Informed consent can be burdensome and confusing for eligible participants.
The informed consent process is a critical, but sometimes cumbersome, part of enrolling in a research study. Consent forms often contain a lot of text that can be difficult to read. As a result, important study information can be easily missed, and eligible participants can lose trust in the informed consent process.
Worst Case Scenario: A Burdensome Informed Consent Process
Having a straightforward informed consent process can increase understanding.
An engaging and easy-to-navigate consent process can help eligible participants make an informed decision about their study participation. Providing this information in a transparent, easy-to-digest way also demonstrates that the research team respects the eligible participant’s trust and privacy, regardless of their decision to participate in the study.
Best Practice: A Web Browser- and Mobile App- Friendly Informed Consent Process
What to prepare?
Determine what information to include in your informed consent procedures.
Depending on the nature of the study, devices used, and data to be collected, you may need to include various types of information in the informed consent process. Be sure to follow guidelines from the relevant federal regulations and ethical review boards to determine what information you must provide to eligible participants.
Decide how eligible participants should review the informed consent materials.
Do you prefer eligible participants review all information in order or out of order? The browser and mobile format of the informed consent process will depend on this decision. Ensure there is a logical flow to the process and that all content is written at a middle school reading level.
Provide eligible participants with engaging visuals and resources.
The Elements of Informed Consent
Project Baseline Eligibility
All of Us Consent Process
National Institutes of Health
Use of Electronic Informed Consent
Food and Drug Administration
Design Issues in E-Consent
Informed Consent Patterns