Protection of human subjects in clinical research: the pitfalls in clinical research.

摘要

Clinical trials are an important part of medical research and must be done with good conduct and intention. Using a suitable approach is part of research practice, which favors protection of research subjects. Good Clinical Practice is being promulgated as a universal ethical approach toward protection of the human subject's rights. Appropriate scientific design, good performance, better analyses, informed consent, and credible scientific data with the confidentiality of the research subject all contribute to Good Clinical Practices. The first and possibly the most important step toward protection of the research subject is to appropriately obtain an informed consent, which identifies respect, beneficence, and justice for the enrolled research subjects.