How do we gain patient consent in research?
Only patients who agree beforehand to participate in clinical research studies can be included by researchers. But in emergencies or where patients are severely unwell, it is not always possible to give a detailed explanation or get direct, written consent from a patient in the normal way. So how do we ensure that severely ill patients can still benefit from new treatments, and research can still be carried out to help others like them in future?
Before we address this question directly, let’s look at how consent is gained in an ideal situation.
How we normally gain consent
For consent to be valid it must be “fully informed" and patients must have “capacity” to agree. Patients are given all the information they need and opportunities to ask questions before agreeing to participate.
We obtain consent before any trial-specific activity is undertaken i.e. anything that goes beyond “treatment as usual”, and we make sure that consent is freely given without undue pressure.
Gaining consent for research is not a simple "yes" or "no". The research team will introduce themselves to the patient with the agreement of their care team, describe the study in detail, answer any questions and provide written information which can be shared with family and others.
This is all good clinical practice to help patients make the right decision for their ongoing treatment. All processes are agreed with an NHS Research Ethics Committee before the research study can start. This ensures that recruitment into trials is fair, consistent and safe.
What happens in an emergency situation?
In emergency situations, where illness or injury is severe or life-threatening, we may not be able to follow all of these steps. This is especially critical if a patient is vulnerable and lacks the capacity to make an informed decision. So what can we do in situations like these?
Once again we must agree any alternative recruitment and consent processes with the NHS Research Ethics Committee before we can conduct such a study. They will only agree to include vulnerable patients in a study if there is a critical need. For example, a trial of emergency treatments for head injuries may include many patients who lack capacity at the time of recruitment.
By contrast, there is no benefit in including patients without the capacity to give consent into a trial looking into the use of a new drug for acne, for example.
Who else can give consent?
Even in an emergency, if a patient lacks capacity, our immediate priority is to try to identify someone suitable who can act as a 'consultee' for them.
A 'personal consultee' is someone with a close personal relationship to the patient, usually their next-of-kin, a family member or even a close friend. A second option is to identify a 'nominated consultee', often a senior member of the medical or nursing team who is independent of the study, to act in place of a personal consultee. Our final option for consent, if neither consultee option is possible without delaying treatment, is that consent may be 'deferred'.
We only use the options above as a last resort, as many patients, including very ill patients can and do give consent for research treatments. We also review the process we have used in each case.
What happens next?
Once a consultee is available, or when the patient regains capacity, we confirm that they agree for their participation in the study to continue as soon as possible. If the patient does not agree, we take them out of the study when it is safe to do so.
Our teams of research nurses and doctors are formally trained, regularly reviewed and highly skilled in these processes. We can help even the most vulnerable patients, their families and care teams to come to a safe and appropriate decision about when a research trial is likely to be suitable for a patient in an emergency.
All of these rules are set out in the Clinical Trials of Investigational Medicinal Products (CTIMPs) Regulations. Further information about research approvals, regulation and consent in emergencies and severe illness can be found via these organisations:
National Institute for Health Research
NHS Health Research Authority.
Medical Research Council