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E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

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Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With

Michael T Buckley¹, Molly R O'Shea¹, Sangeeta Kundu¹

¹Memorial Sloan Kettering Cancer Center, New York, NY.

JCO Oncology Practice

|December 19, 2022

Summary

Electronic informed consent (eIC) did not increase technology burden and maintained comprehension, while improving participant agency and consent form completeness compared to paper. This supports wider adoption of eIC to enhance research processes.

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Area of Science:

Clinical research methodology
Digital health technologies
Informed consent process

Background:

Informed consent is crucial for clinical research and care.
Digital strategies may optimize consent processes.
Evaluating electronic informed consent (eIC) against traditional paper methods is essential.

Purpose of the Study:

To compare electronic informed consent (eIC) with paper consent.
To assess technology burden, protocol comprehension, participant agency, and document completeness.

Main Methods:

A 3-year study (2019-2021) at an academic cancer center.
Participant experience assessed via surveys (pre- and intra-pandemic).
Consent document completeness evaluated through electronic health records.

Main Results:

eIC was easy to use for 83% of participants; technology discomfort was not a barrier.
Comprehension scores were similar between eIC and paper consent groups.
eIC enhanced participant-reported positive feedback and eliminated completeness errors (0% vs. 6.4% for paper).

Conclusions:

eIC is a viable alternative to paper consent, offering comparable comprehension and agency.
eIC significantly improves the completeness of consent documentation.
Wider implementation of eIC is recommended to enhance participant experience and data integrity in clinical research.