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Clinical Research

Bringing Discoveries to the "Bedside"

CHaRM Manuscript Submission and Authorship Policies

Process

Any CHaRM member is welcome to bring protocols to our meetings or submit directly to the appropriate subcommittee. This requires pre-circulation of a written protocol to the subcommittee. Before a study is affiliated with the CHaRM name in a grant or publication, the protocol must be discussed at a meeting of the CHaRM, and approved by the membership. Part of this process would also include the maintenance of a database detailing the name of the principle investigator, research personnel, funding source/amount, patient target and projected study start and completion date. To this end, the following Scientific Subcommittees will be formed:

Clinical Trials: This subcommittee will receive and review all protocols for clinical trials. These will typically be Phase II or higher trials, being performed either locally, as part of industry sponsored trial or as part of a collaborative in a multi-centre randomized clinical trial. New or experimental therapy/device protocols will be vetted through the Basic Science/Translational Science Subcommittee (see below).

Outcomes: This subcommittee will receive and review all protocols and clinical epidemiology studies to be conducted on cardiac patients in Manitoba. The Subcommittee will be ultimately responsible for database management for all patients receiving a cardiac catheterization, coronary intervention, device implant, or a cardiac surgery procedure coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and heart valve replacement surgery in Manitoba.

Basic Science/Translational: This subcommittee will receive and review all protocols that involve newly developed technologies or experimental therapeutic agents (not formally enrolled in clinical trials as described above) that study on human subjects. This may involve developing new cardiac imaging techniques, tissue sampling and other translational basic science studies to be conducted on cardiovascular patients in Manitoba.

Within each Subcommittee, there will be alternate members to avoid conflicts of interest if members of the Subcommittee are co-authors of the submitted protocol/manuscript. After protocol presentations, revisions may be recommended by the Group before grants may be submitted with the affiliation of the CHaRM name. A grant application for funding under the auspices of the CHaRM must be endorsed by the CHaRM Executive prior to its submission. In the latter situation, the Executive in association with one or more members will provide an internal review of the protocol and provide feedback within 2 weeks. The goal of this feedback is provision of constructive comments to investigators about their studies which represent CHaRM membership views on issues of methodology and implementation.

CHaRM Authorship

CHaRM authorship must be acknowledged in the grant proposal submitted for funding if all of the following criteria are fulfilled a) the protocol has been presented at a CHaRM meeting, b) support has been given to the project by the CHaRM membership at one of the meetings, c) explicit agreement regarding grant submission was obtained, and d) feedback on the grant itself was provided by the CHaRM Executive. Without these 4 steps, investigators are requested not to make reference to the CHaRM in their proposal.

CHaRM authorship must be acknowledged in all manuscripts submitted for publication if in the opinion of the CHaRM Executive and the investigators, substantial scientific support has been provided by the group/subcommittee at our meetings and between meetings. Without this agreement, investigators are requested not to make reference to the CHaRM in their manuscript.

Before CHaRM authorship is finalized, the CHaRM Executive must review all manuscripts to be submitted to peer-review journals. To allow for (inevitable) last minute preparation, abstracts of CHaRM projects may be submitted to scientific meetings without a priori review by the Executive, but should been vetted through the appropriate Subcommittee.

CHaRM authorship must be acknowledged in all manuscripts submitted for publication which, in the opinion of the CHaRM executive and investigators, have received substantial scientific support and input through review and discussion at CHaRM meetings or the process of scientific review by the Scientific Subcommittee.

Publications affiliated with the CHaRM should be denoted as:

  • X,Y, Z, for the CHaRM Investigators, or
  • The XYZ Group for, or in collaboration with the CHaRM Investigators
  • The CHaRM Investigators