Human tissue: ethical and legal issues
The report considered that there was an important and urgent need to consider, clarify and, where necessary, strengthen the ethical and legal framework within which the clinical and research uses of human tissue take place. The ethical issues related directly to the core of respect for human beings, namely that they and their bodies should not be injured and that nothing should be done to them without their consent. In the UK the legal status of human tissue was unclear and a coherent approach was needed to guide any further regulation. The need to clarify the law was important in so far as its uncertainty may impede legitimate uses or even encourage illegitimate uses of tissue.
The Working Party recommended that when a patient consented to medical treatment involving the removal of tissue, that consent should be taken to include consent to subsequent disposal, storage or acceptable use of the tissue, provided that such a use was regulated by appropriate ethical, legal and professional standards.
Genuine consent needs to be based on adequate understanding of the treatment and explanations used in the consent procedures need to make it clear that consent covers acceptable further uses of tissue removed during treatment.
On the matter of the disposal of tissue, the report recommended that organisations handling and disposing of human tissues, including fetal tissues, ensure that they meet both the requirements of law and professional standards and also ensure that major body parts, such as limbs, and tissue subject to special public concern or scrutiny, such as fetal tissue, are handled and disposed of in ways that show respect.
The report also discussed removal of tissue from children or those deemed incompetent to consent and noted the difficulties raised by the legal uncertainty in this area. It proposed that the removal of tissue from children and those incompetent to consent would only be acceptable if the procedures involved were of negligible risk and burden, and if the donor did not object, or appear to object, to the procedures.
With regard to children, the consent of the person with parental responsibility should be sought, and, where appropriate, the children themselves should be consulted and their agreement obtained. Where tissue was removed from the dead for purposes which were acceptable, in that they contributed directly or indirectly to medical treatment, but might not have been expressly provided for by statute, appropriate consent from the deceased or next-of-kin had been obtained, these removals should be regarded as lawful.
The report discussed the arguments for and against the commercial organisation of the procurement of tissue and concluded that there were strong arguments against organising such procurement along commercial lines.
Organisations responsible for removing donated human tissue should operate on a non-commercial basis.
Payments to donors should only cover their reasonable expenses and inconvenience incurred and should not act as an inducement. Tissue banks should continue to operate on a non-profit-making basis and the Department of Health should establish a central register of approved tissue banks. Human tissue used in the development of products for direct or indirect therapeutic use should only be obtained from such sources.
Considering whether a person has or retains any claim over tissue removed from his or her body, the Working Party recommended that the law should proceed on any such claim by examining the basis of the consent given to the procedure that resulted in the removal of tissue. In particular, it should be entailed in consent to medical treatment that tissue removed in the course of treatment would be regarded as having being abandoned by the person from whom it was removed.