All research involving human tissue samples at the University must be approved by the appropriate research ethics body.

These include:

• Health Research Authority (HRA)

• NHS research ethics committees (RECs) for NHS patients and healthy controls

• Multi-centre research ethics committees (MRECs) for samples obtained from a Human Tissue Authority-licensed tissue bank

• University ethics approval for healthy volunteers

What is considered human tissue?

The Human Tissue Authority provides a list of relevant material. This list is not intended as exhaustive or exclusive but is intended to provide guidance in respect of a number of materials that might be considered relevant material. As a general rule, relevant material is anything that contains viable cells.

What do I have to do if I want to work with human tissue?

Responsibility for complying with requirements lies with the principal investigator (PI), or supervisor for student projects. You must inform your Research Institute Ethics Lead of any human tissue samples that have been acquired under HRA NHS research ethics committee approval or from an HTA approved tissue bank with REC approval. Non-conformance will constitute research misconduct.

The HTA provides full details of codes of practice for using human tissue in research. Please read Code A: Guiding Principles and the Fundamental Principle of Consent and Code E: Research, to ensure you are well informed about research using human tissue when planning your project.

To collect tissue samples from volunteers at the University, staff and doctoral students must obtain favourable ethics review for their study via the University's Ethics Review System before the work commences. For students on taught courses, a UREC 4 form must be completed and approved prior to work commencing.

Where do I store my human samples?

Storage at the University

The Human Tissue Authority licences the storage of relevant material for research in England, Wales and Northern Ireland. Hallam University does not possess a HTA licence. However such a licence is not required and samples can be stored at the University if:

• Relevant material is being held for a research study approved by an NHS Research Ethics Committee (or where an application for approval is pending).

• Relevant material is acquired from an HTA-licenced research tissue bank that has in place a generic ethical approval from an NHS REC (provided your study meets their conditions of approval).

• The first 2 conditions are not fulfilled but relevant material will stay in Hallam University for hours, days and certainly no more than one week, pending transfer to another organisation or before it is rendered acellular (examples on pages 21-22 of the Code E).

Human tissue samples must be stored in designated freezers and fridges in your Faculty.

The samples should be clearly identified as being human tissue using specific labels, including the required information. For information on containers to be used, labelling of boxes and tubes containing human tissue, please refer to the SOP for storage and labelling.

Storage at the biorepository

Sheffield Hallam University researchers can store research samples that come under the regulation of the Human Tissue Act in the Sheffield Biorepository at the University of Sheffield, located at the Royal Hallamshire Hospital.

This will allow samples from healthy volunteers to be collected at the University and subsequently stored at the Sheffield Biorepository. These samples can be stored at the University for up to seven days, after which time they must be transferred to the Biorepository. Ensure that arrangements with the Biorepository are in place for the transfer of your samples before the collection has started as it can take time to organize the transfer.

Samples need to be stored in the biorepository after a REC approved research project has ended.

To store human tissue samples at the biorepository, you will need to complete a sample transfer form. Refer to the documentation of the biorepository: Transfer of existing collections into the biorepository. The biorepository will issue a receipt when returning your samples. No form is required for this, but you must update the human tissue log on return of the samples to the University. When samples logged at the biorepository are disposed of please complete a sample disposal report. Send it to the Biorepository.

The Standard Operating Procedures (SOPs) to be used in tissue collection, sampling, storage and the documents required to do so have been agreed with the manager of the biorepository.

When the Sheffield Biorepository is audited by the Human Tissue Authority, they may visit Sheffield Hallam University to follow up on specific tissue samples. It is therefore crucial that the agreed SOPs are followed for all aspects of this work. Failure to comply with this will constitute research misconduct.

When transferring human tissue samples to and from the University to the Sheffield Biorepository you must follow the procedures provided in the transport risk assessment document.

Human tissue log

All human tissue stored at SHU must be logged in the human tissue log. To get access to this document, please email human humantissue@shu.ac.uk with the following details:

• ethics committee approval for the project (please attach your approval email or reference number)

• your name

• college 

• full project title and project number

You will be sent a link which will give you access to the section of the Human tissue log that is relevant to you and your college.

Disposal of human tissue

Please familiarise yourself with the disposal procedures as set out in HTA Code A and HTA Code E. Details of sample disposal at Sheffield Hallam University are provided in the SOP human tissue disposal document and details of disposal of clinical waste bins are provided in the relevant SOP (SOP103).

End of project

At the end of your project you will be required to complete an end of project report and checklist.