1
Code of Practice
Acquisition, Storage and Use of Human Biological Material for Research
SOP Reference: / COP/HTA/v2.0Version Number / 2.0
Date: / 12/9/2014
Effective Date: / 12/9/2014
Review by: / 11/9/2016
Author:Dr Natalie Chaplin
Designation: Tissue Governance Manager; Brighton and Sussex Medical School / Signature / Date
Authorised By:Prof Kevin Davies
Designation: HTA Research Licence Designated Individual; Brighton and Sussex Medical School
Expert Authorisation
Designation:
Contact Details
Version
/Date
/Reason for Change
2.0
/Change in licencing at BSMS- BSUH relinquished satellite licence
Code of Practice for the Acquisition, Storage and Use of Human Biological Material for Research
Author: Tissue Governance Manager
Approved by: BSMS HTA Governance Group and BSMS Research Sub-Committee
Implemented by: HTA Research Licence Designated Individual
Prof Kevin Davies
Authorised by: Dean, BSMS
Prof Gordon Ferns
Summary of Document
This documents sets out the Brighton and Sussex Medical School (BSMS) policy on the acquisition, storage and use of human biological material for research purposes, with particular reference to activities relating to the Human Tissue Act research licence12561. The document defines the responsibilities and accountabilities in relation to such.
Distribution
The authorised policy will be distributed to the licence holder, designated individuals, all clinical directors and general managers within BSMS Research sites and cascaded to other BSMS and research active staff in partner Trusts. It will also be distributed to the persons designated on the HTA research licence. This policy, together with associated Standard Operating Procedures,will also be posted on the BSMSpublic website and made available to all research active staff in BSMS.
Timetable
The Code of Practice will be reviewed annually or more frequently if deemed necessary by the BSMS HTA GovernanceCommitteeor other universitygroups like the HTA Coordination Group or the Unviersity Research Governance Committee (URGC).
Implementation
The Designated Individual (DI) on the BSMS HTA research licence is responsible for ensuring that this code of practice is implemented across all HTA research licence sites. The DI will, with the approval of the BSMS Research Sub-Committee, delegate the task of implementing this code of practice to the Individuals Designate.
Contents
1.0Introduction
2.0Definitions
3.0Scope
4.0Governance
4.1Duties and Obligations
4.2Research Approvals
4.3Consent
4.4Confidentiality
5.0Acquisition of Human Biological Material
5.1Material acquired for a specific project
5.2Material acquired for unspecified future use
6.0Storage of Human Biological Material
6.1Specimen tracking
6.2Surplus diagnostic specimens
6.3Nucleic acid storage
6.4Historical collections
7.0Export of material
8.0Disposal
9.0Adverse events
10.0Risk management systems
11.0Complaints
12.0Training
13.0Premises and Equipment
13.1Equipment
13.2 Receipt and distribution of local and national alerts
13.3Contingency plans
14.0Monitoring and auditing
1.0Introduction
The purpose of this policy is to ensure that all staff and students under supervision undertaking research using human biological specimens do so within the framework of the Brighton and Sussex Medical School (BSMS) Human Tissue Authority (HTA) Research Licence and know and comply with relevant sections of the Human Tissue Act (2004), HTA licensing conditions, Codes of Practice and related policies.
BSMS has a duty of care to anydonor who has consented to the storage and use of their biological specimens for research to ensure that the material is treated with respect and is handled in accordance with the terms of the consent given and the appropriate legislation.
This policy has been developed through theBSMS HTA Governance Group and sets out:
- BSMS’s position in relation to the acquisition, storage, use and disposal of Human Biological Material for Research Purposes so as to comply with the law (Human Tissue Act (2004)) and the Licensing conditions imposed by the HTA.
-the terms and conditions under which human biological material can be stored and used for research within the Medical School (MRB and the Trafford Centre).
This policy has also been developed to provide reassurance to research participants, funding bodies, external regulators and the public that BSMS’s activities in relation to the use of human tissue for research complies with the law and current guidance and that there are systems in place to monitor such.
2.0Definitions
Adverse Incident: HTA definition: Any event that:
-caused harm or had the potential to cause harm to staff, research participants or visitors;
-any event that led to or had the potential to lead to a breach of security of the premises and the contents contained therein;
-any event that caused harm or had the potential to cause harm to stored human tissue (including loss);
-any other event that gives rise to an internal inquiry;
-any breach of the HT Act or the Codes of Practice.
Anonymisation: samples or data where any identifying information removed, such that it is not possible for the researcher using them to identify the individual to who they relate. They may be:
-Linked anonymised – Specimens are fully anonymous to the people who use them but remain coded such that an appropriately authorised person could link them back to the person from whom they came.
-Unlinked anonymised -the link between the specimen and the person from whom it camehas been irreversibly broken.
Appropriate consent: consent as defined by the Human Tissue Act and the guidance from the Human Tissue Authority in Code of Practice 1: Consent.
Donated material/tissue: human biological material that has been removed with appropriate consent as set out in section 1 of the Act.
HTA: Human Tissue Authority, the independent body set up under the Human Tissue Act (2004) to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of “Scheduled Purposes”.
Human Biological Material: For the purposes of this policy Human Biological Material shall refer to material that has come from a human body and consists of or includes human cells (the definition of ‘relevant material’ used in the Human Tissue Act (2004) section 53).
Human Tissue Act (2004) [“The Act”]: legislative framework covering the uses to which human biological samples can be put. Material not covered by the Act include hair and nail of a living person, gametes and embryos, which are separately regulated by the Human Fertilisation and Embryology Act (1990), established cell lines, human material created outside the human body or rendered acellular by processing (eg serum, plasma, cell free supernatants, DNA).
HTA Licences: BSMS holds 2 licences from the HTA defined as follows:
Research Licence(licence number 12561): allows BSMS to legally store human biological material for research purposes (Medical Research Building site + 1 satellite site (Trafford Centre)).
Designated Individual: Prof Kevin Davies
Anatomy Licence: (licence number 12098): allows BSMS to legally carry out post mortem examinations and to remove and retain samples from the deceased for scheduled purposes (BSMS Dissecting Room in the Teaching Building).
Designated Individual: Dr Claire Smith
Surplus Human Biological Material: refers to material that has been removed from a patient for the primary purpose of diagnosis, treatment or a specific research project and is no longer required for that purpose.
3.0Scope
The scope of this policy covers the HTA research licence only (12561). It applies to the removal, storage, use and management of all specimens of human biological material forresearch purposes collected since 1st September 2006.
It is the responsibility of all BSMS, Brighton and Sussex University Hospitals’ (BSUH) staff and any staff from other HEIs, NHS trusts, organisations or who have honorary status working at BSMS and HTA licence sites to be aware of and comply with the requirement of the licences, the law and this policy.
Employees of the Trust who do not hold honorary BSMS contracts but who use or store human biological material at BSMS’s HTA licence sites and under the terms of BSMS’s HTA licences, will observe those parts of the policyas defined in the Human Tissue Governance agreements made between BSMS and BSUH and must comply with BSMS’s research governance requirements.
4.0Governance
The Tissue Bank Governance Committee (TBGC)oversaw the implementation of the BSMS Research Licence, which was awarded in April 2010 and developed BSMS policy in relation to the Act, HTA licence conditions and codes of practice to ensure that BSMS can comply with current legislation and guidance. Subsequent to the withdrawal of the Clinical Investigation Research Unit (CIRU) as a satellite on the BSMS HTA Research licence in Sep 2013, the TBGC was dissolved and the duty of overseeing the research licence was passed to the BSMS HTA Governance Group which will report to the BSMS ResearchSub-Committee andwill now ensure that BSMS policies and procedures are implemented at local level and will monitor compliance. The BSMS Research Sub-Committee is accountable tothe BSMS Dean’s Executive Group. Minutes will also be passed to the University of Sussex HTA Coordination Group which reports to the University of Sussex Research Governance Committee. The BSMS Research, Governance and Ethics Committee will also be informed and consulted on HTA issues pertinent to its remit (detailed in figure below).
In addition, the BSMS HTA Governance Manager will participate in the University of Sussex HTA Coordination Group which will meet four times/year, providing a forum to discuss common issues and to develop governance structures. The Code of Practice (COP) and associated Standard Operating Procedures will beformally reviewed every two years by the UoS HTA Coordination Group or when procedures and practices change.
BSMS HTA Research Licence Reporting Structure
4.1Duties and Obligations
Designated Individual: the designated individual has the primary legal responsibility to ensure that suitable practices are used when undertaking the licensed activity, that the other persons who work under the licence are appropriate for their role and that the conditions of the licence are complied with.
BSMS HTA Governance Group(HGG):HGG is responsible for developing policies and procedures to ensure BSMS is compliant with the Human Tissue Act, HTA codes of practice and licensing requirements and to ensure the research participants and public have confidence in the Medical School’s practices with regard to the removal, storage, use and disposal of human biological material.
BSMS Research Sub-Committee: responsible for overseeing and approving the work of the BSMS HGG and reporting to the BSMS Dean’s Executive Group.
Tissue Governance Manager: The tissue governance manager will facilitate the HGG in carrying out its role and will provide advice, information and training in relation to this and related policies and procedures.
Person Designated: The person designated at each licence site has a duty to provide local site-specific advice and information relating to the research and the use of human biological material to both Principal Investigators and other researchers. The PDs will take a lead in implementing BSMS policies and procedures and HTA licence conditions locally and will be appointed on a two year rotating basis by the HGG.
Principal Investigator (PI): The principal investigators are responsible for all aspects of their research activity including the acquisition, storage, use and disposal of human biological material. They must be familiar with all current requirements and BSMS procedures relating to research and the use of human biological material as defined in this policy and related procedures and guidance and must have systems in place to ensure compliance with them. The PIs have a duty to make sure that their entire team know and adhere to any relevant procedures and policies put in place to ensure compliance with the law, HTA licensing conditions, codes of practice and the Research Governance Framework for Health and Social Care.
Researcher/research staff: All staff involved in research must comply with all relevant SOP’s, policies and standards of good practice to ensure compliance with the law, HTA licensing conditions, codes of practice and the Research Governance Framework for Health and Social Care.
4.2Research Approvals
Research using human biological material from BSMS cannot be carried out unless the project has been approved by an appropriate Research Ethics Committee (as defined by HT Act 2004, Statutory Instrument 2006 No 1260 Section 1 (2)) and has been sponsored by University of Sussex or appropriate body if the samples are from NHS patients or individuals recruited in an NHS setting. As a rule of thumb, all studies involving NHS patients will require NHS Research Ethical Committee (NREC) review and NHS R&D sponsorship and those involving healthy volunteers will require University ethical review and sponsorship, although this may vary depending on the specifics of the project.
Agreements with outside bodies and organisations involving human tissue must not be entered into by the researcher without the agreement of the University Research & Enterprise officeand the signing of Material Transfer Agreements. Investigators also have a responsibility to inform the BSMS RGEC of their proposed research plans (
The University of Sussex Research Governance Code of Practice ( and procedures and the Research Governance Framework for Health and Social Care (2nd Edition, 2005) ( apply to all research using human biological material.
Tissue Banking
Researchers intending to use stored residual material from previous studies in a new study will need to seek appropriate ethical approval and sponsorship for the new study, ensuring that the tissue being used has appropriate consent for its future use.
It is anticipated that the HTA licence for research will lead to the establishment of a Research Tissue Bank (RTB) at BSMS. An application for ethical review (“Generic Ethical Approval for Projects Receiving Tissue”) for the RTB for collection, storage, use and distribution will be made to a recognised NREC in the future, once this has been deemed strategically favourable. This will offer additional reassurance to end-user researchers, donors, funding bodies and the public that its operation meets the highest ethical standards. In addition, in the future, ethical approval for the RTB may facilitate research programmes without a need for individual project-based ethical approval.
The appropriateness of a proposed research project using tissue from the RTB will be appraised by the HGGwhich will review all applications to use tissue bank resources. Where this committee feels it does not have the sufficient expertise to review an applicationcomprehensively, external peer review will be sought.
4.3Consent
Human biological material can only be acquired, stored and used for researchif appropriate consent has been obtained. (For exceptions see: 6.2 Use of surplus diagnostic specimens).The giving of consent must be a positive act, the absence of refusal is not evidence of consent.
Anyone removing, storing or using material in circumstances for which the HT Act requires consent must be satisfied that consent is in place. They do not need to have taken or recorded consent personally. It is the principal investigator’s responsibility to ensure that appropriate consent procedures are in place as well as appropriate Service Level Agreements in the case of a third party taking consent.
Any person taking consent must be trained in accordance with Good Clinical Practice (GCP) guidelines, see section 13.
Living research participants
These processes are outlined in detail in SOP/HTA/001: Consent.
Patients:patient consent will generally be obtained by an NHS research nurse who will have received appropriate training. Consent forms will then be retained by their R&D department and samples will be issued to the PI anonymised with the clinical care team retaining the link to identification.
Healthy Volunteers: consent will be obtained by the PI (subsequent to appropriate GCP training) who will store consent forms securely according to the BSMS data governance policy. Samples will used anonymously with the PI retaining the link to identification in a separate, secure (link-anonymised) database. PI’s requiring human biological material as controls in experiments are encouraged to follow the protocol developed and approved by BSMS RGEC - Investigation of Pathological Mechanisms of Disease, R&D Ref No:13/182/LLE, PI: Dr Martin Llewelyn.
Future use:If it is anticipated that samples acquired as part of a research project will not be used fully during the initial project, researchers may ask participants to consent for the continued storage of residual specimens and their potential ‘secondary use’ for broadly defined areas of ethically approved research at a later date. The donor must give explicit consent for this use and this should be clearly documented in the patient’s/healthy volunteer’s notes. It is now customary for all residual tissue acquired through research studies to be stored for future use. Researchers should thus consider this carefully and ensure that they obtain appropriate consent.