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 evaluation ResearchAuditService Evaluation New KnowledgeInformation 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 Collection of data/investigation/samples additional to that of routine care Analysis of routine data but may involve simple interview or questionnaire May involve allocation of patients to intervention groups No intervention REC reviewNo 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