Ethics and approvals

How pre-study regulation makes sure there is no/little risk to patients

Each study is reviewed and approved by both the UK regulatory authority (MHRA) and an independent ethics committee who review the risk benefit profile of the study. No study is without risk, but every endeavour is made to minimise risk and to ensure that the risk benefit ratio is acceptable. All possible risks are explained to potential participants before they consent to take part and are described in writing in a Patient Information Sheet (PIS) which is reviewed and approved by the ethics committee. The Research Ethics Committee includes healthcare professionals as well as non-medical people. All members of the committee are completely independent from anyone organising the study.

What happens if there is any adverse reaction

Patients are monitored throughout a study by the study clinical team. Depending on the nature of the event, the study team will arrange appropriate follow up and management. All clinical trials have insurance and indemnity provisions in place which again are reviewed by regulatory agency and ethics committees and are described in the PIS.

If patients are not happy with the general care and treatment received during the study, they will speak first to study doctor or nurse, who will try to resolve the problem. He/she should also tell the patient about the surgery or clinic's standard complaints procedure in case they wish to take the matter further.

A copy of the guidelines is available from GP surgeries or clinics; or write to ABPI, 12 Whitehall, London SW1A 2DY; Tel: 020 7930 3477 or in Scotland, ABPI, Royal College of Physicians, 9 Queen St, Edinburgh; Tel: 0131 247 3688.

Summary of ethics requirements

Submission of protocol, background of product, recruitment methods (ie how, and what materials), for ethical consideration by central ethics committee. The Ethics Committee includes healthcare professionals as well as non-medical people. All members of the committee are completely independent from anyone organising the study.

Each investigator and all site details are submitted to the local ethics committee to review the suitability of the study and the site to conduct the study in the local area, taking into consideration the local population. This process of review takes 60days for review to approval.