倫理規定・コンプライアンス
Bay Biosciences Groupはヒト組織・血液等の生体試料について、ヘルシンキ宣言、ヒトゲノム・遺伝子解析研究に関する倫理指針、およびその他の法令並びに指針に沿った倫理的配慮の下、取り扱いをしております。
Bay Biosciences Groupは、コンプライアンス、規制ガイドライン、品質管理認証に準拠して、各ドナーの方からはインフォームドコンセントを取得しております。また、それぞれの調達医療サイトにおいてIRB取得等の手続きが取られていることを確認しています。
● FDA Current Good Tissue Practices (CGTP) compliant
● FDA compliant
● Hazmat certified
● ASQ certified
● Current Good Manufacturing Practices (CGMP) compliant
● AABB compliant
● JCAHO compliant
● Department of Public Health Tissue Bank License
● FDA Good Laboratory Practices compliant
● Fully DOT and IATA compliant shipping managers
Bay Biosciences Groupの倫理規定・コンプライアンスは以下の通りです（英文）。
Regulatory and Ethics
Our Bio-specimens and clinical data are handled in accordance with the highest ethical standards and in strictest compliance with all applicable rules and regulations including the recommendations of the Council of the Human Genome Organization (HUGO) Ethical, Legal, and Social Issues Committee (HUGO-ELSI, 1998); with the United Nations Educational, Scientific, and Cultural Organization’s (UNESCO) Universal Declaration on the Human Genome and Human Rights (1997); and with recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions.
Our customized approach to providing these bio-specimen procurement services guarantees that every bio-specimen is specifically tailored to each client’s needs. This custom service has made us an industry leader in the biotechnology, pharmaceutical, and related research fields. Our clients are assured of the highest quality products and customized service resulting from years of experience with collection sites around the globe.
iosciences LLC., is an industry leader in meeting compliance, regulatory guidelines and quality control certifications. Our certifications and observational compliance includes:
- FDA Current Good Tissue Practices (CGTP) compliant
- FDA compliant
- Hazmat certified
- ASQ certified
- Current Good Manufacturing Practices (CGMP) compliant
- AABB compliant
- JCAHO compliant
- Department of Public Health Tissue Bank License
- FDA Good Laboratory Practices compliant
- Fully DOT and IATA compliant shipping managers
- Validated temperature monitoring system for freezers and dewars.
Bay Biosciences LLC., is constantly improving itself and we strive to provide the best bio specimen procurement services available in the world.
That starts with a complete and thorough understanding of all applicable laws and regulations. We retain our own legal team, an external IRB to oversee all domestic collections.
All of the samples collected at our Global collection sites are procured and processed using a validated SOP and under the oversight of local IRB’s. Many of our Global Procurement sites have exclusive collection contracts therefore they follow only our exclusive protocol when collecting samples.
This is why we can offer customized collections so easily. We have some of the largest facilities around the world for the collection of bio specimens.
反社会的勢力に対する基本方針
- 反社会的勢力とは、一切の関係をもちません。そのため、相手方が反社会的勢力であるかどうかについて、注意を払うとともに、反社会的勢力とは知らずに何らかの関係を有してしまった場合には、相手方が反社会的勢力であると判明した時点や反社会的勢力であるとの疑いが生じた時点で、速やかに関係を解消いたします。
- 反社会的勢力への資金提供は、絶対に行いません。
- 反社会的勢力による不当要求に対して一切拒絶します。また外部専門機関に相談するとともに、暴力追放運動推進センター等が示している不当要求対応要領等に従って対応し、法律に照らして相当な範囲で責任を負わせます。
- 反社会的勢力による不当要求が、事業活動上の不祥事や従業員の不祥事を理由とする場合であっても、事案を隠ぺいするための裏取引を絶対に行いません。