Patients are more likely to complete electronic informed consent forms than paper informed consent forms, according to research published in JCO Oncology Practice.
Researchers found that protocol comprehension and the ability to self-advocate were similar whether patients completed electronic or paper informed consent forms. However, patients using electronic forms were more likely to complete all mandatory consent fields.
For this study, researchers compared electronic and paper-based informed consent using 2 surveys of clinical research participants conducted over 3 years. The first survey of 777 participants was designed to evaluate technology burden. The second survey of 455 participants was designed to evaluate comprehension and agency.
In survey 1, 83% of respondents said electronic informed consent was easy or very easy to use, and 95% said they would recommend electronic informed consent to another research participant.
When participants were asked what they like most about electronic informed consent, 3 themes emerged:
- Respondents said it was easy to use and convenient
- They valued having the electronic version of the final consent available for their reference
- They said the video helped with their overall comprehension of the clinical trial.
In survey 2, responses to statements about agency were similar between the electronic and paper groups. These questions included whether the respondent chose to participate in the study, if they felt respected during the consent process, if they were able to ask questions, whether their questions were answered and they felt understood, whether they had sufficient time to read the consent form, and whether they were able to pick the consent method.
Free-text responses to agency statements were more frequent with paper than with electronic informed consent — 87% and 62%, respectively. For electronic informed consent, 44% of free-text responses were positive and 15% were negative. For paper consent, 32% of free-text responses were positive and 24% were negative.
Examples of negative comments about electronic informed consent included discomfort with electronic signature using a finger and that elderly individuals may have difficulty with electronic informed consent.
For electronic informed consent forms, all fields were completed. There were 0 deficiencies in 235 electronic forms.
With paper informed consent, there were 15 deficiencies in 235 forms (6.4%). These deficiencies included missing pages, missing dates, and missing information from required fields.
“The results support a broader call for organizations to offer eIC [electronic informed consent] for clinical research discussions to enhance the overall participation experience and increase the completeness of the consent process,” the researchers concluded.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Buckley MT, O’Shea MR, Kundu S, et al. Digitalizing the clinical research informed consent process: Assessing the participant experience in comparison with traditional paper-based methods. JCO Oncol Pract. Published online December 19, 2022. doi:10.1200/OP.22.00425.