the work of the research ethics committee dr carol chu
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The work of the Research Ethics Committee
Dr Carol Chu
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Role of Research Ethics Committee
The purpose of the NHS Research Ethics committee is to safeguard the rights dignity and welfare of people participating in research in the NHS
Committee is independent of researcher and organisation hosting and funding research
Appointing authorities for REC is SHA
COREC is part of National patient safety agency and coordinates development of operational systems for RECs, manages MRECS, regional offices and maintains quality control
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Types of Committees 185 committees Recognised – can
review clinical trials of investigational medicinal medicinal products (CTIMPs) – three types
Authorised – research other than CTIMP
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Why,who, where, what, how? Why research ethics
committees were formed
Who makes up the committees
What studies need approval
Where the committees are
How they work
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Why research ethics committees? Following WWII and
Declaration of Helsinki Designed to protect
individual and part of research governance
RECs formally established in 1991 in UK
EU clinical Trials Directive enacted 2004
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Who makes up the committees?
Specially trained in research ethics
Administrator Chair Vice-chair/s Professional
members Lay members
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Where do committees sit? Short answer –
everywhere Very variable Look on COREC
website to see where and when
Meetings take place at different times day or evening
Last from 4 to 6 hours at a sitting
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What studies need approval?
Any proposal involving Patients and users of
NHS including relatives Access to data, organs
or other bodily material past or present
Fetal material NHS staff NHS premises or
facilities Clinical trials
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Research, audit, service evaluationResearch Audit Service Evaluation
New Knowledge Information to inform delivery of healthcare
Define or judge healthcare
Tests hypothesis or explores new themes
Asks question does this service reach a standard
Designed to ask what standard does this service
reach
Evaluation or studying new interventions
Involves an intervention in use only
Involves an intervention in use only
Collection of data/investigation/samples additional to that of routine
care
Analysis of routine data but may involve simple interview
or questionnaire
Analysis of routine data but may involve simple interview
or questionnaire
May involve allocation of patients to intervention
groups
No intervention No intervention
REC review No REC review No REC review
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How to go about applying for ethical approval for a study 1. Go to the COREC website
and get guidance Don’t panic! Form is not
as bad as it looks! Apply for R and D at
same time Often useful to get peer
review (R and D can arrange)
Remember to write the summary of the study in plain English and try and tell us what you are trying to do!
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How to apply for ethical approval for a study 2 – tips to get through
Follow guidance for PIS and consent forms and use standard format
Use plain simple language in PIS: Avoid medical jargon or if using it explain it Say how often side effects occur – not just “rarely” but 1 in
1000 Remember children need their own information sheets in
language relevant to them Be very aware of vulnerable patients and explain why you
want to use them and can’t use anyone else Be aware of Mental Capacity Act, Human Tissue Act etc If in doubt ask advice from administrator If you attend meeting to explain try not to
condescend to the committee!!
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How do the committees work 1?
Main REC meetings held monthly
Sub-committee meetings also held monthly
REC must hold at least 10 meetings per year
All members should have application form and all supporting documentation prior to meeting
Meetings must be quorate – at least 7 members including chairman or vice chair, one lay member and one expert member
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How do committees work 2? Committees often
appoint one (or more) lead reviewers for an application
Members often complete a checklist for each study they review
The chief investigator is invited to attend the meeting
Supervisors are invited to attend with students
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How do committees work 3?
During meeting each study is discussed by the whole committee and if researcher is coming questions decided upon
After researcher has been asked questions committee will discuss again and reach decision
Decision will be favourable, unfavourable or provisional with request for further information or no opinion until specialist referee has been consulted
REC must give opinion in 60 days
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What RECs consider Scientific design and
content of study Recruitment of participants Care, safety and protection
of participants – equity Confidentiality Informed consent
procedures “Poor science is poor
ethics”
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After meeting. The administrator writes
to investigator with decision
Committee only allowed to ask for further information once – clock stops until information received back
If favourable opinion study can start
Any substantial amendments go to subcommittee for opinion
Researcher has to submit update reports and final report