Human Tissue in Research

Aston University is licensed by the Human Tissue Authority for “storage of relevant human material for a scheduled purpose" under the Human Tissue Act (2004), subject to compliance with its strictly regulated code of practice. If you are working or intend to work with relevant human material as defined by the Act, you must contact the Research Integrity Office before the research begins. We require all researchers working with relevant human material to take the training provided online through the Medical Research Council's Regulatory Support Centre.

HTA regulates 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.

Under the Act the Designated Individual (DI) under the licensed is responsible for licensed activities and supervising compliance with the licensing arrangements:

• License Number: 12381
• License Holder: Aston University
• Licensed Premises: Aston University
• Designated Individual (DI): Becky Case

The Quality Manual

Aston University operates a quality management system for the governance of the acquisition, storage, use and disposal of human tissue. This system ensures that all work involving human tissue is conducted in accordance with “good practice” and complies with the Human Tissue Act (2004).

The Quality Manual procedures are applicable to all research involving human tissue at Aston University. This manual sets out the operating procedures for the system. The associated Standard Operating Procedures are available here.

You will require approval from the Designated Individual before you can collect or store human tissue as part of your research. Please contact research governance before your research begins, so that the appropriate approvals can be processed.

Aston staff and students who work with human tissue at another site (e.g. another University or NHS Trust) may be asked to confirm that they will adhere to the Quality Manual, but will also be asked to ensure that they will abide by any local arrangements and practices.

A Material Transfer Agreement is usually required for transferring human tissue samples in or out of Aston University. Please contact research governance if this applies to your research.

The Research Integrity Office provides the secretariat support for HTA Oversight Group, for any queries please contact research governance.

Page last updated on: 20/10/2022