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
Human tissue storage
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.
These samples can be stored at the University for up to seven days, after which time they must be transferred to the Biorepository, should they not be exhausted. 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.
Any tissue bought commercially does not have to be monitored.
Human tissue log
All human tissue stored at the University has to be logged in the human tissue log. To get access to this Google Sheets document, please email email@example.com with the following details
- ethics committee approval for the project (please attach your approval letter)
- your name
- full project title
- 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 Faculty. For more information on the human tissue log please refer to the SOP for entering data onto the human tissue log.
Human tissue storage
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. 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.
How to store human tissue samples at the biorepository
You will need to complete a sample transfer form. Refer to the biorepository's standard operating procedure documentation. 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.
How to store your human tissue at the University
Human tissue samples must be stored in the 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 standard operating procedure for storage and labelling.
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.
End of project
At the end of your project you will be required to complete an end of project report and checklist.
Summary of forms and documentation