Experimental Therapeutics MSc Human Tissue Act and Biobanks Gemma Marsden Oxford BioResource Governance Manager University of Oxford, Research Services.

Experimental Therapeutics MSc Human Tissue Act and Biobanks Gemma Marsden Oxford BioResource Governance Manager University of Oxford, Research Services

Genes protecting smokers’ health one of many UK Biobank findings
“Some smokers seem to be spared the lethal effects of tobacco, and the UK Biobank might know why. The biobank opened in 2012 and it contains detailed health information on 500,000 middle-aged volunteers. Martin Tobin at the University of Leicester, UK, and colleagues analysed 50,000 volunteers’ DNA – including non-smokers and heavy smokers. They identified six genes that seem to have a role in lung health. While some people appear to have protective versions, others may have one or more harmful kinds. This might explain why some heavy smokers don’t develop chronic obstructive pulmonary disease – a group of disorders that together form the third most common cause of death worldwide (The Lancet Respiratory Medicine, doi.org/7zn). But Tobin warns that smokers’ lung function will still be weaker, even if they are disease-free. “There is no real green light here.”” New Scientist issue 3041 published 3 October 2015 “Biorepositories have emerged as a critical platform for all the advanced, large-scale genomics and proteomics research that will inform and drive the development of a new generation of targeted diagnostics and therapies, which in turn will transform clinical outcomes.” The increased demand is due to a number of factors, genomic and proteomic research require access to large numbers of samples. Review of 4 cancer research journals: Cancer Research, Clinical Cancer Research, British Journal of Cancer and International Journal of Cancer – published at 5 year intervals. Biospecimens were used in 1292/3307 (39%) of publications analysed. Cohort sizes increased proportion of studies using frozen or fresh tissues alone has decreased while those using FFPE alone or combined FFPE/frozen has increased. TMA, antigen retrieval from FFPE, but also more general shift to validate biomarkers in the most common clinical format. Demand for fresh biospeciemens has remained static for 20 years, expansion of certain research areas (e.g. stem cell and immunological research) may also stimulate the need for live cell biobanking in the next decade. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

We are in the ‘Age of the Biobank’
Advances in science require access to large numbers of high quality samples and associated data Biorepositories that coordinate the activity of biobanking rank amongst the most important of established health research infrastructures as contributors to research publications. Castillo-Pelayo T et al. The importance of biobanking in cancer research. Biopreservation and Biobanking 2015 Jun;13(3):172-7. “Biorepositories have emerged as a critical platform for all the advanced, large-scale genomics and proteomics research that will inform and drive the development of a new generation of targeted diagnostics and therapies, which in turn will transform clinical outcomes.” The increased demand is due to a number of factors, genomic and proteomic research require access to large numbers of samples. Review of 4 cancer research journals: Cancer Research, Clinical Cancer Research, British Journal of Cancer and International Journal of Cancer – published at 5 year intervals. Biospecimens were used in 1292/3307 (39%) of publications analysed. Cohort sizes increased proportion of studies using frozen or fresh tissues alone has decreased while those using FFPE alone or combined FFPE/frozen has increased. TMA, antigen retrieval from FFPE, but also more general shift to validate biomarkers in the most common clinical format. Demand for fresh biospeciemens has remained static for 20 years, expansion of certain research areas (e.g. stem cell and immunological research) may also stimulate the need for live cell biobanking in the next decade. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Outline What is a Biobank? Types of Biobanks The role of the Biobank
How a Biobank functions Informed consent Ethics and governance Sample collection Data Quality control Accessing the Biobank BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

What is a Biobank? A collection of biological materials and the associated data Staff and management Ethical and legal oversight Financial systems IT systems Processing facilities Storage facilities and access Based in: Academic medical institutions / pharmaceutical / biotechnology companies / stand-alone organisations. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Key requirements for establishing a biobank
Ensuring compliance with the regulatory environment Ensuring biobank materials are ‘fit for purpose’ Ensuring appropriate governance mechanisms Ensuring long-term sustainability Ensuring optimal use of biobank assets to meet organisation’s strategic aims Biobank assets = materials and infrastructure Ensuring compliance with the regulatory environment (local, national and international) Ensuring biobank materials are ‘fit for purpose’ (data and samples) Streamlining the process e.g. on-line search and request of samples. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Types of Biobanks A traditional biobank model involves the collection and storage of specimens and associated data at a central facility: generic biobank project driven biobank (e.g. to support a translational research programme associated with a clinical trial) A virtual biobank model involves specimens collected and stored locally with the associated specimen data centralised. Requests for specimens are handled through a central coordinating office. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Project-driven biobanks
Generic biobanks Analysis of results Application to biobank Topic for research Continuing collection Project-driven biobanks Analysis of results Prospective collection of tissue Topic for research No further collection BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Role of Biobanking in Research
Clinical data Biobank Clinical trials Identify and validate drug targets Identify disease mechanisms Develop screening tests for biomarkers associated with certain sub-types of a disease Group patients based on their genetic characteristics and likelihood of positive response, for testing of new drugs Group patients based on the “biomarkers” of their disease to determine which treatment is appropriate Develop personalised medicine BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

The Role of the Biobank Interface between sample donors in the clinical care setting and scientists performing biomedical research in an academic or pharmaceutical setting. The biobank’s role is to act as a bridge for samples and data to move between the two environments. Responsibilities: To patients and healthy volunteers, the biobank has a responsibility of not interfering in their clinical care, and protecting their rights of privacy and the confidentiality of the information they have donated. To researchers, the biobank has a responsibility of providing high quality data and biomaterials so that the highest-calibre research can be conducted. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Collection and storage
Donor recruitment Informed consent process Protocol design and ethics review Collection and storage Inventory and Pathology Data Clinical data SECURE BIOBANK DATABASE Coded-linked data and samples Sample Processing Inventory data Biobank Activities

Informed Consent A member of the clinical or biobank team will approach potential donors to: give them information about why researchers are asking for their tissue and data to be put into a biobank/ used for specific ethically approved research talk about any potential risks ask the potential donors for permission BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Biobanks as Ethical Ecosystems
Research biobanks are “ecosystems” of diverse stakeholders: Public, patients, healthcare professionals, scientists, government, funders, healthcare service providers, ethicists, regulators…. Central role in the multidisciplinary “chain of supply” that carries samples and data between donor and researcher Each person involved with the supply chain should adhere to common overall guiding principles to ensure biosample supply is in line with the original donor’s wishes BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Informed consent and commercial involvement
Review of the Peterborough NHS tissue bank 3140 preoperative interviews, 38 (1.2%) refusals Reasons: Incidents at Alder Hey and Bristol (2), extreme anxiety (2), perceived lack of time to make decision (2), problem understanding (4), hostile patient (3). Remaining individual patients refused because of fear of compromising diagnosis, objection to disclosure of medical history, fear the surgeon would take extra tissue, fear that anonymity would not be upheld, spiritual reasons, or emotional attachment to the organ to be removed. Only 2 patients were specifically against commercial involvement Why surgical patients do not donate tissue for commercial research: review of records. Jack AL, Womack C (2003) BMJ 327: 262 BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Sample collection: what to collect?
Diverse range: Biopsies of solid tissues Surgical resection of solid tissues Blood samples and their derivatives Fine needle aspiration biopsies of solid lesions Fine needle aspirations of body fluids, other than blood, including the fluids in body cavities, joints, abscesses, cysts etc. Collections of secreted or excreted body fluids, including urine, sputum, saliva, tears etc. Cells shed or scraped from body surfaces including: skin scrapes, buccal scrapes Hair, teeth, nail, skin debris Whole organs, limbs, larger structures Collection for a purpose Maximising usage of each sample BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Formats of biosamples Formalin fixed paraffin embedded Frozen Blood
Morphology Histopathology Molecular histology Molecular analysis Frozen Biochemical analysis Blood BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

123/03 123/03 TMA101 TMA102 TMA103 Slide from donor block
marked for coring Cores extracted from donor block Donor block 123/03 123/03 123/03 Cores implanted into replicate arrays TMA101 103-1 103-2 TMA102 103-3 Each array block produces several hundred sections 103-4 103-5 TMA103 Diagram courtesy of Dr R Leek

Oxford standard 8 x 15 (6 element) TMA (1mm diameter cores)
Position A1 Slide label Position H15 Diagram courtesy of Dr R Leek

Accessing the Biobank – key considerations
Is the project inline with the consent gained from the patient? Who needs access? Will their work bring benefit to patients? Who is acceptable to the donors of the samples? Has the work got a favourable opinion from an appropriate ethics committee? Is the work properly insured? (I.e. is there trust management approval and/ or appropriate sponsorship) Will the work deplete the samples? Should those who contribute to the collection be afforded preferential access? Should those who contribute to the collection have some control over access? BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Data Collection In the UK, data processing must be compliant with the Data Protection Act 1998 Parallel process to tissue collection Data is as important as the biospecimen Data sources: donor’s medical record interview process with patients themselves, their care providers, and sometimes their relatives if genetic diseases are being studied third party databases may be accessed if such permission is granted BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

What data elements are you going to collect?
General demographic information History of present illness, treatments, and responses Longitudinal information Clinical outcomes Disease specific data elements Scientific data generated by researchers BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Importance of Quality Control
Good quality research depends on good quality material “Garbage in – Garbage out” For example use pathology review to verify that sample X is sample X Delta QC and rate of AT drop out are measures of DNA quality currently used by the Genomics England 100, 000 Genomes Project. Qualify the sample as to its physical characteristics and its appropriateness for various research uses Control pre-analytical conditions of collection Must be fit for purpose – needs to be handled correctly and stored appropriately BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Multiple pre- and post-collection variables can affect the quality of tissue samples
Pre-collection variables Antibiotics Other drugs Type and duration of anaesthetic Arterial clamp time How hydrated the patient is Post-collection variables Time at room temperature Type of fixative Time in fixative Rate and temperature of freezing Size of aliquots Patient Surgery Collection Processing Storage Quality Control Distribution BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Why is standardisation of biobank practices important?
‘The majority of pre-analytical errors for tumour markers are attributable to simple sample handling errors, such as inappropriate timing and incorrect specimen identification’ Sturgeon CM et al, National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Clinical Practice: Quality Requirements. Clinical Chem 2008;54(8):e1-e10 BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Requesting samples Researchers identify the samples that they need for their studies by contacting the biobank or “querying” the biobank database direct For example, a researcher might define the following parameters about the samples required: The clinical history of the donor The treatment regimen prescribed to the donor Characteristics of the sample Format of the sample The research project is reviewed, this ensures: that the research is inherently valuable samples are used wisely as part of the “chain of trust” with donors the project is ethically sound with respect to donor safety and privacy Most biobanks are non-profit organisations, however researchers will often have to reimburse the biobank for costs associated with providing the samples. Cost recovery/cost contribution. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Challenges in obtaining funding to support tissue banking
“Researchers fear that current access to tumour samples is not sufficient to unpick cancer’s secrets” Nature, 4 April “Pricey cancer genome project struggles with sample shortage” Nature Medicine, April 2007 Challenges in obtaining funding to support tissue banking Variable quality of collected tissue, histopathology and clinical data Lack of clarity in legal/ethical framework Lack of co-operation and co-ordination between research groups BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

National Network: Wales Cancer Bank
The Wales Cancer Bank aims to collect samples of tumour, normal tissue and blood from all patients in Wales who are undergoing an operation to remove tissue where cancer is a possible diagnosis. These samples will be banked to build up a research resource that will be used by research groups to help understand the molecular mechanisms involved in cancer and work towards the selection of optimum targeted treatment for individuals. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

National Network: Children's Cancer and Leukaemia Group
Applications from all researchers carrying out biological investigations of childhood cancer invited to access samples from the CCLG Tissue Bank Free publications available to all Fund raising for research, so research grants can be funded Coordinating centre for many collection centres across UK BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Virtual Networks – UKCRC Tissue Directory and Coordinating Centre (National)
The UKCRC Tissue Directory and Coordination Centre is a new initiative to improve access to human tissue samples for research purposes in the UK. Human tissue samples are collected by various researchers and biobanks across the UK. These samples are collected under specific permission from the Human Tissue Authority and/or a Research Ethics Committee. There is an increasing need to be able to find samples across the UK and to make sure researchers can access them for high quality research. The role of this new centre is to provide leadership and coordination in order to fulfil the funders' vision for human tissue resources. BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Virtual Networks - BBMRI-ERIC (International)
BBMRI-ERIC (Biobanking and BioMolecular resources Research Infrastructure - European Resources Research Infrastructure Consortium) shall establish, operate and develop a pan-European distributed research infrastructure of Biobanks and Biomolecular Resources in order to facilitate the access to resources as well as facilities and support high quality biomolecular and medical research.

Ensuring compliance with the regulatory environment – national / international
National (UK) National Research Ethics Service Data Protection Act 1998, Caldicott Report Human Tissue Act 2004 International Specific regulations of source country Seamless transfer of material between countries ‘Home country’ rule promoted by TuBaFrost Consortium Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Get in on the (Human Tissue) Act!
What is it? Why did we need it? What activities require consent? What activities require licensing? Consent exemptions Licensing exemptions Research Tissue Banks What is the Human Tissue Authority? Licensing process Offences BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Image courtesy of DavidCockerton.com
BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

The Human Tissue Act 2004: what is it?
A regulatory framework for: The storage and use of dead bodies The removal, storage and use of tissue and organs from the deceased The storage and use of tissue and organs from the living Does not include removal, storage or use of tissue from living for diagnosis or treatment Applies in England, Wales and Northern Ireland (Human Tissue Act Scotland 2006) Triggered by organ retention scandals BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Why did we need it? Organ retention scandals highlighted the fact that organ retention without relatives’ full knowledge and agreement was widespread Alder Hey Inquiry Report: “When I met the families from Alder Hey, from Bristol and elsewhere, they told me that had they been asked properly, they would have been only too willing to allow their child’s death to help another child live” Former Health Secretary Alan Milburn Retained Organs Commission Re-write of Human Tissue Act 1961 Tissues and organs had been systematically taken during or after post-mortem on babies and children who had died following paediatric cardiac surgery. The tissue and organs were used for a variety of purposes including audit, medical education or research. Some had simply been stored. BRISTOL: When Coroners' post-mortems were carried out, parents were not told that the pathologist might take or retain tissue or organs, or the uses to which retained tissue and organs might be put. Consent was not sought. When hospital post-mortems were carried out, 'consent forms' were often signed but there was little information on what tissue or organs would be taken or the uses to which they might be put. The term 'tissue' was not defined. In particular it was not explained that this could include whole organs. LIVERPOOL: Tissues and organs systematically taken at post-mortems over a long period of time on babies or children who had died Between 1988 and 1995, all organs were removed from babies and children on whom post-mortems were conducted Still-born babies and fetuses were also kept, or their organs and tissue retained Failure to determine whether parents objected or even provide adequate information Stored against the possibility of being used in future research No choices were offered on methods of disposal Further samples of tissue were taken from organs In some cases, families appear to have been pressurised into agreeing to a hospital post-mortem In some cases, consent to post-mortem, when given, was exceeded or ignored where families had sought to limit the extent of the post-mortem examination Families misinformed about the organs and tissue retained after post-mortems The term "tissue" was not explained BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Questions Am I storing ‘relevant material’? Do I need a licence?
Do I need consent? Samples are being stored here only briefly…do I need a licence? I have ethical approval for my research…do I need a licence? I’m importing samples…what consent is required? BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

What is ‘relevant material’?
“Relevant material” means material from a human body which consists of or includes human cells YES Organs Tissue* Blood Saliva Faeces Urine ….etc. * Cells or sections of tissue on slides ARE classed as relevant material NO Serum DNA RNA ….etc. Material divided or created outside the human body. Cells that have been treated, processed or lysed through a process intended to render them acellular. EXCLUSIONS Human cell lines for research purposes (created outside the human body) Hair and nails from the living (except where used for DNA analysis) Live gametes and embryos (HFEA) BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

What activities require consent?
Consent is the over-arching principle within the Act “Scheduled purposes” PART 1: Purposes requiring consent where the tissue is from the living or deceased Anatomical examination Determining the cause of death Establishing after a person’s death the efficacy of any drug or other treatment administered 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 Transplantation “Scheduled purposes” PART 2: Purposes requiring consent where the tissue is from deceased persons Clinical audit Education or training related to human health Performance assessment Public health monitoring Quality assurance Act defined these scheduled purposes BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Consent for Research (and exceptions)
Consent is the fundamental principle underpinning the HT Act Consent must be obtained for the removal, storage and use of tissue from the deceased Consent for the storage and use of tissue from the living must be in place except where ethical approval is in place and: the tissue is imported or the tissue is anonymised to the researcher or the tissue is part of an existing holding (collected before 1st September 2006) CONSENT IS BEST PRACTICE BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

What activities require licensing?
Anatomical examination Post-mortem examination Removal of relevant material from a deceased person Storage of relevant material from a deceased person Storage of anatomical specimens Storage of relevant material from a living person for research or for human application Public display of a body or material from a deceased person BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Types of Licence Human Application Anatomy Research Pathology
Public Display Research licence: storage of relevant material from the living or the deceased for research in connection with disorders or functioning of the human body BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Licensing exemptions Licensing exemptions – deceased
Material more than 100 years old Stored for purpose of “qualifying research” Licensing exemptions – living or deceased Storage incidental to transport CONSDIER WHETHER TO LEAVE IN BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Exceptions to Research Licence
Exception to licensing requirement for research where appropriate* ethical approval is in place Exception is only in place for the duration of the study *From a recognised Research Ethics Committee (REC):  a REC) established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments  an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004. Relevant material stored for research Is it stored for a specific ethically approved research project? Yes Is a licence required? No No Is a licence required? Yes Do I undertake research on tissue samples from living patients? Tissue removed and stored for the primary purpose of diagnosis or treatment? No licence Tissue removed and stored for the primary purpose of research Distribution to other researchers (tissue bank) – licence A specific research project with ethical approval – no licence A possible project in the future - licence BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Research Licence Summary
To store human tissue for research a Human Tissue Authority research licence is needed Exceptions are when appropriate ethical approval is in place Appropriate ethical approval is National Research Ethics Service approval It is a criminal offence to store or use human tissue for research without a licence or ethical approval BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Research Tissue Banks (RTB) National Research Ethics Service
Provide for UK-wide ethical review of RTB on voluntary basis. Encourage applications to flagged Research Ethics Committees Generic consent may be sought from donors for use of samples in future research The main REC may give generic ethical approval for future research subject to conditions without further review of individual projects Researchers can obtain ethical approval via an approved RTB as an alternative to project-specific application The RTB must be licensed BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Human Tissue Authority
Aim: To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence An independent regulator Inspiring professional, patient and public confidence A proportionate regulator Inspecting according to risk Flexible Collaborating with other regulators best practice and avoid duplication Wide consultations, provide clear guidance Inspects licensed establishments BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Issues addressed in licensing
Suitability of Designated Individual and other persons Premises Facilities Equipment Donor identification and tracking systems Security and risk management Consent (compliance with statutory requirements, records of consent) Arrangements for disposal of samples Quality systems Internal/external audit Staff training BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Overview of the licensing process
Compliance report licence application Standards and guidance notes On-line application Deemed licences Licensing database Evaluating licence applications Licensing panels Issuing licences Representations and appeal BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Licensing One activity per licence
A licence must specify the premises where the activity is to be carried out A licence cannot authorise licensed activity on premises at different places, unless registered as ‘satellites’ One person (Designated Individual) supervises the activities under a licence BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Offences Removal, storage or use of human tissue for “scheduled purposes” without consent Undertaking licensable activities without a licence Using tissue stored for one purpose for another DNA analysis of human tissue (including hair, nail and gametes) without consent – DNA theft Fine or imprisonment BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

What is the Oxford Radcliffe Biobank (ORB)?
Research facility of the Oxford Radcliffe Hospitals NHS Trust and the University of Oxford ORB provides a simple and efficient way to collect and store samples according to regulatory requirements, and ensures fair access to the samples ORB is licensed by the Human Tissue Authority and is an ethically approved research tissue bank BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Group exercise 1 The fundamental guiding principle of the Human Tissue Act is Consent. Taking into account that consent is seen as so important that it is a legal requirement under the HT Act, how would you ensure that consent is appropriately obtained? Consider: Specific versus broad consent Appropriateness of consent (who can give consent) Validity of consent (given voluntarily; adequately informed) Conditions on consent Duration of consent Withdrawal of consent BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Group exercise 2 You are setting up a project to collect mesenchymal stem cells (MSC’s) for use in research on graft versus host disease following bone marrow transplantation. What will you need to consider? Hints - think about the following areas: Consent Ethics and governance Study questions and design Operational aspects and management BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Group exercise 3 You are applying to a tissue bank for access to umbilical cord tissue so that you can use umbilical veins to validate an in vitro technology that you have developed as a novel method for drug delivery from the bloodstream into target tissues. What would you need to do? Hints How do you find the right tissue bank? What approvals or licences do you need? BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Group exercise 4 Genomics England are running a project called the 100, 000 Genomes project in Cancer and Rare Diseases (RD). The consent process includes delivering complex information on primary findings of sequencing a persons genome but also secondary findings. These secondary findings include a variety of diseases (not linked to the cancer diagnosis) with a known genetic basis which could be found as a result of genome sequencing. Patients are asked if they would like to receive feedback of these secondary findings. For the cancer programme specifically, the consent process usually takes part not long after the diagnosis of cancer. The consent takers have noticed that it is very difficult to gain consent from patients for this project, with a high proportion refusing to take part. How could this be resolved? BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

Further information Human Tissue Authority http://www.hta.gov.uk
MRC Data and Tissue Toolkit Clinical Trials and Research Governance Integrated Research Application System (IRAS) Oxford Radcliffe Biobank (ORB) BIOBANKING HUMAN TISSUE ACT OXFORD RADCLIFFE BIOBANK

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Experimental Therapeutics MSc Human Tissue Act and Biobanks Gemma Marsden Oxford BioResource Governance Manager University of Oxford, Research Services.

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Experimental Therapeutics MSc Human Tissue Act and Biobanks Gemma Marsden Oxford BioResource Governance Manager University of Oxford, Research Services.

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