2 Preparing tissue for histopathology
In order to take any tissue, it is first necessary to obtain the informed consent of the patient, i.e. the person must understand why the tissue is taken and what it will be used for. The regulations that govern this area differ from one country to another, but in the UK, the Human Tissue Authority (HTA) oversees the process, which may be regulated by the Human Tissue Act 2004. Tissue which is taken from live individuals for diagnosis or treatment requires consent which is generally taken when the person consents to their treatment, and does not fall within the scope of the Act; tissue taken for essentially any other purpose is regulated by the Act. Since each individual must know at the time they give consent what their tissue may be used for, tissue that is taken for one purpose (e.g. diagnosis or a particular research project) cannot be used for another purpose later.
A patient arrives in a hospital from a car accident, in which they sustained injuries to the leg. The surgeon has to remove a small piece of skin in order to set the bone. This piece of skin would normally go into clinical waste and be incinerated, but the histology laboratory would like to have a small piece of normal skin as a control in order to validate their immunohistochemistry. Is it permissible to use the clinical waste for this purpose?
No it is not, because the patient was in no position to give informed consent for the use of their tissue, and it does not aid their own diagnosis or treatment.