The HPSS Ethics System Northern Ireland

1
The HPSS Ethics SystemNorthern Ireland

• Dr Siobhan McGrath
• Office for Research Ethics Committees
• Northern Ireland
• May 2006

2
Outline of presentation

• UK policy
• Structure of RECs in UK
• HPSS RECs
• The process for ethical review

3
Scope

• All HPSS Research
• DOH/DHSSPS has applied standards to all research
  under its remit
• One set of Standard Operating Procedures
• One GAfREC
• RGF

4
ORECNI- History

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

5
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.

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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

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HPSS RECS

• REC 1 Chair Ms Sandra McElhinney
• REC 2 Chair Dr Theresa Donaldson
• REC 3 Chair Dr John Trinder

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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

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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?

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When to submit?

• Sponsor agreed
• External peer review
• Arrangements have been made with the care
  organisation
• Evidence of funding/ project resources

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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

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The process for ethical review

• New application form
• Standard letters
• Database

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Terminology

• Favourable opinion
• Unfavourable opinion
• Provisional opinion
• Site specific assessment
• Amendment

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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

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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

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Types of decision

• No opinion
• Favourable opinion
• Unfavourable opinion
• Provisional opinion

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Timelines

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

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Principles of Ethical Conduct

• Autonomy -right to choose for oneself
• Non-maleficence- not harmful
• Beneficence- doing good, active kindness
• Justice- justness, fairness

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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

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Elements of the Review Process
Helsinki Declaration 2000 CIOMS Guidelines 2002
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2004-5 performance data (1)

• Type of study
• CTIMP 9
• Student 26.5
• Other 64.5

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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

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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

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2004-5 Performance Data

• Favourable- 33
• Unfavourable 19
• Provisional- 48

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ORECNI- Useful Details

• Web www.orecni.org.uk
• Email info_at_orec.n-i.nhs.uk
• Tel [phone]
• Fax [phone]

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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