The HPSS Research Ethics Service Northern Ireland Dr Siobhan McGrath Office for Research Ethics...
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Transcript of The HPSS Research Ethics Service Northern Ireland Dr Siobhan McGrath Office for Research Ethics...
The HPSS Research Ethics Service Northern Ireland
Dr Siobhan McGrath
Office for Research Ethics Committees
Northern IrelandMar2007
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Outline of presentation
UK policyStructure of RECs in UK HPSS RECsThe process for ethical review
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Scope
All HPSS Research (Health and Social Care)DOH/DHSSPS has applied standards to all
research under its remitOne set of Standard Operating ProceduresOne GAfRECRGF
Office for Research Ethics CommitteesNorthern 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
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
ORECNI- History
Established as part of CSA by DHSSPS (2003)
Set up 3 HPSS RECs (Feb 2004)
Office for Research Ethics CommitteesNorthern 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.
Office for Research Ethics CommitteesNorthern 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
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
HPSS RECS
REC 1 Chair Mr Mark NelsonREC 2 Chair Dr Theresa DonaldsonREC 3 Chair Dr John Trinder
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
HPSS RECs -Remit
All health and social care research HPSS staff premises patients services users carersAccess to service user or patient recordsAccess or collection of tissueQualitative or quantitative research
Office for Research Ethics CommitteesNorthern 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?
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
When to submit?
Sponsor agreed External peer review Arrangements have been made with
the care organisation Evidence of funding/ project resources
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Research Category?
CTIMPsClinical Investigations of Medical DevicesResearch Administering questionnaires for
quantitative analysisResearch involving qualitative methodsResearch working with new tissue samplesNon-interventional researchOther
The process for ethical review
New application form Standard letters Database
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Terminology
Favourable opinionUnfavourable opinionProvisional opinionSite specific assessmentAmendment
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
HPSS REC Meetings
3 HPSS RECs3 opportunities to submit new
applications per monthOther business e.g amendments,
annual reports, queries handled by sub-committee
See: www.orecni.org.uk
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Committee Composition
Maximum 18Chair, Vice-Chair and Alternate Vice-
ChairAt least 1/3 lay membershipQuorate- 7 members Experts Social Care and Clinical
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Types of decision
No opinionFavourable opinionUnfavourable opinionProvisional opinion
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Timelines
Total Review 60 calendar daysAmendments 35 calendar daysSSA 25 daysBook slot by telephone-4 days to keep slots
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Principles of Ethical Conduct
• Autonomy -right to choose for oneself
• Non-maleficence- not harmful
• Beneficence- doing good, active kindness
• Justice- justness, fairness
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Protection for Research Participants
Potential RiskVulnerable
populationsPsychological
/emotional harmNegative impact on
servicesRisks 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
Office for Research Ethics CommitteesNorthern 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’ confidentiality5. Informed consent process
6. Community considerations
Helsinki Declaration 2000CIOMS Guidelines 2002
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
2005-6 performance data (1)
Type of study by number reviewed (all RECs)CTIMP 60Student 107Other 119
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Pitching the Information
Overall qualityCorrect spelling and grammarAttention to details- not rushed or incompleteOffer reasonable explanations if question is
inappropriate to your particular methodologyAttend meeting- many issues better explained face
to face
Office for Research Ethics CommitteesNorthern 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
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
2004-5 Performance Data
Favourable- 30% (15%)Unfavourable - 6.8% (6.9%)Provisional- 46.7% (60%)Withdrawn- 14.7% (14.9%)
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
ORECNI- Useful Details
Web: www.orecni.org.uk/Email: [email protected]: 028 9260 3107Fax: 028 9260 3619
Office for Research Ethics CommitteesNorthern Ireland (ORECNI)
Useful Contacts- ORECNI
Dr Siobhan McGrath ORECNI Manager
HPSS REC Administrators:Kathryn Taylor- HPSS REC 1Katrina Walls -HPSS REC 2Jan Daley- HPSS REC 3
ORECNI Office Assistant- Tony Hanna