Study design and Ethical Approval
The Technological-Educational Journal Docentes 2.0 (TEDJ) shares and promotes the guidelines of ethics and good editorial practices of the COPE (Committee of Publication Ethics), thus guaranteeing transparency and integrity in all processes by the journal's editorial team, as well as their collaborators in the roles of authors and evaluators.
As defined by COPE (199): Good research must be well-justified, well-planned, adequately designed, and ethically approved. Investigating to a lower standard may constitute misconduct.
(1) Laboratory and clinical research should be driven by protocol; pilot studies should have a written rationale.
(2) Research protocols should seek to answer specific questions, rather than just collect data.
(3) Protocols must be carefully agreed by all contributors and collaborators, including, if appropriate, the participants.
(4) The final protocol should form part of the research record.
(5) Early agreement on the precise roles of the contributors and collaborators and on matters of authorship and publication is advised.
(6) Statistical issues should be considered early in the study design, including power calculations, to ensure there are neither too few nor too many participants.
(7) Formal and documented ethical approval from an appropriately constituted research ethics committee is required for all studies involving people, medical records, and anonymized human tissues.
(8) Use of human tissues in research should conform to the highest ethical standards, such as those recommended by the Nuffield Council on Bioethics.
(9) Fully informed consent should always be sought. It may not always be possible, however, and in such circumstances, an appropriately constituted research ethics committee should decide if this is ethically acceptable.
(10) When participants are unable to give fully informed consent, research should follow international guidelines, such as those of the Council for International Organizations of Medical Sciences (CIOMS).
(11) Animal experiments require full compliance with local, national, ethical, and regulatory principles and local licensing arrangements. International standards vary.
(12) Formal supervision, usually the principal investigator's responsibility, should be provided for all research projects: this must include quality control and the frequent review and long-term retention (may be up to 15 years) of all records and primary outputs.
*Statement based on COPE Best Practice Guidelines for Journal Editors and Elsevier recommendations.