Transcript Document

Research and regulation
Sandy Mather
Director of Regulation
Aims
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To explain the HTA’s structure, ethos and functions
To explain the legislative framework for licensing
and inspection
To summarise our standards for licensing and
explain compliance reporting
To explain the role of the Designated Individual,
Licence Holder and Persons Designated
Outcomes
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Delegates should have a greater understanding of
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the HTA’s structure, ethos and functions
how the HT Act affects researchers
HTA standards for licensing, inspection and compliance
reporting
the role of the Designated Individual, Licence Holder and
Persons Designated
HTA will have a greater understanding of
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the issues which effect the research community
the practical implications of being a Designated Individual or
Person Designated
Structure, ethos and functions
HTA - structure
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Human Tissue Authority - members
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17 (including the Chair)
Lay majority
Professional representatives
Human Tissue Authority – staff
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20 (including Chief Executive)
Four directorates – regulation, policy, communication and
resources
The HTA’s regulatory 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
What we are
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An independent regulator
Inspiring professional, patient and public confidence
A proportionate regulator
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Inspecting according to risk
Flexible
Supportive
Collaborating with other regulators
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Best practice and avoid duplication
How we will do this
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By consulting widely and listening
By providing clear guidance and advice
Keeping things as uncomplicated as possible
How will we license and inspect?
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Compliance reporting
HTA evaluate evidence in compliance report
Inspect according to risk
Inspection
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Inspection process includes site visits and desk-based
evaluation of information
Site visits
 carried out prudently to benefit both applicant and
the regulator
 gather additional visual and aural evidence
 test compliance with standards
 test validity of risk assessment and evidence
provided
Licensing storage of human
tissue for research activities
The legislative framework
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The HT Act and EU Tissues and Cells Directive
Two stages of commencement for licensing
April 2006 – establishments storing tissue for
human application
September 2006 – all other sectors
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Storage for research
Anatomical examination
Public display
Pathology
The HT Act – S16
16(1) No person shall do an activity to which this section
applies otherwise than under the authority of a licence
granted for the purposes of this section.
16 (2)(e) the storage of
(i) the body of a deceased person, or
(ii) relevant material which has come from a human body
for use for a scheduled purpose
HT Act
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The HT Act makes consent the
fundamental principle
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Storage and use of body parts, organs and tissue
from the living or deceased for specified purposes
Removal of material from the deceased
Licensing
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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
One person (Designated Individual) supervises
the activities under a licence
Research
Research - will I need a licence?
Q – Do I undertake research on tissue samples from living patients?
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Tissue removed and stored for the primary purpose of diagnosis
or treatment
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No licence
Tissue removed and stored for the primary purpose of research
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Distribution to other researchers (tissue bank) – licence
A specific research project with ethical approval – no licence
A possible project in the future – licence
Research – will I need a licence?
Q – Do I undertake research on tissue samples from deceased
patients?
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Tissue removed and stored to determine the cause of death
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Licence required
Tissue removed and stored for the primary purpose of research
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Distribution to other researchers (tissue bank) – licence
A specific research project with ethical approval – no licence
A possible project in the future – licence
PRIMARY PURPOSE:
Research
Is it stored for a specific
ethically approved
research project?
Yes
Is consent
required?
Yes, unless
material is obtained
from a living
person and is
anonymised
No
Is a licence
required?
Is consent
required?
Is a licence
required?
No
Yes
Yes
The licensing process
Overview of the licensing process
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Role of Designated Individual and Licence Holder
Compliance report, standards and guidance notes
On-line application
Deemed licences
Licensing database
Evaluating licence applications
Licensing Panels
Issuing licences
Representations and appeal
The Designated Individual
The role of the Designated Individual (DI)
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Specific responsibilities as set out in section 18
of the Human Tissue Act
The DI is the person under whose supervision
the licensed activity/ies are authorised to be
carried on
HT Act does not state who should be a DI
The role of the DI – Lord Warner’s view
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‘The person might be a head of department, a
clinician, a scientist, or a manager. What is
important is that it is a person who is in a position to
secure that activities are conducted properly by
people who are suitable to carry out those activities
and that all the necessary requirements are
complied with’
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Lord Warner – House of Lords – Grand Committee
The role of the DI – HTA’s view
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DI has to have knowledge and understanding of the HT
Act and the relevant Codes of Practice
DI has to demonstrate managerial capability, ensuring
development and implementation of quality
management systems and be able to effect change
Links to board level
Have time within substantive role to carry out
responsibilities and ensure compliance with licensing
conditions
The role of the DI – the sectors’ views
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Varying views about who should be the DI across 5
sectors
Varying organisational structures
Concern about level of responsibility
We found that licence applicants tended to have a
limited understanding of
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Duty of ‘Designated Individual’ (Section 18)
Role of ‘Licence holder’ (Para 6(4) of Schedule 3)
Role of ‘Designated Persons to whom a licence applies’
(Section 17)
The role of the DI – set out in HT Act
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Designated Individual
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Person under whose supervision the licensed activity is
authorised to be carried on
Must consent to an application or make it himself
Has statutory duties as set out in Section 18
- that the other persons to whom the licence applies are
suitable persons to participate in the carrying-on of the
licensed activity
- that suitable practices are used in the course of carrying on
that activity and
- that the conditions of the licence are complied with
The role of the DI – set out in HT Act
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Securing compliance with licence conditions
Licence conditions can be statutory, standard and additional
Examples of statutory licence conditions – the “givens”
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The licensed activity must only take place on the premises specified in
the licence
“Supervise” activities carried on under a licence
Record information as required by HTA (direction making powers)
Keep records specified by HTA as required by HTA
Provide copies of records or extracts to HTA as may be specified
Pay fees to the Authority in respect of its costs in “superintending
compliance with the terms of licences”
The role of the DI – ensuring
compliance with conditions
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Standard conditions apply to all licences of a particular type
Additional conditions are specific to a licence and are imposed
on the grant of a licence.
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Help to achieve compliance with HTA licensing requirements
Can also be used to restrict the manner in which a licensable activity can
be performed
Written using the SMART principle
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Simple
Measurable
Achievable
Relevant
Time bound
HTA Governance framework
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Various models of governance
HTA aims to explain the roles and responsibilities
Provide education and training via workshops
E-learning packages
HTA Governance Framework
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Designated Individual
Licence applicant (if different to DI)
Person Designated as a person to whom the
licence applies
Persons acting under the direction of a DI or
Person Designated by DI
Governance
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Licence holder (if different to DI)
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Must have consent of DI for application
Can apply to vary licence to remove DI without his/her
consent
Can be a corporate body eg NHS trust
Governance
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Person designated as a person to whom the
licence applies
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Persons acting under the direction of a DI or
Person Designated
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Must be named in a notice given by the DI to the Authority
Other people can work under the direction of this person
Any person
Responsible Person under the EUTCD
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Must have scientific or medical experience
HTA framework - based on governance
of institution
Designated
Individual
Person
Designated
by DI
Licence Holder
(if not DI)
Other people working on licensed premises and carrying out licensed
activities do so under the direction of
the Designated Individual or a Person Designated by the DI
Role of the Authority
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Pre-conditions to the grant of a licence
The Authority must be satisfied that
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The proposed DI is a suitable person to supervise the activity to be
authorised by the licence
The applicant is a suitable person to be the holder of the licence
The premises are suitable for the activity to be authorised by the
licence
A copy of the conditions to be imposed by the licence must be
acknowledged in writing by the applicant for the licence and where
different the proposed DI
Compliance report and application form enable the Authority
to determine “suitable”
DI training days
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15 June – Liverpool
19 June – London
5 July – Bristol
19 July – London
9 August – Birmingham
January 2007 – tbc
Email [email protected]
Compliance reporting
Compliance report and guidance notes
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Compliance report
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Establishment Information
Designated Individual
Licence holder (corporate or individual)
Consent – 3 standards
Governance and Quality Systems – 8 standards
Premises, Facilities and Equipment – 5 standards
Disposal – 2 standards
Guidance
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Website
Licensing FAQs
A guide to licensing for DIs and Licence Holders
Application guidance
Telephone and email advice
The Compliance Report
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Standards in a tabulated format
On-line document
Narrative and numerical scoring
Licence applicant and Designated Individual
complete jointly with team
Standards
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Standards
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Generic
Goal to be achieved
Assess compliance with the Act and Codes of Practice
Evidence of compliance
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Sector specific
Activities that are needed to achieve the standard
Compliance Report
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Purpose
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Allows applicant to reflect on progress against standards
Enables an evaluation of suitability for a licence
Advantages
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Engenders change
Drives up standards
Empowers regulated sector
Identifies areas for improvement
Implements changes to achieve them
On line application
Applications for licences
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Storage of tissue for human application
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Licence will be for storage for transplantation
Storage of tissue for research
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Licence will be for storage for use for a Scheduled
Purpose other than transplantation
Deemed licences
Issuing deemed licences
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Applications to be received by mid August 2006
HTA check contact details and issue deemed
licence by 1 September 2006
Customer satisfaction questionnaire included
Data transferred from website to licensing
database for HTA evaluation
Evaluating licence
applications
How the compliance report is evaluated
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Numerically
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Qualitatively
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Scale of 1-4
1 – Standard not met
4 – Standard fully met
Scores are not cumulative
Narrative to support the self-assessed score by the applicant
Compliance report is evaluated by the regulator
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Regulator awards a score based on an evaluation of the
available information about an applicant
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Regulator allocates a final score taking account of the
applicant’s self-assessment score
Licensing Panels
Licensing panels
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Two panels working on a fortnightly rotation –
Panel A and B
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Each panel comprises two members of staff
Chaired by a manager
Escalate if there is disagreement or legal advice
may be needed
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Director of Regulation or other member of SMT joins the
panel and takes over the Chair (has casting vote)
Legal advisor may be engaged
Making judgements about
“suitability” as per the HT Act
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Licensing Panel to decide
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Whether satellite arrangements are suitable
If the proposed DI is suitable
If the licence holder is suitable
If the premises are suitable for the proposed activity
Whether suitable practices take place at those premises
Whether to apply conditions
Whether to grant a licence
The duration of the licence
To refuse to grant a licence
Issuing licences
Two documents
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Letter to offer licence
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Sent from chair of Licensing Panel
Includes guidance about the right to make representations
Requirement to acknowledge licence in writing
Licence with four annexes
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Additional conditions (plus reasons)– specific to application
Standard conditions – sector specific and imposed by HTA
Statutory conditions – sector specific and as set out in the HT Act
Definition of terms
Summary
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HTA’s approach to regulation
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How we will licence the research sector
To explain the role of the Designated Individual,
Licence Holder and Persons Designated
Compliance reports
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Flexibility, advice and guidance,
Developed standards with each sector
Applicant critically reviews own progress against standards
Licensing storage of tissue for research from 1
September 2006
www.hta.gov.uk