Human Tissue Act compliance

The Human Tissue Act

The Human Tissue Act 2004 repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 (in England and Wales).

The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes or public display, and is punishable by a fine and/or 3 years' imprisonment. In addition, there are a number of activities in the Act that require a license from the Human Tissue Authority before they can be lawfully undertaken.

The Human Tissue Authority (HTA) was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes (such as research, transplantation, and education and training) set out in the Human Tissue Act.

In order to carry out research that leads to human benefit, or is for teaching purposes, the University of Bristol uses and stores tissue that falls within the remit of the HTA. The University therefore has obligations under the Human Tissue Act.

Definition of relevant material

The definition of relevant material in the Human Tissue Act 2004 (excluding human application) is:

Section 53: Relevant Material

  1. In this Act, "relevant material" means material, other than gametes, which consists of or includes human cells.
  2. In this Act, references to relevant material from a human body do not include:
    1. embryos outside the human body, or
    2. hair and nail from the body of a living person.

To supplement the HTA's broader policy framework on relevant material, a list has been produced to provide stakeholders with guidance on whether specific materials fall within the definition of relevant material under the Human Tissue Act 2004.

Research

What do I need to do if my study involves human tissue research?