Informed Consent
Conditions
Keywords
informed consent, public led trials, shared decision making,
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
Interventions
BEHAVIORALIntervention A: Questionnaire accuracy
Participants will be tested by questionnaire to measure how well consent is understood
BEHAVIORALIntervention B: Questionnaire speed of completion
Time to complete questionnaire from time of presentation
BEHAVIORALIntervention C: Questionnaire Completion rate
Number of participants who complete the questionnaire
Sponsors
ThinkWell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| level of consent comprehension | immediately following intervention | assessed by accuracy on scored questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete consent | immediately following intervention | Time between presentation of consent materials and signing of consent |
| Compliance | immediately following intervention | number of participants who complete consent questionnaire |
Outcome results
None listed