NIGB

1. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance #NIGB #HSCIG NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE Leeds – Birmingham - London

2. Consent for Consent An Information Governance Framework to Enable Research and Improve Patient Care Dr Murat Soncul Head of Information Governance NIGB Collaborative Workshops27-29 June 2012

3. Objectives • Introduction • Transition and empowerment • Concept and objectives • Stakeholder involvement • Key aspects • Challenges and lessons learnt • Next steps • Conclusions

4. Introduction- History Bethlem Royal Hospital founded in 1247. Oldest psychiatric institution in the world. Maudsley Hospital founded in 1930 with £30K donation from Dr Henry Maudsley. South London and Maudsley NHS Foundation Trust was formed in 1999. William Hogarth - 1735 Henry Maudsley BRH in 1896 – Now the Imperial War Museum

5. Introduction- Today Provider of mental health and substance misuse services from 4 hospitals and 100 community sites. Largest provider of specialist mental health services in Europe. Jointly operates the NIHR Biomedical Research Centrefor Mental Health with the Institute of Psychiatry, KCL. Member of Kings Health Partners Academic Health Sciences Centre.

6. Transition Implemented a single electronic health records system across all clinical services in 2006. ePJS • Tailored to the needs of services • 200,000 health records • Electronic records directly linked to legacy records • Reporting tools for better data quality, improved outcomes and regulatory compliance CRIS • Informatics to make best use of clinical information • Enabling research • Effective anonymisation/pseudonymisation

7. Transition

8. Empowerment Secure Network Data Interchange with GP systems PROMs My Care Plan My Monitor Resources Diary Trust Electronic Patient Record ePJS Personal Health Record HealthVault Connection Centre Pseudonymisation Research Information System CRIS

9. Design and Governance Trust Board Strategic Steering Groups Programme Board Design Authority Caldicott CommitteeCRIS Oversight Committee ICT Security Committee Stakeholder reference groups Implementation groups Monitoring Committees

10. C4C – Concept and Objectives No decisions about me without me! To develop the pseudonymised research database (CRIS) that extracts data from electronic health records (ePJS) for non-contact research to facilitate contact research. To design a process to seek explicit patient consent to be contacted to discuss potential participation in research study/clinical trial. To maintain the principle of initial communication within the clinical care team. To enable de-anonymisation in a safe haven for patients who have consented.

11. Key aspects Consent for Consent is an integral part of the electronic health records system (ePJS). Initial contact for C4C is made by the clinician who has a therapeutic relationship with the patient. Patients’ specific wishes are recorded. C4C decision revisited by the clinician during the course of care, especially when there are substantial changes to diagnosis and at discharge.

12. Key aspects C4C data is linked to the pseudonymised research database for translation in the safe haven. Authorised researchers with ethics approved projects utilise the pseudonymised research database (CRIS) to identify patients that match their research criteria. Approved researchers in SLaM only gain access to contact details of patients who have given consent. Patients’ wishes are monitored. Projects that each patient is associated with are recorded.

13. Key learning points and challenges • Information governance and ethics led • Regulatory approval • Clinical service ownership • Patient awareness • Guidance and training for clinical and research staff • Capacity to consent • Proxy arrangements • Monitoring to limit involvement and avoid overload

14. Next steps Review of initial results / feedback Monitoring of implementation Caldicott review Well-informed patients Appropriately trained staff

15. Conclusions • Development of an EPR that meets the requirements of the organisation • Effective anonymisation / pseudonymisation that enables research • Consent and security models for compliance • Active stakeholder involvement (patients, carers, clinicians, researchers and service leads) • Senior management ownership • Information governance is an ‘enabler’ when appropriately and timely involved

16. Thank you! Dr Murat Soncul Head of Information Governance Murat.Soncul@slam.nhs.uk NIGB Collaborative Workshops27-29 June 2012

17. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance #NIGB #HSCIG NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE Leeds – Birmingham - London

18. Consent and the Information Revolution Dr Karen Melham University of Oxford NIHR Biomedical Research Centre Oxford

19. Information Strategy and Governance Consent Information Revolution

21. Patients at the Centre 1. Defining the change 2. Practical implications

22. Information – and IT NHS Future Forum Recommendation

23. Information – and IT NHS Future Forum Recommendation “The NHS must move towards using its IT systems to share data about individual patients and service users electronically – NHS Future Forum, January 2012 in the interests of high quality care.”

24. High Quality Care: Consent

26. High Quality Care: Translational Research

27. Traditional Relationships Governance Researcher Research Info mgt Consent Patient Participant

28. Changing the Orbits GovernanceG Governance Research Researcher Patient Partner Consent Information management

29. “It’s going on in me”

30. Why Now? New Challenges

31. Consent – Informed?

32. Difficulties with Informed Consent • D

33. Confidentiality, Anonymity?

35. Patients at the Centre: New possibilities

36. Patient-centred information management • Individuals at centre of decision making • Individuals set preferences • Interactions over time

37. Patient Centred Initiatives: Individual voice Individual choice

40. Informing policy Equipping Individuals

41. Maintaining the Chain of Trust

42. Acknowledgements HeLEX –Centre for Health, Law and Emerging Technologies http://www.publichealth.ox.ac.uk/helex/ NIHR Biomedical Research Centre Oxford www.oxfordbrc.org/

43. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance #NIGB #HSCIG NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE Leeds – Birmingham - London

44. Cross-sector information sharing “STRIKING THE BALANCE” Practical Guidance On the application of Caldicott Guardian Principles to Domestic Violence and MARACs (Multi Agency Risk Assessment Conferences) Christopher Fincken Chairman UK Council of Caldicott Guardians

45. “STRIKING THE BALANCE” "Any fool can make things complicated, but it requires a genius to make things simple." E.F. Schumacher

46. “STRIKING THE BALANCE” “It cannot be ‘ethically’ justified if we hold information that we know could prevent serious harm to others and yet knowingly decide not to share it.” Christopher Fincken - Striking the Balance

47. “STRIKING THE BALANCE” Who knows about us?

48. “STRIKING THE BALANCE” Domestic Abuse Abuse & Violence Large Scale National Problem Can be behind closed doors but agencies and individuals may also be aware. Not just health and social care But Vets!

49. “STRIKING THE BALANCE” MARACs (Multi Agency Risk Assessment Conferences) Local, multi agency victim-focused meeting where information is shared on the highest risk cases of domestic abuse between different agencies including: police, criminal justice, health, child protection, housing, IDVAs (Independent Domestic Violence Advisers) as well as other specialists from the statutory and voluntary sectors. A safety plan for each victim is then created.

50. “STRIKING THE BALANCE” An individuals Information can be shared only: • With Valid Consent (For Consent to be valid they must have mental capacity) • When required by Law (Mandatory) • When there is a legal gateway (Permissible)