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How to... Carry out clinical research

The MDU's Dr Claire Macaulay says GPs must follow GMC guidance and put patients' interests first.

Trial participants should provide informed consent and this should be in writing, dated and signed
Trial participants should provide informed consent and this should be in writing, dated and signed

Clinical research is vitally imp-ortant for improving healthcare. However, GPs involved in research are responsible for ensuring participants are fully aware of the risks they may be undertaking and give informed consent.

The GMC has recently upd-ated its Good Practice in Research and Consent to Research guidance. The new guidance stresses that the safety, dignity and wellbeing of participants should take precedence over the development of treatments or furthering of knowledge.

The MDU opens around two files a month from members with questions about research, and answers many more questions on its advice line.

Common queries include: how much information to give to patients taking part, with whom information from trials should be shared, whether research data should be included in a patient's record and about indemnity arrangements.

Ethical guidance
GPs involved in conducting clinical research or with pat-ients in research trials need to be aware of the wide-ranging GMC guidance and of their legal responsibilities.

Good Practice in Research (paragraph 5), says that research must be based on a properly developed protocol that has been approved by a research ethics committee and that foreseeable risks to participants are kept as low as possible.

Research should be halted where results indicate that participants are at risk of significant harm and adverse findings should be reported to the participants and to the ethics committee (paragraphs 15 to 16).

When obtaining consent, Consent to Research states it is vital that patients are given enough information about what is involved, including any potential risks, in a way they can understand.

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 (paragraph 7). Getting the patient's written consent for trials of investigational medicinal products is a legal requirement.

Doctors should make a note of the consent discussion (paragraph 11) and, with the participant's consent, they should usually inform the person's own GP about their involvement (paragraph 12) as the GP may want to note this in the patient's records.

The GMC's guidance also provides advice on research involving children, vulnerable adults and adults who lack capacity. For example, it states that research should not involve children or adults who lack capacity if the same research can be carried out on adults who have capacity.

What the law says
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 state that clinical trials must have authority from the Medicines and Healthcare products Regulatory Agency and approval by the local research ethics committee (regulated by the United Kingdom Ethics Committee Authority).

Schedule 1, part 2 of the regulations sets out the conditions and principles that apply to all clinical trials.

While the pharmaceutical company, university or medical school sponsoring a clinical trial will usually provide indemnity for any injury that occurs to a trial participant as a result of a clinical trial, such as an unexpected side-effect of a drug, GPs should check that this is actually the case before the trial begins.

  • Dr Macaulay is a medico-legal adviser at the Medical Defence Union, www.the-mdu.com
SCENARIO

A practice had recently run a trial, in conjunction with a pharmaceutical company, on the effectiveness of various smoking cessation treatments. The GP leading the research had submitted the results with patient details fully anonymised, but the drug company asked for patients' addresses because it wished to feed back to them on the trial results. The GP wondered whether he could disclose such information without the patients' consent.

 

The GMC says it is usually necessary to disclose only anonymous or coded information with this type of research. The GP must therefore be satisfied that there is a justifiable reason for disclosure, and that there is no alternative solution. For example, can the surgery pass on the information to patients?

 

The GMC's Confidentiality 2009 guidance says (paragraphs 40 to 41) in this scenario if you are satisfied it is necessary to disclose the requested identifiable information, you should usually get patients' express consent. If patients refuse, you should respect their wishes.

 

This case is fictitious but based on cases from the MDU's files.

CLINICAL TRIALS CONDITIONS AND PRINCIPLES

Under the Medicines for Human Use (Clinical Trials) Regulations 2004, schedule 1, part 2, these include:

  • Before the trial begins, weighing foreseeable risks and inconveniences against the anticipated benefit for the trial participants and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over interests of science and society.
  • Trial participants (or their representatives if they are unable to consent) should provide informed consent. This should be in writing, dated and signed, or (if the person is unable to do so) otherwise marked or given orally in the presence of at least one witness and recorded in writing.
  • Doctors are responsible for the medical care given to and medical decisions made on behalf of trial participants and they should be appropriately qualified and experienced.
  • All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.
  • The confidentiality of records that could identify subjects should be protected, in accordance with the Data Protection Act 1998 and the law relating to confidentiality.

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