Biological monitoring is a common procedure in assessing the dose of contaminants from a workplace atmosphere. It may include measuring a contaminant, such as lead in blood, or a resulting metabolic product, such as mandelic acid in urine following styrene exposure. A related process is using adhesive tape to strip the surface layer of a small area of skin to measure the dermal deposit. Clearly these procedures require the consent of the person monitored, and this is not an issue. In Britain such procedures are included in various HSE regulations and guidance. They are commonly used in research.
The Human Tissue Act 2004 (http://www.opsi.gov.uk/acts/acts2004/20040030.htm) requires a licence from the Human Tissue Authority for the storage of material from a human body (section 16e), for purposes which include “obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)” (Schedule 1). Most of the Act came into force in April 2006.
The editor has been told by members of his Editorial Board that this is being deemed to include blood and skin samples taken for biological monitoring purposes. This is clearly an unintentional result of inadequate drafting.
This Act applies in England, Wales, and Northern Ireland. The Human Tissue (Scotland) Act 2006 focuses on tissue for transplants, and apparently does not cause a problem for biological monitoring. The BMA Medical Ethics Department has produced guidance on the Acts (http://www.hta.gov.uk/_db/_documents/Human_Tissue_Legislation_-_Sept_06_final.pdf) but this does not mention the biological monitoring problem.
Clearly this is more of a problem for researchers than for journals directly, except for the general ethical problem of supporting the law. For the moment the editor is thinking of adding to the paragraph on ethics in the instructions to authors a requirement that studies must comply with the law in the place where they are carried out, but is not proposing to question authors of English papers which include biological monitoring.
Has COPE any advice or comments, please?
Members of the Forum believed that in this situation, the onus is on the authors and the institutions to ensure that any procedures carried out are legal. Also, the ethics committees should be aware of whether or not an individual or institution has approval to carry out certain procedures. The Forum recommended that the editor write to the Health and Safety Executive explaining the issues and request further advice from them.