Research and regulation

1. Research and regulation Sandy Mather Director of Regulation

2. 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

3. 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

4. Structure, ethos and functions

5. 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

6. 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

7. 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

8. How we will do this • By consulting widely and listening • By providing clear guidance and advice • Keeping things as uncomplicated as possible

9. How will we license and inspect? • Compliance reporting • HTA evaluate evidence in compliance report • Inspect according to risk

10. 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

11. Licensing storage of human tissue for research activities

12. 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

13. 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

14. 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

15. 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

16. Research

17. 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

18. 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

19. PRIMARY PURPOSE:Research Is it stored for a specific ethically approved research project? No Yes Is a licence required? Is consent required? Is consent required? Is a licence required? Yes, unless material is obtained from a living person and is anonymised No Yes Yes

20. The licensing process

21. 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

22. The Designated Individual

23. 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

24. 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

25. 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

26. 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)

27. 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

28. 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”

29. 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

30. HTA Governance framework • Various models of governance • HTA aims to explain the roles and responsibilities • Provide education and training via workshops • E-learning packages

31. 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

32. 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

33. 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

34. HTA framework - based on governance of institution 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

35. 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”

36. DI training days • 15 June – Liverpool • 19 June – London • 5 July – Bristol • 19 July – London • 9 August – Birmingham • January 2007 – tbc • Email di@hta.gov.uk

37. Compliance reporting

38. 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

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

40. 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

41. 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

42. On line application

43. 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

47. Deemed licences

48. 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

49. Evaluating licence applications

50. 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