Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care.

Cluster randomized trials are increasingly common. Obtaining informed patient consent to participation in these trials raises practical challenges and ethical issues. The aims of this paper were to 1) develop a typology of interventions employed in cluster randomized trials in primary care; 2) assess whether the likelihood of seeking individual consent to participation varies by intervension type; 3) assess whether this likelihood has increased over time; 4) assess evidence for under reporting of consent procedures; 5) articulate reasons for not obtaining consent; and 6) make recommendations for future trial investigators. We collected data on trial interventions and consent procedures from reports of 152 recently published trials, and 47 unpublished trials. We develop a typology of interventions based on reasons for adopting a clustered design. We examine proportions seeking individual consent to participation among trials involving different types of intervention, in different periods, and among published and unpublished trials. Two-thirds of the trials had multifaceted interventions. Trials involving different types of intervention had different propensities to seek consent, largely because of practical obstacles to obtaining consent. Obtaining consent can compromise internal validity. More recent trials are no more likely to obtain consent than past trials. There was no evidence of under-reporting of consent procedures in publications. In conclusion, future trial investigators should consider both practical reasons and scientific arguments for not obtaining individual patient consent for all interventions in their trials. Where feasible, they should allow patients to opt out of the trial. Lay individuals should represent trial participants as part of the process of cluster consent to participation, and lay individuals could also be involved in considering ethical issues during trial planning. A more public debate may clarify the general acceptability of not obtaining consent in certain situations.