RESEARch Ethical Considerations in Research on  Human Subjects and Specimens Derived  from Humans Biosafety Control Ethical Considerations in Animal Testing Handling of Intellectual Property clInIcAl DEVEloPmEnT Protection of Human Rights, Privacy and Confidentiality of Personal Information of Research Subjects, and Assurance of  Reliability in Clinical Trials Astellas conducts research on human subjects and research on  specimens derived from humans, following obtained appropriate  consent in accordance with the laws, regulations and guidelines  of relevant countries. In Japan, Astellas offers training for  researchers in areas such as bioethics, genomic research and  clinical studies, based on a strong commitment to respecting  the human rights of research subjects, protecting privacy and  ensuring the reliability of research. Furthermore, Astellas has an  Astellas Research Ethics Committee, which consists of nine  members of both genders, including 4 outside members. The  Committee deliberates on the scientific propriety and the ethical  acceptability of research. In fiscal 2013, the Committee met 12  times and deliberated on 27 issues. Astellas has established the Institutional Animal Care and Use  Committee, in which outside members participate as committee  members, overseeing the Company’s animal testing and breed- ing plans in Japan. In fiscal 2013, the Company established the  Global Policy for the Use and Care of Animals. Astellas’ initiatives in animal testing are recognized by AAALAC  International*. As a result, all of Astellas’ animal testing facilities in  Japan and our U.S. subsidiary Agensys have acquired accredita- tion from AAALAC International. In fiscal 2013, the Tsukuba  Research Center and the Yaizu Technology Center received  follow-up audits by AAALAC International to renew their accredi- tations. In March 2014, the accreditations of both facilities were  renewed. Astellas regards its intellectual property (patents in particular)  relating to new compounds or other findings as valuable busi- ness assets. Employees receive ongoing training to raise their  awareness on obtaining patents and swiftly making patent appli- cations and acquiring rights. At the same time, we emphasize  respecting the rights of others. We make sure our research does  not infringe on third-party patents, and if necessary, we obtain  approval to use them so as not to infringe on the patent estate  of others. In fiscal 2013, we unified the standards underlying our  approach to intellectual property on a global basis by establishing  the Global Policy on Intellectual Property. Experiments using genetically modified organisms, or materials  containing pathogens are performed under the World Health  Organization (WHO) Laboratory Biosafety Manual and the Centers  for Disease Control and Prevention (CDC)/National Institute of  Health (NIH)  Biosafety in Microbiological and Biomedical   Laboratories , as well as the laws of individual countries. In Japan,   Astellas has established biosafety management rules in compli- ance with the Cartagena Protocol on Biosafety* and related  ministerial ordinances, and has set forth detailed handling proce- dures. We have also set up the Biosafety Committee to review  whether the experiments meet the standard required by these  rules. Laboratory personnel receive regular training courses once  a year (1,037 participants in fiscal 2013), in order to rigorously  enforce safe and proper biosafety management and use of these  organisms and suchlike. In the U.S., we conduct such experi- ments based on the rules established by the occupational health  and safety (OHS) authorities. * AAALAC International: The Association for Assessment and Accreditation  of Laboratory Animal Care International. An organization that promotes  the humane treatment of animals through voluntary accreditation and  assessment programs. Studies are undertaken both from scientific and  ethical standpoints to verify the quality of animal control and use programs. * Law Concerning the Conservation and Sustainable Use of Biological  Diversity through Regulations on the Use of Living Modified Organisms of clinical trial subjects. Furthermore, it is crucial to conduct  assessments in clinical trials scientifically and accurately in order  to develop new drug candidates into drugs that can be used  confidently by patients. Accordingly, Astellas has a clinical devel- opment framework in place to ensure compliance with GCP and  relevant laws and regulations. Moreover, our clinical trials are  conducted only at medical institutions complying with the rel- evant laws and regulations. In clinical trials, we investigate new drug candidates developed  through drug discovery research in further detail, and assess their  efficacy and safety in patients. Under the Helsinki Declaration*,  clinical trials must be fully ethically planned and safely conducted  with full consideration to protecting the human rights and privacy  Astellas Pharma Inc.  _ Annual Report 2014 54