FHS Study Policies
A. Publications and Presentation Policy
Final Papers and Presentations - Category 1
Other papers and presentations are those not encompassed by the above
two categories; they relate to work done in ancillary studies, or by a
single or subset of centers. All publications or abstracts that contain
data collected by the Family Heart Study should be considered under this
category, even if data from the parent study (e.g., ARIC, Framingham Study),
or other groups are included as well.
A.3 Administrative Structure
The Chair of the P&P Subcommittee reports to the FHS Steering Committee, on behalf of the membership of the P&P Subcommittee, on all matters relating to the publication or presentation of FHS material.
This subcommittee serves an executive function to the FHS Steering Committee which has the final authority for approval or disapproval of all recommendations of the subcommittee on FHS publications, presentations, and the composition of writing committees.
The P&P Subcommittee, with approval of the FHS Steering Committee,
sets priorities for FHS related publications.
To initiate the process that leads to a presentation at a scientific meeting or writing paper for publication, all FHS investigators are invited to submit ideas for abstracts or papers and suggestions for writing group membership to the Publications and Presentations (P&P) Subcommittee. The first author of the paper is the individual who submitted the topic; he or she assumes leadership in writing the manuscript and serves as the writing group chairperson.
Ideas are submitted using the Manuscript Proposal Form (see section A.11). Before submitting a proposal, the investigator reviews the database of approved proposals to determine if any overlap exists. The writing group chairperson, or their Principal Investigator, speaks with relevant members of those writing groups, resolves overlap issues and invites their participation in the current proposal. Other FHS investigators whose experience or expertise is needed are also invited to collaborate. A member of the FHS Coordinating Center serves on each writing group, unless deemed unnecessary by either the Center, the P&P Subcommittee or the FHS Steering Committee. Each of the coauthors receives a copy of the manuscript proposal and has an opportunity to provide input to the manuscript proposal before it is submitted to the P&P Subcommittee. The writing group chair is encouraged to contact their center's representative on the Analysis Subcommittee for assistance with usual or difficult analytic plans. The form is submitted to the P&P Subcommittee chairman (currently R. Curtis Ellison) and Coordinating Center Project Manager (currently Jeanne Cashman) via e-mail. A manuscript number is assigned to the proposal for tracking purposes. The proposal is then distributed to the rest of the P&P Subcommittee for approval.
The P&P Subcommittee is responsible for promptly submitting suggested outlines of all P&P approved papers to the Coordinating Center for review. Final drafts of proposed outlines are circulated to the Steering Committee, and other investigators involved in the writing group, for expression of any concern that they might have regarding the accuracy or appropriateness of the presentation or publication. The Steering Committee then votes their approval or disapproval. Additions of other interested and qualified FHS researchers to the writing group can be made at this time.
All writing group members are expected to work towards the final preparation
of the FHS manuscript assigned to them, including prompt response to the
Chairperson's inquiries and comments. Otherwise, they will be excused from
A.5 Preparation and Submission of Papers
The following steps are followed in the preparation of the FHS manuscripts. The chairperson of a writing group:
If an individual wants to join a writing group already in progress,
he/she contacts the writing group chairperson, who in turn informs the
Publications Chair and CC. The Steering Committee is then informed of this
addition to the writing group.
The Coordinating Center's role is to:
A.6 Authorship and Clearance
The main "author" of all FHS final papers, including the FHS design paper(s) and presentations is denoted as the "NHLBI Family Heart Study Research Group." It is the intent of the Policy for all professional staff of each FHS center, who have worked collaboratively in the design and conduct of the Study, to claim credit for these papers. This includes the staff of the Coordinating Center and Project Office.
For mainstream papers and presentations, names of members of the writing group are listed as authors in the masthead, with the addition of the phrase "on behalf of the NHLBI Family Heart Study Research Group." The chairperson of each writing group, with the concurrence of other members of the group, determines the order of authorship. A major criterion for this determination is the effort and contribution made by the members of the writing group in preparation of the manuscript. Disagreement about the order of authors, which cannot be resolved by the chairman of the writing group, is resolved by the Publications and Presentations Subcommittee, with the Steering Committee as the final arbitrator.
For other FHS papers, the authorship is determined by the principal investigators of those centers which have collaborated in the conduct of the work leading to the preparation of these others papers (e.g., an ancillary study).
To enable easy identification of FHS papers and presentations, include *NHLBI Family Heart Study' in the title. A credit roster of major committees and FHS centers, with their members is listed at the end of each final and mainstream paper. Other FHS units, when appropriate, also appear at the end of the paper. Also, each paper includes a statement citing the NHLBI's grant support for the work, listing the appropriate number. (Appendix I).[the appendix will need to be updated] If the paper results from an ancillary study funded by NIH, this support also is cited.
All requests for reprints of final and mainstream papers are directed to the FHS Center associated with the first author of the paper. Each Center was awarded budgetary provisions in its annual budgets to defray the cost of these reprints.
To minimize the probability of inaccurate data in published materials, it is the policy of the Publications and Presentations Subcommittee that all data considered for final mainstream and other papers, and all abstracts for presentation at scientific meetings are submitted to the subcommittee for review and submitted to the FHS Steering Committee for approval. Also, the Coordinating Center reviews these materials to verify that they are accurate in nature and are consistent.
The FHS Steering Committee has the authority to review and approve all FHS papers for the FHS investigators, including papers on ancillary studies, substudies, or local center data for publication, by ratifying the recommendation of the Publications and Presentations Subcommittee. Since the data and samples were collected during the contract to NHLBI and many of the FHS participants are drawn from NHLBI-supported parent studies, pre-publication draft findings such as manuscripts, abstracts and reports for public distribution are submitted for review by the relevant P&P Subcommittees and by NHLBI. Review by NHLBI Staff does not lead to approval or rejection of a manuscript; rather it provides scientific peer review and guards against the inadvertent dissemination of inconsistent findings from NHLBI-supported studies that share common data bases.
Three copies of the manuscript, or abstract, is submitted: one to the Chairman of the Publications and Presentations Subcommittee; one to the Coordinating Center; and one to the FHS Project Office. The P&P chairman assigns a primary reviewer who is sent the manuscript by express mail. This review is completed within two weeks of receipt by the primary reviewer and includes an assessment of whether a statistical review by the Analysis Subcommittee is necessary. The completed review is returned to the P&P chair and the Coordinating Center Special Projects Assistant via e-mail for distribution to the rest of the P&P Subcommittee. The P&P Subcommittee discusses the review and manuscript during conference calls, which are scheduled as needed. Approved manuscripts are then sent to the SC for review within two weeks, and any comments are sent to the P&P chair and the Coordinating Center Special Projects Assistant via e-mail. If no comments are received within this time period, the manuscript is considered approved.
The NHLBI Project Scientist will submit P&P approved manuscripts for NHLBI review, which is completed within four weeks. This review can be concurrent with the Coordinating Center and the Steering Committee review, but it may be delayed if the FHS P&P or SC Committee feels it is premature to submit a given manuscript for NHLBI review.
The Coordinating Center staff review is completed within a reasonable time limit (not more than two weeks) and feedback is then provided to the chairman of the Publication and Presentation Subcommittee. The Publications and Presentations Subcommittee tracks the return time utilized by the Coordinating Center, the investigators, and the NHLBI.
It is understood that the procedures outlined above are not intended in any way to stifle initiation of ideas by investigators to produce meaningful and relevant manuscripts, but rather to enhance it.
Since not all circumstances that might cause disagreement among investigators
on the merit of a given paper can be foreseen, these disagreements are
resolved by the Publications and Presentations Subcommittee and, ultimately,
by the FHS Steering Committee.
A.7 Manuscript Progress
The FHS Investigators are committed to publishing findings from the FHS study and recognize that publication productivity may serve as a measure of progress of a study. In order to track status of manuscripts, a FHS Manuscript Progress Report is completed by each FHS writing group chair (first author or the first listed FHS Investigator in the case that another collaborator is the lead author) every six months. Specific papers of high priority may be followed up with more frequent contact with the writing group chair if deemed necessary by the P&P, Executive Committee or Steering Committee.
This report is distributed via e-mail and completed forms are returned to the P&P Subcommittee chair (currently R. Curtis Ellison) and the CC Project Manager (currently Jeanne Cashman) by e-mail. It is then forwarded to the other P&P members for review of progress and incentives for improvement.
If the writing group does not produce the final manuscript within a
reasonable time, as determined by the P&P Subcommittee and approved
by the FHS Steering Committee, it may be disbanded. Similarly, if some
writing group members do not perform their assigned tasks within a reasonable
time, they will be excused from further work in the group and from authorship
of the report in preparation.
Family Heart Study
Publications Progress Reporting Form
Please complete this form for FHS papers in which you are the LEAD author. Return completed form to Curtis Ellison, FHS Publications Chairperson and Jeanne Cashman at the FHS Coordinating Center.
Name of FHS Lead Author Reporting:
Date of Report:
1. FHS manuscript proposal numbers for which you are FHS Lead:
(add or edit if incorrect) _______ _______ _______ _______
2. How much ANALYSIS done? (none, some, most,all) _______ _______ _______ _______
3. Realistic DATE for ALL ANALYSES done! _______ _______ _______ _______
4. Manuscript draft status: (none, 1st,2nd,final) _______ _______ _______ _______
5. Realistic DATE for NEXT DRAFT done! _______ _______ _______ _______
6. HOURS last [ ] months analysis/report writing: _______ _______ _______ _______
7. How strong is your interest in remaining FHS Lead
for this proposal? (strong, weak, give up?) _______ _______ _______ _______
Please EMail this completed form by [determined date] to: Jeanne Cashman <email@example.com>
A.8 Preparation and Submission of Abstracts for Meetings
The FHS P&P Subcommittee maintains a current list of all relevant meetings and their deadlines for submission of abstracts. It is preferable that abstracts of papers for presentations be prepared when a paper on the same issue is in preparation (final, mainstream, or ancillary papers).
Abstracts submitted to the P&P Subcommittee for review are accompanied, if appropriate, by copies of tables and graphs that include data on which the text of the abstract is based, so that the data may be reviewed along with the abstract. It is understood that some descriptive abstracts may not require data submission. In order for the Coordinating Center to meet the request of investigators for data analysis for abstracts and allow sufficient time for writing the abstract, careful selection of analysis requests is needed. That is, only tables which relate to the major topics of the abstract are requested. Detailed analysis dealing with special topics are reserved for the preparation of the text for presentations or the manuscript for publication.
Abstracts are approved by the FHS P&P Subcommittee, and the FHS Steering Committee, and reviewed by NHLBI before submission to any national or international organization for consideration. The time limit for review and approval of an abstract is one week after the chairman has received the abstract. Abstracts are sent by the first author via e-mail to the P&P Chair and the Coordinating Center Project Manager (currently Jeanne Cashman), who forward the abstracts via e-mail to the other members of the P&P committee and the Steering Committee. The NHLBI Project Scientist submits the e-mailed abstract for NHLBI review.
If an abstract is prepared on a topic for which a writing group has
not yet been selected, it is the responsibility of the P&P Subcommittee
to select a writing group as soon as the content of the abstract is approved.
A.9 Selection of Presenters
The selection of the person presenting the material in the abstract at the respective national or international meeting is decided by the respective writing group (if any). If a writing group has not been constituted, the P&P Subcommittee Group will make the selection of the presenter, and forward it to the FHS Steering Committee for approval. Preparation of slides is the responsibility of the writing group.
Once a final, mainstream, or other paper has been presented at a scientific meeting, the tables are available for use by FHS professional staff at other scientific meetings. However, such subsequent presentations are not to appear in published form unless the data in the original paper are already published and appropriately referenced.
In the case of papers scheduled for presentation before organizations
issuing press releases, approval by the P&P Subcommittee, FHS Steering
Committee, and NHLBI is needed before the text is released to the press.
A.10 Invitations to FHS Investigators to Present at Meetings
The FHS Research Group welcomes opportunities to participate and present reports at national and international scientific meetings. When an invitation is received by a member of the Research Group, FHS policies with regard to publications and presentations apply as follows:
A.11 Manuscript Proposal Form
The FHS Proposal Form is submitted by the writing committee chairperson to the P&P Subcommittee and includes this information:
List of writing committee members
Time line (estimated dates for tabulations and first draft)
Rationale (Reason and need for the report)
Data (variables, time window, sources, inclusions/exclusions)
List of FHS manuscript numbers of approved proposals that involve similar variables or hypotheses, and brief discussion of overlap issues.
Lead author full name, academic affiliation and title, address, telephone
number, fax number and e-mail address, enabling easy access to contact
FOR ADMINISTRATIVE USE
2. Writing Group (list individual with lead
*1. 4. 7.
2. 5. 8.
3. 6. 9.
3. Timeline (approximate dates for): Starting
Submission for Publication:
5. Main Hypothesis:
6. Data (variables, time window, source, inclusions/exclusions):
7. List of FHS manuscript numbers of approved
proposals that involve similar
variables or hypotheses, and brief discussion of overlap issues.
8. Analysis by Data Coordinating Center or
by Local Investigator?
9. Target Journal?
*10. Lead author contact information (affiliation,
address, telephone number, e-mail address):
A.12 Publication Costs:
The costs of slides for specific presentations, publication of specific
manuscripts and reprints are the responsibility of the main author. Extra
copies of slides requested by other centers are paid for by those requesting
B. Publications Database
The Coordinating Center will provide access to a publications database
management system located on the wubios computer at Washington University.
This system has been used in other studies (FICSIT, HERITAGE, etc.). It
is a SAS/UNIX application which keeps each publication/abstract/presentation
as 1 record in a SAS database, containing the title, authorship list, journal,
status of the paper, date it reached this stage, and expected date to pass
to the next stage. The intent is to enter a paper from the moment it is
proposed and to trace it through to publication, so that bottlenecks can
be identified and eliminated. In particular, the dates of stage entry and
expected change to next stage can be used to ensure that a publication
does not spend undue time in an incomplete state.
The following reports will be distributed at each Steering Committee meeting:
Investigators are encouraged to propose and conduct ancillary studies. Such studies enhance the value of the FHS and ensure the continued interest of the diverse group of investigators who are critical to the success of the study as a whole. To protect the integrity of FHS, ancillary studies are reviewed and approved by the Steering Committee before their inception. An ancillary study is one based on information from FHS participants in an investigation which does not coincide with a scientific aim or study question addressed by the FHS, and requires data which are not collected as part of the established FHS data set. In general, ancillary studies require external (non-FHS) funding.
Funding for an ancillary study must cover the costs incurred by the FHS Biochemistry Laboratory (e.g., to process and/or ship samples), and to the Coordinating Center (for tasks such as to process and ship analysis files, provide documentation, participate in statistical analysis, and integrate the new ancillary data back into the combined FHS database). No funds for this purpose are available within the study.
It is an expectation that an FHS principal investigator or co-investigator be included as a co-investigator in every ancillary study proposal. A co-investigator from the FHS Coordinating Center is included as a co-investigator in every ancillary study proposal, unless the Coordinating Center deems this not to be necessary.
The FHS Steering Committee is responsible for initial review of the ancillary study. Investigators provide a two to three page summary of the proposed study to describe the study to FHS investigators and discuss the scientific rationale for the question(s) being addressed.
This summary includes:
Initiating investigators, collaborators, sites involved
Planned starting date
Funding plans and estimated cost
B. Design and Methods:
Brief background and rationale
Study questions or hypotheses
Sample size, justification
Methods, data to be collected, analytic plan
Burden on FHS study participants
Impact on the main study
C. Data Requirements:
Data needed from FHS analysis files
Specimens needed from the FHS repositories, specifying type and amount
Expected impact on Coordinating Center or local sites
D. Handling of FHS Data and Specimens:
Disposition of stored samples from main study and those processed by ancillary study
Disposition of ancillary study data at the conclusion of the ancillary study
The Steering Committee considers this information to assess the priority of the proposed study and determine its potential impact on the main study (FHS). Highest priority is given to studies which: 1) do not interfere with main FHS objectives, 2) have the highest scientific merit, 3) have objectives closest to those of FHS, and 4) can draw on the unique characteristics of the FHS cohort.
The Steering Committee reviews the proposal to determine that it does not compromise, hinder, or jeopardize the conduct of the FHS. Review of proposed ancillary studies for scientific merit is not the primary responsibility of this review process, but optional suggestions of a scientific nature may result from the review. Ancillary study proposals approved by the Steering Committee must be submitted to the Monitoring Board, who recommends approval or disapproval to NHLBI. NHLBI approval is required before grant applications or requests for funding are submitted.
The FHS investigator collaborating with the ancillary study PI is expected to facilitate the preparation of the ancillary study proposal, its submission to the FHS steering committee, and the communication between the collaborating studies throughout this process. The FHS investigator provides copy of the FHS ancillary study policy to the outside investigator(s), and assists in the preparation of the proposal. After favorable review by the FHS steering committee, the FHS makes available a copy of its publications policy to the ancillary study investigators. When applications for (non-FHS) funding for an ancillary study to FHS are submitted, it is requested that a courtesy copy be sent at that time to the FHS Scientific Officer.
At the time of distributing FHS specimens and/or information, the FHS PI responsible for that portion of the FHS data base (Coordinating Center, Central Laboratory) makes explicit arrangements with the ancillary study PI for the security of these study materials, and for their final disposition at the conclusion of the ancillary study. The safety and confidentiality of the FHS data at the collaborating institution is the responsibility of the ancillary study PI, as is the appropriate disposition of these materials after the study has been completed. Left-over DNA and laboratory specimens is destroyed or returned, as appropriate; files of FHS data are returned or deleted, as established at the outset of the collaboration. An archival copy of the newly collected data and/or laboratory results is sent to the FHS Coordinating Center at the conclusion of the data analysis and publication of the main (ancillary) study hypothesis. This transfer is the responsibility of the ancillary study PI and his/her FHS collaborator(s).
The Steering Committee monitors the development of the ancillary studies, receipt of funding, initiation dates, and progress. A written progress report on ancillary studies is made periodically to the Steering Committee and the Monitoring Board. Publications resulting from ancillary studies follow the same policies as described in the document on FHS Publication and Presentation policy.