In December 2016, the Food and Drug Administration and the Department of Health and Human Services released joint guidance about the use of electronic informed consent. This guidance applies to the use of electronic systems and processes for providing information to potential subjects and documenting their agreement to participate in a research study.

The electronic consent process must do the following:

• Protect the rights, safety and welfare of human subjects
• Facilitate subject comprehension of the information presented about the study
• Result in appropriate documentation of consent
• Ensure the quality and integrity of the electronic informed consent data, including site-specific versions of the consent document, all required elements of consent, a valid electronic signature by the subject or their Legally Authorized Representative (LAR) and the date of the signature

Come and learn about the guidelines for using an electronic informed consent process for a UI research study.

Pre-registration is recommended.

Individuals with disabilities are encouraged to attend all University of Iowa- sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact the Human Subjects Office in advance at (319) 335-6564.