Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written (...) material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved. (shrink)

De Marco and colleagues claim that the standard account of invasiveness as commonly encountered ‘…does not capture all uses of the term in relation to medical interventions1 ’. This is open to challenge. Their first example is ‘non-invasive prenatal testing’. Because it involves puncturing the skin to obtain blood, De Marco et al take this as an example of how an incision or insertion is not sufficient to make an intervention invasive; here is a procedure that involves an incision, but (...) it is regarded as non-invasive. However, this ignores the context, and the term should really be understood in reference to the fetus. It is hard to believe healthcare professionals regard taking blood to measure, for example, ferritin levels as invasive but taking blood to look for fragments of fetal DNA as not. If anyone uses the term thinking it is not invasive to the mother, the solution would be to call it invasive, not redefine what is invasive. De Marco and colleagues’ second example is describing electroconvulsive therapy (ECT) as invasive. However, this is not borne out by their referenced papers. The first cited source is about non-invasive brain stimulation2 and only contains a single sentence about ECT. This sentence may suggest that their view is that ECT …. (shrink)

Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an Information and (...) Decision Aid (IDA) that can support decision making and be used to guide the dialogue between researcher and potential participant. Our proposal requires limited changes to current processes or paperwork and would provide an easily accessible document for others that the potential participant might approach for advice. It could later be integrated with the Informed Consent Form to ensure all matters of concern to the individual participant have been addressed before consent is formally signed off. (shrink)