Exploring the ethical and practical challenges of conducting clinical trials in care home settings

Background The PAAD Study (Probiotics for Antibiotic Associated Diarrhoea in care homes) involves 2 stages. The first stage is a prospective 12 month observational study to collect data on the amount and type of antibiotic prescribed episodes of Antibiotic Associated Diarrhoea and C.difficile Associated Diarrhoea and outcome in a randomly selected sample of 9 care homes. The second stage is currently being designed but will take the form of a RCT of probiotic vs. placebo administered alongside the antibiotic. These two studies are governed by separate laws and regulations in relation to mental capacity. PAAD stage 1 is covered by the Mental Capacity Act and, for those service users who lack capacity, personal consultees are able to give agreement to the service user’s participation. PAAD stage 2 is covered by the Medicines for Human Use (Clinical Trials) Regulations and consent is given by a personal legal representative or a professional legal representative of the participant. The PAAD study also presents novel challenges in relation to advanced consent. We propose to explore some of the ethical and practical challenges of conducting these studies (and others like it) within the care home setting using qualitative methods. Our purpose is to optimise the informed consent process in a vulnerable population in preparation for stage two of PAAD.