This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2 weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific (...) content areas. Results support the use of corrected feedback for improving consent recall. (shrink)

Introduction Research supports the efficacy of both a remedial consent procedure ) and a motivational consent procedure for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information.Methods We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual condition or (...) an incentivised CF condition . All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed.Results Quiz scores in the two conditions did not differ at the first administration ; however, ICF scores were significantly higher at each subsequent administration .Conclusions The ICF procedure increased consent recall from 72% to 83%, compared with the CAU condition in which recall decreased from 69% to 59%. This supports the statistical and clinical utility of a combined remedial and motivational consent procedure for enhancing recall of study information and human research protections. (shrink)

Illicit drug users are frequently identified as a ‘vulnerable population’ requiring ‘special protection’ and ‘additional safeguards’ in research. However, without specific guidance on how to enact these special protections and safeguards, research ethics committee (REC) members sometimes fall back on untested assumptions about the ethics of illicit drug use research. In light of growing calls for ‘evidence-based research ethics’, this commentary examines three common assumptions amongst REC members about what constitutes ethical research with drug users, and whether such assumptions are (...) borne out by a growing body of empirical data. The assumptions that form the focus of this commentary are as follows: (i) drug users do not have the capacity to provide informed consent to research; (ii) it is ethically problematic to provide financial incentives to drug users to participate in research; and (iii) asking drug users about their experiences ‘re-traumatizes’ and ‘re-victimizes’ them. (shrink)