Ethics – where to start!

October 2013

Lois Neal

FMS Research & Innovation Office

Why is ethical review needed?

To ensure good practice in research

To deliver research with credibility

To safeguard the researcher & explain to the world that the work is acceptable

To minimise risks

Where and how to start?

A good research proposal

Clearly defined question

An investigation that will answer the question

Suitable data collection

Appropriate analyses

A written protocol

Peer Review

AND early consideration of ethics:

Preliminary ethical assessment (Stage 1)

http://www.ncl.ac.uk/res/research/ethics_governance/ethics/procedures/staff_review.htm

Retain the form with your protocol!

Preliminary Ethical Assessment Stage 1

To find out:

a) Is formal ethical review needed?

If needed,

b) Which authority should it come from?

Which Authority?

Ethical Review Committee at the University

set up by the Home Office

Research Ethics Committees (RECs)

set up to review clinical research through

the National Research Ethics Service (NRES)

Social Care Research Ethics Committee (SCREC)

part of NRES - set up to review social care research studies

University’s Governing Body

discharged by the University Ethics Committee via the three Faculty Ethics Committees

How are they accessed?

Home Office Licence

Contact the CBC/Faculty Office

National Research Ethics Service (NRES)

http://www.nres.nhs.uk

Submission through the IRAS portal

https://www.myresearchproject.org.uk/

Social Care Research Ethics Committee (SCREC)

http://www.screc.org.uk/

University

Faculty Research & Innovation Office

http://www.ncl.ac.uk/res/research/ethics_governance/ethics/index.htm

FMSEthics@ncl.ac.uk

Hints and Tips

Must have a clearly defined proposal – with academic/scientific review

- check whether ethics is already in place!

Must have good documentation

Must carry out a risk assessment

Must allow enough time

– the process will be iterative

Hints and Tips

Common documentation required:

Information sheet(s)

Consent form

Debriefing sheet(s)

Contact points

Questionnaires

Pictures of equipment

Advertisements

Web- interface

Good Documentation

Spelling and grammar

Consistent information

Accessible information

Jargon-free

Good documentation

Have spelling and grammatical problems been avoided? Particularly in the consent and/or participant information sheets

Is the information consistent across the whole application? Eg the consent sheet and application text

Will potential participants understand the aims and methods of the study?

Is unnecessary jargon and technical detail used? Or have they been explained?

R&D Approval

For clinical studies:

The NHS organisation will also require R&D Approval!

http://www.newcastle-hospitals.org.uk/about-us/staff-information_research-development.aspx

www.newcastlejro.org.uk

Getting Ethical Review

Submit documentation

-NRES – the Committee will meet and consider, if invited please attend!

-Home Office – the Newcastle Committee will meet and consider

-FMS Ethics – selects Reviewers to comment

Almost always there will be issues to address and respond to!

Once issues are resolved:

Letter to confirm ethical opinion – specific project and period

Subsequent changes/issues

amendments MUST be notified

adverse incidents MUST be reported

Help and advice?

Project supervisor

Research team

Faculty Research & Innovation Office

(3rd floor Leech)

Joint Research Office (Governance Manager for clinical research)

(Leazes Wing RVI by CRF)

The web

For further guidance ask:

Lois Neal, FMS Research & Innovation Office

lois.neal@ncl.ac.uk

University applications forms send to:

FMSethics@ncl.ac.uk