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CTT Ethical guidelines

Ethical Guidelines

Clinical Research

All research involving human participants must have been approved by the authors' institutional review board or equivalent committee(s) and that board must be named by the authors in the manuscript. For research involving human participants, informed consent in written must have been obtained from all persons taking part in the study, or the reason for lack of consent explained. Manuscripts must include a statement that all human studies have been approved by the authors' Institutional Review Board. In addition, CTT requires a statement confirming that all clinical investigation has been conducted in accordance with the Helsinki Declaration, and that patients gave their written, informed consent. CTT reserves the right to ask for a copy of the clinical protocol, the patient information, the informed consent statement and the approval documents.

We follow the WHO definition (http://www.who.int/ictrp/en/) of a clinical trial:

"... a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials."

CTT supports the position of the International Committee of Medical Journal Editors (ICMJE) on trial registration (http://www.icmje.org/faq_clinical.html). All trials started after July 1, 2005, must be registered in advance in a publicly accessible registry before patient recruitment has begun, otherwise they will not be considered for publication. Trials initiated before July 1, 2005, must also be registered before submission to our journal in a publicly accessible registry. See the ICMJE FAQ on trial registration for further details. We use the WHO's list of approved registries as reference. CTT reserves the right to inform authors’ institutions or ethics committees about unregistered trials that have been carried out.

If your study is a randomized controlled trial, it must follow the CONSORT reporting guidelines appropriate to the trial design. Please check the CONSORT statement Web site (http://www.consort-statement.org/) for information on the appropriate guidelines for specific trial types.

Animal Studies

For studies involving animals, all work and experiments done must follow the relevant national and international guidelines. For all protocols and research a permission or permit by the authors' institutional ethics board or similar committee(s) must exist in writing and that board and permit number(s) must be named in the manuscript. CTT may ask for a copy of the approval documents.

CTT strongly encourages all authors to comply with the "Animal Research: Reporting In Vivo Experiments" (ARRIVE) guidelines (http://www.nc3rs.org.uk/ARRIVE), developed by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). The standards of reporting set by ARRIVE helps to make sure that the data from animal experiments can be of maximal use and fully checked and verified by others. These guidelines can be used in all areas of bioscience research using laboratory animals.

Example of statement of ethical approval: "This study was carried out in strict accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals of the National Institutes of Health. The protocol was approved by the Committee on the Ethics of Animal Experiments of the University of Minnesota (Permit Number: 27-2956). All surgery was performed under sodium pentobarbital anesthesia, and all efforts were made to minimize suffering."

Please note that where research may be confused as pertaining to clinical research, the animal model should also be noted in the title.

See also Submission Guidelines for Authors