Regulating doctors, ensuring good medical practice

Consent to research: Loss of capacity during a research project

  1. 31. Some people with capacity will consent to take part in research, but then may lose capacity before the end of the project. If you become aware that a participant has lost capacity, you should consider carefully the benefits and harm that could occur from their continued participation in the research, and you must follow the law that applies where you work.19
  2. 32. If you are seeking to involve a person in research who you believe may lose capacity during the course of the project, you should consider seeking their views about the circumstances in which they would wish to continue to participate. You should explain to them the steps that would be taken to decide whether they should continue to take part and how their wishes, if known, would be taken into account.

 

Footnotes

19 There are specific regulations under the Mental Capacity Act 2005 for participants who gave consent before 31 March 2008 to take part in research that began before October 2007 but subsequently lost capacity to consent to continue to take part in the project.

Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007

Mental Capacity Act 2005 (Loss of Capacity during Research Project) (Wales) Regulations 2007

There are no specific legal provisions under the Adults with Incapacity (Scotland) Act 2000 relating to the loss of capacity during research in Scotland. In clinical trials of investigational medicinal products, consent from an adult to participate in a trial remains valid after loss of capacity providing the trial is not significantly altered (Medical Research Council ethics guide: medical research involving adults who cannot consent, 2007).