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Standard Operating Procedures (SOPs)

As part of the Quality Management System (QMS) governing all research by staff and students, a number of Standard Operating Procedures (SOPs) have been developed, detailing polices and instructions on all the processes that affect the quality and safety of human samples used in research.

The SOPs provide a uniform approach to the performance of specific functions to ensure continuity and consistency across the University. They have been produced in line with the relevant HTA’s Codes of Practice and Standards and should be read in conjunction with them. They have been approved through the Human Samples Steering Group (HSSG) and will be regularly reviewed and updated as required.

Please ensure that you are working to the latest version of each SOP and that out-of-date versions and copies are destroyed.

SOP No.  Version 

Approved:

 Standard Operating Procedures   HS1

x.04

February 2015

 Consent  

HS2

x.04

February 2015

 Acquisition and Transfer  

HS3

x.04

February 2015

 Storage   HS4

x.04

February 2015

 Adverse Events   HS5

x.04

February 2015

 Disposal  

HS6

x.04

February 2015

 Training   HS7

x.04

February 2015

 Audit   HS8

x.04

February 2015

*The latest version of the Biological Risk Assessment (appendix 3) can be found on the University's Health and Safety webpages. This should be submitted to the Director of Health and Safety for review by GMBSC.

SOP sign-off

As a requirement for the registration of all staff and students undertaking research involving the use of human samples, a Personal Training Portfolio must be maintained which includes a SOPs Sign-Off   form which must be completed by each individual involved in working with human samples to certify that he/she has:

  • read the SOPs relevant to their role;
  • understood how to apply the SOPs to their work;
  • know where to locate a copy of the current SOPs.

     

Obtaining Ethical Approval

All research involving the use of human samples must have appropriate ethical approval before the research can begin (i.e. a favourable opinion from a recognised research ethics committee). This should be current and specific for the research to be undertaken. ‘Specific’ approval may be given for an experiment, project or programme of research.

Ethical approval may be obtained through:

  • an NHS Research Ethics Committee – for example, where NHS patients, data, staff and/or facilities are used;
  • an overseas ethics committee – for example, where the research is being conducted, or samples are being collected, overseas;
  • the University’s Biomedical Research Ethics Sub-Committee (BSREC) – for example, where samples are taken from healthy volunteers and there is no NHS involvement. Overseas studies may also require review by BSREC but this should be by an expedited process.

     

For applications requiring ethical approval from an NHS REC, see:

National Research Ethics Service (NRES) is now part of the Health Research Authority

Integrated Research Application System myresearchproject.org.uk/ 

Sponsorship

Where an NHS REC application for ethical approval requires sponsorship from the University, the Director of Research & Impact Services will authorise the Declaration by the sponsor’s representative, on behalf of the University. Please contact your departmental contact in Research & Impact Services in the first instance.

Issues about ethical approval

Ethical approval must be current. It is usual for research ethics committees to grant ethical approval for the period of the research project specified, or, for example, for 3 or 5 years for a programme of research. Applying for an extension of ethical approval when a project, for example, runs over time, is usually straightforward and can be achieved by submitting an amendment to the original approval given. This is usually approved through a speedy, expedited process.

It is also critical that the application for ethical approval accurately and fully reflects the nature of the research you are undertaking, and includes all the researchers who will be taking part. If there are any changes to the scope of the project or to the researchers or organisations taking part in the project, these must be notified to the ethics committee and the appropriate amendments sought and approved.

See also: SOP HS3 Acquisition and Transfer  *

*The latest version of the Biological Risk Assessment (appendix 3) can be found on the University's Health and Safety webpages. This should be submitted to the Director of Health and Safety for review by GMBSC.

Importing and Exporting Human Samples

When human samples are being brought into the University from overseas or elsewhere in the UK, including those collected in UHCW, the Lead Investigator or Person Responsible on the research project must complete and submit to the Designated Individual for authorisation:

Where a project is receiving samples at different times but from the same source/organisation, one set of forms is sufficient but should be updated annually for ongoing collections. Where samples are being acquired from multiple sources/organisations – a set of forms is required for each source/organisation (for which there must be a formal Materials Transfer Agreement with the University to receive and use the samples for the specified research).

Materials Transfer Agreement

The acquisition and receipt of any human samples transferred into the University from another organisation must be under an appropriate legal agreement – usually an MTA. This will include specification of the conditions of transport, storage and use of the samples, the researchers who will have access to the samples, the research project, the length of time the samples are given to the University and the fate of the samples at the end of the project, for example, whether they can be retained, or must be returned or destroyed.

It is common for the researcher in receipt of the imported material to be named on and be a signatory to a MTA but only in addition to the official signatory on behalf of the University.

No individual member of staff, head of an academic department or student can officially accept an agreement on behalf of the University.

A legal contract or MTA is not required for transfer of human samples between departments of the University. However, the reasons for transfer, the storage conditions and use of the samples should be documented and approved by the DI prior to the transfer. Where custodianship of the samples is being transferred between researchers, this must be in line with the terms of the original Materials Transfer Agreement, or the original agreement must be re-negotiated.

Similarly, for the export of samples and the transfer of custodianship to another organisation, the Lead Investigator or Person Responsible must complete an Authority to Export Human Samples   form, authorised by the DI and have an appropriate agreement in place through Research & Impact Services or Warwick Ventures.

Tissue Register must be updated following the import and/or export of samples.

For further information on MTAs, contact your departmental contact in Research & Impact Services

See also: SOP HS3 Acquisition and Transfer  *

*The latest version of the Biological Risk Assessment (appendix 3) can be found on the University's Health and Safety webpages. This should be submitted to the Director of Health and Safety for review by GMBSC.

Traceability of Samples – Tissue Register 

The Lead Investigator or Person Responsible, receiving or exporting the human samples, is responsible for ensuring the Tissue Register is updated with the details of the samples transferred to or out of the University and that a unique identifier is assigned to each sample and to each of the products associated with it. Numbering and labelling of samples (using labelling that is clear, robust and appropriate to the storage conditions) must be in accordance with the SOP HS4 Storage(PDF Document).

All human samples need to be traceable from consent to disposal, its location catalogued and all relevant information held securely on Tissue Register when samples are received into the University. Every use of each sample must be tracked through the maintenance of comprehensive records in laboratory note books in accordance with Good Laboratory Practice (GLP). Tissue Register must be updated when any sample is finished with, disposed of or exported.

Human samples should be stored separately from non-human samples.

Tissue Register will record the following details:

  • Sample location (freezer, shelf & rack number)
  • Sample unique identifier code
  • Sample container type
  • Sample type and amount (wt/vol)
  • Name of Lead Investigator or Person Responsible
  • HTA licence status
  • Supplying individual/organisation
  • Import authorisation reference number
  • MTA reference number
  • Date of import
  • Research proposal reference number
  • RIS SAP project code
  • Ethical approval reference number
  • Ethical approval end date
  • Project start date and end date
  • Project completion details
  • Date of transefr/export
  • Shipment or transportation details
  • Date of disposal

Records must not contain any patient identifiable data including, for example, patient name, date of birth, date of death, address, NHS number, G.P, etc.

For access to Tissue Register, please contact the Human Samples Office.

See also: SOP HS4 Storage  

Disposal of Human Samples

Lead Investigator or Person Responsible is responsible for the disposal of human samples used in their research. Disposal must observe due care and respect for the samples, the donor and/or family, be recorded on a Human Samples Disposal   form and be carried out separately from the disposal of other forms of waste.

All human samples to be disposed of should be collected in the rigid yellow containers marker 'for the disposal of human material' and then disposed of by incineration.

See also: SOP HS6 Disposal  

Forms

Authority to Import Human Samples  

Biological Risk Assessment  

Authority to Export Human Samples  

Human Samples Disposal