Who will take informed consent? {26a}
RECRUITMENT
Potentially eligible patients will be approached by their clinicians to introduce the study to them. Individuals who respond to the study information with interest will be contacted and invited to attend a face-to-face meeting with a researcher who will provide them with further information. Researchers will go through consent forms (in their preferred language) with interested individuals and take time to answer any questions or concerns that are raised. All participants are asked to provide informed consent by signing and dating an informed consent form prior to any data collection commencing. The University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) instrument will be used to rate the ability of individuals to provide informed consent. This form was adapted to our consent form and a score of 12 or above qualifies the patient to take part in the RCT. Once the ability to provide informed consent has been ascertained, participants will be provided with two copies of the written consent form, which will be signed by the participant and a member of the research team in order to proceed with study participation. The participant will keep one copy of the informed consent form and the research team will keep the other, storing it in a locked filing cabinet. Where participants are not literate, an additional witness will also be required to sign the consent form.All researchers have received training based on Good Clinical Practice by members of the UK-based research team, senior members of the local research team and/or through online courses. If there are any doubts regarding the individual’s capacity to consent to take part in research, this will be resolved before proceeding with study participation. If any doubts about their capacity emerge during the recruitment process, or capacity to consent appears to change during their participation in the study, their capacity to consent will be re-evaluated before continuing with study participation.