Question

Dr. Apple wants to study a drug to manage diabetes in adolescents. The researcher plans to use an electronic informed consent (eIC) form presented on a tablet device. Per FDA guidance on the “Use of Electronic Consent in Clinical Investigations” (2016), can adolescent subjects assent using an electronic device?

Answer 1

Answer: Yes, the eIC could be used for assent.

Explanation:

Electronic informed consent (eIC) may be used for seeking, confirming and documenting informed consent.

Answer 2

Answer:

• TRUE, the eIC process can be used for assent.

Explanation:

The eIC process can be used to obtain the consent of pediatric subjects and parental permission.

Technological advances led to new forms of data collection in clinical research. This type of process seeks to provide adequate information about the research to the subjects who participate in it in order to allow this information to allow them to make a voluntary decision about their inclusion in the study.