Research Ethics Committee

In research and development of a new drug, before starting clinical trials on people, various studies need to be conducted using animals such as rats and mice, to examine the effects of the drug (drug efficacy evaluation), how the drug is absorbed, metabolized, broken down and excreted in the body (pharmacokinetic studies), and its safety in administration (safety studies), for the purpose of predicting its safety and effectiveness on humans. Such prediction is, however, not always easy.

This is because of the difference in drug metabolism or drug effect between human and animal. Even though a drug is found effective and sufficiently safe in animal studies, it may not show efficacy or may cause an unexpected side effect on humans. Such differences in drug reaction among animal species are called species differences.

In recent years, to bridge such species differences, studies using surgically removed human tissues or human cells have been increasingly conducted before clinical trials in addition to animal studies, and systems for such studies have been being established in Japan. In the United States and Europe, institutions for providing human tissues and cells have been founded and networks between the provider institutions and medical institutions or pharmaceutical companies have also been established, contributing to improving the predictability of efficacy and safety on humans in clinical trials and substantially reducing the number of experimental animals used.

Meanwhile, in line with the rapid advancement of life science in recent years, advanced issues, such as genes and genomes (entire sets of chromosomes and genes) and protein produced by genes, have been actively studied in research and development for new drugs.

In proceeding with these studies, human-derived materials (blood, tissues, etc.) obtained with proper “explanation and consent” to and from providers are necessary. 

Studies using such human tissues, etc. are expected to facilitate the significant advancement of new drug development and new disease treatment and help prevent adverse side effects of drugs, thereby contributing greatly to future medical treatment. Such studies, however, should also be promoted with adequate ethical considerations, such as protection of privacy. For studies that include genetic research, in particular, which may deal with personal information of not only the sample providers but also their relatives, ethically appropriate handling is strongly required. From this viewpoint, on March 29, 2001, the Ethical Guidelines for Human Genome/Gene Analysis Research was released and enforced jointly by three ministries of the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry.

In response to these guidelines, Shionogi set up the “Ethics Committee for Human Tissue and Genetic Research” on May 26, 2001. This ethics committee is composed of external members, including lawyers, doctors and general citizens, as well as internal members. All research programs to be conducted at Shionogi using human tissues or genes (including externally commissioned research) are required to be examined and approved by this ethics committee in advance.