Be aware of research risks advises MDU
The Medical Defence Union (MDU) is reminding doctors involved in conducting clinical research to ensure patients fully understand the risks and benefits of taking part and to be aware of their legal and ethical responsibilities.
Media contact: Press Office on 020 7202 1535 or 020 7202 1504
Publication date: 12 May 2010
The MDU opens around two files per month from members with questions about research, and answers many more questions on its advice line. 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, Good practice in research and Consent for research, which have just been published1:
"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.
"The MDU advises members who become involved in carrying out research that involves patients or healthy volunteers to follow the GMC's new guidance which stresses that the safety, dignity and wellbeing of participants should take precedence over the development of treatments or furthering of knowledge. 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."
The MDU also stresses the need for doctors involved in trials to understand their legal obligations. For example, the Medicines for Human Use (Clinical Trials) Regulations 2004 states that clinical trials must have authority from the Medicines and Healthcare products Regulatory Agency (MHRA) and approval by local research ethics committees (regulated by the United Kingdom Ethics Committee Authority). 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. The insurance policy provided as part of MDU membership covers members involved in clinical trials for allegations of negligence arising from the routine clinical care of patients, subject to the policy terms.2 MDU members with queries about this, or any other medical-legal queries about clinical trials can contact the MDU for individual advice.
Further information
- Good practice in research and Consent for research, GMC, 13 April 2010
- Policy underwritten by SCOR UK Company Limited and by International Insurance Company of Hannover Limited.
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