The work of the Research Ethics Committee

Dr Carol Chu

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

Types of Committees 185 committees Recognised – can

review clinical trials of investigational medicinal medicinal products (CTIMPs) – three types

Authorised – research other than CTIMP

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

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

Who makes up the committees?

Specially trained in research ethics

Administrator Chair Vice-chair/s Professional

members Lay members

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

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

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

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!

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!!

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

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

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

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”

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