Getting It “Right”

Abstract

Getting It ‘Right’: Ensuring Informed Consent for an Online Clinical Trial Ethical principles in conducting technology-based research require effective and efficient methods of ensuring adequate informed consent. This study examined how well participants understood the informed consent form for an online postpartum depression trial. Pregnant women (N=1,179) who consented to the trial demonstrated an understanding of the purpose (86.1%) and procedures of the study (75.8%); and the minimal risks associated with answering sensitive questions online (79%). Almost all (99.6%) understood that psychological treatment was not offered. Participants with current depression incorrectly indicated that participation would replace current psychological treatment relative to participants with a lifetime or no depression history, (19.6% vs. 13.5 % vs. 10.4%, respectively) and that there were no associated risks with participation (29.6% vs.17.6% vs. 16.7%, respectively). Findings provide initial evidence that most individuals who seek online psychological resources are informed consumers.

Electronic Informed Consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks. Studies within Randomised Controlled Trials. Systematic Review.

“…Studies varied in their participants' characteristics as they targeted selected groups (Table 1). Mean age was reported in 10 studies, ranging from 27 to 73 years (39)(40)(41)(42)(43)(44)(45)(46)(49)(50). Two studies did not provide mean age of participants (47)(48).…”

“…Level of education was reported in nine studies, with three reporting no formal education in the majority of their sample (45,47,48). The remaining six studies reported educational level ranging from university to college education (40) (43-44) (46) (49)(50).…”

“…Other comparators were used in two studies: standard information read out by researcher (48) and pre-and postintervention comparison in patient's preference (43). Two studies (44,50) did not include a comparator.…”

“…Five studies (40,41,47,48,50) measured patient´s comprehension and understanding of the information as their primary outcome.…”

Men living through multiple miscarriages: protocol for a qualitative exploration of experiences and support requirements

“…We will make every effort to secure written records of informed consent with wet signatures, but a flexible approach may be necessary in the absence of face-to-face interactions. [76][77][78][79] Table 2 describes our preparations to facilitate recruitment without undue loss of fidelity to ethical principles of voluntary participation, research integrity and transparency. 79 80 data collection in work package 1: individual interviews The study team will liaise with each prospective and consented participant by email, telephone, SMS and/ or post to arrange a mutually convenient opportunity for semistructured interview via telephone within our work package 1.…”