We first set out to determine patients' preferences on informed consent for biobanking, asking them to choose one of three consent models: (a) specific/re-consent, (b) one-time general consent, and (c) tiered consent.
We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment".
36 patients were eligible for response evaluations for one case of consent withdrawal and one case of dropout.
Of the 24 patients entered, 20 had cycle 1 and 16 patients had both cycles 1 and 2. Four patients had not received the planned first courses of consolidation therapy due to the following reasons: progressive disease (one patient), persistent chest infection (one patient), withdrawal of consent (one patient) and inadequate haematological recovery (one patient).
At the time of the study, the consent model for the SCR was one of implied consent or "opt-out" (that is, unless a person explicitly withdrew consent, an SCR would be created), although this model is now being revisited.
There's no one age of consent where a child just decides she is ready to rally.
Approximately one third of consent forms were not returned, and an additional 14% of those consented refused to participate in the study.
To enhance understanding around the different consent models, participants were given a sheet presenting three different scenarios, each of which elaborated on one of the three consent models chosen for discussion (see online supplementary appendix III, p.4).
It was notable, in this study that post-test, the only significant change in attitude was a decrease in the number of participants who favoured a change in the law from the current system of informed consent to one of presumed consents.
The solution cannot just be one of informed consent from the data providers, because in most situations no one has the information necessary to give their consent.
