1. The HPSS Research Ethics Service Northern Ireland Dr Siobhan McGrath Office for Research Ethics Committees Northern Ireland Mar2007

2. Office for Research Ethics Committees Northern Ireland (ORECNI) Outline of presentation §UK policy §Structure of RECs in UK §HPSS RECs §The process for ethical review

3. Office for Research Ethics Committees Northern Ireland (ORECNI) Scope §All HPSS Research (Health and Social Care) §DOH/DHSSPS has applied standards to all research under its remit §One set of Standard Operating Procedures §One GAfREC §RGF

4. Office for Research Ethics Committees Northern Ireland (ORECNI) Scope UK context §Implementation of DH Research Governance Framework requires that independent ethics review is undertaken of all health and social care research §Currently there is no national system for review of social care research comparable to that of NHS RECs

5. Office for Research Ethics Committees Northern Ireland (ORECNI) ORECNI- History §Established as part of CSA by DHSSPS (2003) §Set up 3 HPSS RECs (Feb 2004)

6. Office for Research Ethics Committees Northern Ireland (ORECNI) ORECNI Mission To maintain a Research Ethics Service to protect the rights, dignity and welfare of research participants within the HPSS/NHS, and to protect the rights of researchers to perform ethical research and legitimate investigation.

7. Office for Research Ethics Committees Northern Ireland (ORECNI) ORECNI Objectives §To support the HPSS RECs and link with the Central Office for Research Ethics Committees (COREC) §Ensure the HPSS RECS comply with governance arrangements as set out in the Northern Ireland Research Governance Framework, GAfREC and the UK Clinical Trials Regulation (2004) §Provide training and administrative support to the HPSS RECs §Ensure all stakeholders understand arrangements §Develop and maintain effective working arrangements

8. Office for Research Ethics Committees Northern Ireland (ORECNI) HPSS RECS §REC 1 Chair Mr Mark Nelson §REC 2 Chair Dr Theresa Donaldson §REC 3 Chair Dr John Trinder

9. Office for Research Ethics Committees Northern Ireland (ORECNI) HPSS RECs -Remit All health and social care research §HPSS staff § premises § patients § services users § carers §Access to service user or patient records §Access or collection of tissue §Qualitative or quantitative research

10. Office for Research Ethics Committees Northern Ireland (ORECNI) When should I apply? §Is your research in the field of health and/or social care? §Does it involve HPSS service users/patients? §Does it involve HPSS staff or premises? §Do you need access to user/patient/staff data? §Do you need to take human tissue samples? §Does your research involve qualitative or quantitative methodologies?

11. Office for Research Ethics Committees Northern Ireland (ORECNI) When to submit? §Sponsor agreed §External peer review §Arrangements have been made with the care organisation §Evidence of funding/ project resources

12. Office for Research Ethics Committees Northern Ireland (ORECNI) Research Category? §CTIMPs §Clinical Investigations of Medical Devices §Research Administering questionnaires for quantitative analysis §Research involving qualitative methods §Research working with new tissue samples §Non-interventional research §Other

13. The process for ethical review New application form Standard letters Database

14. Office for Research Ethics Committees Northern Ireland (ORECNI) Terminology §Favourable opinion §Unfavourable opinion §Provisional opinion §Site specific assessment §Amendment

15. Office for Research Ethics Committees Northern Ireland (ORECNI) HPSS REC Meetings 3 HPSS RECs §3 opportunities to submit new applications per month §Other business e.g amendments, annual reports, queries handled by sub- committee See: www.orecni.org.uk

16. Office for Research Ethics Committees Northern Ireland (ORECNI) Committee Composition §Maximum 18 §Chair, Vice-Chair and Alternate Vice- Chair §At least 1/3 lay membership §Quorate- 7 members §Experts Social Care and Clinical

17. Office for Research Ethics Committees Northern Ireland (ORECNI) Types of decision §No opinion §Favourable opinion §Unfavourable opinion §Provisional opinion

18. Office for Research Ethics Committees Northern Ireland (ORECNI) Timelines §Total Review 60 calendar days §Amendments 35 calendar days §SSA 25 days §Book slot by telephone-4 days to keep slots

19. Office for Research Ethics Committees Northern Ireland (ORECNI) Principles of Ethical Conduct Autonomy -right to choose for oneself Non-maleficence- not harmful Beneficence- doing good, active kindness Justice- justness, fairness

20. Office for Research Ethics Committees Northern Ireland (ORECNI) Protection for Research Participants Potential Risk §Vulnerable populations §Psychological /emotional harm §Negative impact on services §Risks to researcher Potential Benefit §Clearly state background and rationale §Describe likely impact of research findings §Describe benefits to research participants §Provide details of peer review comments

21. Office for Research Ethics Committees Northern Ireland (ORECNI) Elements of the Review Process 1. Methodology and conduct of the study 2. Recruitment of research participants 3. Care and protection of research participants 4. Protection of participants confidentiality 5. Informed consent process 6. Community considerations Helsinki Declaration 2000 CIOMS Guidelines 2002

22. Office for Research Ethics Committees Northern Ireland (ORECNI) 2005-6 performance data (1) Type of study by number reviewed (all RECs) §CTIMP 60 §Student 107 §Other 119

23. Office for Research Ethics Committees Northern Ireland (ORECNI) Pitching the Information §Overall quality §Correct spelling and grammar §Attention to details- not rushed or incomplete §Offer reasonable explanations if question is inappropriate to your particular methodology §Attend meeting- many issues better explained face to face

24. Office for Research Ethics Committees Northern Ireland (ORECNI) What HPSS RECs want §Clear description on LAY terms §Researcher has considered and understood the ethical issues §Adequacy of your proposals to address these issues §Peer review §Consistency: application/ other documents §Sufficient measures in place to protect research participants §Well presented information sheets and consent forms

25. Office for Research Ethics Committees Northern Ireland (ORECNI) 2004-5 Performance Data §Favourable- 30% (15%) §Unfavourable - 6.8% (6.9%) §Provisional- 46.7% (60%) §Withdrawn- 14.7% (14.9%)

26. Office for Research Ethics Committees Northern Ireland (ORECNI) ORECNI- Useful Details §Web: www.orecni.org.uk/ §Email: info@orec.n-i.nhs.uk §Tel: 028 9260 3107 §Fax: 028 9260 3619

27. Office for Research Ethics Committees Northern Ireland (ORECNI) Useful Contacts- ORECNI Dr Siobhan McGrath ORECNI Manager HPSS REC Administrators: §Kathryn Taylor- HPSS REC 1 §Katrina Walls -HPSS REC 2 §Jan Daley- HPSS REC 3 ORECNI Office Assistant- Tony Hanna