Regulating doctors, ensuring good medical practice

Consent to research: Seeking to involve adults without capacity in research

  1. 27. You should consider the views of people close to the adult who lacks capacity to consent before involving that person in a research project. They are often best placed to know the person’s wishes about taking part in research. In clinical trials of investigational medicinal products, you must get consent from a legal representative.15
  2. 28.  Under the Mental Capacity Act 2005 (in England and Wales) you must consult a consultee16about whether the adult who lacks capacity should take part in the research, and what they think that person’s wishes would be if they had capacity to decide for themselves. If the consultee considers that they probably would not wish to take part, you must not include them in the research. Under the Adults with Incapacity (Scotland) Act 2000, you must get consent from any guardian or welfare attorney who has power to consent to the adult’s participation in research or, if there is no such guardian or welfare attorney, from the person’s nearest relative.17
  3. 29. If you are seeking to involve an adult who has lost capacity to consent, for example, through onset or progress of a condition that has impaired their capacity, such as dementia, you should take all reasonable steps to find out whether they have previously indicated their wishes about participating in future research, including any refusal to participate. You must consider any evidence of the person’s previously expressed preferences, such as an advance statement or decision.18

 

Footnotes

15 A legal representative under the Medicines and Human Use (Clinical Trials) Regulations 2004 means a person who is suitable to act as a legal representative for a minor (under 16) or an adult who lacks capacity for the purpose of the trial and is available and willing to do so. They must not be involved in the conduct of the trial. For trials involving adults who lack capacity in Scotland, a legal representative means any guardian or welfare attorney who has power to consent, or the adult’s nearest relative. In all cases, if there is no such person, a doctor not connected with the conduct of the trial but who is responsible for the medical treatment of the minor or adult, or a person nominated by the relevant healthcare provider can be approached. You should refer to the regulations for a full description.

16 Guidance on nominating a consultee for research involving adults who lack capacity to consent (Department of Health, 2008)

17 The Adults with Incapacity (Scotland) Act 2000 Part 5 Code of Practice: A short guidance to the Act provides information about guardian and welfare attorneys.

18 Mental Capacity Act Code of Practice (chapter 11, paragraph 11.30); Adults with Incapacity (Scotland) Act 2000 Part 5 Code of Practice (the general principles section); Medicines for Human Use (Clinical Trials) Regulations 2004 (schedule 1, part 1, section 1(5)).