Were the benefits and risks of participating in DART explained to trial participants?
Patients who enrolled in DART were first given information on the study objectives and the procedures. This was generally done by a team of trained counsellors. Participants were then provided with a detailed information sheet (approved by independent local ethics committees) to take home with them. They were asked to return about 2 weeks later to enrol in the study, to give them ample time to consider and discuss DART with family or friends, if they wished. At enrolment there was further counselling and opportunities to ask any further questions. There was then a formal signing of the Trial Consent Form, only when all concerns had been addressed.Of those initially screened for DART only around 50% actually enrolled. Of those that did not go on to enrol, the majority were found to be ineligible (e.g. CD4 count was too high) but there were also a number that simply decided that the study was not for them.It is clearly not in the interests of a long term study like DART to coerce or misl
Patients who enrolled in DART were first given information on the study objectives and procedures, this was generally carried out by a team of trained counsellors. Participants were then provided with a detailed information sheet, approved by independent local ethics committees, to take home with them. They were asked to return around two weeks later to enrol in the study to give them ample time to consider and discuss DART with family or friends if they wished. During trial enrolment there was further counselling and opportunities to ask any questions. The formal signing of the Trial Consent Form only took place after all concerns had been addressed. Of those initially screened for DART, only around 50 per cent actually enrolled. Of those that did not enrol, the majority were found to be ineligible (e.g. CD4 count was too high) but there were also a number of people that simply decided that the study was not for them. It is clearly not in the interests of a long term study like DART t
