NCT02332837

Interactive Tool for Informed Consent

Interactive Tool for Informed Consent: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ThinkWell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

• Informed Consent

Interventions

Type	Name	Description
BEHAVIORAL	Intervention A: Questionnaire accuracy	Participants will be tested by questionnaire to measure how well consent is understood
BEHAVIORAL	Intervention B: Questionnaire speed of completion	Time to complete questionnaire from time of presentation
BEHAVIORAL	Intervention C: Questionnaire Completion rate	Number of participants who complete the questionnaire

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-11-01
• Completion: 2020-06-01
• First posted: 2015-01-07
• Last updated: 2021-03-23