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: info@orec.n-i.nhs.ukTel: 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