1. Sandy Mather Head of Regulation 1 March 2006 Research Governance Issues in Higher Education Brunswick Sub-Group, Imperial College London

2. 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

3. Structure, ethos and functions

4. 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

5. 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

6. 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

7. 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

8. 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)

9. 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

10. Regulation – workstreams Licensing Pilot methodology Standards Self assessment Designated Individual Inspections Fees EUTCD Advice and guidance

11. 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)

12. 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

13. 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

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

15. 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

16. Standards

17. 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

18. Compliance reporting

19. The Compliance Report Standards in a tabulated format On-line document Narrative and numerical scoring Licence applicant and Designated Individual complete jointly with team

20. 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

21. 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

22. 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

23. The Designated Individual

24. 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

25. 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

26. Gathering evidence Code of Practice consultation Telephone interviews Workshops and meetings Letters and email Hansard Legal advice

27. 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

28. 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”

29. 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”

30. 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

31. 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

32. 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

33. 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

34. 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”

35. 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

36. 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

37. 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”

38. 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

39. 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

40. HTA framework - based on governance of institution Designated Individual 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

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

42. www.hta.gov.uk