How does participant safety relate to clinical trial ethics?

Participant safety is a fundamental responsibility of researchers conducting clinical trials. The ethical principle of "do no harm" is a cornerstone of clinical research ethics, emphasizing that the welfare of participants should always take precedence. In clinical trials, researchers are obligated to ensure that the risks involved are minimized and are justified by the potential benefits to participants and to society. This includes thorough risk assessments and implementing safety measures throughout the study.

Ethically, researchers must obtain informed consent, making sure that participants are fully aware of any potential risks. By prioritizing participant safety, researchers uphold the integrity of the study and maintain public trust in the research process. This care for participant welfare aligns with various ethical guidelines and regulatory requirements, such as the Declaration of Helsinki and Good Clinical Practice (GCP) standards, which underscore that the well-being of individuals involved in research must always be the primary consideration.