Committee. A copy of all accepted manuscripts of the ancillary study (and published papers when available) should be sent to the Coordinating Center. Availability And Analysis Of Data Prioritization Requests for DASH data and their analyses will be submitted to the Coordinating Center after approval by the Publications and Ancillary Studies Committee. The Coordinating Center will notify the Publications and Ancillary Studies Committee if resource limitations do not permit a timely completion of an analysis request, and the Publications and Ancillary Studies Committee will assign priority rankings to projects so that the highest priority projects are completed first. Data Tapes It is the intention of the Coordinating Center to supply clean data tapes to the clinical centers and to the Project Office at the end of the trial so that additional analyses can proceed after the termination of the Coordinating Center's grant award. So long as the Publications and Ancillary Studies Committee remains active, it must continue to approve all analysis proposals and review all manuscripts and abstracts, even if the analyses are done locally. Use of DASH Computing Equipment Kaiser Permanente Center for Health Research (CHR), as DASH Coordinating Center, is supplying the following equipment for use by DASH Study intervention sites: DASH Manual of Procedures Version 4.2 06-Dec-1996 Page 2-11 • 1 DELL 466LV Desktop Server system • 3 Compaq LTE Lite 4/25E Laptop systems (4 at Baltimore) • 1 Hewlett Packard DeskJet 500 printer • 1 Compaq Desktop Expansion Base • All Required peripherals, batteries, cables, and connectors CHR retains rights of ownership for this equipment and all installed software. The equipment and software are provided for the sole purpose of conducting DASH activities as specified in the DASH Manual of Procedures (MOP). These activities include, but are not limited to, study communications, data entry, data transfer, report swapping, data edits, and data repairs. This equipment will be returned to the CHR upon demand. Additional uses or modifications of the equipment, software, and/or configuration, are not authorized, except as approved by the Coordinating Center Project Administrator, and are considered a violation of study procedures. Non-authorized use or modification include but are not limited to: personal use of equipment or software, making and/or distributing unlicensed copies of DASH study software, installing additional softwares, making configuration changes to equipment or existing software, or connection to nonstudy networks. Any request for exceptions to this policy must be authorized by the DASH Coordinating Center Project Administrator prior to action. Access to Stored Laboratory Specimens Dash will store a variety of frozen blood and urine samples from DASH participants. Proposals to use these samples should be submitted to the DASH Steering Committee in writing. These proposals should include the type of study/test proposed, the amount of each sample required to conduct it, the rationale for the test, the study questions and hypotheses to be addressed, the plans for publication of the data, the approximate cost of the proposed test(s), and the source of funds to conduct them. Study investigators not involved in the initial proposal may request to be included in the work group conducting the additional studies. The discussion of whether to permit use of the store samples should include attention to possible alternative uses of limited materials. That is, the Steering Committee will attempt to plan for optimal uses of the stored s