Clinical trials run only after approval of a list of preclinical trial norms and protocols. Different national and international laws govern these norms and protocols. In India, The Prevention of Cruelty to Animals Act, 1960 (PCA Act) and The Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 (BEACS Rules) framed under the PCA Act regulate the preclinical trials or studies on animals. The BEACS Rules states that any protocol for preclinical trials must ensure that animals first considered for any experimental procedure should stand lowest on the phylogenetic scale, which may give scientifically valid results. The experiment should be so designed that a minimum number of animals are used to give statistically valid results, establishing a 95 percent degree of confidence. Take Clinical Research Training.
Before experiments can be conducted on animals, experiment-specific permission is required from a designated committee or authority. As regulated by different laws regulating preclinical trials across the world, some of the crucial requirements include study rationale, study design, subject eligibility, study treatment, and background of the principal investigator. Generally, an ethics committee is also set up to review and approve the clinical trial prior to its operations commencement. The ethics committee is also responsible for reviewing and approving any changes or updates made to the clinical trial protocols prior to their implementation. However, prior approval from the ethics committee is not required when the implementation of updates is necessary for patients' health and safety.