Sandy MatherHead of Regulation

1 March 2006Research Governance Issues in Higher EducationBrunswick Sub-Group, Imperial College London

Aims

To explain the HTA’s structure, ethos and functions To summarise our standards for licensing To explain compliance reporting To explain the role of the Designated Individual,

Licence Holder and Persons Designated

Structure, ethos and functions

HTA - structure

Human Tissue Authority - members 17 (including the Chair) Lay majority Professional representatives

Human Tissue Authority – staff 18 (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

Supportive Collaborating with other regulators

Best practice and avoid duplication

How we will do this

By consulting widely and listening before preparing guidance and advice

By providing clear guidance and advice – keeping things as uncomplicated as possible

How will we license?

Engage sector – workshops High level requirements – outcomes Self-assessment/compliance reporting HTA evaluate evidence in SA/compliance report Inspect according to risk (every 2 years for centres

affected by the EU Tissue and Cells Directive)

Project management approach – working groups

Professional and lay representatives Range of expertise Regulation, transplantation, storage for human

application, import/export, research, pathology, public display, emergency licensing

Time-limited – focussed on key outputs

Regulation – workstreams

Licensing Pilot methodology Standards Self assessment Designated Individual Inspections Fees EUTCD Advice and guidance

The legislative framework

The HT Act and EU Tissues and Cells Directive Commence the HT Act to give the Authority

power to license Two stages of commencement for licensing

Apr 2006 – limited to tissue establishments storing tissue for human application

Sep 2006 – all other aspects including storage (for scheduled purposes such as research)

Regulation – activities to be licensed

Anatomical examinations Post mortem examinations Removal of PM material Storage of PM material for a “scheduled purpose” Storage of anatomical specimens Storage of material from a living person for a

“specified purpose” Public display

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

Milestones

Phase 1a (up to Apr 2006) Phase 1b (Apr - Sept 2006) Phase 2 (Sep 2006 – Mar 2007) Phase 3 (Apr 2007 – Mar 2008)

Programme milestones

Phase 1a – up to Apr 2006 Commence relevant parts of the Act for storage of tissue for human

application Engage sectors to develop standards Publish licensing standards for all sectors on the website Prepared and consulted on Codes of Practice Draft Codes of Practice on the website Transplant timetable announced

Phase 1b – Apr - Sept 2006 Commence the Act to enable licensing in other sectors Regulatory timetable - training for DIs, fees, inspections etc Final Codes of Practice (approved by Parliament) published on website

Standards

Standards

Four themes Consent Governance and Quality Systems Premises, Facilities and Equipment Disposal

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 reporting

The Compliance Report

Standards in a tabulated format On-line document Narrative and numerical scoring Licence applicant and Designated Individual

complete jointly with team

Compliance Report

Purpose Allows applicant to reflect on progress against standards Enables an evaluation of suitability for a licence

Applicant evaluates progress against a regulator’s standards

Engenders change Drives up standards

Regulator evaluates applicant’s evidence and determines “suitability”

Advantages Empowers regulated sector Identifies areas for improvement Implements changes to achieve them

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

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

The Designated Individual

The role of the Designated Individual

‘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

HTA framework

Five broad sectors to license Varying organisational structures Range of opinion One model doesn’t fit all situations HTA framework is to provide advice and guidance

Explain the role and responsibilities Model scenarios with advantages and disadvantages Provide education and training via workshops E-learning packages

Gathering evidence

Code of Practice consultation Telephone interviews Workshops and meetings Letters and email Hansard Legal advice

Who should be the Designated Individual (DI)?

Varying views about who should be the DI 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)

Concern about level of responsibility

Who should be the DI?

Pathology - Chief executive or equivalent “The DI needs to have the accountability and the control to

ensure compliance with the conditions of the licence.”

Anatomy - Licensed anatomy teacher “There should be a designated individual holding the licence and

it should be the lead anatomist in the relevant department/medical school”

Public display – limited feedback “It should be someone on the Board for governance reasons”

Who should be the DI?

Storage of tissue for human application - Mixed views “ In the NHS it should be someone at board level covering the risk

management of clinical governance.”

Storage of tissue for research - Mixed views “DI could be Head of Group or Individual researcher” “There should be a degree of flexibility”

NHS Confederation – Chief Executive “CEO takes all responsibility for everything that happens on their

site. It is quite an accepted thing if legal compliance is required by the organisation”

Governance

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 Responsible Person under EUTCD

Governance

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

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

Role of the Designated Individual

Must be the applicant for a licence or consent to it Must be a “suitable person” to supervise the activity

authorised by the licence Must secure that

other people “to whom the licence applies” are “suitable” “suitable practices” are used there is compliance with licence conditions

Role of the Designated Individual

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”

Role of the Designated Individual

Additional specific licence conditions Require compliance where a standard is not being met Can be supportive – to improve standards

Written using the SMART principle Simple Measurable Achievable Relevant Time bound

Role of the Designated Individual

Status of the Codes of Practice The Codes are guidance and a breach of a Code will not

directly lead to a licence being revoked, however….. The HTA can use a breach of the Code when considering

whether the DI’s duties under s18 of the Act are being fulfilled “Suitable practices are used”

HTA can revoke, vary or suspend a licence (Sch 3, s7) Any information in the application is false or misleading DI has failed to discharge the duty under s18 Premises are no longer suitable

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”

HTA framework

Five broad sectors to license Varying organisational structures Range of opinion One model doesn’t fit all situations HTA framework is to provide advice and guidance

Explain the role and responsibilities Model scenarios with advantages and disadvantages Provide education and training via workshops E-learning packages

HTA framework

The Designated Individual needs to Have knowledge and understanding of the Act and the relevant

Codes of Practice Have time to carry out the of DI in addition to their substantive role Ensure compliance with licence conditions Demonstrate managerial capability ensuring quality and

supervising responsibility to effect change Links to board level Know when to seek specialist advice to perform his/her role

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

Conclusion

HTA’s structure, ethos and functions Standards for licensing Compliance reporting The role of the Designated Individual, Licence

Holder and Persons Designated

www.hta.gov.uk