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Research and regulation
Sandy Mather
Director of Regulation
Aims
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
Delegates should have a greater understanding of 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 the issues which effect the research community the practical implications of being a Designated Individual or
Person Designated
Structure, ethos and functions
HTA - structure
Human Tissue Authority - members 17 (including the Chair) Lay majority Professional representatives
Human Tissue Authority – staff 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
An independent regulator Inspiring professional, patient and public confidence A proportionate regulator
Inspecting according to risk Flexible
Supportive Collaborating with other regulators
Best practice and avoid duplication
How we will do this
By consulting widely and listening By providing clear guidance and advice Keeping things as uncomplicated as possible
How will we license and inspect?
Compliance reporting HTA evaluate evidence in compliance report Inspect according to risk
Inspection
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
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
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
The HT Act makes consent the fundamental principle Storage and use of body parts, organs and tissue
from the living or deceased for specified purposes Removal of material from the deceased
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 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?
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
Research – will I need a licence?
Q – Do I undertake research on tissue samples from deceased patients?
Tissue removed and stored to determine the cause of death Licence required
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
PRIMARY PURPOSE:Research
Yes, unless material is obtained
from a living person and is anonymised
Is it stored for a specific ethically approved research project?
Yes No
Is a licence required?
Is a licence required?
Yes
Is consent required?
Yes
Is consent required?
No
The licensing process
Overview of the licensing process
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)
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
‘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’
Lord Warner – House of Lords – Grand Committee
The role of the DI – HTA’s view
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
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 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
Designated Individual 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
Securing compliance with licence conditions Licence conditions can be statutory, standard and additional Examples of statutory licence conditions – the “givens”
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 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. 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 Simple Measurable Achievable Relevant Time bound
HTA Governance framework
Various models of governance HTA aims to explain the roles and responsibilities Provide education and training via workshops E-learning packages
HTA Governance Framework
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
Licence holder (if different to DI) 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
Person designated as a person to whom the licence applies Must be named in a notice given by the DI to the Authority Other people can work under the direction of this person
Persons acting under the direction of a DI or Person Designated Any person
Responsible Person under the EUTCD Must have scientific or medical experience
HTA framework - based on governance of institution
DesignatedIndividual
Licence Holder (if not DI)
Person Designated
by 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
Pre-conditions to the grant of a licence The Authority must be satisfied that
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
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 Compliance report
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 Website Licensing FAQs A guide to licensing for DIs and Licence Holders Application guidance Telephone and email advice
The Compliance Report
Standards in a tabulated format On-line document Narrative and numerical scoring Licence applicant and Designated Individual
complete jointly with team
Standards
Standards Generic Goal to be achieved Assess compliance with the Act and Codes of Practice
Evidence of compliance Sector specific Activities that are needed to achieve the standard
Compliance Report
Purpose Allows applicant to reflect on progress against standards Enables an evaluation of suitability for a licence
Advantages Engenders change Drives up standards Empowers regulated sector Identifies areas for improvement Implements changes to achieve them
On line application
Applications for licences
Storage of tissue for human application Licence will be for storage for transplantation
Storage of tissue for research Licence will be for storage for use for a Scheduled
Purpose other than transplantation
Deemed licences
Issuing deemed licences
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 Numerically
Scale of 1-4 1 – Standard not met 4 – Standard fully met Scores are not cumulative
Qualitatively Narrative to support the self-assessed score by the applicant
Compliance report is evaluated by the regulator Regulator awards a score based on an evaluation of the
available information about an applicant Regulator allocates a final score taking account of the
applicant’s self-assessment score
Licensing Panels
Licensing panels
Two panels working on a fortnightly rotation – Panel A and B Each panel comprises two members of staff Chaired by a manager
Escalate if there is disagreement or legal advice may be needed 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
Licensing Panel to decide 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
Letter to offer licence Sent from chair of Licensing Panel Includes guidance about the right to make representations Requirement to acknowledge licence in writing
Licence with four annexes 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
HTA’s approach to regulation Flexibility, advice and guidance,
How we will licence the research sector To explain the role of the Designated Individual,
Licence Holder and Persons Designated Compliance reports
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
