MRC Elsie Widdowson Laboratory

Research Quality and Governance

EWL strives to ensure our research is of a high scientific standard, is conducted safely, and respects the wishes and integrity of any patients or volunteers involved. All staff, students and visiting workers are required to operate within the expectations of MRC policy and guidance, Ethics and Research Governance on scientific and ethical principles underpinning research, and also the Joint Code of Practice for Research (Defra).

Quality Assurance in Research

EWL places strong emphasis on assuring the quality of its research activities. Quality assurance is governed through local management systems and external audit of specific research activities where required. EWL has a Quality Management System, certified to ISO 9001:2008 (since January 2006), which is maintained to control and monitor our performance and to continually improve our effectiveness. EWL is externally audited twice annually by Lloyd’s Register Quality Assurance to ensure compliance with the requirements of ISO 9001:2008. View our certificate here: LRQA certificate 2015

Further information on MRC guidance can be found here.

This page contains information on:


Human Tissues Licence

Background

Since the establishment of the Human Tissue Authority (HTA, effective from 1 September 2006), there have been legally binding conditions to follow when storing and using human tissue under the stipulations of the Human Tissue Act (HT Act) 2004.

Any activity in EWL that involves the use of tissues and cells therefore has to follow strict and standard conditions. These conditions are internally monitored and regulated through EWL’s Quality Management System, certified to ISO 9001:2008.

In order to comply with the Act, all establishments storing tissue and cells for research purposes, other than for a specifically approved research project, have to be licensed. Licensing arrangements under the Human Tissue Act (2004) stipulate certain requirements including the roles of Designated Individuals (DI), Licence Holders and Persons Designated.

EWL Research Licence

EWL has been granted a Research Licence under Section 16 (2) (3) (ii) of the Human Tissue Act 2004.

This licence authorises the storage of relevant material for the scheduled purposes below:

* Establishing after a person’s death the efficacy of any drug or other treatment administered to him
* Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)
* Public Display
* Research in connection with disorders, or the functioning of the human body
* Clinical audit
* Education or training relating to human health
* Performance assessment
* Public health monitoring
* Quality Assurance

Designated Individual: Polly Page, Head of Operations (EWL Representative for Research Governance). The DI takes ultimate responsibility for compliance with the Act.

Licence Holder: MRC  Elsie Widdowson Laboratory (EWL)

Licensed Premises: Elsie Widdowson Laboratory

Persons Designated: Persons Designated act in a supplementary role to the DI, to support in advising and supervising other persons to whom the licence applies about procedures and systems agreed by the DI that ensure compliance with the Human Tissue Act and the terms of EWL’s licence.

  • Director and Group Leader: Ann Prentice
  • Group Leaders: Polly Page
  • Team Leaders: Lorna Cox, Sumantra Ray
  • Health and Safety and Quality Manager: Sarah Casey
  • Sample Tracking and Human Tissues Advisor: Karen Chamberlain

EWL works in accordance with the HTA’s codes of practice and standards on consent, storage, disposal and import and export of human tissue.

Further information on the Human Tissue Act can be obtained from the Human Tissue Authority and the MRC.


EWL Policy on Disposal of Human Tissue

This Policy is written in accordance with ‘The Human Tissue Act 2004’. It should be read in conjunction with HNR’s standard procedures for ‘Collection, Storage or Use of Human Tissue Samples’ (SOP.0539) and Disposal (SOP.0509). Staff are also advised to refer to the Human Tissue Authority Code of Practice for Disposal.

The Human Tissue Act 2004 requires that human tissue is treated and used with respect and in accordance with the wishes of donors or their relatives. HNR procedures for handling and disposing of human tissue fully comply with the requirements of the Human Tissues Act and reflect accepted good practice.

EWL is licensed by the Human Tissue Authority (HTA Licence No. 12383) to store ‘relevant material’ from a human body for ‘scheduled purposes’ subject to specific conditions. In accordance with HTA expectations, we have a documented disposal policy which is made available to the public.

Scope

This policy applies to all EWL personnel responsible for and coordinating human research studies, those taking consent and those responsible for or involved in the disposal of human tissue.

Policy Statement

For EWL research, human tissue samples are generally donated by the living and most commonly by healthy volunteers who provide, with their consent, tissue samples for the purposes of our research. Most tissue samples are blood, urine, saliva or small biopsy samples (e.g. fat or muscle).

Given the nature of EWL’s research, it is likely that there will be less sensitivity about the disposal arrangements for tissue. That said, research staff should be familiar with local arrangements and options for disposal and prepared to discuss disposal arrangements and/or provide written information for participants if requested.

All EWL research operates under external ethical approval, generally via the National Research Ethics Service (NRES). Depending on the study, tissue samples may be collected by HNR personnel or by third party collaborators. For studies carried out in collaboration with others, a formal agreement is signed between MRC EWL and the third party. Such agreements include responsibility for samples and disposal where applicable.

Disposal

Under the HT Act it is lawful to treat as ‘waste’ any human tissue donated by a living person participating in research when that ceases to be used or stored for further use in research.

Disposal of tissue must also be in compliance with health and safety recommendations.

Tissue from the living will therefore normally be disposed of by incineration in accordance with current guidelines on Safe Disposal of Clinical Waste (1999). Large quantities of urine, such as acquired during 24-hour urine collections, may be flushed down the toilet.

There are greater sensitivities to take into account when disposing of tissue donated from the deceased or by a member of a research study who has since died. Such tissue will be handled in accordance with any reasonable wishes expressed by the deceased person or their relatives, as long as the method of disposal is safe and legal.

Requests by research participants to retain their tissue samples or to arrange disposal themselves will be considered on a case-by-case basis, taking into account any risk to the participant and others and lawful methods of disposal.

At the end of a research study, samples are stored for future use or are disposed of in accordance with the terms of the ethical approval and participant consent. HNR has standard procedures for sample tracking. Sample disposal is logged and recorded, including the date of and reason for disposal.

Definitions

SCHEDULED PURPOSES: The activities relating to the removal, storage and use of human organs and other tissue that require consent, listed in Schedule 1 of the HT Act, e.g. research in connection with disorders or the functioning of the human body.

RELEVANT MATERIAL: The HTA defines this as material other than gametes, which consists of or includes human cells (does not include embryos). Further information is on the HTA website.

RESIDUAL TISSUE: Material left over from a diagnostic or therapeutic intervention.

SURPLUS TISSUE: Relevant material which has come from a body in the course of receiving treatment, diagnostic testing or participating in research.

Further Information and guidance
MRC summary of legislation on disposal.
Human Tissue Authority and HTA Codes of Practice
HNR Contacts: Human Tissues Advisor, Quality Manager and Head of Operations.


Freedom of Information

What is the Freedom of Information Act 2000 (FoI)?
The FOI Act is a law giving people general right of access to see all types of recorded information held by public authorities. It sets out exemptions to that right and places a number of obligations on public authorities (including the MRC and MRC Establishments such as EWL).

Under the FoI Act, any person who makes a written request to a public authority for information must be informed whether the public authority holds that information, and, subject to exemptions, be supplied with that information. The public authority must reply promptly, not later than the 20th working day following receipt of the request for information, and in the format requested.

What is MRC’s approach to FOI?
Effective handling of FoI requires a commitment to openness, good record keeping and effective communication. MRC is starting from the position that all information would be made freely available, unless there were good reasons not to do so (in line with relevant exemptions). MRC’s web site and MRC Establishment Web Sites have been, and will continue to be, developed with this goal in mind.

MRC’s FoI Publication Scheme sets out much of the information the MRC holds, in what form (i.e. electronic, paper) and how to obtain this information.

Enquirers under the Act can make written requests concerning MRC Elsie Widdowson Laboratory  directly to the Unit or through the MRC Head Office:

MRC Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9NL

Telephone: +44 (0)1223 426356
Email: foi@mrc-ewl.cam.ac.uk

Freedom of Information Officer
Corporate Affairs Group
Medical Research Council
14th Floor
One Kemble Street
London
WC2B 4AN

Telephone: +44 (0)1793 416200
Email: foi@headoffice.mrc.ac.uk


Data Protection

The Data Protection Act gives individuals the right to know what information is held about them, and it provides a framework to ensure that personal information is handled properly.

EWL complies the requirements of the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal information and is committed to upholding the Act’s core data protection principles.

Useful link: MRC Policy and Guidance on Data Protection.