Doctors involved in clinical research have to ensure patients fully understand the risks and benefits of taking part and to be aware of their legal and ethical responsibilities, a defence body has warned.
Last week, the GMC launched new guidance called Good Practice in Research and Consent to Research, which set out the good practice principles that doctors are expected to understand and follow if they are involved in research.
The MDU claims to receive numerous enquiries from doctors about research. Common questions include how much information to give to patients taking part, with whom information from trials should be shared, whether data should be included in the patient’s records and about indemnity arrangements.
Dr Udvitha Nandasoma, an MDU medico-legal adviser, says doctors involved in research need to be aware of the wide ranging new GMC guidance.
“Clinical research is vitally important for improving healthcare. However, the outcome of each individual trial may be uncertain and it is important that participants in clinical research are fully aware of the risks they might be undertaking and give informed consent.
“It is vital that patients are given enough information about what is involved, including any potential risks, in way they can understand and the GMC says this will usually be backed up with information leaflets about the trial and, if appropriate, a copy of the protocol approved by the ethics committee.”
Doctors involved in trials also need to understand their legal obligations, the defence body says. For example, the Medicines for Human Use (Clinical Trials) Regulations 2004 state that clinical trials must have authority from the Medicines and Healthcare products Regulatory Agency and approval by local research ethics committees. It is also a legal requirement for participants to give written consent.
While the pharmaceutical company, university or medical school that is sponsoring a clinical trial will usually provide indemnity for any injury that occurs as a result of a clinical trial, such as an unexpected side-effect of a drug, the MDU advises doctors to check that this is the case before the trial begins.
Read the GMC guidance in full.
Tags: Research
