Is tissue engineering a new paradigm in medicine? Consequences for the ethical evaluation of tissue engineering research.

Ex-vivo tissue engineering is a quickly developing medical technology aiming to regenerate tissue through the introduction of an ex-vivo created tissue construct instead of restoring the damaged tissue to some level of functionality. Tissue engineering is considered by some as a new medical paradigm. We analyse this claim and identify tissue engineering's fundamental characteristics, focusing on the aim of the intervention and on the complexity and continuity of the process.

An exploratory survey on the views of European tissue engineers concerning the ethical issues of tissue engineering research.

We present the first exploratory survey about the views of tissue engineers on the ethical issues of tissue engineering (TE), conducted among participants of a large European TE consortium. We analyzed the topics for which ethical guidance is necessary and the preferred dissemination channels, which are relevant issues and goals of clinical trials with human tissue-engineered products, and which information is to be given to trial participants. The need for comprehensive, specific ethical guidance of TE is a first key finding of this survey.

The importance of the values attached to cells for a good informed consent procedure in cell donation for tissue engineering purposes.

In this article the scope and contents of informed consent for cell donation in tissue engineering are discussed. We evaluate the various values donors may attach to cells and that may influence their decision to donate. Awareness of the various meanings of the value of the cells is therefore essential for all involved in cell transfer.

Informing participants in clinical trials with ex vivo human tissue-engineered products: what to tell and how to tell it?

Ex vivo tissue-engineered products are increasingly entered into clinical trials. To allow prospective participants to make a fully informed, autonomous decision on their participation, we have to adapt the informed consent process by taking the specific aspects of tissue engineering into consideration. New elements in ex vivo tissue engineering are the source and manipulation of the cells in the product, the implantation of the product and the additional risks and benefits due to the construction of the product and its activity in the body.

A critical assessment of the directive on tissue engineering of the European union.

The development of tissue engineering in Europe suffers from the absence of a coherent regulatory framework. Therefore, the European Commission has drafted a directive to regulate all tissue-engineered products in a comprehensive yet flexible framework. This article analyzes the directive from an ethical viewpoint.