Human Tissue: Ethical and Legal Issues
International recommendations
International recommendations
The European Group on Ethics in Science and New Technologies published the Adoption of an Opinion on Human Tissue Banking in 1998. Australia has also recently produced a Statement on Ethical Conduct in Research Involving Humans
European Group on Ethics in Science and New Technologies
Adoption of an Opinion on Human Tissue Banking (1998)
The Opinion focuses on four main areas:
- Therapeutic Opportunities
The peak in use of human tissues especially for grafting purposes (e.g. corneas, tendons, bone, skin) was recognised. However it was acknowledged that limited information is available about actual practices with human tissue in EC countries, for example about collection and storage, and legislation
- Safety
This was emphasised as an ethical imperative. The report recommended that Community standards be developed for the quality and safety of human tissues and proposed that a European structure for the protection of health be created in collaboration with the European Agency for the Evaluation of Medicinal Products. The report also made calls for strict controls of tissue banks’ activities, that they be subject to authorisation, and that tissues be traceable.
- Donation
Must be free, anonymous (donor and recipient), based on requirement of prior consent entrenched in national legislative rules. Information should be supplied to the donor in all cases, and there should be respect for privacy or confidentiality of donors and their families.
- Transparency
Periodic surveys of practices in member states should be encouraged, looking at procurement, storage, distribution of human tissues and imports. The Group felt that improved transparency would also aid equitable access to tissues.
Australia
Australian National Statement on Ethical Conduct in Research Involving Humans (2001)
For the first time this statement includes guidelines in relation to the ethical conduct of research. The recommendations were developed with reference to Nuffield report.
Last Updated Tue, 8 August 2006