Code E: Research, human application and clinical trials
This section covers the interface between research, human application and clinical trials
Tissue and cells, including stem cells and cell lines
117. The use of tissues and cells in human application and clinical trials is a rapidly developing field. As the boundaries between research and human application are continually shifting, the potential for cross-over between the sectors is significant. To ensure that you are up to date with the regulatory requirements, you are advised to keep abreast of information provided by the HTA via the e- newsletter and website.
118. Human tissue for research in vitro (i.e. will not be transplanted into humans) must be stored under a HTA licence, subject to the exceptions set out in the licensing section of this Code (see paragraph 84).
119. Tissue or cells, including cell lines, which may be transplanted into humans, even where it is for research, must be licensed by the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). For detailed information about the licensing requirements, see the HTA’s website or contact a member of HTA staff.
120. Tissues and cells for transplantation into patients, including stem cells and cell lines, are regulated by three regulatory bodies for human application:
a) the HFEA regulates the creation and use of embryos in the derivation of embryonic stem cell lines. The HFEA’s remit ceases at the point the embryo is dissociated, at which point the HTA’s remit begins;
b) the HTA regulates the procurement, testing, processing, storage, distribution and import/export of tissues and cells, including cell lines, intended for human application;
c) the Medicines and Healthcare products Regulatory Agency (MHRA) regulates when a cell therapy is deemed to be a Medicinal Product (MP) or Investigational Medicinal Product (IMP).
121. Researchers planning to work with tissue and cells with a reasonable expectation that those cells will be used in patients, should contact the MHRA for a decision as to whether the product could be a MP or an IMP.
122. Treatments classed as MPs or IMPs are regulated by the HTA only for procurement and testing of tissue. The subsequent steps are regulated by the MHRA. If a treatment containing human tissue or cells is not considered an MP or IMP by the MHRA, it will be regulated entirely by the HTA under the Q&S Regulations.
123. The HTA has produced statements in conjunction with the MHRA and HFEA, which explain our regulatory remits in regulating stem cells and Advanced Therapy Medicinal Products (ATMPs). A regulatory route map is also available on the HTA’s website.
Clinical trials
124. The storage of human tissue as part of a clinical trial (where the material itself will not be used in human application) must take place on HTA-licensed premises, subject to the exceptions set out in the licensing section of this Code (see paragraph 84).
125. Following the conclusion of a clinical trial, researchers may wish to store relevant material collected during the trial for research within the scope of the HT Act. Where there are plans to do this, researchers must have regard to the relevant consent and licensing requirements of the HT Act, as set out in this Code.
126. Establishments using tissues or cells for human application as part of a clinical trial must be licensed under the Q&S Regulations. It is important to note that licensing under the Q&S Regulations still applies where tissue or cells are used for human application as part of a clinical trial approved by a United Kingdom Ethics Committee Authority (UKECA) - recognised ethics committee.
Disposal
127. Processes should be in place to inform donors how their tissue will be disposed of after use. The HT Act permits disposal of surplus tissue as waste.
128. The HTA recognises that what is sensitive and what is feasible at local level needs to be taken into account. It is good practice for human tissue to be bagged separately from clinical waste. It is not necessary for each tissue sample to be bagged and disposed of individually.
129. Establishments may have collections of existing holdings that are considered to be valuable for teaching or possible future research. They should review the usefulness of these collections on a regular basis and, where items are found not to be of value, they should be disposed of sensitively and respectfully, and the details documented.
130. The HTA has issued separate guidance on the sensitive handling of pregnancy remains, which is available on our website.