Research using Human Samples
Knowing your Responsibilities
Professor John Davey
Designated Individual (HTA Licence)
Challenges
Who is using human samples in their research ?
What samples are they using ?
What research are they doing ?
Where are the samples from ?
Was there consent to collect the samples ?
Is there ethical approval to use the samples ?
Are the samples stored appropriately and securely ?
How is the use of the samples tracked ?
What is the quality of the samples ?
Do we need to consider all human samples ?
Are the HT Act and the HTA Licence the same ?
Do we have enough storage space as we increase research ?
Aims of the presentation
The presentation aims to:
• Outline the Human Tissue Act, 2004
• Describe UoW approach to research with human tissue
• Seek input to further inform the process
Following this session, you will:
• Have an overview of the Human Tissue Act 2004
• Know when the Act applies
• Understand what constitutes best practice
• Be armed with advice to support compliance
• Know where to find help
Human Tissue Regulation
Provides a framework for research with human tissue:
• Removal
• Retention
• Use
• Disposal
Legislation is enacted through the Human Tissue Act 2004.
Previous legislative framework includes:
• Human Tissue Act 1961
• Anatomy Act 1984
• Human Organ Transplants Act 1989.
Human Tissue Authority
The HTA enacts the Human Tissue Act.
It licences organisations that store and use human tissue.
There are 5 licensed sectors:
• Human application
• Post-mortem services
• Research
• Anatomy
• Public display
Risk
Arms Length Body Review
Functions will continue, but transferred to other organisations
Warwick’s HTA Licence
Our licence covers storage/use of human tissue for research.
Hub = CSRL at UHCW
Satellite = Gibbet Hill
Key individuals
Licence Holder’s Representative
Designated Individual
Deputy DI
Person Designated (CSRL)
Person Designated (Gibbet Hill)
University Registrar
Professor John Davey
Dr Andrew Blanks
Dr Mei Gu
Dr Robert Eason
Roles & responsibilities
Licence Holder proposes the DI, approved by HTA
DI supervises our activities under the licence
Deputy DI and PDs assist the DI in these activities
Researcher, Lead Investigator and Person Responsible
Roles and responsibilities
Researcher
Suitably trained individual responsible for undertaking research
involving human samples.
Lead Investigator
Appropriately qualified individual who has responsibility for the conduct
of the research and the human samples being acquired, stored and
used on the research project. Usually the Chief or Principal Investigator
but who might delegate responsibility for the human samples to a
suitably trained Person Responsible.
Person Responsible
Suitably trained individual responsible for the human samples acquired,
stored and used for research, as delegated to do so by the Lead
Investigator for the research project.
Human Tissue Act, 2004 – Offences
Offences under the act include:
• Not having appropriate consent
• Not having appropriate ethical approval
• Using tissue collected for one purpose for another
• Carrying out licensable activities without a licence
• Trafficking in human tissue for transplantation purposes
Penalties against individuals and institutions:
• Conditions/restrictions placed on the licence
• Suspension/withdrawal of the licence
• Fines and up to 3 yr imprisonment, or both
Things we need to understand
We need to understand the following:
• Registration (researchers and projects)
• Relevant material
• Scheduled purpose
• Consent
…understand them in the context of UoW
• Ethical approval
Ongoing, based on discussions with:
• HTA and NHS Research Ethics Service
• Importing samples
• Researchers (UoW and elsewhere)
• Storage and tracking
• NHS Research & Development
• Disposal
• UoW committees (Audit, BSREC, RGaEC)
• Research Support Services
• Exporting samples
• Inspection and audit
Our procedures – Quality Manual and SOPs
The Quality Manual documents UoW’s Quality Management
System for the governance of the acquisition, storage, use and
disposal of human samples for research.
www2.warwick.ac.uk/services/rss/researchgovernance_ethics/research_code_of_practice/humanparticipants_m
aterial_data/research_human_samples-copy/
Standard Operating Procedures:
1.
2.
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5.
6.
7.
8.
Writing a SOP
Consent
Acquisition and Transfer
Storage
Adverse events
Disposal
Training
Audit
HTA report “a very good and proportionate set of procedures”
Register of researchers using human material
SOP7 – Training
We have a ‘register’ of researchers using human material.
Researchers need to demonstrate competency.
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Be familiar with relevant documentation
Undergo training relevant to the work
Maintain a training portfolio
Registration is a 3-stage process:
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Training session with DI (Knowing your responsibilities)
MRC e-learning module (www.rsclearn.mrc.ac.uk)
Complete a ‘declaration’ of registration
Registration will need to be renewed every 3 years.
Relevant material – HT licence
HT licence - material which consists of or includes human cells.
Fundamental principle is that a sample containing even just a
single cell from a human body is classified as relevant material.
Examples of relevant material under HT licence:
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Specifically identified relevant material (arms, legs, heads)
Bodily waste products (urine, sweat, pus, washings)
Cell deposits and tissue sections on slides
The following are excluded from the HT licence:
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Gametes and embryos outside the human body (HFEA)
Hair and nail from a living person
Cell lines which have divided outside the human body
Samples that are more than 100 years old
Samples stored incidental to export or processing to acellular (<1 wk)
Samples being used for an NHS REC-approved project
Human samples at the University of Warwick
ALL human samples are ‘relevant’ under the HT Act:
• ALL human samples at UoW will be treated as RELEVANT
• There will be a SINGLE set of policies and procedures
• These will cover ALL human samples
• This will provide clarity, consistency and confidence
• This will permit a more practical approach to tracking
We will know what is under our HTA Licence, when required.
Scheduled purpose – research
Our licence allows us to carry out ‘research’.
Research attempts to derive new knowledge and includes studies that
address clearly defined questions, aims and objectives in order to
discover and interpret new information or reach new understanding of the
structure, function and disorders of the human body.
Our licence covers some other (limited) purposes – Appendix 1.
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Includes public display, clinical audit, health education & training
Research is not:
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Having a look to see what happens
Gathering preliminary data for a grant application
Checking something from a paper
Seeing if the samples are any good
Using up left over material
Consent
Consent is a central tenet of the HT Act.
It is best practice to obtain consent
If this is not possible, seek reassurances and/or consider the issues
There is an increasing trend towards ‘generic’ consent
Consent is considered in applications for ethical approval
The HT Act provides limited and specific exemptions:
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Old samples (“existing holdings”, prior to Sept 2006)
Imported samples (from outside England, Wales, Northern Ireland)
Anonymised samples (with NHS REC approval) – Appendix 2
UoW will hold information related to consent for all samples:
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Patient Information Sheets and consent proforma (ethics application)
Individual consent forms can (and will) be requested during audits
Ethical approval
Ethical approval is required for all studies using human samples.
Ethical approval should be specific and current.
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Approval can be ‘specific’ for an experiment, project or programme
Ethical approval must be granted by one of the following:
• NHS Research Ethics Committee
o NHS patients/tissue/data
• Overseas Ethics Committee
• UoW Biomedical and Scientific Research Ethics Committee
o Healthy individuals
o Overseas studies might need University review (expedited process)
Ethical approval is part of the application to Tissue Banks.
Issues to consider about ethical approval
When was ethical approval obtained ?
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Updating NHS REC approvals is straightforward (and fast)
What is the ethical approval for ?
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We need the original ‘full’ application for ethical approval
Overseas applications/approvals must be in English
Translations need to be by an approved service
Is Warwick and/or the researcher named in the application ?
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Changes should be by amendments not through new applications
Amendments should be considered by the original committee
NHS REC approvals can be amended easily
Amending approvals from overseas committees is possible
Importing human samples into UoW
SOP3 - Acquisition and Transfer
The Lead Investigator or Person Responsible must:
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Complete an “Authority to Import Human Samples” form
One set of forms is required for each contractual obligation (MTA)
Ongoing collections require forms to be updated annually
Import from another organisation requires an agreement (MTA):
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Prepared by Research Support Services
Signed/agreed by an official signatory (RSS Director, not researcher)
Names of UoW researchers and their roles/responsibilities
What we have agreement to do
The length of time the agreement is for
Fate of samples at end of agreement (retained, returned, destroyed)
Use of the retained samples when the agreement ends
Storing and tracking samples
SOP4 – Storage
Samples need to be traceable from consent to disposal.
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You need to demonstrate a sample is what you think it is
You need to demonstrate a sample is where you think it is
You need to catalogue the location of ALL samples.
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Information to be recorded on Tissue Register (securely)
You need to track EVERY use of EACH sample.
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Researchers maintain a record of usage in laboratory books
Tissue Register is updated only when sample is finished/disposed
Disposal of human samples
SOP6 – Disposal
The Lead Investigator is responsible for the disposal of samples.
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Lead Investigator can delegate responsibility to Person Responsible
Disposal of human samples must:
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Observe due care & respect for the samples, the donor and/or family
Be recorded on the “Human Samples Disposal” form
Be carried out separately from other waste
Human samples to be disposed of should be:
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Sealed in a separate clear autoclave bag
Autoclaved at 131oC for 30 min
Stored in a thick gauge yellow plastic clinical waste bag until collection
Tissue Register must be updated following disposal of samples.
Exporting human samples
Lead Investigator is responsible for the export of samples.
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Lead Investigator can delegate responsibility to Person Responsible
The Lead Investigator or Person Responsible must:
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Complete an “Authority to Export Human Samples” form
Export to another organisation requires an agreement (MTA):
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The agreement is to transfer custodianship, not the samples
Prepared by Research Support Services and/or Warwick Ventures
Signed/agreed by an official signatory (not the researcher)
Tissue Register must be updated following export of samples.
We are here to help
John Davey (Designated Individual)
Tel: 02476 524204
J.Davey@Warwick.ac.uk
Emily Dight (HTA Administrator)
Tel: 02476 528207
Tel: 02476 151755
HTA@Warwick.ac.uk