Completing your Initial Informed Consent

Default Initial Informed Consent

All studies need to communicate the risks and benefits associated with participation. Therefore, ProofPilot, automatically includes the Initial informed consent study task. Individuals who pass the eligibility check will be presented with a study task to review the risks and benefits of participating in the study. They then either agree or disagree to be part of your study. An individual is not part of your study until they’ve agreed to the initial informed consent.

Studies without an Initial Informed Consent will not be approved to launch on ProofPilot. We want to make sure that everyone understands the risks and benefits of participating in studies. And an informed consent is an opportunity, for you, the researcher, to communicate your respect for participants.

You may add additional consent tasks throughout your study by creating an Informed Consent Study task. It is available as an Intervention study template.

Adding Content to the Initial Informed Consent

First, find the Initial informed consent on your study flow page. It will be in your “Recruitment and Join” process arm.

Click on the Initial Informed consent task, and then click “Define” You will be presented with the Your consent page.

The first thing you will want to do is set your confirmation method:

  • Button Based Consent gives the user a button that says “I Accept.” Once they click that button, ProofPilot register that the user has consented, and is part of the study.
  • Electronic signature based consent requires the user also put in their password. This is an extra level of assurance and is used in studies where the risks are more significant.

Creating Your First Consent Page

If you’ve worked with informed consent before, you will know it’s often a long document that’s not particularly easy to read, nor all that interesting to look at.

The consent process is one of the first interaction points you have with your participants. You are also communicating some important information. So, ProofPilot makes it easier to present engaging consent information in an easy to digest format. Instead of one long page with lots of text, ProofPilot divides the consent into muliple pages that people can swipe through.

ProofPilot automatically creates the first consent page for you. We’ve named it “What You Need to Know.”  You can change the title if you would like.

Primary Presentation vs Full Description

Each page gives you an opportunity to convey an important point or two about a participants involvement in your study. Some users will only want topline information. Others may want to learn more.

Therefore, ProofPilot presents consent information on each page in a two step format.

First the user is presented with primary summary information. This provides the most important information in as simple a format as possible.

You put this summary information in “Primary Presentation.” It may be in the form of text or photo/image/illustration.

Some users may wish to review more information about the particular topic. They may click “Learn More.” The information you present in “Full Description” provides more detail, but may not be necessary for all potential participants.

Saving Changes and Editing Consent Pages

Press “Save Changes” to save the page. It will appear in the order it will be presented to participants in the “What you need to know” section.

Adding a New Consent Category (otherwise known as Page)

To add a new page to your consent process. Click “Add new category.” Give your page a heading or “Name” (by default it will just provide a page nuber”

Include your primary presentation and full description information. Then save your changes by clicking “Save changes.”

Editing, Reordering and Deleting Consent Categories (or Pages)

You can edit consent categories (otherwise known as pages), by clicking on the pencil. You can delete them by clicking on the X. If you would like to reorder the pages, you can drage them and drop them into place.

Using a photo for primary presentation in a consent category (otherwise known as a page).

By default, ProofPilot assumes you would like to present text based information in the consent category primary presentation. However, visual information can quickly convey important information. Therefore we provide the possibility to instead presenta  photo, image or other graphic.

To do so, simply press on “Photo Presentation.”

Click on “Add Image” and you will navigate to an image saved on your computer.

We do not recommend editing your study on an tablet or phone based device. But if you do, you can access your camera photos with this functionality.

Once you slect your photo, it will be loaded and will replace the text field. You may remove the photo and replace it with another. You may also change to text presentation to remove the phone.

If the potential participant wants additional information beyond the image. They will click “Learn More.” The information you provide in “Full Description” will be the material presented to that user.