Interactive Tool for Informed Consent

Overview

Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety and understanding. This trial will compare understanding of traditional digital consent with multi-media consent and with consent that is multi-media and interactive and uses a test and train model. The computer will assign participants to 1 of 3 methods to present online consent to participants

Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety. Without accurate knowledge decision-making is not informed. Informed consent for participation in research is part of this process. In online trials the opportunity for face-to-face signed consent with researchers is not an option. Consent acts as a safeguard that full disclosure occurred. Adequate documentation is evidence against false reports of coercion. Informed consent inclusive of signed participant information sheets provide a record between researcher and participant of the roles and agreements they share. According to existing research, only 6% of consents and participant information sheets are written below an eighth grade level of comprehension; 54% of participants with an 8th grade level education partially understood the consent with figures rising to 72% for participants with greater than 8th grade educations, however no participant fully understood the consent materials. The deficits ranged from misunderstandings about risk, side effects, adverse effects reporting, a participants right to withdraw, confidentiality and even the purpose of the trial. This trial will compare understanding of traditional digital consent with multi-media consent and with consent that is multi-media and interactive and uses a test and train model. The computer will assign participants to 1 of 3 methods to present online consent to participants

Conditions

Interventions

Eligibility

Outcomes