The Informed Consent Domain
Introduction
Pragmatic trials are designed to maximise the applicability of results to usual clinical practice. These types of trials often have different informed consent needs from explanatory trial designs. The PRECIS-2 tool helps triallists view their design decisions in relation to the pragmatic-explanatory continuum in ten domains e.g. ‘participant eligibility’ onto a wheel. However, there is no PRECIS-2 domain for informed consent – the activities relating to the provision of trial information and the seeking and obtaining of consent from the target population (informed consent).
Figure 1 Informed Consent - the missing PRECIS Domain
We are developing the Informed Consent Domain to support those designing and reviewing informed consent processes for pragmatic trials.
This domain is supported by an Informed Consent Domain framework. This framework is intended to aid those designing and reviewing trials in their informed consent design choices – the methods used to ensure that the conversations between patients and clinicians and trials are acceptable, ethical and fit for purpose. The ICD framework consists of a series of questions, graphical summaries and a terminology glossary to support informed consent design thinking, decisions, and descriptions.
Informed Consent Domain Framework
As the purpose of a trial should determine its structure and design, the first question the framework asks is Why? i.e. what is the clinical purpose of the trial? This is followed by five questions regarding the information given and the consents sought (Who? What? When? Where? and How?). Answers to these questions can help create a full picture of the overall informed consent process. The answers to each question are then placed on the PRECIS wheel to help assess and display the position of each informed consent design decision within the pragmatic–explanatory continuum.
At the centre of the wheel are informed consent design decisions commonly found in explanatory trials (e.g. explicit information to everyone and all consents obtained and documented formally). At the rim of the wheel are informed consent design decisions more commonly found in usual health care and sometimes pragmatic trials (e.g. information given in stages and tailored to the patient care pathway).