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The ethics of clinical trials

Professor Rodger Charlton explains what GPs need to know about the role of research ethical committees in protecting patients who take part in trials.

All drug trials, interventions or evaluations must be approved by an REC to ensure they are fair to patients and ethical
All drug trials, interventions or evaluations must be approved by an REC to ensure they are fair to patients and ethical

You may not be involved in research, but GPs need to know a little about clinical trials.

Every so often we receive letters informing us a patient has agreed to enter a double-blind, controlled trial, where neither the researcher nor the patient knows whether the drug prescribed is the existing treatment or the proposed new one. The letter should detail research ethical committee (REC) approval. If not, you should be concerned and contact your patient.

All trials, interventions or evaluations must be approved by an REC to ensure they are fair to patients and ethical. Your patient should have been given an information leaflet and signed a consent form.

Guardian angels
RECs are 'guardian angels' scrutinising and overseeing research projects. They have the power to stop a project if they have any concerns about patient safety or a lack of truly informed consent.

RECs are an opportunity to inspect a study and where there is concern, to consider possible outcomes before it ends.

Research ethical committees are the guardian angels scrutinising and overseeing research projects

Studies checked out
RECs will request a detailed study protocol with the proposed research methods, interventions and whether participants are being fairly recruited.

They should ask if the intervention proposed is in a worthy cause and about potential risks to participants.

A trial should be conducted in line with the protocol supplied. It should be clear who is conducting the research.

Judgments
REC members will include practitioners, academics and lay people and may contact the researcher for clarifications. They will examine participants' ability to provide informed consent, particularly in vulnerable groups such as children, and whether they are competent and willing to take part.

They also ask if participants can withdraw at any point without penalty. Will their anonymity and confidentiality be assured and the data kept securely? Where vulnerable groups are involved, has a Criminal Records Bureau check been provided by the researcher?

Judgments also have to be made for studies not involving drug trials, for example, where the intervention is a questionnaire. Again, the REC will ask about potential risks to participants such as questions that could cause distress.

  • Professor Charlton is a GP and a professor of medical education at Swansea University

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