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Human biomaterials research

Use of human tissues for research purposes is one of a number regulated activities under the Human Tissue Act (2004). Therefore, studies involving the acquisition, storage, use or disposal of human tissue for research must be conducted in a manner which is compliant with this legislation.

1. Planning a human tissue research project

Keele University requires the monitoring of all projects using human tissues regardless of their legal status under the Human Tissue Act. Therefore prior to acquiring any human tissues or cells, researchers will need to ensure that all appropriate approvals and documentation have been secured. This will often take some time and such this should ideally be started a few months in advance of when the investigator wishes to begin their work. Anyone considering a project using human tissues should consult with the Human Tissue Officers, Dr Alan Harper (a.g.s.harper@keele.ac.uk) or Dr Daniel Tonge (d.p.tonge@keele.ac.uk) as soon as possible. They will be able to guide you through the process to help ensure that they acquire all the correct permissions and approval prior to beginning work.

These procedures are also described in the HTA-2 standard operating procedure (SOP).

This SOP refers to the following documentation:

2. Consent

The Human Tissue Act places the appropriate acquisition of consent of human tissue as a central tenet of all human tissue research. Removing, storing or using human tissue for a scheduled purpose (such as research) without appropriate consent is an offense under the Human Tissue Act (2004). This process is a sensitive and difficult task and therefore must be performed by an appropriately trained individual. HTA-37 Acquiring consent for use of human tissue for research purposess details the procedures that must be followed to ensure that appropriate, valid consent has been obtained for use of human tissue for research purposes.

3. Staff Training

All Staff and students who are who are working with human tissue must be appropriately qualified to do this. The required training is detailed on page 16 of the Human Tissue Handling Manual (see below). They should read the University Human tissue handling manual and relevant HTA codes of practices prior to beginning work, as well as completing and returning the HTA-40 form if they have not done previously

All Staff and students working with human tissue must also attend the Human Tissue Act training offered through the Learning and Professional Development Centre

4. Working with human materials

Staff working with human tissues are working with sensitive and potentially dangerous materials. Therefore we have a range of SOPs which must be followed when working with human tissues to ensure that best practice is followed. These include the human tissue handling manual (see above) as well as:

5. Documenting human tissue acquisition, storage, use and disposal

As part of our requirements of holding a human tissue authority license, we must document the acquisition, storage, use and disposal of human tissue. To do this we use two spreadsheets to log the use of human tissue which must be maintained by each research group who uses human tissues. These are HTA-8 and HTA-9 spreadsheets. These are used for logging human tissues (HTA-8) or isolated primary cells (HTA-9). Some groups may acquire human tissue from which they isolate specific primary cells – in which case both spreadsheets must be used.

In addition to the logbook, groups must also maintain a record of a range of different documentation associated with their project. The procedures for doing this are outlined in the HTA-39 SOP

To ensure that groups are compliant with both the Human Tissue Act and local University regulations, the Human Tissue Officers will perform an audit of the cells/tissues held in the university every 3 months. This will ensure that tissue and cells are correctly obtained, used, documented and stored. The procedure for the audit procedure is described in the HTA-12 SOP.

6. Reporting Adverse events and complaints relating to human tissue projects

Although Keele University has developed a quality management system designed to ensure the safe acquisition, storage, use and disposal of human tissues and cells, occasionally unexpected events occur that leads to damage to tissues. These events are referred to as adverse events and it is imperative these are reported to the Human Tissue Officers to ensure that corrective and protective actions can be put in place to prevent them occurring again. An adverse event is defined as any event that:

i) Causes harm or has the potential to cause harm to staff, visitors or research volunteers.

ii) Leads to or could lead to a breach of security of the premises and any relevant materials held within.

iii) Causes harm too, or have the potential to, cause harm to stored human tissue samples.

iv) Triggers an internal enquiry.

v) Is in breach of the Human Tissue Act or HTA codes of practices.

Anybody observing or involved with such an event should report this to the Human Tissue Officers using the following form and SOP

In addition, if a participant in a human tissue research project complains about the conduct of this research, this must also be reported to the Designated Individual, Prof Nicholas Forsyth, as soon as possible using the following SOP and form.

7. Any further questions

If you have any further questions relating to the planning or conduct of a research project using human tissues please contact the Human tissue Officers, Dr Alan Harper (a.g.s.harper@keele.ac.uk) or Dr Daniel Tonge (d.p.tonge@keele.ac.uk), who will be happy to assist you.

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