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The HPSS Research Ethics Service Northern Ireland

The HPSS Research Ethics Service Northern Ireland. Dr Siobhan McGrath Office for Research Ethics Committees Northern Ireland Mar2007. Outline of presentation. UK policy Structure of RECs in UK HPSS RECs The process for ethical review. Scope . All HPSS Research (Health and Social Care)

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The HPSS Research Ethics Service Northern Ireland

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

  2. Outline of presentation • UK policy • Structure of RECs in UK • HPSS RECs • The process for ethical review

  3. 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. 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. ORECNI- History • Established as part of CSA by DHSSPS (2003) • Set up 3 HPSS RECs (Feb 2004)

  6. 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. 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. HPSS RECS • REC 1 Chair Mr Mark Nelson • REC 2 Chair Dr Theresa Donaldson • REC 3 Chair Dr John Trinder

  9. 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. 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. When to submit? • Sponsor agreed • External peer review • Arrangements have been made with the care organisation • Evidence of funding/ project resources

  12. 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. Terminology • Favourable opinion • Unfavourable opinion • Provisional opinion • Site specific assessment • Amendment

  15. 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. 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. Types of decision • No opinion • Favourable opinion • Unfavourable opinion • Provisional opinion

  18. Timelines • Total Review 60 calendar days • Amendments 35 calendar days • SSA 25 days • Book slot by telephone-4 days to keep slots

  19. Principles of Ethical Conduct • Autonomy -right to choose for oneself • Non-maleficence- not harmful • Beneficence- doing good, active kindness • Justice- justness, fairness

  20. 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 Protection for Research Participants

  21. 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 Elements of the Review Process Helsinki Declaration 2000 CIOMS Guidelines 2002

  22. 2005-6 performance data (1) Type of study by number reviewed (all RECs) • CTIMP 60 • Student 107 • Other 119

  23. 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. 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. 2004-5 Performance Data • Favourable- 30% (15%) • Unfavourable - 6.8% (6.9%) • Provisional- 46.7% (60%) • Withdrawn- 14.7% (14.9%)

  26. ORECNI- Useful Details • Web: www.orecni.org.uk/ • Email: info@orec.n-i.nhs.uk • Tel: 028 9260 3107 • Fax: 028 9260 3619

  27. 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

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