Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions.

Area of Science:

• Clinical Research
• Public Health
• Implementation Science

Background:

• The COVID-19 pandemic imposed significant restrictions on research activities.
• Adapting to these restrictions was crucial for continuing essential studies.

Purpose of the Study:

• To describe the development and implementation of electronic informed consent and assent procedures.
• To identify challenges and lessons learned from using these procedures in a multisite pediatric trauma trial.

Main Methods:

• Developed and tested three electronic informed consent options.
• Trained research staff on new consent procedures.
• Implemented procedures in 10 pediatric trauma centers.

Main Results:

• Enrolled 25 participants in an effectiveness-implementation trial.
• Utilized hybrid or electronic consent for 11 participants.
• Identified challenges including participant confusion and family re-engagement.

Conclusions:

• Electronic consent procedures can be adapted for multisite research during public health crises.
• Addressing challenges is key to strengthening and increasing the utilization of electronic consent.
• Further research is needed to optimize electronic informed consent and assent processes.