Transcript No Slide Title

The HPSS Research Ethics
Service Northern Ireland
Dr Siobhan McGrath
Office for Research Ethics Committees
Northern Ireland
Mar2007
Outline of presentation
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UK policy
Structure of RECs in UK
HPSS RECs
The process for ethical review
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
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
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)
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.
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
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
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
HPSS RECs -Remit
All health and social care research
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HPSS staff
premises
patients
services users
carers
 Access to service user or patient records
 Access or collection of tissue
 Qualitative or quantitative research
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?
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
When to submit?
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Sponsor agreed
External peer review
Arrangements have been made with the
care organisation
Evidence of funding/ project resources
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
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
The process for ethical review
 New application form
 Standard letters
 Database
Terminology
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Favourable opinion
Unfavourable opinion
Provisional opinion
Site specific assessment
Amendment
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 subcommittee
See: www.orecni.org.uk
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
Committee Composition
 Maximum 18
 Chair, Vice-Chair and Alternate ViceChair
 At least 1/3 lay membership
 Quorate- 7 members
 Experts Social Care and Clinical
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
Types of decision
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No opinion
Favourable opinion
Unfavourable opinion
Provisional opinion
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
Timelines
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Total Review 60 calendar days
Amendments 35 calendar days
SSA 25 days
Book slot by telephone-4 days to keep slots
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
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
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
Elements of the Review Process
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
1.
Helsinki Declaration 2000
CIOMS Guidelines 2002
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
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
Pitching the Information
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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
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
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
2004-5 Performance Data
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Favourable- 30% (15%)
Unfavourable - 6.8% (6.9%)
Provisional- 46.7% (60%)
Withdrawn- 14.7% (14.9%)
Office for Research Ethics Committees
Northern Ireland
(ORECNI)
ORECNI- Useful Details
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Web: www.orecni.org.uk/
Email: [email protected]
Tel: 028 9260 3107
Fax: 028 9260 3619
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
Office for Research Ethics Committees
Northern Ireland
(ORECNI)