In a letter to MPs today, the Nuffield Council on Bioethics calls for new legislation on Human Tissue to be clear and coherent.
The Council supports the introduction of the Human Tissue Bill in principle and welcomes the emphasis given to consent as the fundamental principle guiding the lawful use of human tissue. But the Council has a number of concerns about ambiguities in the current Bill. If the requirements for consent become too bureaucratic or too onerous, research leading to potential benefits might suffer.
Specifically, the scope and specificity of requirements for ‘appropriate consent’ are not defined in the Bill. The Council suggests that the minimum requirements for consent should be clarified, and the Bill should clearly state that broad consent for the use of tissue might be appropriate.
The Council recommends that consent to treatment should be drafted given in general terms. It should include consent to the subsequent disposal or storage of the tissue, and to any further acceptable use provided that this is appropriately regulated. Information about these possible uses should available for patients. The ethically significant requirement is that consent should be genuine, rather than complete.
It is crucial that regulations, guidance and codes of practice are not drawn so restrictively that they inhibit clinical medicine and research. If the consent requirements are too onerous, research leading to potential benefits for public health may suffer.
“We urge parliament to address these concerns in order to restore public confidence and ensure that medical research, education and scholarship can continue to its maximum potential,” says Professor Sir Bob Hepple, Chairman of the Nuffield Council.
Notes to Editors:
1. The Nuffield Council on Bioethics is an independent body which examines ethical issues raised by developments in medicine and biology. Established in 1991, it is funded by The Nuffield Foundation, the Medical Research Council and the Wellcome Trust.
2. The Council published a report, Human Tissue: ethical and legal issues in 1995.