At present, the international community cannot be assured that the quality and, in particular the safety of tissues for transplants, is properly guaranteed in all countries and regions. Shortcomings of international and regional ethical rules and standards in the field of tissue banking, the lack of national ethical rules and standards in force in several countries, the lack of proper regulatory oversight and overall lack of harmonisation of existing ethical rules and standards, contribute to the problem.This book addresses the issues by promoting the adoption of an ethical policy and the use of a model code of ethics and a model code of practice as a reference for the tissue banking community, government agencies and policy-makers worldwide. This will facilitate the use of tissue processed in one country in any other country that needs it with the additional assurance of quality and safety that is lacking presently.

The use of human tissue for medical research and scientific progress raises many ethical and legal challenges. This multi-authored interdisciplinary text provides a fascinating insight into interlinking research perspectives and serves as a comprehensive reference to the state of play ethically and legally in Europe.

This book highlights the importance of adopting ethical policies and a code of ethics concerning tissue banking. It also shares the experience of a select group of countries in the adoption, implementation, and use of ethics in the creation and maintenance of tissue establishments. Describing the difficulties faced and the measures adopted to overcome them, the book provides several essential recommendations for governments, professional associations and international organizations involved in tissue banking, with the goal of strengthening tissue banking activities in interested countries and improving the quality of all tissue establishments.

Provides a comprehensive background of the ethical problems in tissue transplantation by explaining the historical development, breadth, and organization of the tissue industry, including the technical develoments that have made it simultaneously clinically relevant and an attractive market for investment capital. Contributions to the book come from an interdisciplinary group of scholars, industry representatives, government regulators, and not neast, families who have donated tissue from their dead loved ones.

The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis.This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system.

"Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ('Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union--an Evidence-Based Impact Analysis') to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results"--Publisher's description

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.