Links
Human Tissue Authority
The HTA license and inspect organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching and public exhibitions. |
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EU Tissues and Cells Directive 2004
The EU Tissues and Cells Directive sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application. It was adopted by the European Parliament on 7th April 2004. |
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US Food and Drug Administration (FDA)
FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. |
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European Medicines Agency (EMEA)
The European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. |
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UK Medical Research Council, Ethics Research and Guidance
The Medical Research Council provides guidance to help our scientists to implement good practice and meet legal and ethical requirements. |
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British Association of Tissue Banks
The British Association for Tissue Banking (BATB) was formed in 1992 in response to the growing clinical need for human tissue for transplantation.
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National Research Ethics
Research Ethics Committees (RECs) safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service.
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National Cancer Institute (USA NIH) Best Practices for Bio Repositories
The National Cancer Institute (NCI), through its Office of Biorepositories and Biospecimen Research (OBBR), is leading a national initiative to systematically address and resolve one of the most difficult problems that will drive 21st century cancer research: the limited availability of carefully collected and controlled, high-quality human biospecimens annotated with essential clinical data and properly consented for broad investigational use.
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US Office for Human Research Protections.
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
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The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (USA)
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. This website provides information on the Privacy Rule for the research community. |
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