Committee for Research Ethics Concerning Human Subjects (Non-NHS)

Guidance for The Collection and Storage of Blood

and Human Tissue Samples for use in Research

  1. All studies involving the recruitment of participants via the NHS, or the use of human tissue obtained from NHS sources, must seek and receive approval from an NHS Research Ethics Committee before commencing. These projects cannot be approved by the University’s internal ethics system.
  2. Projects seeking to collect human tissue (primarily small samples of blood) from healthy volunteers may be approved by the University’s internal ethics system. This is allowed because the University holds a licence from the Human Tissue Authority for research (Licensing Number 12384).
  3. N.B. Point 2, above, was confirmed as meeting the requirements of the Human Tissue Act (2004) by correspondence (held on file) from The Human Tissue Authority received in June 2009.
  4. Such projects must be ethically reviewed via the University’s internal system to the agreed standards outlined in the University’s Research Ethics Code of Practice. Specifically, appropriate consent must be obtained. This is a legal requirement of the Human Tissue Act (2004), and failure to comply with this requirement can result in severe penalties, including substantial fines and imprisonment. It is the policy of the University of Leicester that appropriate consent must be fully informed and recorded.
  5. Projects must include arrangements for a donor to withdraw consent and request the destruction of their tissue.
  6. It is good practice to label samples with an ID number and keep a log of these in a separate secure location. Samples must not be labelled with a donors name or initials or any other identifying data, e.g. date of birth.
  7. Tissue may not be used for a purpose for which consent was not given, i.e. for another research project. To do so would be an offence under the Human Tissue Act (2004).
  8. Following use in the project for which consent was given,unless it is proposed to seek appropriate ethical approval and donor consent for its further use,any remaining or excess tissue must be destroyed according to laboratory standard operating procedures. (See 5)
  9. If it is desired to use the excess or remaining tissue in a further research project, the tissue must be transferred to the University’s Licensed Area for tissue holding in the Robert Kilpatrick Clinical Sciences Building. Researchers must contact the University’s Human Tissue Act Committee for details of how to arrange this. (
  10. While the tissue is in storage in the Licensed Area, it is then necessary to seek ethical approval for the new project via the University’s internal ethics system, and then to obtain new informed consent from the original donors of the tissue. If it is not possible to contact the original donor to seek new informed consent,the tissue may only be used for further research after approval has been granted by an NHS Research Ethics Committee. There is no limit to the length of time tissue may be held in the licensed area. It should be noted that Human Tissue Authority guidance states that “Human tissue is an invaluable resource for research, and disposal should be a last resort”.
  11. The technician maintaining the University’s Licensed Area for tissue holding must be informed if consent for further use of the tissue is denied, and the tissue will be destroyed according to the standard operating procedures.
  12. Departmental Ethics Officers, Ethics Committee members and researchers can obtain ethical and technical advice on the use of human tissue in research from the University’s Human Tissue Act Committee. (
  13. The collection of blood must be undertaken by someone competent in taking blood samples, or supervised by an experienced colleague until competent.
  14. Blood and tissue collection should be undertaken away from public areas.

May 2010