Interactive Tool for Informed Consent

Not Applicable

Withdrawn

• Conditions: Informed Consent

• Registration Number: NCT02332837
• Lead Sponsor: ThinkWell

Brief 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

Study Timeline

• Study First Submitted: 2015-01-04
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Study Start: 2019-07
• Primary Completion: 2019-11
• Study Completion: 2020-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• pre-screened as eligible for a ThinkWell PLOT trial
• 18 years of age
• No personal email address

Exclusion Criteria

• not pre-screened or eligible for an existing ThinkWell PLOT trial
• people without internet access
• People who cannot read
• People without the ability to understand the website and informed consent documents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
level of consent comprehension	immediately following intervention	assessed by accuracy on scored questionnaire

Secondary Outcome Measures

Name	Time	Method
Compliance	immediately following intervention	number of participants who complete consent questionnaire
Time to complete consent	immediately following intervention	Time between presentation of consent materials and signing of consent