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Electronic Informed Consenting Improves Data for Clinical Research

Clinical research participants completed 100 percent of electronic informed consenting fields, compared to 94 percent of data in paper-based consenting surveys.

Electronic informed consenting (eIC) for clinical research via EHR patient portals could help improve the completeness of required fields compared to paper-based consenting surveys, according to a study published in JCO Oncology Practice.

Researchers assessed participant experience with eIC compared with traditional paper-based consenting and compared the completeness of required fields over three years (2019-2021).

The study authors invited participants who consented to a clinical trial at a large academic cancer center via paper or eIC to either survey one (technology burden) or survey two (comprehension and agency).

Participants self-selected their method of consent to their primary protocol. For both surveys, researchers sent participants electronic surveys to their patient portal.

On survey one, 83 percent of respondents indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with eIC discomfort.

“Survey one showed that our implementation of eIC was well tolerated, did not present a technology burden, and offered satisfactory functionality for participants in the consenting process,” the study authors wrote. “This suggests that the eIC application is approachable and accessible to participants even in the setting of technology aversion.”

For survey two, eIC and paper consenters had similar comprehension scores. However, eIC generated a higher proportion of positive free-text comments, with themes such as thoroughness of the discussion and consenter professionalism.

eIC use yielded no completeness errors across 235 consents versus 6.4 percent for paper. Survey cohorts were similar across race and ethnicity.

“Scores suggest a high degree of participant satisfaction and maintenance of a positive consent experience overall, regardless of consent medium or protocol,” the researchers noted. “Scores suggest that even in cases when one or more agency-associated criteria were not met (eg, participant was not offered the choice of consent method), participants did not feel their overall experience was undermined.”

The researchers said areas for improvement include giving participants enough time to make their decision, adequate information regarding complex or detailed study elements, and consent medium choice.

A potential study limitation was that participants’ responses might have been influenced by recall bias since the researchers did not impose a time limit for survey completion.

“Survey burden was likely a driver for our observed response rates, with higher survey burden resulting in more dropouts and/or nonresponse,” the researchers said. “Survey one had lower survey burden with five opinion questions (27 percent response), whereas survey two had higher survey burden with a 10-question comprehension and agency assessment (19 percent response).”

“Other limitations are that this study was conducted at a single center, and only two protocols were chosen to assess consent comprehension and agency,” they added. “Further investigation into participant self-advocacy, knowledge as a currency of power, and the locus of decision making as elements of the consent discussion is warranted.”

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