Can patients who lack capacity participate in research?
Yes. Under the Act it is lawful to involve adults who lack capacity in research – excepting clinical trials which are separately regulated – provided it is related to the condition, or treatment for the condition, from which they are suffering. The research must be approved by an appropriately established research ethics committee, or, in Wales, its equivalent. It must not be possible to conduct the research involving individuals who have the capacity to consent it.
Where the research is ‘therapeutic’ and is expected to benefit the individual directly, the risks must not be excessive in relation to the anticipated benefits. Where the research is not expected to deliver direct benefit to the patients but is intended to investigate the condition from which they suffer, the risk to individuals must be negligible and any restriction on liberty or intrusion must be kept to a minimum.
[Clinical trials into pharmaceutical products are regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004. In April 2014, the EU adopted the Clinical Trials Regulations 2014 that repeal the earlier Directive on which the 2004 Regulations are based. It is unlikely that these Regulations will come into force prior to May 2017. Research on anonymised medical information or tissue is regulated separately by either the Data Protection Act 1998 or the Human Tissue Act 2004.]
What safeguards exist for individuals who lack capacity?
Before an incapacitated adult can be involved in research, the researcher must make reasonable efforts to identify someone who is close to them – although not in a professional capacity – who is willing to be consulted about the appropriateness of their involvement. This will ordinarily be a family member. It could also be an attorney or courtappointed deputy. In the absence of such a person, the researcher must nominate somebody who is independent of the research in accordance with guidance set out in 2008 by the Department of Health and Welsh Assembly.
The following additional safeguards are provided under the Act once the research has started.
- Nothing should be done to incapacitated adults as part of the research to which they appear to object, unless it is intended to protect them from harm or to reduce or prevent pain or discomfort.
- Where incapacitated individuals show signs of distress or resistance, or indicate by any means the wish not to continue in the research, they must be withdrawn.
- The interests of individuals must outweigh the interests of medical science and society.
- Nothing must be done that is contrary to any advance decision or statement, or prior statement of wishes or preferences – provided those statements or decisions have not subsequently been withdrawn.
Where an adult is withdrawn from research he or she may continue to receive any treatment they had received as part of the research where there are good grounds to believe that its withdrawal would pose a significant risk to the individual’s health.
Can research take place in an emergency situation where the patient lacks capacity?
In December 2006, an amendment to the 2004 Clinical Trials Regulations introduced provisions enabling patients to be enrolled in clinical trials of pharmaceutical products without prior consent in emergency situations provided the research is approved by an appropriate research ethics committee. Where research falls outside the Clinical Trials Regulations it would need to be lawful under the terms of the Mental Capacity Act.
Doctors have always modified methods of investigation and treatment in light of experience and so innovative therapy is a standard feature of good care. There are occasions however where innovative treatment may involve exposing patients to unknown or significant risks.
Where adults lack the capacity to consent to innovative treatment, any such treatment must be governed by the Act, in particular it must be in the incapacitated person’s best interests.
Where any proposed treatment differs significantly from existing practice and involves unknown or significant risk, considerable care must be taken as innovation can give rise to legal and ethical uncertainty. In these circumstances, it is advisable to seek both expert clinical scrutiny and legal advice.
Card 10 (PDF)