the hpss research ethics service northern ireland l.
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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

The HPSS Research Ethics Service Northern Ireland

Dr Siobhan McGrath

Office for Research Ethics Committees

Northern Ireland


outline of presentation
Outline of presentation
  • UK policy
  • Structure of RECs in UK
  • The process for ethical review
  • 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
scope uk context
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
orecni history
ORECNI- History
  • Established as part of CSA by DHSSPS (2003)
  • Set up 3 HPSS RECs (Feb 2004)
orecni mission
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.

orecni objectives
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
hpss recs
  • REC 1 Chair Mr Mark Nelson
  • REC 2 Chair Dr Theresa Donaldson
  • REC 3 Chair Dr John Trinder
hpss recs remit
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
when should i apply
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?
when to submit
When to submit?
  • Sponsor agreed
  • External peer review
  • Arrangements have been made with the care organisation
  • Evidence of funding/ project resources
research category
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
the process for ethical review

The process for ethical review

New application form

Standard letters


  • Favourable opinion
  • Unfavourable opinion
  • Provisional opinion
  • Site specific assessment
  • Amendment
hpss rec meetings
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


committee composition
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
types of decision
Types of decision
  • No opinion
  • Favourable opinion
  • Unfavourable opinion
  • Provisional opinion
  • Total Review 60 calendar days
  • Amendments 35 calendar days
  • SSA 25 days
  • Book slot by telephone-4 days to keep slots
principles of ethical conduct
Principles of Ethical Conduct
  • Autonomy -right to choose for oneself
  • Non-maleficence- not harmful
  • Beneficence- doing good, active kindness
  • Justice- justness, fairness
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

Protection for Research Participants

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

2005 6 performance data 1
2005-6 performance data (1)

Type of study by number reviewed (all RECs)

  • CTIMP 60
  • Student 107
  • Other 119
pitching the information
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
what hpss recs want
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
2004 5 performance data
2004-5 Performance Data
  • Favourable- 30% (15%)
  • Unfavourable - 6.8% (6.9%)
  • Provisional- 46.7% (60%)
  • Withdrawn- 14.7% (14.9%)
orecni useful details
ORECNI- Useful Details
  • Web:
  • Email:
  • Tel: 028 9260 3107
  • Fax: 028 9260 3619
useful contacts 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