Ethical Approvals and Informed Consent

Clinical Trials and Practice (CTP) is committed to upholding the highest ethical standards in research involving human participants and animal subjects.

Research Involving Human Participants

For any manuscript reporting a clinical trial or research involving human participants, authors must confirm that:

  • The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, in its current, most recently revised version
  • The study was conducted in accordance with Good Clinical Practice (GCP) guidelines
  • The study received approval from an appropriate institutional review board (IRB) or independent ethics committee, with the approving body's name and approval reference number stated in the manuscript
  • Informed consent was obtained from all participants (or their legal guardian/representative), including specific consent for publication where identifiable information or case details are included
  • Participant confidentiality and privacy were protected throughout the research process

Clinical Trial Registration

All clinical trials reported in CTP must be registered in a publicly accessible clinical trials registry (e.g., ClinicalTrials.gov, WHO ICTRP) prior to enrollment of the first participant, with the registration number stated in the manuscript. Authors reporting randomized trials should adhere to the CONSORT 2010 guideline.

Research Involving Animal Subjects

For manuscripts reporting research involving animal models, authors must confirm that:

  • The study was conducted in accordance with the US Department of Health and Human Services Guide for the Care and Use of Laboratory Animals or an equivalent national/institutional guideline
  • The study received approval from an appropriate institutional animal care and use committee (IACUC) or equivalent ethics body, with the approval reference stated in the manuscript
  • All reasonable steps were taken to minimize animal suffering and use the minimum number of animals necessary for valid results

Non-Compliance

Manuscripts that do not include the required ethical approval, trial registration, and consent statements will be returned to the authors for clarification before proceeding to peer review, and may be rejected without further processing. CTP reserves the right to reject or retract a manuscript at any stage if serious ethical concerns are identified, in accordance with COPE guidelines.