Consent to research: When adults without capacity might be involved in research

1. 25. You must only undertake research involving an adult who lacks capacity if it is related to their incapacity or its treatment. You must not involve in research adults who lack capacity if the same or similar research could be undertaken by involving only people with capacity.
2. 26. You should only involve in research adults who lack capacity, including clinical trials of investigational medicinal products, if the research is expected to provide a benefit to them that outweighs the risks. Research, not including clinical trials of investigational medicinal products, may also involve adults who lack capacity if the research is not expected to provide a direct benefit to them but is expected to contribute to the understanding of their incapacity, leading to an indirect benefit to them or others with the same incapacity, and if the risks are minimal. This means that the person should not suffer harm or distress by taking part. In all research involving adults who lack capacity, you must make sure that the foreseeable risks are kept as low as possible.¹⁴