A participant is deemed eligible, typically (but not always) the next task is Main Informed Consent. A potential participant is not counted as a participant in a study until they have accepted the Main Informed consent. All study templates on ProofPilot (including those that are blank), include a placeholder for this task.
Research protocol designers may also add additional consent tasks at other points of the study.
Like every task on ProofPilot, the informed consent is introduced to participants with a task introduction. Like all other tasks, research designers are encouraged to replace default ProofPilot imagery, task titles, and instructions to be culturally relevant to the participants involved.
Every consent page has several components.
- A page title: Meant to convey a key point that will be covered in the page.
- Page content summary: The key takeaways that participants should be aware of.
- Learn more: an option for the potential participant to access additional detailed information by expanding the page.
- Expanded material or detail: The detailed material expanded.
The consent designer may elect to replace the page content summary with an image for more participant engagement when it is appropriate. In this case, the page title should convey one important point, with “learn more” providing optional detail.
our consent task may include one or more consent pages. The last page will include functionality for the participant to confirm they understand the consent material via “I Accept” or “I Accept” with an electronic signature.
Ascent: The participant clicks “I Accept” on the last page of the consent task.
Signature-Based Consent: The participant “signs” with their password, and then clicks I accept.
Users may exit the consent process at any time. They may also decline consent. However, we find that few potential participants bother to press exit or decline. They just leave the ProofPilot experience.
Ability to access the consent information after the participant is in the study. The welcome e-mail discussed earlier has a link to the informed consent. The Study Intro page (available from the SMS welcome notification) also has a link to informed consent.
ProofPilot does not send a separate link to the informed consent.
- This reduces over communication with the participant the early stage of the project.
- We also keep the information HTML, as we’ve found the standard PDF file often provided in other online environments is not always openable on some mobile devices,
- many PDF document based informed consents don’t format to the user’s screen, making them very difficult to read.
After the user accepts informed consent, they are officially part of the study, and study tasks fire as appropriate.