Human and Animal Rights Policy

Clinical Trials and Practice (CTP) is committed to the ethical treatment of both human participants and animal subjects involved in research published in the journal, consistent with internationally recognized standards.

Human Rights

All research involving human participants must be conducted in accordance with the ethical principles of the Declaration of Helsinki, in its current, most recently revised version, and with Good Clinical Practice (GCP) standards. This includes respect for participant autonomy, privacy, dignity, and the right to withdraw from a trial at any time without consequence or effect on their ongoing care.

Given the nature of clinical trial research, particular attention is paid to the ethical treatment of vulnerable populations — including pediatric participants, pregnant individuals, cognitively impaired individuals, and populations in resource-limited settings — who require additional protections and are subject to heightened editorial scrutiny.

Procedural requirements for documenting ethical approval, trial registration, and informed consent are set out in full in the journal's Ethical Approvals and Informed Consent policy.

Animal Rights

Where preclinical or animal research supports a clinical research program, such work must be 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 journal endorses the principle of the 3Rs — Replacement, Reduction, and Refinement — encouraging researchers to:

  • Replace animal models with non-animal methods wherever scientifically valid alternatives exist
  • Reduce the number of animals used to the minimum necessary for statistically valid, reproducible results
  • Refine procedures to minimize pain, distress, and suffering

Procedural requirements for documenting institutional animal ethics committee approval are set out in the journal's Ethical Approvals and Informed Consent policy.

Enforcement

Manuscripts that raise concerns regarding compliance with human or animal rights standards will be returned to the authors for clarification, and may be rejected or, if identified post-publication, retracted, in accordance with the journal's Misconduct and Sanctions policy.